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Cernevit (10 vials)

Cernevit (10 vials)

Cernevit

Pharmaceutical Product
  • Licensed prescription Only medicine (POM) in multiple countries with approved Summary of Product Characteristics for use as a multivitamin in parenteral nutrition.
  • Manufactured in accordance with Good Manufacturing Practice (GMP) standards for sterile parenteral pharmaceutical products.
  • Formulation and quality specifications aligned with international guidelines for parenteral micronutrient supplementation in adults and children over 11 years.
Parenteral multivitamin powder for solution for injection/infusion

Description

Cernevit is a sterile, lyophilised, parenteral multivitamin preparation from Baxter, supplied as a powder for solution for injection or infusion. Each single-dose vial contains a combination of 12 essential water-soluble and fat-soluble vitamins (except vitamin K) formulated with mixed micelles (glycocholic acid and lecithin) to allow both vitamin groups to be solubilised in one vial. After reconstitution with 5 ml of Water for Injections or compatible infusion fluids, Cernevit is administered intravenously as part of parenteral nutrition regimens to supply the daily vitamin requirements of adults and children over 11 years of age when oral or enteral intake is contraindicated, impossible or insufficient.

Bnefits

  • Provides 12 essential vitamins (9 water-soluble and 3 fat-soluble, excluding vitamin K) in a single daily-dose vial for parenteral use.
  • Formulated with mixed micelles (glycocholic acid and lecithin) to combine water-soluble and lipid-soluble vitamins in one preparation, simplifying prescribing and administration.
  • Supports daily vitamin requirements in patients receiving parenteral nutrition when oral or enteral intake is not possible or inadequate.
  • Suitable for adults and children over 11 years who require multivitamin supplementation by the intravenous route.
  • Lyophilised powder for reconstitution, giving good stability and convenient storage prior to use.
  • Can be added to standard parenteral nutrition admixtures or administered by slow intravenous injection/infusion, offering flexibility of use in hospital settings.
  • Manufactured by Baxter, a long-established global company specialising in parenteral nutrition products and injectable therapies.

Indications

  • Supply of vitamins corresponding to the daily needs of adults and children over 11 years requiring multivitamin supplementation by the parenteral route.
  • Indicated when oral or enteral nutrition is contraindicated, impossible or insufficient (e.g. due to malnutrition, gastrointestinal malabsorption, severe illness, or when patients are receiving total parenteral nutrition).
  • Used as part of complete parenteral nutrition regimens, usually in combination with amino acids, lipids, carbohydrates, electrolytes and trace elements.

Composition

  • Each vial of lyophilised powder contains the following active ingredients (values approximate per official SmPC):
  • Retinol palmitate (vitamin A) corresponding to retinol 3500 IU.
  • Cholecalciferol (vitamin D3) 220 IU.
  • DL-α-tocopherol (vitamin E) 10.2 mg (≈11.2 IU).
  • Ascorbic acid (vitamin C) 125 mg.
  • Cocarboxylase tetrahydrate 5.8 mg (corresponding to thiamine/vitamin B1 3.51 mg).
  • Riboflavin dihydrated sodium phosphate 5.67 mg (corresponding to riboflavin/vitamin B2 4.14 mg).
  • Pyridoxine hydrochloride (vitamin B6) 5.5 mg (corresponding to pyridoxine 4.53 mg).
  • Cyanocobalamin (vitamin B12) 6 micrograms.
  • Folic acid 414 micrograms.
  • Dexpanthenol 16.15 mg (pro-vitamin B5).
  • D-Biotin 69 micrograms.
  • Nicotinamide (vitamin PP/niacinamide) 46 mg.
  • Excipients include glycine, glycocholic acid, soybean phosphatides (soy lecithin) and small amounts of sodium hydroxide or hydrochloric acid for pH adjustment; sodium content is approximately 24 mg (1 mmol) per vial.

Formulation

  • Pharmaceutical form: lyophilised sterile powder for solution for injection or infusion.
  • After reconstitution with 5 ml of Water for Injections or compatible infusion solutions, the preparation is administered by slow intravenous injection or infusion, or added to a parenteral nutrition admixture.
  • Contains both water-soluble and fat-soluble vitamins (no vitamin K) combined in a micellar system.
  • Prescription-only medicine used in hospital and clinical settings as part of parenteral nutrition.

Packaging

  • Brown/amber glass single-dose vials containing an orange-yellow cake of lyophilised powder.
  • Pack size: carton containing 10 vials (Cernevit 10-vial pack), as supplied by Teleta and other distributors; other pack sizes such as 1 or 20 vials may exist but may not be marketed in all regions.
  • Each vial is intended for single use after reconstitution and must be discarded after opening and administration.
  • Outer carton labelled with product name (Cernevit), description (powder for solution for injection or infusion), manufacturer (Baxter), batch number, expiry date, storage instructions and legal category.

Usage

  • Use only under the supervision of a physician experienced in parenteral nutrition.
  • Reconstitute the contents of one vial immediately before use by adding 5 ml of Water for Injections or other compatible infusion fluid, following aseptic technique.
  • After complete dissolution of the lyophilised cake, the solution may be:
  • - Injected slowly intravenously over at least 10 minutes, or
  • - Added to a suitable infusion solution such as 0.9% sodium chloride, 5% glucose, or a parenteral nutrition admixture (compatibility and stability must be confirmed), and infused intravenously.
  • The usual maintenance dose in adults and children over 11 years is one vial per day, but the exact regimen is determined by the prescribing physician based on the patient’s clinical condition and nutritional needs.
  • Do not mix Cernevit in the same syringe or infusion container with other medicinal products unless compatibility has been established.
  • Inspect the reconstituted solution visually; only clear, particle-free solutions should be used.
  • Use immediately after reconstitution; discard any unused portion in accordance with local requirements for medical waste.
  • Cernevit must not be administered undiluted by rapid intravenous injection or by the intramuscular or subcutaneous route.

Contraindications

  • Known hypersensitivity to any of the active vitamins or excipients, including soybean phosphatides (soy lecithin), glycocholic acid or other components.
  • Known hypersensitivity to peanut or soy, because of the presence of soybean-derived phosphatides; product is not suitable for patients with nut/peanut/soy allergies.
  • Hypervitaminosis of any fat-soluble vitamin present in the formulation (e.g. vitamin A, D or E).
  • Severe cholestasis or significant disorders of fat metabolism where administration of fat-soluble vitamins is contraindicated.
  • Use in neonates or children under 11 years of age (standard Cernevit formulation is indicated only for adults and children >11 years unless otherwise specified in local product information).
  • Any other contraindications listed in local Summary of Product Characteristics or patient information leaflets.

Adverse Effects

  • Hypersensitivity reactions, including rash, pruritus, urticaria or, rarely, more severe reactions such as bronchospasm or anaphylactoid reactions, especially in patients with known allergy to any component.
  • Injection- or infusion-related reactions such as pain, warmth, redness, irritation or phlebitis at the injection site.
  • Flushing, headache, nausea or vomiting, particularly if administered too rapidly or in sensitive individuals.
  • Dizziness, malaise or fever-like symptoms in rare cases.
  • Laboratory changes related to vitamin supplementation (e.g., alterations in certain biochemical tests), typically of limited clinical significance when used at recommended doses.
  • Very high or inappropriate dosing may contribute to hypervitaminosis of fat-soluble vitamins, especially in patients with pre-existing vitamin accumulation or hepatic dysfunction.
  • Any suspected adverse reactions should be reported and evaluated according to local pharmacovigilance requirements.

Storage Conditions

  • Store in the original carton to protect from light.
  • Do not store above 25°C, unless otherwise specified in the local product literature.
  • Do not freeze.
  • Keep vials dry and in their outer packaging until time of use.
  • Keep out of the sight and reach of children.
  • After reconstitution, use immediately; do not store reconstituted solutions unless stability for a particular admixture has been formally demonstrated and is supported by local guidelines.

Duration

The duration of Cernevit therapy is determined by the treating physician and is usually continued for as long as the patient requires parenteral nutrition or parenteral multivitamin supplementation; this may range from a few days to prolonged periods in chronically ill or long-term parenterally fed patients.

Onset

Vitamin supplementation begins as soon as the reconstituted preparation is infused and systemic distribution occurs. Clinical effects relate to correction or prevention of vitamin deficiencies and may not produce an immediate subjective change; normalization of biochemical markers and improvement in deficiency symptoms occurs over days to weeks depending on baseline status.

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