Gastrocrom Concentrate

Pronunciation: KROE-moe-lin
Generic Name: Cromolyn
Brand Name: Gastrocrom

Gastrocrom Concentrate is used for:

Treating mastocytosis, including improvement of symptoms such as diarrhea, flushing, headaches, vomiting, hives, stomach pain, nausea, and itching in some patients. It may also be used for other conditions as determined by your doctor.

Gastrocrom Concentrate is a mast cell stabilizer. It works by preventing the mast cells of the body from releasing substances that cause symptoms of mastocytosis.

Do NOT use Gastrocrom Concentrate if:

• you are allergic to any ingredient in Gastrocrom Concentrate

Contact your doctor or health care provider right away if any of these apply to you.

Before using Gastrocrom Concentrate:

Some medical conditions may interact with Gastrocrom Concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have liver or kidney problems

Some MEDICINES MAY INTERACT with Gastrocrom Concentrate. However, no specific interactions with Gastrocrom Concentrate are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gastrocrom Concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gastrocrom Concentrate:

Use Gastrocrom Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gastrocrom Concentrate comes with an additional patient leaflet. Read it carefully and reread it each time you get Gastrocrom Concentrate refilled.


• Take Gastrocrom Concentrate 30 minutes before meals and at bedtime unless directed otherwise by your doctor.


• To use Gastrocrom Concentrate, break open the number of ampules prescribed by your doctor and squeeze the medicine into a glass of water. Stir and then drink all of the liquid.


• Do not use Gastrocrom Concentrate if it contains particles, is cloudy, or becomes discolored.


• Continue to use Gastrocrom Concentrate even if you feel well.


• Gastrocrom Concentrate works best if it is used at regular intervals throughout the day as directed. Do not miss any doses. If you miss a dose of Gastrocrom Concentrate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Gastrocrom Concentrate.

Important safety information:

• Caution is advised when using Gastrocrom Concentrate in CHILDREN younger than 2 years of age because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Gastrocrom Concentrate during pregnancy. It is unknown if Gastrocrom Concentrate is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the benefits and risks to your baby.

Possible side effects of Gastrocrom Concentrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; hoarseness; mental or mood changes; seizures.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Gastrocrom side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Gastrocrom Concentrate:

Store Gastrocrom Concentrate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Store ampules in pouch until ready to use. Keep Gastrocrom Concentrate out of the reach of children and away from pets.

General information:

• If you have any questions about Gastrocrom Concentrate, please talk with your doctor, pharmacist, or other health care provider.


• Gastrocrom Concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Gastrocrom Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Gastrocrom resources

• Gastrocrom Side Effects (in more detail)
• Gastrocrom Use in Pregnancy & Breastfeeding
• Gastrocrom Drug Interactions
• Gastrocrom Support Group
• 0 Reviews for Gastrocrom - Add your own review/rating

Compare Gastrocrom with other medications

• Inflammatory Bowel Disease
• Systemic Mastocytosis

Penicillin-V-Wolff

Penicillin-V-Wolff may be available in the countries listed below.

Ingredient matches for Penicillin-V-Wolff

Phenoxymethylpenicillin

Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Penicillin-V-Wolff in the following countries:

• Germany

International Drug Name Search

Garamycin Eye Ointment

gentamicin sulfate

Dosage Form: ophthalmic ointment
Garamycin brand of Gentamicin Sulfate Ophthalmic Ointment, USP Sterile Rx Only

DESCRIPTION:

Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group.

Gentamicin Sulfate Ophthalmic Ointment USP is a sterile ointment for topical ophthalmic use.  Each gram contains gentamicin sulfate (equivalent to 3 mg gentamicin) in a base of white petrolatum and mineral oil.

Gentamicin is obtained from cultures of Micromonospora purpurea.  Gentamicin sulfate is a mixture of the sulfate salts of gentamicin C1, C2 and C1A.  All three components appear to have similar antimicrobial activities.  Gentamicin sulfate occurs as a white powder and is soluble in water and insoluble in alcohol.  The structural formula is as follows:

CLINICAL PHARMACOLOGY:

Microbiology:  Gentamicin sulfate is active in vitro against many strains of the following microorganisms:

    Staphylococcus aureus, Staphylococcus epidermidis,

    Streptococcus pyogenes, Streptococcus pneumoniae,

    Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae,

    Klebsiella pneumoniae, Neisseria gonorrhoeae,

    Pseudomonas aeruginosa, and Serratia marcescens.

INDICATIONS AND USAGE:

GARAMYCIN Ophthalmic Ointment is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms:

    Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

CONTRAINDICATIONS:

GARAMYCIN Ophthalmic Ointment is contraindicated in patients with known hypersensitivity to any of the components.

WARNINGS:

NOT FOR INJECTION INTO THE EYE.  Gentamicin Sulfate Ophthalmic Ointment is not for injection.  It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

Precautions

General:

Prolonged use of topical antibiotics may give rise to overgrowth of non-susceptible organisms including fungi.  Bacterial resistance to gentamicin may also develop.  If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation, and appropriate therapy should be instituted.

Ophthalmic ointments may retard corneal healing.

Information For Patients:

To avoid contamination, do not touch tip of container to the eye, eyelid, or any surface.

Carcinogenesis, Mutagenesis and Impairment of Fertility:

There are no published carcinogenicity or impairment of fertility studies on gentamicin.  Aminoglycoside antibiotics have been found to be non-mutagenic.

Pregnancy:

Teratogenic effects - Pregnancy Category C.  Gentamicin has been shown to depress body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose.  There are no adequate and well-controlled studies in pregnant women.  Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use:

Safety and effectiveness in neonates have not been established.

ADVERSE REACTIONS:

Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.

The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.

Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura, and hallucinations.

To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604, Monday - Friday 9am-5pm EST, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION:

Apply a small amount (about 1/2 inch) to the affected eye(s) two to three times a day.

HOW SUPPLIED:

GARAMYCIN Ophthalmic Ointment (equivalent to 3 mg gentamicin) is supplied as follows:

NDC 48102-009-35                  3.5 gram tubes

Store at 25oC (77oF); excursions permitted to 15-30oC (59-86oF)

[see USP Controlled Room Temperature].

GARAMYCIN is a Trademark of Fera Pharmaceuticals, LLC.

Mfd. for:

Fera Pharmaceuticals, LLC

Locust Valley, NY  11560

PRINCIPAL DISPLAY PANEL - CARTON

NDC 48102-009-35

STERILE      Rx only

GaramycinTM

brand of

GENTAMICIN

SULFATE

OPHTHALMIC

OINTMENT, USP

Gentamicin Sulfate,

USP equivalent to 3 mg

gentamicin per gram.



Net Wt. 3.5g (1/8 Oz)

PRINCIPAL DISPLAY PANEL - TUBE

NDC 48102-009-35

STERILE      Rx only

GaramycinTM

brand of

GENTAMICIN

SULFATE

OPHTHALMIC

OINTMENT, USP

Gentamicin Sulfate,

USP equivalent to 3 mg

gentamicin per gram.

Each gram contains:

Gentamicin sulfate,

USP equivalent to 3 mg

gentamicin base, in a

base of white petrolatum

and mineral oil.

Net Wt. 3.5 g (1/8 Oz)

GARAMYCIN  gentamicin sulfate  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 48102-009 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GENTAMICIN SULFATE (GENTAMICIN) GENTAMICIN SULFATE 3 mg  in 1 g

Inactive Ingredients Ingredient Name Strength MINERAL OIL   PETROLATUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 48102-009-35 1 TUBE In 1 CARTON contains a TUBE 1 3.5 g In 1 TUBE This package is contained within the CARTON (48102-009-35)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065024	10/08/2010

Labeler - Fera Pharmaceuticals, LLC (831023713)

Registrant - Fera Pharmaceuticals, LLC (831023713)

Revised: 09/2010Fera Pharmaceuticals, LLC

More Garamycin Eye Ointment resources

• Garamycin Eye Ointment Side Effects (in more detail)
• Garamycin Eye Ointment Dosage
• Garamycin Eye Ointment Use in Pregnancy & Breastfeeding
• Garamycin Eye Ointment Support Group
• 0 Reviews for Garamycin Eye - Add your own review/rating

Compare Garamycin Eye Ointment with other medications

• Conjunctivitis, Bacterial

ganirelix Subcutaneous

ga-ni-REL-ix

Commonly used brand name(s)

In the U.S.

• Antagon

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Antagonist

Uses For ganirelix

Ganirelixis used as a fertility medicine to prevent premature luteinizing hormone (LH) surges in women undergoing the fertility procedure of controlled ovarian hyperstimulation. LH is involved in ovulation, which is the development of eggs in the ovaries. Ganirelix may help reduce the need for follicle-stimulating hormone (FSH) , which is also involved in ovulation.

Ganirelix is available only with your doctor's prescription.

Before Using ganirelix

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ganirelix, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ganirelix or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of ganirelix. Make sure you tell your doctor if you have any other medical problems.

Proper Use of ganirelix

To make using ganirelix as safe and reliable as possible, you should understand how and when to use ganirelix and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of ganirelix. Read this paper carefully and ask your health care professional for any additional information or explanation.

Sometimes ganirelix can be given by injection at home. If you are using ganirelix at home:

• Understand and use the proper method of safely preparing the medicine if you are going to prepare your own medicine.


• Wash your hands with soap and water and use a clean work area to prepare your injection.


• Make sure you clearly understand and carefully follow your doctor's instructions on how to give yourself an injection, including using the proper needle and syringe.


• Do not inject more or less of the medicine than your doctor ordered.


• Remember to move the site of injection to different areas to prevent skin problems from developing.


• Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.


• Tell your doctor when you use your last dose of ganirelix. Your doctor will give you another medicine called human chorionic gonadotrophin (hCG) or arrange for you to get ganirelix at the right time.

Dosing

The dose of ganirelix will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ganirelix. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For treatment of female infertility:
    
    • Adults—After receiving FSH treatment on Day 2 or 3 of your menstrual cycle, 250 micrograms (mcg) of ganirelix is injected under the skin once a day during the early to midfollicular phase (about Day 7 or Day 8 of your menstrual cycle).
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using ganirelix

It is very important that your doctor check your progress often at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will probably want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood stream.

If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you do this every day. Using a BBT record or some other method, your doctor will help you decide when you are most fertile and when ovulation occurs. It is important that sexual intercourse take place around the time when you are most fertile to give you the best chance of becoming pregnant. Follow your doctor's directions carefully.

If severe abdominal pain occurs with use of ganirelix, discontinue treatment and report the problem to your doctor immediately. Do not receive the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.

ganirelix Side Effects

Side Effects of ganirelix

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking ganirelix and get emergency help immediately if any of the following effects occur:

Less common

• Abdominal pain (severe)


• nausea and vomiting


• weight gain (rapid)

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Nausea


• vaginal bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Headache


• redness, pain or swelling at injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: ganirelix Subcutaneous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More ganirelix Subcutaneous resources

• Ganirelix Subcutaneous Side Effects (in more detail)
• Ganirelix Subcutaneous Use in Pregnancy & Breastfeeding
• Ganirelix Subcutaneous Drug Interactions
• Ganirelix Subcutaneous Support Group
• 0 Reviews for Ganirelix Subcutaneous - Add your own review/rating

Compare ganirelix Subcutaneous with other medications

• Gonadotropin Inhibition

Gainpro

Dosage Form: FOR ANIMAL USE ONLY
Gainpro 10

FRONT PANEL

Gainpro 10

For increased rate of weight gain and

improved feed efficiency in cattle fed in

confinement for slaughter. For increased rate

of weight gain in pasture cattle (slaughter,

stocker and feeder cattle, and dairy and beef

replacement heifers).


ACTIVE INGREDIENTS

Bambermycins 10 grams per pound (22

grams per kilogram)


INGREDIENTS

Roughage products and/or calcium carbonate,

dried bambermycins fermentation product,

mineral oil.


MIXING DIRECTIONS AND PERMITTED

CLAIMS ON REVERSE SIDE.

FOR USE IN MANUFACTURED FEEDS ONLY.

NOT FOR HUMAN USE

Restricted Drug (California)-

use only as directed


Net Weight—50 pounds (22.68 kg)


Distributed by:

HUVEPHARMA, INC.

Peachtree City, GA 30269

NADA # 141-034, Approved by FDA

MIXING DIRECTIONS AND PERMITTED CLAIMS

Type A

Medicated Article

PERMITTED CLAIMS AND LIMITATIONS

Species                 Drug                 Level                 Claim(s)                 Limitations

Cattle Fed in          Bambermycins 10 to 20               Increased rate        None

Confinement for                             mg/hd/day**        of weight gain,

Slaughter*                                                               improved feed

                                                                              efficiency

Pasture                Bambermycins   10 to 40              Increased rate        None

Cattle*                                           mg/hd/day***      of weight gain

*Only a single level of bambermycins (i.e. 2 grams bambermycins/ton) can be

indicated on a feed tag. A different feed tag must be submitted for each level of

bambermycins needed for your complete feeding program.

CATTLE FED IN CONFINEMENT FOR SLAUGHTER:

**THE APPROVED DOSAGE IN CATTLE FED IN CONFINEMENT FOR SLAUGHTER IS 10

TO 20 MG OF BAMBERMYCINS/HD/DAY. The amount of bambermycins will range between

1 and 4 grams per ton of feed depending upon the daily feed consumption of the cattle fed in

confinement for slaughter. The amount of Type A Medicated Article added to the complete

ration (Type C Medicated Feed) must be based on daily feed consumption, the number of

animals in the pen and the level (10-20 mg/hd/day) of bambermycins being fed. From this

information the grams of bambermycins per ton of feed can be calculated in order to fulfill

feed assay requirements. No Type C Medicated Feed should be manufactured with less than

1 g bambermycins/ton. Feed assays for bambermycins with expected levels below 1 g/t may

not be accurate. See the following table for conversions from mg/hd/day to g/t.

EXAMPLE OF CONVERTING THE BAMBERMYCINS CATTLE DOSAGE FROM

                        MG/HEAD/DAY TO GRAMS/TON*



                                                                                                Mg

                   Average Feed            Grams                Bambermycinx

Cattle         Consumption/         Bambermycins/         Fed Daily to

Weight         Head/Day             Ton of Feed               each Animal

Lbs.     Kg         Lbs.1                Low         High         Low             High

400     181.4     10.0                 2.00         4.00         10.0             20.0

500     226.8     14.0                 1.50         2.80         10.5             19.6

600     272.2     17.0                 1.25         2.30         10.6             19.6

700     317.5     20.0                 1.00         2.00         10.0             20.0

800     362.9     22.0                 1.00         1.80         11.0             19.8

900     408.2     23.0                 1.00         1.70         11.5             19.6

1000   453.6     24.0                 1.00         1.60         12.0             19.2

1100   499.0     25.0                 1.00         1.60         12.5             20.0

1200   544.3     26.0                 1.00         1.50         13.0             19.5

1300   589.7     27.0                 1.00         1.40         13.5             18.9

*Dosage range is 10 to 20 mg/head/day             1Assumes as fed ad libitum

consumption and average daily gain

of 2.0 to 3.0 lbs./day


Example Calculation—Amount of Gainpro®-10 premix added to feed for a pen of cattle.

Given: Average Weight—800 lbs.; Number in pen—100 hd.; Dosage—20 mg/hd/day; Daily

Feed Consumption—22 lbs./day.

• 100 hd x 20 mg = 2,000 mg or 2 grams bambermycins.

• Gainpro®-10 contains 10 grams bambermycins/lb., therefore add 0.2 pound of

Gainpro®-10 premix to the daily feed for this pen of 100 animals.

• 22 lbs./day x 100 hd = 2,200 lbs. total feed consumption.

• 2 grams bambermycins ÷ 2,200 lbs. = .000909 g/lb.

• .000909 x 2,000 lbs. = 1.82 g bambermycins/ton of feed.



MIXING DIRECTIONS:

It is recommended that Gainpro®-10 be diluted with a suitable grain carrier before addition

to the final feed. A dilution of 1 part of Gainpro®-10 and 9 parts grain carrier is the

suggested working premix. The table below shows premix and working premix addition levels

for various commonly used feeds.


                                                                    Pounds Premix To Be Added Per Ton

Feed             Bambermycins Level         Gainpro®-1   1-9 Working Premix

Cattle Fed in         1 gram/ton                                0.1                                1

Confinement         2 grams/ton                              0.2                                 2

for Slaughter         3 grams/ton                              0.3                                 3

                            4 grams/ton                              0.4                                 4

     


Thoroughly mix both working premix and finished feed to ensure complete and uniform

distribution of the Gainpro®-10.


FEEDING DIRECTIONS:

Feeds containing Gainpro®-10 should be fed continuously in a complete feed. Complete

feed for cattle fed in confinement for slaughter must be fed continuously at a rate of 10-20 mg

bambermycins/hd/day from Type C Medicated Feed containing 1-4 g bambermycins/ton.



TYPE B LIQUID FEEDS INTENDED FOR ADDITION TO DRY FEEDS FOR

CONFINEMENT CATTLE

•Type B Liquid Feeds should be in a pH range of 3.8 to 7.5 and should have a moisture

content between 30 and 45%.

•Type B Liquid Feeds must be mixed into the dry feed within 8 weeks of manufacture.

•Type B Liquid Feeds can be manufactured containing 40.0 to 800.0 g of bambermycins/ton.

Mixing directions into dry feed are as follows:


Before feeding, the Type B Medicated Liquid feed must be thoroughly mixed with other feed

materials to make a complete feed (Type C Medicated Feed). Examples of addition rates to

complete feeds are shown in the following table.


                                                    Addition Rate of Type B     Bambermycins (g/ton) in

Bambermycins (g/ton) in         Liquid Feed (pounds/ton) to     Final Complete Feed

Type B Liquid Feed                     Complete Feed                     (Type C Medicated Feed)

40.0                                                         50.0                                          1.0

40.0                                                         200.0                                         4.0


100.0                                                        20.0                                          1.0

100.0                                                        80.0                                           4.0


400.0                                                         5.0                                           1.0

400.0                                                       20.0                                           4.0


800.0                                                         2.5                                           1.0

800.0                                                       10.0                                           4.0

The complete dry feed (Type C Medicated Feed) may only be fed to cattle in confinement for

slaughter and must be fed within one week after mixing.


PASTURE CATTLE:

***THE APPROVED DOSAGE IN PASTURE CATTLE IS 10 TO 40 MG OF BAMBERMYCINS/

HD/DAY. Daily intakes of bambermycins in excess of 20 mg/head/day have not

been shown to be more effective than 20mg/head/day. Blend 0.8 pound of Gainpro®-10

with 1999.2 pounds of suitable grain carrier. This supplemental feed will contain 4 mg bambermycins

per pound (8 g/ton). This supplemental feed can be fed at a rate of 2.5 to 10

pounds per head per day to achieve a daily intake of 10 to 40 mg bambermycins/head/day.

See the following table for additional examples of conversion from mg/hd/day to g/t.


MIXING DIRECTIONS:

It is recommended that Gainpro®-10 be diluted with a suitable grain carrier to provide a

supplemental feed. The table below shows examples of premix addition levels.


                                                                Pounds

                                                            Gainpro®-10

Feed         Bambermycins Level    To Be Added Per Ton        Feeding Rate

Pasture             2 grams/ton                         0.2                         10.0 lb./hd/day

Cattle                4 grams/ton                         0.4                         5.0-10.0 lb./hd/day

                        8 grams/ton                         0.8                         2.5-10.0 lb./hd/day

                       20 grams/ton                        2.0                         1.0-4.0 lb./hd/day

                       40 grams/ton                        4.0                         1.0-2.0 lb./hd/day

                       80 grams/ton                        8.0                         1.0 lb./hd/day


Thoroughly mix both working premix and supplemental feed to ensure complete and uniform

distribution of the Gainpro®-10.


FEEDING DIRECTIONS:

Feed for Pasture Cattle must be fed continuously at a rate of 10-40 mg bambermycins/hd/day

in at least one pound and not more than 10 pounds of Type C Medicated Feed containing 2-

40 g bambermycins/ton. Daily intakes of bambermycins in excess of 20 mg/head/day have

not been shown to be more effective than 20 mg/head/day.


FREE-CHOICE (SELF-FED) SUPPLEMENT:

Free-choice supplements must be formulated to provide not less than 10 mg nor more than

40 mg bambermycins per head per day. An FDA approved formula must be used to manufacture

free-choice medicated feeds containing bambermycins. Feed mills that use a proprietary formula

are required to be licensed.

Bag Label Image

Bag Label Image

Gainpro  10 bambermycins  powder

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 23243-2070 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BAMBERMYCINS (BAMBERMYCINS) BAMBERMYCINS 22 g  in 1 kg

Inactive Ingredients Ingredient Name Strength MINERAL OIL

Product Characteristics Color brown ((Off White to Tan)) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 23243-2070-5 22.68 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141034	06/29/2009

Labeler - Huvepharma, Inc. (619153559)

Registrant - Huvepharma AD (552691651)

Establishment
Name	Address	ID/FEI	Operations
Huvepharma, Inc.		619153559	manufacture, analysis, label, pack

Revised: 03/2010Huvepharma, Inc.

gadopentetate dimeglumine

Generic Name: gadopentetate dimeglumine (gad oh PEN te tate dye MEG loo meen)

Brand names: Magnevist, Multihance(obsolete)

What is gadopentetate dimeglumine?

Gadopentetate dimeglumine is a contrast agent that produces magnetic effects. It is used in combination with magnetic resonance imaging (MRI) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRI.

Gadopentetate dimeglumine is used to help diagnose certain disorders of the heart, brain, blood vessels, and spinal tissues.

Gadopentetate dimeglumine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about gadopentetate dimeglumine?

Gadopentetate dimeglumine can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:

• 
  

  burning, itching, swelling, scaling, and tightening or hardening of your skin;

  
  


• 
  

  muscle weakness;

  
  


• 
  

  joint stiffness in your arms, hands, legs, or feet;

  
  


• 
  

  deep bone pain in your ribs or your hips;

  
  


• 
  

  trouble moving; or

  
  


• 
  

  skin redness or discoloration.

  
  

Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadopentetate dimeglumine. Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.

What should I discuss with my health care provider before receiving gadopentetate dimeglumine?

Gadopentetate dimeglumine can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:

• 
  

  burning, itching, swelling, scaling, and tightening or hardening of your skin;

  
  


• 
  

  muscle weakness;

  
  


• 
  

  joint stiffness in your arms, hands, legs, or feet;

  
  


• 
  

  deep bone pain in your ribs or your hips;

  
  


• 
  

  trouble moving; or

  
  


• 
  

  skin redness or discoloration.

  
  

Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadopentetate dimeglumine.

To make sure you can safely receive this medication, tell your doctor if you have any of these other conditions:

• 
  

  diabetes;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  liver disease (or liver transplant);

  
  


• 
  

  asthma, hay fever, or a history of food or drug allergies;

  
  


• 
  

  if you are over 60 years old;

  
  


• 
  

  if you have ever had any type of reaction to a contrast agent; or

  
  


• 
  

  if you have recently had an injury, surgery, or severe infection.

  
  

FDA pregnancy category C. It is not known whether gadopentetate dimeglumine will harm an unborn baby. Before you receive this medication, tell your doctor if you are pregnant. Gadopentetate dimeglumine can pass into breast milk and may harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is gadopentetate dimeglumine used?

Gadopentetate dimeglumine is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting during your MRI.

Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.

What happens if I miss a dose?

Since gadopentetate dimeglumine is used only during your MRI, you will not be on a dosing schedule.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving gadopentetate dimeglumine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Gadopentetate dimeglumine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst, loss of appetite;

  
  


• 
  

  swelling, weight gain, feeling short of breath; or

  
  


• 
  

  swelling, irritation, or skin changes where the injection was given.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  dizziness; or

  
  


• 
  

  nausea.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Gadopentetate dimeglumine Dosing Information

Usual Adult Dose for CNS Magnetic Resonance Imaging:

0.1 mmol/kg (0.2 mL/kg) as a rapid bolus intravenous injection, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 pounds has not been studied. To ensure complete injection of the medium, the injection should be followed by a saline flush of at least 5 mL.

Usual Adult Dose for Vascular Magnetic Resonance Imaging:

0.1 mmol/kg (0.2 mL/kg) as a rapid bolus intravenous injection, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 pounds has not been studied. To ensure complete injection of the medium, the injection should be followed by a saline flush of at least 5 mL.

Usual Pediatric Dose for CNS Magnetic Resonance Imaging:

2 years to 18 years of age: 0.1 mmol/kg (0.2 mL/kg) as a rapid bolus intravenous injection, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 pounds has not been studied. To ensure complete injection of the medium, the injection should be followed by a saline flush of at least 5 mL.

Usual Pediatric Dose for Vascular Magnetic Resonance Imaging:

2 years to 18 years of age: 0.1 mmol/kg (0.2 mL/kg) as a rapid bolus intravenous injection, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 pounds has not been studied. To ensure complete injection of the medium, the injection should be followed by a saline flush of at least 5 mL.

What other drugs will affect gadopentetate dimeglumine?

This medication can harm the kidneys in certain people, and this effect may be increased if you also use other medicines harmful to the kidneys. Before you receive gadopentetate dimeglumine, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

There may be other drugs that can affect gadopentetate dimeglumine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More gadopentetate dimeglumine resources

• Gadopentetate dimeglumine Side Effects (in more detail)
• Gadopentetate dimeglumine Dosage
• Gadopentetate dimeglumine Use in Pregnancy & Breastfeeding
• Gadopentetate dimeglumine Drug Interactions
• Gadopentetate dimeglumine Support Group
• 1 Review for Gadopentetate dimeglumine - Add your own review/rating

• Gadopentetate Dimeglumine MedFacts Consumer Leaflet (Wolters Kluwer)


• Magnevist Prescribing Information (FDA)


• Magnevist Advanced Consumer (Micromedex) - Includes Dosage Information


• Magnevist Consumer Overview

Compare gadopentetate dimeglumine with other medications

• CNS Magnetic Resonance Imaging
• Vascular Magnetic Resonance Imaging

Where can I get more information?

• Your doctor or pharmacist can provide more information about gadopentetate dimeglumine.

See also: gadopentetate dimeglumine side effects (in more detail)

Gentle Laxative

Generic Name: bisacodyl (bis AK oh dil)

Brand Names: Alophen, Bisac-Evac, Bisco-Lax, Carters Little Pills, Correctol, Doxidan Tablet, Dulcolax Laxative, Evac-U-Gen, Ex-lax Ultra, Feen-A-Mint, Fleet Bisacodyl, Gen Lax, Gentlax Tablet, Gentle Laxative, Laxative Gentle Suppositories, Magic Bullet, Modane, Veracolate

What is Gentle Laxative (bisacodyl)?

Bisacodyl is a laxative that stimulates bowel movements.

Bisacodyl is used to treat constipation or to empty the bowels before surgery, colonoscopy, x-rays, or other intestinal medical procedure.

Bisacodyl may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Gentle Laxative (bisacodyl)?

Do not use bisacodyl if you have stomach (abdominal) pain, nausea, or vomiting, unless directed by a doctor.

If you notice a sudden change in bowel habits that persists over a period of 2 weeks, consult your healthcare provider before using a laxative.

Bisacodyl products should not be used for longer than one week, unless otherwise directed by your healthcare provider.

Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a more serious condition. Stop using bisacodyl and contact your healthcare provider.

What should I discuss with my healthcare provider before using Gentle Laxative (bisacodyl)?

You should not use this medication if you are allergic to bisacodyl, or if you have:

• 
  

  severe stomach pain, nausea, or vomiting;

  
  


• 
  

  a perforated bowel;

  
  


• 
  

  a blockage in your intestines;

  
  


• 
  

  fructose or galactose intolerance;

  
  


• 
  

  an allergy to yellow food dye;

  
  


• 
  

  severe constipation or dehydration;

  
  


• 
  

  inflammatory bowel disease, toxic megacolon; or

  
  


• 
  

  a sudden change in bowel habits lasting 2 weeks or longer.

  
  

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use bisacodyl:

• 
  

  kidney disease;

  
  


• 
  

  trouble swallowing;

  
  


• 
  

  a history of bowel obstruction, diverticulitis, ulcerative colitis, or other intestinal disorder; or

  
  


• 
  

  if you are taking a diuretic ("water pill").

  
  

Do not use bisacodyl without telling your doctor if you are pregnant. Do not use bisacodyl without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child without the advice of a doctor.

When used to treat constipation, bisacodyl is only part of a complete program of treatment that may also include diet and exercise. Follow your doctor's instructions very closely.

How should I use Gentle Laxative (bisacodyl)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

For best results, take bisacodyl on an empty stomach, or at bedtime. Do not crush, chew, or break the enteric-coated tablet. Swallow it whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. Do not take a bisacodyl rectal (enema or suppository) by mouth. It is for use only in your rectum.

Try to use the rectal form of this medicine at a time when you can lie down afterward and hold the medicine in. Avoid using the bathroom during this time.

If you are using bisacodyl before surgery or a medical procedure, follow your doctor's instructions about the timing of your dose (the number of days or hours) before your procedure.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Lie on your side and gently insert the suppository pointed end first. For best results, hold in the suppository for a 15 to 20 minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after you have inserted the suppository.

Shake the rectal enema gently just before use. Remove the protective cap from the applicator tip. You may use the enema lying down or seated on a toilet. Gently insert the tip into your rectum and lightly squeeze the bottle to release the enema. Hold the enema in for a few minutes and then release into the toilet.

The rectal forms of bisacodyl should produce a bowel movement within 15 minutes to 1 hour.

The tablet form of bisacodyl should produce a bowel movement within 6 to 12 hours, or overnight when taken at bedtime.

Call your doctor if you do not have a bowel movement after using this medication. Do not use bisacodyl for more than 7 days in a row unless your doctor tells you to. Store bisacodyl at room temperature away from moisture and heat.

What happens if I miss a dose?

Since bisacodyl is used only once or as needed, you are not likely to be on a dosing schedule.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include watery diarrhea, stomach cramps, muscle weakness, or urinating less than usual.

What should I avoid while using Gentle Laxative (bisacodyl)?

Avoid using any other medications within 2 hours before or after using bisacodyl.

Avoid drinking milk within 1 hour after using bisacodyl.

Gentle Laxative (bisacodyl) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

  
  


• 
  

  swelling, weight gain, feeling short of breath;

  
  


• 
  

  rectal bleeding;

  
  


• 
  

  severe stomach pain or cramps, severe or ongoing diarrhea or vomiting; or

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

  
  

Less serious side effects may include:

• 
  

  dizziness, weakness;

  
  


• 
  

  increased thirst;

  
  


• 
  

  mild stomach pain, gas, indigestion;

  
  


• 
  

  diarrhea or loose stools;

  
  


• 
  

  mild nausea; or

  
  


• 
  

  skin rash.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Gentle Laxative (bisacodyl)?

There may be other drugs that can interact with bisacodyl. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Gentle Laxative resources

• Gentle Laxative Side Effects (in more detail)
• Gentle Laxative Use in Pregnancy & Breastfeeding
• Gentle Laxative Drug Interactions
• Gentle Laxative Support Group
• 0 Reviews for Gentle Laxative - Add your own review/rating

• Bisacodyl Prescribing Information (FDA)


• Bisacodyl Professional Patient Advice (Wolters Kluwer)


• Bisacodyl Monograph (AHFS DI)


• Bisacodyl MedFacts Consumer Leaflet (Wolters Kluwer)


• Evac-u-gen Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Gentle Laxative with other medications

• Bowel Preparation
• Constipation

Where can I get more information?

• Your pharmacist can provide more information about bisacodyl.

See also: Gentle Laxative side effects (in more detail)