Cernevit

Cernevit

Manufacturer:

Baxter Healthcare

Distributor:

Baxter Healthcare
Concise Prescribing Info
Contents
Retinol palmitate corresponding to retinol 3,500 IU, cholecalciferol 220 IU, DL α-tocopherol 10.2 mg (corresponding to α-tocopherol 11.2 IU), ascorbic acid 125 mg, cocarboxylase tetrahydrate 5.8 mg (corresponding to thiamine 3.51 mg), riboflavin Na phosphate dihydrate 5.67 mg (corresponding to riboflavin 4.14 mg), pyridoxine HCl 5.5 mg (corresponding to pyridoxine 4.53 mg), cyanocobalamin 0.006 mg, folic acid 0.414 mg, dexpanthenol 16.15 mg (corresponding to pantothenic acid 17.25 mg), D-biotin 0.069 mg, nicotinamide 46 mg
Indications/Uses
Parenteral administration of daily vit requirements in adults & childn >11 yr when oral administration is either contraindicated, impossible, or insufficient.
Dosage/Direction for Use
Adult & childn >11 yr 1 vial daily by slow IV inj (at least 10 min) or by infusion in a 5% glucose soln or 0.9% NaCl soln for infusion. May be included in the composition of nutritive mixt provided that compatibility & stability have been confirmed.
Contraindications
Hypersensitivity to the active substances, especially vit B1, or to soy or peanut proteins/products. Hypervitaminosis. Neonates, infants, childn <11 yr.
Special Precautions
Reports of severe systemic hypersensitivity reactions. Cross-allergic reactions between soybean & peanut proteins. Immediately stop inj or infusion if signs or symptoms of hypersensitivity reaction develop. Monitor clinical status & blood vit conc (especially vit A, D, & E), particularly in patients who receive additional vit from other sources or use other agents that increase risk of vit toxicity, & in patients receiving long-term supplementation. Increased risk for hypervitaminosis A & vit A toxicity in patients w/ protein malnutrition, renal impairment (w/ or w/o vit A supplementation), hepatic impairment, small body size (eg, paed patients), & patients on chronic therapy. Refeeding severely undernourished patients may result in refeeding syndrome, as well as thiamine deficiency & fluid retention. Reports of pulmonary vascular precipitates, precipitation distal to the in-line filter, & suspected precipitate formation in the bloodstream. Stop infusion if signs of pulmonary distress occur. Monitor liver function parameters, particularly in patients w/ hepatic jaundice or other evidence of cholestasis. Reports of liver enzyme increases, including isolated ALT increases in patients w/ inflammatory bowel disease, & increased bile acid levels. Risk of hepatobiliary disorders, including cholestasis, hepatic steatosis, fibrosis & cirrhosis (possibly leading to hepatic failure), cholecystitis, cholelithiasis. Maintain adequate vit D status in patients w/ severe renal impairment. Reports of pyridoxine hypervitaminosis & toxicity in patients on chronic haemodialysis receiving IV multivit 3x wkly containing 4 mg pyridoxine. Does not contain vit K. Evaluate vit B12 status prior to initiation of supplementation in patients at risk for vit B12 deficiency &/or when supplementation over several wk is planned. Biotin may interfere w/ lab tests that are based on a biotin/streptavidin interaction. Presence of ascorbic acid in blood & urine may cause false high or low glucose readings in some urine & blood glucose testing systems. Patients on controlled Na diet. Pregnancy & lactation. Elderly.
Adverse Reactions
Drug Interactions
Increased risk for pseudotumor cerebri w/ concomitant administration of vit A & agents that can cause pseudotumor cerebri (including certain tetracyclines). Increased risk of vit A hepatotoxicity w/ chronic excessive alcohol consumption. Vit E can add to the inhibition of platelet function of antiplatelets (eg, aspirin). Reduced folic acid levels w/ high-dose aspirin. Folate, pyridoxine & vit D deficiencies w/ phenytoin, carbamazepine, phenobarb, valproate. Decreased vit D levels w/ efavirenz & zidovudine. Decreased formation of active vit D metabolite w/ PIs. Inhibited hematological response to vit B12 therapy w/ chloramphenicol. Increased risk of Fe-induced cardiac failure w/ concomitant administration of vit C & deferoxamine. Increased cytotoxicity of fluoropyrimidines (5-fluorouracil, capecitabine, tegafur) w/ folic acid. Reduced folate effectiveness w/ folate antagonists (eg, MTX, sulfasalazine, pyrimethamine, triamterene, trimethoprim, high-dose tea catechins). Pyridoxine may interfere w/ concurrent levodopa therapy. Increased risk of toxicity w/ concomitant administration of vit A & retinoids (including bexarotene). Risk of excess vit E w/ tipranavir oral soln. Enhanced anticoagulant effect of vit K antagonists (eg, warfarin) w/ vit E. Folic acid supplementation can decrease the serum conc of anticonvulsants (phenytoin, fosphenytoin, phenobarb, primidone); can decrease the antimetabolite effects of folate antimetabolites (MTX, raltitrexed). Pyridoxine deficiency w/ ethionamide; pyridoxine antagonists, including cycloserine, hydralazine, INH, penicillamine, phenelzine; theophylline. Potential increase in response of concomitantly administered drugs known to bind to α1-acid glycoprotein eg, propranolol, prazosin. Enhanced amiodarone-induced photosensitivity w/ vit B6. Increased bleeding risk w/ concomitant administration of high-dose vit A & agents w/ anticoagulant effects (eg, abciximab, clopidogrel, heparin, warfarin). Chemotherapy activity of chemotherapeutic agents that rely on production of reactive O2 species for their activity may be inhibited by the antioxidant effects of high-dose vit E. High-dose vit E may reduce the haematological response to Fe in anaemic patients. Breakthrough bleeding & contraceptive failure w/ concomitant administration of high-dose vit C & OCs. Large nicotinamide doses can inhibit carbamazepine metabolism; can decrease sensitivity to insulin & antidiabetics; can increase primidone levels. Large pyridoxine doses can increase phenobarb metabolism; can lower serum levels of phenytoin & fosphenytoin. Folic acid may obscure pernicious anaemia.
MIMS Class
Vitamins &/or Minerals
ATC Classification
A11BA - Multivitamins, plain ; Used as dietary supplements.
Presentation/Packing
Form
Cernevit powd for soln for inj or infusion
Packing/Price
10's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in