Vitamin B Complex

Dosage Form: injection, solution

Vitamin B Complex Description

Vitamin B-Complex 100 Injection is a sterile solution for intramuscular or slow intravenous injection comprised of vitamins which may be categorized as belonging to the Vitamin B Complex group.

Each mL contains: Thiamine Hydrochloride 100 mg, Riboflavin 5’ Phosphate Sodium 2 mg, Pyridoxine Hydrochloride 2 mg, Dexpanthenol 2 mg, Niacinamide 100 mg, with Benzyl Alcohol 2% as preservative, in Water for Injection. Sodium Hydroxide and/or Hydrochloric acid may have been used to adjust the pH.

INDICATIONS & USAGE

In disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist.

Contraindications

Sensitivity to the ingredients listed.

Warnings

Anaphylactogenesis may occur with parenteral thiamine. Use with caution. An intradermal test dose is recommended prior to administration in patients suspected of being sensitive to the drug.

Precautions

The usual precautions for parenteral administration should be observed. Do not inject if precipitate occurs. Inject slowly by the intravenous route. High concentrations should be diluted using Normal Saline Injection when giving intravenously.

Adverse Reactions

Mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching transitory exanthema, feeling of swelling of entire body, anaphylactic shock and death. Sensitivity to the ingredients listed may occur (See WARNINGS). Use should be discontinued upon observance of any untoward reaction. Pain upon intramuscular injection may be noted.

DOSAGE & ADMINISTRATION

Usually 0.25 to 2 mL by intramuscular or slow intravenous injection. High concentrations given intravenously may be diluted using parenteral infusion solutions. (See PRECAUTIONS).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit (See HOW SUPPLIED).

How is Vitamin B Complex Supplied

Vitamin B-Complex 100 Injection is available in a 30 ml multiple dose vial individually boxed (NDC 67157-108-30) or in a 5 vial shelf pack (NDC 67157-108-31).

Phase separation due to reduced solubility can occur under certain conditions of shipping or storage (e.g. accidental freezing), which may produce visible particles. Do not use product if these do not re-dissolve on warming to body temperature and shaking well.

Refrigeration of the product may cause darkening of the solution due to the riboflavin content. The color does not affect the safety or efficacy of the product.

PROTECT FROM LIGHT:

Store in carton until contents are used. Store under refrigeration 2oC – 8oC (36oF – 46oF). Do not permit to freeze.

Rx ONLY

Manufactured By:

McGuff Pharmaceuticals, Inc. Santa Ana, CA 92704 U.S.A. 

MD381-0024 rev: NEW 8/2009

VITAMIN B-COMPLEX  thiamine hydrochloride, riboflavin 5 phosphate sodium, pyridoxine hydrochloride, dexpanthenol, niacinamide  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67157-108 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE HYDROCHLORIDE 100 mg  in 1 mL RIBOFLAVIN 5'-PHOSPHATE SODIUM (RIBOFLAVIN) RIBOFLAVIN 5'-PHOSPHATE SODIUM 2 mg  in 1 mL PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 2 mg  in 1 mL DEXPANTHENOL (DEXPANTHENOL) DEXPANTHENOL 2 mg  in 1 mL NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 100 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL 2 mL  in 100 mL WATER   SODIUM HYDROXIDE   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67157-108-30 1 VIAL In 1 PACKAGE contains a VIAL, MULTI-DOSE 1 30 mL In 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (67157-108-30) 2 67157-108-31 5 VIAL In 1 PACKAGE contains a VIAL, MULTI-DOSE 2 30 mL In 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (67157-108-31)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/25/2010

Labeler - McGuff Pharmaceuticals Inc. (134632103)

Establishment
Name	Address	ID/FEI	Operations
McGuff Pharmaceuticals Inc.		134632103	manufacture

Revised: 01/2010McGuff Pharmaceuticals Inc.

More Vitamin B Complex resources

• Vitamin B Complex Use in Pregnancy & Breastfeeding
• Vitamin B Complex Drug Interactions
• Vitamin B Complex Support Group
• 4 Reviews for Vitamin B Complex - Add your own review/rating

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Vitafol One

Dosage Form: capsule, gelatin coated
Product Information.

Contraindications

Vitafol-One is contraindicated in patients with hypersensitivity to any of its components or color additives.

Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.

Iron Therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B12).

Boxed Warning

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6.  Keep this product out of the reach of children.  In case of accidental overdose, call a doctor or a Poison Control Center immediately.

WARNINGS/PRECAUTIONS:

Vitafol-One should be used with caution in patients with known sensitivity or allergy to soy.


Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kigney stones.  High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues.  Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.


Iodine should be used with caution in patients with an overactive thyroid.


Prolonged use of iron salts may produce iron storage disease.


Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.


The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.


Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding.  Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.


Avoid Overdosage.  Keep out of the reach of children.


Drug Interactions:


Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.


Medications for hypertension used in conjunction with iodine supplementation may increase potassium.


High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs;carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid.  Folic acid may decrease a patient's response to methotrexate.


Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.


Zinc can inhibit the absorption of certain antibiotics; taken at least 2 hours apart to minimize interactions.


Consult appropriate references for additional specific vitamin-drug interactions.


Information for Patients: Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.


Pediatric Use: Not for pediatric use. 

Adverse Reactions

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol-One.  However, allergic and idiosyncratic reactions are possible at any dose.  Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

Dosage and Administration

Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.

How Supplied

Vitafol-One is available as a dark blue, oval shaped softgel capsule imprinted "EV0070".  Avialable in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules), (NDC 0642-0070-30) and as professional samples (NDC 0642-0070-01).

Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat.

Rx Only

Manufactured for

EVERETT LABORATORIES, INC.

West Orange, NJ 07052

1-877-324-9349

Principal Display Panel

Principal Display Panel

VITAFOL  ONE prenatal supplement with dha  capsule, gelatin coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0642-0070 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Vitamin A (Beta Carotene) Beta Carotene 1100 [iU] Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 30 mg Thiamine Mononitrate (Thiamine ) Thiamine Mononitrate 1.6 mg Riboflavin (Riboflavin) Riboflavin 1.8 mg Niacin (Niacinamide) Niacinamide 15 mg Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine 2.5  mg Cyanocobalamin (Cyanocobalamin) Cyanocobalamin .012 mg Folic Acid (Folic Acid) Folic Acid 1 mg Iodine (Iodine) Iodine 0.150 mg Magnesium (Magnesium Oxide) Magnesium Oxide 20 mg Zinc (Zinc Oxide) Zinc Oxide 25 mg Copper (Cupric Oxide) Cupric Oxide 2 mg Vitamin D (Cholecalciferol) Cholecalciferol 1000 [iU] Omega-3 Fatty Acids (Doconexent) Doconexent 200 mg Vitamin E (Alpha-Tocopherol) Alpha-Tocopherol 20 [iU] Iron (Iron) Iron 29 mg

Inactive Ingredients Ingredient Name Strength Gelatin   Sorbitol   Glycerin   Soybean Oil   Water   Yellow Wax   Anhydrous Dibasic Calcium Phosphate   Lecithin, Soybean   Titanium Dioxide   Sodium Thiosulfate   Sunflower Oil   Tocopherol   Ascorbyl palmitate   Caramel   FD&C Blue NO. 1   Corn Oil

Product Characteristics Color blue (Dark Blue) Score no score Shape OVAL (size 12 Oval Capsule) Size 10mm Flavor Imprint Code EV0070 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0642-0070-30 5 BLISTER PACK In 1 BOX contains a BLISTER PACK 1 6 CAPSULE In 1 BLISTER PACK This package is contained within the BOX (0642-0070-30) 2 0642-0070-01 1 BLISTER PACK In 1 BOX contains a BLISTER PACK 2 4 CAPSULE In 1 BLISTER PACK This package is contained within the BOX (0642-0070-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/13/2011

Labeler - Everett Laboratories, Inc. (071170534)

Establishment
Name	Address	ID/FEI	Operations
Intergel Pharmaceutical Inc		964464114	manufacture

Establishment
Name	Address	ID/FEI	Operations
Nutra-Med Packaging, Inc.		022004902	pack

Revised: 05/2011Everett Laboratories, Inc.

Vitamin B Complex/Vitamin C/Choline/Folic Acid

Pronunciation: VYE-ta-min/KOE-leen/FOE-lik AS-id
Generic Name: Vitamin B Complex/Vitamin C/Choline/Folic Acid
Brand Name: Folic Acid XTRA

Vitamin B Complex/Vitamin C/Choline/Folic Acid is used for:

A dietary supplement to help maintain a normal blood level of homocysteine or provide vitamins for those who do not receive the proper amount from their diet. It may also be used for other conditions as determined by your doctor.

Vitamin B Complex/Vitamin C/Choline/Folic Acid is a vitamin and folic acid combination. It works by providing vitamins and folic acid to the body to help meet nutritional requirements.

Do NOT use Vitamin B Complex/Vitamin C/Choline/Folic Acid if:

• you are allergic to any ingredient in Vitamin B Complex/Vitamin C/Choline/Folic Acid

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

Before using Vitamin B Complex/Vitamin C/Choline/Folic Acid:

Some medical conditions may interact with Vitamin B Complex/Vitamin C/Choline/Folic Acid. 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 certain types of anemia (eg, pernicious anemia or megaloblastic anemia)

Some MEDICINES MAY INTERACT with Vitamin B Complex/Vitamin C/Choline/Folic Acid. Tell your health care provider if you are taking any other medicines, especially any of the following

• Fluorouracil because the risk of its side effects may be increased by Vitamin B Complex/Vitamin C/Choline/Folic Acid


• Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Vitamin B Complex/Vitamin C/Choline/Folic Acid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vitamin B Complex/Vitamin C/Choline/Folic Acid 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 Vitamin B Complex/Vitamin C/Choline/Folic Acid:

Use Vitamin B Complex/Vitamin C/Choline/Folic Acid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Vitamin B Complex/Vitamin C/Choline/Folic Acid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Vitamin B Complex/Vitamin C/Choline/Folic Acid, 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 Vitamin B Complex/Vitamin C/Choline/Folic Acid.

Important safety information:

• Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Vitamin B Complex/Vitamin C/Choline/Folic Acid unless your doctor tells you to.


• Vitamin B Complex/Vitamin C/Choline/Folic Acid contains pyridoxine (vitamin B₆) and folic acid. Before you start any new medicine, check the label to see if it has pyridoxine or folic acid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Vitamin B Complex/Vitamin C/Choline/Folic Acid may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Vitamin B Complex/Vitamin C/Choline/Folic Acid.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vitamin B Complex/Vitamin C/Choline/Folic Acid while you are pregnant. It is not known if Vitamin B Complex/Vitamin C/Choline/Folic Acid is found in breast milk. If you are or will be breast-feeding while you use Vitamin B Complex/Vitamin C/Choline/Folic Acid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Vitamin B Complex/Vitamin C/Choline/Folic Acid:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Vitamin B Complex/Vitamin C/Choline/Folic Acid. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); feeling of swelling of the entire body; numbness or tingling of the skin.

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.

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 Vitamin B Complex/Vitamin C/Choline/Folic Acid:

Store Vitamin B Complex/Vitamin C/Choline/Folic Acid 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. Keep Vitamin B Complex/Vitamin C/Choline/Folic Acid out of the reach of children and away from pets.

General information:

• If you have any questions about Vitamin B Complex/Vitamin C/Choline/Folic Acid, please talk with your doctor, pharmacist, or other health care provider.


• Vitamin B Complex/Vitamin C/Choline/Folic Acid 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 Vitamin B Complex/Vitamin C/Choline/Folic Acid. 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 Vitamin B Complex/Vitamin C/Choline/Folic Acid resources

• Vitamin B Complex/Vitamin C/Choline/Folic Acid Use in Pregnancy & Breastfeeding
• Vitamin B Complex/Vitamin C/Choline/Folic Acid Drug Interactions
• Vitamin B Complex/Vitamin C/Choline/Folic Acid Support Group
• 4 Reviews for Vitamin B Complex/Vitamin C/Choline/Folic Acid - Add your own review/rating

Compare Vitamin B Complex/Vitamin C/Choline/Folic Acid with other medications

• Dietary Supplementation
• Hyperhomocysteinemia

Vitamin A/Vitamin D/Vitamin C/Fluoride

Pronunciation: VYE-ta-min A/VYE-ta-min D/VYE-ta-min C/FLURE-ide
Generic Name: Vitamin A/Vitamin D/Vitamin C/Fluoride
Brand Name: TRI-VIT With Fluoride

Vitamin A/Vitamin D/Vitamin C/Fluoride is used for:

Treating vitamin deficiency in infants. It may also be used to prevent cavities in children over 6 months old when the amount of fluoride in the water supply is too low.

Vitamin A/Vitamin D/Vitamin C/Fluoride is a vitamin and mineral combination. It works by providing vitamin A, D, and C to the body. Fluoride strengthens the teeth and decreases the effects of acid and bacteria on the teeth.

Do NOT use Vitamin A/Vitamin D/Vitamin C/Fluoride if:

• you are allergic to any ingredient in Vitamin A/Vitamin D/Vitamin C/Fluoride

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

Before using Vitamin A/Vitamin D/Vitamin C/Fluoride:

Some medical conditions may interact with Vitamin A/Vitamin D/Vitamin C/Fluoride. 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

Some MEDICINES MAY INTERACT with Vitamin A/Vitamin D/Vitamin C/Fluoride. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acitretin because it may increase the risk of Vitamin A/Vitamin D/Vitamin C/Fluoride's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vitamin A/Vitamin D/Vitamin C/Fluoride 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 Vitamin A/Vitamin D/Vitamin C/Fluoride:

Use Vitamin A/Vitamin D/Vitamin C/Fluoride as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Vitamin A/Vitamin D/Vitamin C/Fluoride by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Vitamin A/Vitamin D/Vitamin C/Fluoride may be mixed with fruit juice, cereal, or other food.


• Use the dropper that comes with Vitamin A/Vitamin D/Vitamin C/Fluoride to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Vitamin A/Vitamin D/Vitamin C/Fluoride, 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 Vitamin A/Vitamin D/Vitamin C/Fluoride.

Important safety information:

• Do not take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Vitamin A/Vitamin D/Vitamin C/Fluoride should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Vitamin A/Vitamin D/Vitamin C/Fluoride is not approved for use in women. If you become pregnant while taking Vitamin A/Vitamin D/Vitamin C/Fluoride, contact your doctor. You will need to discuss the benefits and risks of using Vitamin A/Vitamin D/Vitamin C/Fluoride while you are pregnant. It is not known if Vitamin A/Vitamin D/Vitamin C/Fluoride is found in breast milk. If you are or will be breast-feeding while you use Vitamin A/Vitamin D/Vitamin C/Fluoride, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Vitamin A/Vitamin D/Vitamin C/Fluoride:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Vitamin A/Vitamin D/Vitamin C/Fluoride. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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: Vitamin A/Vitamin D/Vitamin C/Fluoride 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 Vitamin A/Vitamin D/Vitamin C/Fluoride:

Store Vitamin A/Vitamin D/Vitamin C/Fluoride at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Keep Vitamin A/Vitamin D/Vitamin C/Fluoride out of the reach of children and away from pets.

General information:

• If you have any questions about Vitamin A/Vitamin D/Vitamin C/Fluoride, please talk with your doctor, pharmacist, or other health care provider.


• Vitamin A/Vitamin D/Vitamin C/Fluoride 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 Vitamin A/Vitamin D/Vitamin C/Fluoride. 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 Vitamin A/Vitamin D/Vitamin C/Fluoride resources

• Vitamin A/Vitamin D/Vitamin C/Fluoride Side Effects (in more detail)
• Vitamin A/Vitamin D/Vitamin C/Fluoride Use in Pregnancy & Breastfeeding
• Drug Images
• Vitamin A/Vitamin D/Vitamin C/Fluoride Drug Interactions
• Vitamin A/Vitamin D/Vitamin C/Fluoride Support Group
• 0 Reviews for Vitamin A/Vitamin D/Vitamin C/Fluoride - Add your own review/rating

Compare Vitamin A/Vitamin D/Vitamin C/Fluoride with other medications

• Vitamin/Mineral Supplementation and Deficiency

Vitrase

Generic Name: hyaluronidase (Subcutaneous route, Injection route)

hye-al-ure-ON-i-dase

Commonly used brand name(s)

In the U.S.

• Amphadase


• Hydase


• Hylenex


• Vitrase

Available Dosage Forms:

• Powder for Solution


• Solution

Therapeutic Class: Tissue Permeability Modifier

Pharmacologic Class: Enzyme

Uses For Vitrase

Hyaluronidase is a natural substance found in the body. Hyaluronidase is collected from either cows or pigs. It is cleaned up to remove animal substances. Hyaluronidase is a spreading substance. Hyaluronidase is used with other drugs given under the skin to improve their uptake by the body. This method of drug delivery is only used when the drug cannot be given by injection into a vein.

This medicine is available only with your doctor's prescription.

Before Using Vitrase

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Pediatric

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Benzocaine


• Bupivacaine


• Butacaine


• Chloroprocaine


• Cocaine


• Dibucaine


• Etidocaine


• Lidocaine


• Mepivacaine


• Prilocaine


• Procaine


• Proparacaine


• Propoxycaine


• Ropivacaine


• Tetracaine

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 hyaluronidase. Make sure you tell your doctor if you have any other medical problems.

Proper Use of hyaluronidase

This section provides information on the proper use of a number of products that contain hyaluronidase. It may not be specific to Vitrase. Please read with care.

Dosing

The dose of this medicine 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 this medicine. 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 better uptake of other drugs:
    
    • Adults—Use and dose must be determined by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Vitrase

Some people may be allergic to this medicine. Tell your doctor if you develop red or itching skin or if you have trouble breathing after you receive hyaluronidase.

Vitrase Side Effects

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.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Cough


• difficulty swallowing


• dizziness


• fast heartbeat


• hives or welts


• itching


• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue


• redness of skin


• shortness of breath


• skin rash


• tightness in chest


• unusual tiredness or weakness


• wheezing

Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision


• chills


• confusion


• dizziness


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• fast, pounding, or irregular heartbeat or pulse


• flushing


• nausea


• redness of skin


• swelling


• unusually warm skin


• sweating


• unusual tiredness or weakness


• vomiting

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:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site

Incidence not known

• Swelling

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: Vitrase 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 Vitrase resources

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

• Vitrase MedFacts Consumer Leaflet (Wolters Kluwer)


• Vitrase Consumer Overview


• Vitrase Prescribing Information (FDA)


• Hyaluronidase Professional Patient Advice (Wolters Kluwer)


• Amphadase Consumer Overview


• Amphadase Prescribing Information (FDA)


• Hylenex MedFacts Consumer Leaflet (Wolters Kluwer)


• Hylenex Consumer Overview

Compare Vitrase with other medications

• Extravasation
• Hypodermoclysis
• Subcutaneous Urography

Vitamin B 12

Dosage Form: FOR ANIMAL USE ONLY
Vitamin B12 1000mcg Injection

Composition

Each mL of sterile aqueous solution contains: Cyanocobalamin (B12).........1000mcg with sodium chloride 0.8% W/V and benzyl alcohol 1.5% V/V (preservative).

Indications and Usage for Vitamin B 12

For use as an aid in the management of vitamin B12 deficiencies in cattle, horses, dogs and cats.

Storage

Store at controlled room temperature 20°-25°C (68°-77°F)Avoid exposure to light

Vitamin B 12 Dosage and Administration

Inject subcutaneously or intramuscularly. Cattle and Horses-1 to 2 mL Dogs and Cats-0.25 to 0.5 mL May be repeated once or twice weekly, as indicated by condition and response..

Observe Directions

Manufactured by

Supplied in 100mL, 250mL and 500mL glass amber vials

Principal Display Panel

100mL Bottle Label

Principle Display Panel

250mL Bottle Label

Principle Display Panel

500mL Bottle Label

Vitamin B 12  Vitamin B 12  injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 59130-620 Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 1000 ug  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 59130-620-01 100 mL In 1 BOTTLE, GLASS None 2 59130-620-02 250 mL In 1 BOTTLE, GLASS None 3 59130-620-03 500 mL In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		12/30/1992

Labeler - Teva Animal Health, Inc. (625254461)

Revised: 12/2009Teva Animal Health, Inc.

Vitrasert

Generic Name: ganciclovir ophthalmic (gan SYE klo veer off THAL mik)

Brand Names: Vitrasert, Zirgan

What is ganciclovir?

Ganciclovir is an antiviral drug. It slows the growth and spread of the cytomegalovirus.

Ganciclovir ophthalmic (for the eyes) is used to treat certain viral infections affecting the eyes.

Ganciclovir implant (Vitrasert) is used to treat cytomegalovirus (CMV) infection of the eye. This infection usually occurs in patients who have suppressed immune systems such as patients with AIDS and organ transplant patients.

Ganciclovir gel (Zirgan) is used to treat eye ulcers caused by the herpes simplex virus.

Ganciclovir is not a cure for CMV or herpes. This medication will not treat symptoms of these infections in any other part of the body.

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

What is the most important information I should know about ganciclovir?

You should not use this medication if you are allergic to ganciclovir or acyclovir (Zovirax).

Ganciclovir implant (Vitrasert) is used to treat cytomegalovirus (CMV) infection of the eye. Ganciclovir gel (Zirgan) is used to treat eye ulcers caused by the herpes simplex virus.

Ganciclovir is not a cure for cytomegalovirus or herpes. This medication will not treat symptoms of these infections in any other part of the body.

To make sure you can safely use ganciclovir, tell your doctor if you have low levels of platelets in your blood (easy bruising or bleeding), or an infection in any part of your body (other than your eyes).

Do not wear contact lenses while you are using this medication. You should not wear contact lenses at any time you have an active eye ulcer or infection.

What should I discuss with my health care provider before using ganciclovir?

You should not use this medication if you are allergic to ganciclovir or acyclovir (Zovirax).

To make sure you can safely use ganciclovir, tell your doctor if you have any of these other conditions:

• 
  

  an infection in any part of your body (other than your eyes); or

  
  


• 
  

  low levels of platelets in your blood (easy bruising or bleeding).

  
  

Do not wear contact lenses while you are using this medication. You should not wear contact lenses at any time you have an active eye ulcer or infection. FDA pregnancy category C. It is not known whether ganciclovir will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. This medication can decrease sperm count and may affect a man's fertility (ability to have children). It is not known whether ganciclovir passes into breast milk or if it could harm a nursing baby. Do not use Zirgan without telling your doctor if you are breast-feeding a baby. You should not breast-feed after you have received a Vitrasert implant. Ganciclovir gel (Zirgan) should not be given to a child younger than 2 years old.

How should I use ganciclovir?

The Vitrasert implant is surgically placed into the eye. The implant will slowly release ganciclovir into the affected eye over a period of 5 to 8 months.

Use Zirgan gel exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Zirgan is usually applied 5 times each day until your eye ulcer heals. Then the gel is applied 3 times per day for 7 days. Follow your doctor's instructions.

Wash your hands before using the eye drops.

To apply Zirgan:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Use only the number of drops your doctor has prescribed.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

  
  

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Ganciclovir does not cure herpes or CMV. Your disease may continue to progress even after you are treated with this medication. Your doctor will need to check your progress on a regular basis, and you will need routine eye exams.

Store Zirgan at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Since the Vitrasert implant is surgically put into place, you will not be on a dosing schedule for this medication. The implant may be removed and replaced after 5 to 8 months.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ganciclovir?

Do not use any eye medications that your doctor has not prescribed.

Ganciclovir may cause blurred vision, which may last up to 4 weeks after Vitrasert implant surgery. Be careful if you drive or do anything that requires you to be able to see clearly.

Ganciclovir 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:

• 
  

  eye pain, swelling, redness, or watering;

  
  


• 
  

  severe burning or itching of your eyes;

  
  


• 
  

  vision changes, increased sensitivity to light;

  
  


• 
  

  tunnel vision, problems with peripheral (side) vision;

  
  


• 
  

  seeing flashes of light, halos around lights, or "floaters" in your vision;

  
  


• 
  

  white patches on your eyes;

  
  


• 
  

  cloudiness in the pupils or iris of your eyes;

  
  


• 
  

  bleeding, oozing, or crusting of your eyes; or

  
  


• 
  

  sudden vision loss.

  
  

Less serious side effects may include:

• 
  

  blurred vision (may last up to 4 weeks after Vitrasert implant surgery);

  
  


• 
  

  mild eye irritation; or

  
  


• 
  

  increased tearing.

  
  

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 ganciclovir?

It is not likely that other drugs you take orally or inject will have an effect on ganciclovir used in the eyes. But many drugs can interact with each other. 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 Vitrasert resources

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

• Vitrasert Prescribing Information (FDA)


• Vitrasert Advanced Consumer (Micromedex) - Includes Dosage Information


• Vitrasert Implant MedFacts Consumer Leaflet (Wolters Kluwer)


• Zirgan Prescribing Information (FDA)


• Zirgan Advanced Consumer (Micromedex) - Includes Dosage Information


• Zirgan Consumer Overview


• Zirgan Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Vitrasert with other medications

• CMV Retinitis

Where can I get more information?

• Your pharmacist can provide more information about ganciclovir.

See also: Vitrasert side effects (in more detail)