Composition:

Each vial contains:

Retinol 3,500 IU, Cholecalciferol 220 IU, Alphatocopherol 11.2 IU, Ascorbic acid 125 mg, Thiamine 3.51 mg, Riboflavine 4.14 mg, Pyridoxine 4.53 mg, Cyanocobalamine 0.006 mg, Folic acid 0.414 mg, Pantothenic acid 17.25 mg, Biotin 0,069 mg, Nicotinamide 46 mg. Excipients: Glycine 250 mg, Glycocholic acid 140 mg, Soya Lecithin 112,5 mg, Sodium hydroxide q.s, Hydrochloric acid q.s. pH=5.9.

Dosage form:

Lyophilised, orange-yellow, sterile powder

Description:

CERNEVIT is a multivitamin preparation of both water soluble and fat soluble vitamins (except vitamin K) combined with mixed micelles (glycocholic acid and lecithin). Redresses the body's vitamin requirements which may be diminished due to various stress situations (trauma, surgery, burns, infections) which are likely to slow the healing process.

Indications:

CERNEVIT is indicated when the daily requirements of vitamins are required to be given to the patient by the parenteral route because oral administration is either contraindicated, impossible or insufficient (e.g due to malnutrition, gastrointestinal malabsorbtion, etc).

Dosage:

Adults and children over 11 years of age: one vial per day. 5 mL of water for injections should first be added by syringe into the vial and gently mixed to dissolve the lyophilised powder. The resultant solution should then be administered by slow intravenous injection (at least 10 minutes) or by infusion in either isotonic saline or glucose solution. CERNEVIT may be included in the composition of parenteral nutrition mixtures. It is presented as an odourless orange-yellow lyophilised cake of sterile powder to be reconstituted with 5 mL of water for injection or Sodium Chloride 5%, glucose or nutrition mixture solution prior to parenteral administration. When reconstituted with water for injection, the solution has a pH of approximately 5.9.

Contraindications:

Hypervitaminosis, hypersensitivity.

Warning and attentions:

• Anaphylactic reactions may occur in allergic subjects.

• Patients who may be receiving vitamin A from other sources.

• It is advisable to monitor transaminase levels in patient with active inflammatory enterocolitis.

• In the case of impaired kidney function, lipid soluble vitamin levels should be carefully monitored.

• If vitamin K is required by the patient, it must be administered separately.

• Pregnancy & lactation.

Drugs Interaction:

• Phenytoin, levodopa, calcium salts vtamin K bisulfite, some antibiotics.

• Direct addition of CERNEVIT to intravenous fat emulsions is not recommended

Adverse reaction:

Allergic reactionsheadache, dizziness, agitation.

Storage:

Store below 25°C. Protect from heat and light. Reconstituted solution should be used immediately or stored under refrigeration (2°-8°C) for no more than 24 hours.

Packaging:

Box contains 1 vial 750 mg.

FAQ

Pharmacology

What does CERNEVIT contain?

CERNEVIT contains 9 types of water soluble vitamins (B1, B2, B3, B5, B6, B7 or biotin, B9 or folic acid, B12, C) and 3 types of fat soluble vitamins (A, D, E)

What are the benefits of glycin in CERNEVIT?

Glycin functions to accelerate the reconstitution / dissolving of CERNEVIT.

Why doesn't CERNEVIT contain vitamin K?

Because in order not to interact with anticoagulant drugs, it can still be given to patients who are receiving anticoagulant therapy. In patients who require vitamin K therapy, vitamin K can be given with CERNEVIT separately.

Indication/Use

What cases can CERNEVIT use?

CERNEVIT can be given as a daily multivitamin for patients receiving parenteral nutrition and as a multivitamin in patients on intravenous therapy (post-surgery, extensive burns, fractures, infections, etc.)

How to Give/Use

How is CERNEVIT administered?

CERNEVIT is given to adults and children over 11 years of age at a dose of 1 vial per day. CERNEVIT can be given by intravenous bolus slowly (10 minutes) and by intravenous infusion.

What is the maximum dose of CERNEVIT?

CERNEVIT is sufficient to give 1 vial per day.

What solvent is CERNEVIT reconstituted from?

Before being administered, CERNEVIT was reconstituted / diluted with 5 mL of aqua pro injection.

If given intravenously, is CERNEVIT diluted with any solvent?

CERNEVIT is reconstituted first with 5 mL of aqua pro injection, then mixed into infusion solutions, such as 0.9% NaCl, 5% Dextrose, and parenteral nutrients such as a mixture of carbohydrates, amino acids and fats, which have been tested for compatibility and stability. CERNEVIT is not recommended to mix directly into fat emulsions. Cernevit is also not recommended to be mixed with RL infusion solutions or solutions containing calcium / magnesium because there is a risk of sedimentation and has not been tested for compatibility and stability.

If given intravenously, what is the rate of CERNEVIT infusion?

CERNEVIT infusion is given according to the infusion rate of the solvent, the fastest is 1 hour, the maximum is 24 hours.

If given intravenously, how long does it take for CERNEVIT to be fully infused?

CERNEVIT should be infused as soon as 1 hour and should be finished within 24 hours.

When CERNEVIT is being infused, should the infusion bottle be wrapped to avoid sunlight?

The CERNEVIT infusion bottle does not need to be closed unless it is exposed to direct sunlight through a window.

Can CERNEVIT be mixed with other drugs (or supplements)?

CERNEVIT is not recommended to be mixed with other drugs or supplements.

How long is CERNEVIT safe to administer?

There are studies that give CERNEVIT 1 vial per day for 90 days without finding any hypervitaminosis.

Special Patients/Cautions

Can CERNEVIT be given to children?

There have been no studies on the safety of using CERNEVIT in children 11 years of age or younger. If it is absolutely necessary, after considering the benefits and risks, and with the supervision of a doctor, CERNEVIT can be given to children aged 11 years or less at a dose of 0.8 mL / kgBW / day with a maximum dose of 1/2 vial per day.

How is CERNEVIT used in elderly patients?

CERNEVIT can be given to elderly patients.

Can CERNEVIT be given to pregnant women?

There are no safety studies on the use of CERNEVIT in pregnant women. However, if it is absolutely necessary, after considering the benefits and risks, and with the supervision of a doctor, CERNEVIT can be given to pregnant women. Be careful giving vitamin A to pregnant women. Excessive provision of vitamin A to pregnant women (> 10,000 IU) can have a teratogenic risk.

Can CERNEVIT be given to breastfeeding mothers?

It is not recommended to use CERNEVIT in nursing mothers.

How is CERNEVIT used in patients with impaired liver function?

CERNEVIT is well tolerated in patients with liver disease on repeated doses.

How is CERNEVIT used in patients with impaired renal function?

CERNEVIT administration with caution in impaired renal function. Need to monitor vitamin levels.

Drug Interactions

What are the drug interactions with CERNEVIT?

Pyridoxine (vitamin B6) in CERNEVIT might decrease the effects of levodopa. The folic acid and pyridoxine in CERNEVIT can affect phenytoin and phenobarbital levels. Folic acid is also unstable in the presence of calcium salts, such as calcium gluconate. Some of the vitamins (vitamins A, B1, C) in Cernevit can react with vitamin K bisulfite. Vitamins B12 and C can inactivate bleomycin. Be careful when adding cations (Ca ++, Mg ++) because it can cause emulsion instability.

Side Effects

What are the commonly reported side effects of CERNEVIT?

Although rare, a side effect that has been reported is an allergic reaction.

Storage

How is CERNEVIT storage?

Prior to reconstitution, CERNEVIT was stored in a box at room temperature (<30 degrees Celsius).

After being reconstituted, can CERNEVIT still be stored before giving it to a patient?

Once reconstituted, CERNEVIT can be stored in the refrigerator (2-8 degrees Celsius) for a maximum of 24 hours.

Dosage and Packaging Form

What is the dosage form for CERNEVIT?

750 mg of lyophilized powder cake orange yellow in a chocolate vial.