Adult Infuvite Multiple Vitamins For Infusion Pharmacy Bulk (Page 2 of 3)

5.7 Interference with Urine Glucose Testing

INFUVITE ADULT (PHARMACY BULK PACKAGE)contains vitamin C which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose determinations.

5.8 Incompatibility with Intravenous Fat Emulsions

Do not add INFUVITE ADULT (PHARMACY BULK PACKAGE)directly to intravenous fat emulsions.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other section of the labeling.

Allergic and anaphylactoid reactions following intravenous administration of thiamine [see Warnings and Precautions (5.2) ].
Hypervitaminosis A [see Warnings and Precautions (5.3) ]

Other adverse reactions:

Dermatologic: rash, erythema, pruritis

CNS: headache, dizziness, agitation, anxiety

Ophthalmic: diplopia

7 DRUG INTERACTIONS

A number of interactions between vitamins and drugs have been reported. Consult appropriate references for additional specific vitamin-drug interactions. The following are examples of these types of interactions:

7.1 Clinical Interactions Affecting Levels of Co-administered Drugs

Folic Acid

Phenytoin metabolism may be increased by folic acid. Folic acid may lower the serum concentration of phenytoin resulting in increased seizure activity.

Patient’s response to methotrexate therapy may be decreased by folic acid.

Pyridoxine

The metabolism of levodopa may be increased and its efficacy may be decreased by pyridoxine.

Antibiotics

Antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin is decreased by thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin.

7.2 Clinical Interactions Affecting Vitamin Levels

Hydralazine, Isoniazid

Pyridoxine requirements may be increased by concomitant administration of hydralazine or isoniazid.

Chloramphenicol

In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol.

Phenytoin

Serum folic acid concentrations may be decreased by phenytoin and, therefore it should be avoided in pregnancy.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

INFUVITE ADULT (PHARMACY BULK PACKAGE) has not been studied in pregnant women. Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women.

8.3 Nursing Mothers

INFUVITE ADULT (PHARMACY BULK PACKAGE) has not been studied in lactating women.Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirement may exceed those of nonlactating women. Caution should be exercised when INFUVITE ADULT (PHARMACY BULK PACKAGE) is administered to a nursing mother.

8.4 Pediatric Use

Safety and effectiveness in children below the age of 11 years have not been established.

8.5 Geriatric Use

Safety and effectiveness for geriatric use have not been established.

8.6 Renal Impairment

INFUVITE ADULT (PHARMACY BULK PACKAGE) has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin A levels in patients with renal impairment [see Warnings and Precautions (5.4) ].

8.7 Hepatic Impairment

INFUVITE ADULT (PHARMACY BULK PACKAGE) has not been studied in patients with liver impairments. Monitor vitamin A level in patients with liver disease, high alcohol consumption [see Warnings and Precautions (5.4) ].

10 OVERDOSAGE

Signs and symptoms of acute or chronic overdosage may be those of individual INFUVITE ADULT (PHARMACY BULK PACKAGE)component toxicity.

11 DESCRIPTION

INFUVITE ADULT (PHARMACY BULK PACKAGE) is a sterile product consisting of 2 vials – 1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial), provided as a pharmacy bulk package.

A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.

Each 5 mL of Vial 1 contains:

Ascorbic acid (Vitamin C) . . . . . . . . . . . . . . . . . . . . . . . . . . .200 mg

Vitamin A* (as palmitate) . . . . . . . . . . . . . . . . . . . . . . . . . .3,300 IU

Vitamin D3 * (cholecalciferol) . . . . . . . . . . . . . . . . . . . . . . . . .200 IU

Thiamine (Vitamin B1 ) (as the hydrochloride) . . . . . . . . . . . . . 6 mg

Riboflavin (Vitamin B2 )

(as riboflavin 5-phosphate sodium) . . . . . . . . . . . . . . . . . . . . .3.6 mg

Pyridoxine HCl (Vitamin B6 ) . . . . . . . . . . . . . . . . . . . . . . . . . . 6 mg

Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40 mg

Dexpanthenol

(as d -pantothenyl alcohol) . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 mg

Vitamin E* (dl -α-tocopheryl acetate) . . . . . . . . . . . . . . . . . . . 10 IU

Vitamin K1 * . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150 mcg

Inactive ingredients: 1.4% polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection.

*Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K.

Each 5 mL of Vial 2 contains:

Folic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .600 mcg

Biotin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60 mcg

Vitamin B12 (cyanocobalamin) . . . . . . . . . . . . . . . . . . . . . . 5 mcg

Inactive ingredients: 30% propylene glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection.

“Aqueous” multiple vitamin preparation for intravenous infusion:

INFUVITE ADULT (PHARMACY BULK PACKAGE)(Multiple Vitamins for Infusion) makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.

Contains no more than 70 mcg/L of aluminum (combined Vials 1 and 2).

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE ADULT (PHARMACY BULK PACKAGE).

16 HOW SUPPLIED/STORAGE AND HANDLING

INFUVITE ADULT (PHARMACY BULK PACKAGE ) – NDC 54643-5650-2, is available in boxes containing 2 vials – 1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial). Mix contents of Vial 1 with Vial 2 to provide 10 single doses.

Store under refrigeration, 2-8°C (36-46°F).

17 PATIENT COUNSELING INFORMATION

Instruct patient that INFUVITE ADULT (PHARMACY BULK PACKAGE)is indicated for the prevention of vitamin deficiency in adults and children 11 and older receiving parenteral nutrition and in patients with extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, or who undergo surgery.
INFUVITE ADULT (PHARMACY BULK PACKAGE)is contraindicated in patients who have a history of hypersensitivity to any of the vitamins in this product or existing hypervitaminosis due to any vitamins contained in this formulation. Obtain detailed allergy and concomitant drug information from the patient, as well as if they have any kidney or liver impairment and if they are pregnant, prior to INFUVITE ADULT (PHARMACY BULK PACKAGE)administration.
Tell patients to watch for signs of allergic reactions such as urticaria, shortness of breath, wheezing and angioedema, which have been reported following intravenous administration of thiamine.
Instruct patients with renal impairment to immediately report signs of hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision, which has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease.
Instruct patients to report other adverse reactions such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia.
Instruct patients who are on warfarin anticoagulant therapy to monitor periodically blood prothrombin/ INR levels to determine if the dose of warfarin needs to be adjusted.
Explain the significance of periodic monitoring of blood vitamin concentrations to determine if vitamin deficiencies or excesses are developing and the need to monitor renal function, calcium, phosphorus, aluminum and vitamin A levels in patients with renal impairment.

Manufactured by

Sandoz Canada Inc.

145 Jules-Léger Street

Boucherville, Qc, Canada, J4B 7K8

Distributed by

Baxter Healthcare Corporation

Clintec Nutrition Division

Deerfield, IL 60015 USA

Printed in Canada

January 2013

® INFUVITE is a registered trademark of Sandoz Canada Inc.

D46086517

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.