Cernevit Injection
Out of date information, search anotherPRODUCT SUMMARY
1. NAME OF THE MEDICINAL PRODUCT Cernevit.
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Each vial of powder contains: | |
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Retinol palmitate |
3500IU |
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Colecalciferol |
220 IU |
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DL-a-tocopherol |
10.20 mg |
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Ascorbic acid |
125 mg |
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Cocarboxylase tetrahydrate |
5.80 mg |
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Riboflavin dihydrated sodium phosphate |
5.67 mg |
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Pyridoxine hydrochloride |
5.50 mg |
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Cyanocobalamin |
6 Pg |
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Folic acid |
414 pg |
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Dexpanthenol |
16.15 mg |
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D-Biotin |
69 pg |
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Nicotinamide |
46 mg |
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equivalent to: | |
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Vitamin A (Retinol) |
3500 IU |
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Vitamin D3 |
220 IU |
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Vitamin E (a tocopherol) |
11.20 IU |
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Vitamin C |
125 mg |
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Vitamin B1 (thiamine) |
3.51 mg |
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Vitamin B2 (riboflavin) |
4.14 mg |
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Vitamin B6 (pyridoxine) |
4.53 mg |
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Vitamin B12 |
6 Pg |
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Folic Acid |
414 pg |
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Pantothenic acid |
17.25 mg |
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Biotin |
69 pg |
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Vitamin PP (niacin) For the full list of excipients, see section 6.1. |
46 mg |
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion
CLINICAL PARTICULARS
4.
4.1. Therapeutic indications
Supply of vitamins corresponding to the daily needs of adults and children over 11 years requiring multi-vitamin supplementation by the parenteral route when oral nutrition is contraindicated, impossible or insufficient (e.g. due to malnutrition, gastrointestinal malabsorption, parenteral nutrition, etc).
4.2 Posology and method of administration
Dosage
Adults and children aged over 11 years: 1 vial/day.
Administration
Method of Reconstitution
See 6.6 Instruction for use and handling Method of administration
Intravenous route: Using a syringe, inject 5 ml of water for injections into the vial. Mix gently to dissolve the lyophilised powder.
By slow intravenous injection (at least 10 minutes) or by infusion in, for example, isotonic saline or glucose solution.
Cernevit may be included in the composition of nutritive mixtures combining carbohydrates, lipids, amino acids and electrolytes provided that compatibility and stability have been confirmed for each nutritive mixture.
4.3. Contra-indications
Pre-existing hyper-vitaminosis or known hypersensitivity to any of the active constituents, in particular patients with hypersensitivity to thiamine (Vitamin B1).
4.4. Special warnings and special precautions for use
Precautions and Warnings
4.4.1 Due to the presence of Vitamin A (retinol) in this preparation, caution should be exercised when administering Cernevit to patients who may be receiving vitamin A from other sources.
4.4.2 Following IV bolus injection, a moderate rise only in SGPT transaminases has been noted in some patients with active inflammatory enterocolitis. increased levels are rapidly reversible following the interruption of administration. It is advisable to monitor transaminase levels in patients of this type.
4.4.3 Also, in the case of impaired kidney function, lipid-soluble vitamin levels should be carefully monitored.
4.4.4 Cernevit does not contain Vitamin K. Vitamin K must be administered separately if necessary.
4.5. Interaction with other medicinal products and other forms of interaction
4.5. 1 The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.
4.5.2 The dosage of drugs known to be influenced by folic acid, for example phenytoin, must be carefully monitored.
4.5.3 Folic Acid may obscure pernicious anaemia.
4.6. Pregnancy and lactation
In the absence of studies, it is considered inadvisable to administer this product to pregnant and lactating women.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
4.8.1 Because of the presence of Vitamin B1, anaphylactic reactions may occur in subjects with underlying allergy (c.f contraindications).
4.8.2 Elevation of SGPT transaminases following IV bolus injections in some patients (c.f. special warnings and special precautions for use).
Overdose
4.9.
Manifestations of Vitamin A hypervitaminosis and Vitamin D hypervitaminosis (symptomatology related to hypercalcaemia) are possible in case of prolonged administration of significant doses of these vitamins.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Balanced association of all water soluble and fat soluble, vitamins essential for the metabolism of the adult and the child aged over 11 years, with the exception of Vitamin K.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Pre-clinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycine
Glycocholic acid Soybean phosphatides Sodium hydroxide Hydrochloric acid, Concentrated
Incompatibilities
6.2
• In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
• Additives may be incompatible with parenteral nutrition containing Cernevit.
• If co-administration of drugs that are incompatible at the Y-site is necessary, administer via separate IV lines.
• Vitamin A and thiamine in Cernevit may react with bisulfites in parenteral nutrition solutions (e.g., as a result of admixtures) leading to degradation of vitamin A and thiamine.
• An increase in pH of a solution may increase the degradation of some vitamins. This should be considered when adding alkaline solutions to the admixture containing Cernevit.
• Folic acid stability can be impaired with increased calcium concentrations in an admixture.
6.3 Shelf life
Unopened: 2 years.
Chemical and Physical in-use stability has been demonstrated for Cernevit for 24 hours when reconstituted with 5ml of Water for Injections and stored under refrigeration. From a microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution etc has taken place in controlled and validated aseptic conditions.
6.4 Special precautions for storage
Do not store above 25°C
Keep the vial in the outer carton.
6.5 Nature and contents of container
Type I Ph.Eur. brown glass vial with an elastomer stopper, containing an orange-yellow sterile cake of powder.
Box of 1, 10 or 20 vials of lyophilised powder
Not all pack sizes may be marketed
6.6 Special precautions for disposal
Aseptic conditions must be followed during reconstitution and when used as part of an admixture in parenteral nutrition.
Using a syringe, inject 5 ml of water for injections, or 5% glucose solution or 0.9% sodium chloride solution into the vial. The obtained solution is yellow-orange in colour.
Mix gently to dissolve the lyophilized powder.
Before transfer from the vial, Cernevit must be completely dissolved.
Do not use unless the reconstituted solution is clear, the original seal is intact and the container is undamaged.
After addition of Cernevit to a parenteral nutrition solution, check for any abnormal colour change and/or the appearance of precipitates, insoluble complexes, or crystals.
Mix the final solution thoroughly when Cernevit is used as an admixture in parenteral nutrition.
Single use only. Any unused portion of reconstituted Cernevit should be discarded and should not be stored for subsequent admixing.
Use of a final filter is recommended during administration of all parenteral nutrition solutions.
7. MARKETING AUTHORIZATION HOLDER
Baxter Healthcare Ltd.,
Caxton Way,
Thetford,
Norfolk,
1P24 3SE, United Kingdom.
8. MARKETING AUTHORIZATION NUMBER(S)
PL 00116/0305.
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Granted 29.09.97.
10 DATE OF REVISION OF THE TEXT
30/09/2014