Cernevit

Cernevit

Manufacturer:

Baxter Healthcare

Distributor:

Zuellig Pharma

Marketer:

Baxter Healthcare
Concise Prescribing Info
Contents
Per 5 mL 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 16.150 mg (corresponding to pantothenic acid 17.250 mg), biotin 0.069 mg, nicotinamide 46 mg
Indications/Uses
Daily vit for parenteral nutrition.
Dosage/Direction for Use
Adult & childn >11 yr 1 vial daily by slow IV inj over at least 10 min or infusion.
Contraindications
Known hypersensitivity to Cernevit or soy proteins/products. Hypervitaminosis.
Special Precautions
Discontinue if signs or symptoms of hypersensitivity reaction develop; pulmonary distress occur. Cross-reactivity in patients w/ peanut allergies. Increased risk for hypervitaminosis A & vit A toxicity in patients w/ protein malnutrition, renal & hepatic impairment, small body size eg, ped patients & on chronic therapy. Re-feeding syndrome in patients receiving parenteral nutrition; thiamine deficiency & fluid retention. Pulmonary vascular precipitates. Patients w/ inflammatory bowel disease; vit B12 deficiency-associated megaloblastic anemia; on chronic hemodialysis receiving IV multivit w/ pyridoxine 4 mg administered 3 times a wk. May cause false high or low glucose readings in urine & blood glucose test. May falsely decreased or increased test results w/ biotin. Monitor clinical status & blood vit conc in patients receiving parenteral multivit & long term supplementation. Evaluate vit B12 status prior to initiation of supplementation in patients at risk for vit B12 deficiency. Chronic excessive alcohol consumption. Hepatobiliary disorders eg, cholestasis, hepatic steatosis, fibrosis & cirrhosis, possibly leading to hepatic failure, cholecystitis & cholelithiasis. Renal & hepatic impairment. Not to be used in pregnancy & lactation.
Adverse Reactions
Vomiting, nausea; inj/infusion site pain. Systemic hypersensitivity reactions eg, resp distress, chest & epigastric discomfort, throat tightness, urticaria, rash, erythema, cardiac arrest w/ fatal outcome; dysgeusia (metallic taste); tachycardia; tachypnea; diarrhea; pruritus; increased γ-glutamyltransferase; pyrexia, generalized aching, infusion site reactions ie, burning sensation, rash.
Drug Interactions
Increased risk for pseudotumor cerebri (benign/idiopathic intracranial HTN) w/ agents causing pseudotumor cerebri including certain tetracyclines. Increased risk of vit A hepatotoxicity w/ chronic excessive alcohol consumption. Decreased serum conc & increased seizure risk of anticonvulsants eg, phenytoin, fosphenytoin, phenobarb, primidone. Additive platelet function inhibition w/ 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/ deferoxamine. Pyridoxine deficiency w/ ethionamide; pyridoxine antagonists, including cycloserine, hydralazine, INH, penicillamine, phenelzine; theophylline. Increased cytotoxicity w/ fluoropyrimidines eg, 5-fluorouracil, capecitabine, tegafur. Reduced effectiveness w/ folate antagonists eg, MTX, sulfasalazine, pyrimethamine, triamterene, trimethoprim & high doses of tea catechins. Decreased antimetabolite effects of folate antimetabolites eg, MTX, raltitrexed. Increased risk of toxicity w/ retinoids, including bexarotene. Enhanced anticoagulant effect of vit K antagonists (eg, warfarin) by vit E. Increased unbound fraction of drugs known to bind to α1-acid glycoprotein eg, propranolol, prazosin. Enhance amiodarone-induced photosensitivity. Increased bleeding risk w/ agents w/ anticoagulant effects eg, abciximab, clopidogrel, heparin, warfarin. Inhibited metabolism w/ carbamazepine. Inhibited chemotherapy activity by antioxidant effects of high doses vit E. Decreased insulin sensitivity of insulin & antidiabetics. Reduced hematological response to Fe in anemic patients. Breakthrough bleeding & contraceptive failure w/ OCs. Increased metabolism/lower serum levels & reduced effect of phenobarb. Lower serum levels by phenytoin, fosphenytoin. Increased primidone levels.
MIMS Class
Parenteral Nutritional Products / Vitamins &/or Minerals
ATC Classification
A11BA - Multivitamins, plain ; Used as dietary supplements.
Presentation/Packing
Form
Cernevit infusion
Packing/Price
((5 mL)) 10 × 1's
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