Kenyan Health Patient Information Leaflet
Vitamin / mineral / nutritional supplement
Prophylaxis and treatment haemorrhagic disease of the newborn (since vitamin K from the mother may possibly be insufficient due to its poor passage through the placenta and because intestinal bacteria responsible for its natural synthesis are not present for 1st 5-8 days after birth); in the management of overdose of anti-coagulants; in patients with fat mal-absorption (Vitamin K is fat soluble hence it is not absorbed in fat mal-absorption disorders); treatment and prophylaxis of various coagulation disorders due to impaired synthesis of factors II, VII, IX, and X (this may result from vitamin K deficiency, impaired activity of vitamin K eg. hypoprothrombinemia due to coumarin or indanedione-derived oral anticoagulants and other drugs.
• Multiple vitamins injection (adult) is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K 1 , folic acid, biotin, and vitamin B 12 ( 2.1 ) • Multiple vitamins injection (adult) is for administration by intravenous infusion after dilution ( 2.1 ) • Recommended daily dosage is 10 mL ( 2.1 ) • Multiple vitamins injection (adult) is supplied as a pharmacy bulk package. Pharmacy Bulk Package : Add the contents of Vial 1 to the contents of Vial 2. This provides ten 10 mL daily doses. Take 10 mL from Vial 2 and add to not less than 500 mL, and preferably 1,000 mL, of intravenous dextrose, saline or similar infusion solutions. ( 2.2 ) • After dilution in an intravenous infusion, refrigerate resulting solution unless used immediately. Use solution within 24 hours after dilution ( 2.2 ) • Monitor blood vitamin concentrations ( 2.3 ) • See Full Prescribing Information for drug incompatibilities ( 2.4 ) 2.1 Important Dosage Instructions Multiple vitamins injection (adult) is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K 1 , folic acid, biotin, and vitamin B 12 . Multiple vitamins injection (adult) is supplied as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution. Multiple vitamins injection (adult) Pharmacy Bulk Package: • Provides ten 10 mL daily doses when the content of vial 1 is transferred into the content of vial 2. One 10 mL dose is then added directly to intravenous fluid. Pharmacy bulk package of multiple vitamins injection (adult) is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion [ see Dosage and Administration ( 2.2 )]. Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated. Some patients do not maintain adequate levels of certain vitamins when this formulation in recommended amounts is the only source of vitamins. 2.2 Preparation and Administration Instructions Do not administer multiple vitamins injection (adult) as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and possible tissue irritation . Multiple vitamins injection (adult) Pharmacy Bulk Package : • Use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). • Transfer the contents of Vial 1 into the contents of Vial 2 to provide ten 10 mL single doses. • Each bulk vial closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. • Once the closure system has been penetrated, complete dispensing from the pharmacy bulk vial should be completed within 4 hours. The mixed solution may be refrigerated and stored for up to 4 hours. • Discard unused portion. • Visually inspect for particulate matter and discoloration prior to administration. • One daily 10 mL dose should be added directly to at least 500 mL to 1,000 mL, of intravenous dextrose, saline or similar infusion solutions. • After multiple vitamins injection (adult) is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution. • Minimize exposure to light because some of the vitamins in multiple vitamins injection (adult), particularly A, D and riboflavin, are light sensitive. 2.3 Monitoring Vitamin Blood Levels Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as the only source of vitamins for long periods of time. 2.4 Drug Incompatibilities • Multiple vitamins injection (adult) is not physically compatible with moderately alkaline solutions such as a sodium bicarbonate solution and other alkaline drugs such as acetazolamide sodium, aminophylline, ampicillin sodium, tetracycline HCl and chlorothiazide sodium. • Folic acid is unstable in the presence of calcium salts such as calcium gluconate. • Vitamin A and thiamine in multiple vitamins injection (adult) may react with bisulfite solutions such as sodium bisulfite or vitamin K bisulfate. • Do not add multiple vitamins injection (adult) directly to intravenous fat emulsions. • Consult appropriate references for additional listings of physical and chemical compatibility of solutions and drugs with the vitamin infusion when needed. If incompatibilities are identified, avoid admixture or Y-site administration with vitamin solutions.
labeling. • Allergic reactions to thiamine [ see Warnings and Precautions ( 5.2 ) ]. • Hypervitaminosis A [ see Warnings and Precautions ( 5.3 ) ] The following adverse reactions have been identified during postapproval use of multiple vitamins injection (adult). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis and anaphylactoid reactions including shortness of breath, wheezing and angioedema, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Multiple vitamins injection (adult) is supplied as follows: Vial 1 (Pharmacy Bulk Package) is supplied as clear, yellow to orange colored solution in amber glass vial closed with a rubber stopper, aluminum flip-off seals of white color button. Vial 2 (Pharmacy Bulk Package) is supplied as clear, off-white to pale yellow colored solution in amber glass vial closed with a rubber stopper, aluminum flip-off seals of dark blue color button. Multiple vitamins injection (adult) Pharmacy Bulk Package: Carton contains total two vials NDC 60505-6191-0 One Vial 1 (50 mL) NDC 60505-6290-1 One Vial 2 (50 mL Fill in 100 mL Vial) NDC 60505-6291-2 Mix contents of Vial 1 with Vial 2 to provide 10 single doses [ see Dosage and Administration ( 2.1 ) ]. Storage and Handling Minimize exposure of multiple vitamins injection (adult) to light because vitamins A, D and riboflavin are light sensitive. Store under refrigeration, 2°C to 8°C (36°F to 46°F).