CERNEVIT Uses, Dosage, Side Effects, Precautions & Warnings

Generic Drug Class Drug: Anesthesia, resuscitation, analgesic
active ingredients: retinol , cholecalciferol , Alpha-tocopherol (E307) , ascorbic acid (E300) , Thiamine , Riboflavin (E101) , Pyridoxine , Cyanocobalamin , Folic Acid , Pantothenic Acid , Biotin , Nicotinamide

what is CERNEVIT ?

CERNEVIT is a balanced mixture of water-soluble (water-soluble) and fat-soluble (fat-soluble) vitamins allowing vitamin supplementation, during parenteral nutrition for adults and children over 11 years old.

PRESENTATION (S) AVAILABLE FOR CERNEVIT

6 presentations are available for this medication:

• 1 amber glass vial (s)
• 1 amber glass vial (s) with transfer device (s)
• 10 amber glass vial (s)
• 10 amber glass vial (s) with transfer device (s)
• 20 amber glass bottle (s)
• 20 amber glass vial (s) with transfer device (s)

FEATURE	DESCRIPTION
Pharmaceutical class	blood derivatives and various infusions
Active substance (s)	for 1 vial of 5 ml: biotin (0.069 mg), riboflavin sodium phosphate dihydrate (5.67 mg), alpha-tocopherol (11.200 IU), ascorbic acid (125 mg), folic acid (0.414 mg), cholecalciferol (220 IU), cyanocobalamin (0.006 mg), dexpanthenol (16.15 mg), nicotinamide (46 mg), pyridoxine hydrochloride (5.5 mg), retinol palmitate, cocarboxylase tetrahydrate (5.8 mg)
General medicine	no
Pharmaceutical form	powder for solution for injection or infusion
Route (s) of administration	intravenous
Social security reimbursement rate	65%
Laboratory (s)	BAXTER SA
Conditions of issue	available by simple prescription

CERNEVIT Dosage

Dosage

• The usual daily dose is one 5 ml vial.

Administration mode

• Strict intravenous use.
• After reconstitution, administer by slow intravenous injection (at least ten minutes) or by infusion in 5% glucose or 0.9% sodium chloride solution.
• CERNEVIT can be used in the composition of nutrient mixtures, combining carbohydrates, lipids, amino acids, electrolytes, provided that the compatibility and stability have been checked beforehand in the case of each nutrient mixture used.

Reconstitution technique

CERNEVIT (bottle without BIO-SET)

• Using a syringe, inject 5 ml of water for injections or 5% glucose or 0.9% sodium chloride solution into the vial.
• Shake lightly to dissolve the powder.
• The solution obtained is yellow-orange in color.

CERNEVIT BIO-SET

CERNEVIT BIO-SET allows direct reconstitution in the bags (single or multi-compartment plastic bags) including a supplementation site.

Single pocket:

1. Remove the cap by turning it then pulling it to break the safety ring.
2. Directly connect the BIO-SET to the supplementation site of the bag
3. Apply pressure on the transparent mobile part of the BIO-SET to puncture the rubber stopper of the bottle.
4. Hold the connected system (CERNEVIT BIO-SET / infusion bag) in a vertical position, with the bag on top. Gently squeeze the infusion bag several times to transfer solution to the vial (approximately 5 ml). Shake the vial to dissolve CERNEVIT.
5. Turn the connected system over, holding it vertically with the pocket at the bottom. Gently squeeze the infusion bag several times to force air from the top of the bag into the vial, allowing the solution to return to the infusion bag
6. Repeat instructions 4 and 5 until the bottle is empty.
7. Remove the CERNEVIT BIO-SET vial and throw it away.
8. Mix gently

Multi-compartment pocket:

The reconstitution of CERNEVIT BIO-SET must be carried out before reconstitution of the multi-compartment bag (before opening the non-permanent seals and before mixing the contents of the compartments)

1. Place the multi-compartment pocket on a work surface.
2. Remove the CERNEVIT BIO-SET cap by turning it then pulling it to break the safety ring.
3. Directly connect the BIO-SET to the supplementation site of the multi-compartment bag
4. Apply pressure on the transparent mobile part of the BIO-SET to puncture the rubber stopper of the bottle.
5. Hold the vial vertically with the upper part up. Gently squeeze the compartment several times to transfer solution to the vial (approximately 5 ml). Shake the vial to dissolve CERNEVIT.
6. Turn the connected system over, holding the vial vertically upside down. Gently squeeze the compartment several times to pass air from the top of the compartment into the vial allowing the solution to return to the infusion bag
7. Repeat steps 5 and 6 until the vial is empty.
8. Remove the CERNEVIT BIO-SET vial and discard it.
9. Finally, reconstitute the multi-compartment pocket
10. Mix by inverting the bag at least 3 times

Warning :

• Take care that the BIO-SET does not disconnect from the supplementation site during the entire reconstitution process.

Frequency of administration and duration of treatment

• Administration can be continued for the duration of parenteral nutrition.
• Comply with medical advice.

CERNEVIT Contraindications

CERNEVIT should not be used:

• In case of hypersensitivity to the active ingredients, in particular to vitamin B1 or to excipients.
• In newborns, infants and children under 11 years old.

how does CERNEVIT work?

Pharmacotherapeutic group: ADDITIVES FOR INTRAVENOUS SOLUTIONS / VITAMINS

ATC code: B05XC

(B: Blood and hematopoietic organs)

CERNEVIT is a balanced combination of water-soluble and fat-soluble vitamins covering daily needs during parenteral nutrition.

The pharmacodynamic properties of CERNEVIT are those of each of the 12 vitamins included in its composition. The main properties are as follows:

1. Vitamin A : Involved in the processes of cell growth and differentiation, and in the physiological mechanisms of vision.
2. Vitamin D : Regulation of the metabolism of calcium and phosphorus in the bones and kidneys.
3. Vitamin E : Antioxidant properties preventing the formation of toxic oxidation products and protecting cellular constituents.
4. Vitamin B 1 : (thiamine) In association with ATP, formation of a coenzyme involved in the metabolism of carbohydrates.
5. Vitamin B 2 : (riboflavin) Coenzyme action in cellular energy metabolism, tissue respiration systems and macronutrient metabolism.
6. Vitamin B 3 : (PP) Component of the NAD and NADP coenzymes involved in redox reactions essential for macronutrient metabolism and tissue respiration.
7. Vitamin B 5 : (pantothenic acid) Precursor of coenzyme A involved in the oxidative metabolism of carbohydrates, gluconeogenesis and the synthesis of fatty acids, sterols, steroid hormones and porphyrins.
8. Vitamin B 6 : (pyridoxine) Coenzyme in the metabolism of proteins, carbohydrates and fats.
9. Vitamin B 12 : Exogenous source necessary for the synthesis of nucleoproteins and myelin, cell reproduction, growth and maintenance of normal erythropoiesis.
10. Vitamin C : Antioxidant properties, essential for the formation and maintenance of intercellular substances and collagen, the biosynthesis of catecholamines, the synthesis of carnitine and steroids, the metabolism of folic acid and tyrosine.
11. Folic acid : An exogenous source necessary for the synthesis of nucleoproteins and the maintenance of normal erythropoiesis.
12. Biotin : Linked to at least four enzymes, involved in energy metabolism including gluconeogenesis.

How To Store CERNEVIT ?

• Keep this medication out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date refers to the last day of that month.
• Store at a temperature not exceeding 25 ° C.
• Store the vial in the outer carton.
• After reconstitution, physico-chemical stability has been demonstrated for 24 hours at 25 ° C. From a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, storage time and conditions after reconstitution and before use are the sole responsibility of the user and should not normally exceed 24 hours at 2 ° C to 8 ° C, unless reconstitution has taken place in controlled and validated asepsis conditions.
• Do not throw away any medicine at all or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

CERNEVIT Side Effects

Adverse reactions occurring after administration of CERNEVIT are presented by their relative frequency; these include adverse reactions documented in clinical trials and those reported post-marketing. The frequencies of adverse reactions are described using the following convention: very common (≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥ 1 / 1,000, <1/100); rare (≥ 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); and not known (cannot be estimated from the available data).

Adverse reactions related to CERNEVIT, reported in clinical trials and after marketing:

System organ class	MedDRA preferred term	Frequency
Immune system disorders	Hypersensitivity reactions manifested by chest discomfort, rash, urticaria, erythema, anaphylactic shock	indeterminate
Hepatobiliary disorders	Increased liver enzymes (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, alkaline phosphatase)	indeterminate

Hypersensitivity reactions to the components of CERNEVIT are mainly due to allergic reactions to vitamin B1. Their intensity can vary from moderate to severe.

CERNEVIT Interactions

Use of other drugs

• Due to the presence of pyridoxine in CERNEVIT, the combination with levodopa requires precautions for use.
• Due to the presence of folic acid in CERNEVIT, the combination with anticonvulsant drugs containing phenobarbital, phenytoin, or primidone requires precautions for use.
• If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

Drive and use machines

• There is no information available on the effects of CERNEVIT on the ability to drive and use machines.
• CERNEVIT contains soya lecithin as an excipient.

Warnings and Precautions

Special warnings

Hypersensitivity reactions

• Systemic hypersensitivity reactions to constituents of CERNEVIT, mild to severe, have been reported (including vitamins B1, B2, B12, folic acid and soy lecithin) (see Adverse Effects).
• Allergic cross reactions between soybean and peanut proteins have been observed.
• The infusion or injection should be stopped immediately if signs or symptoms of a hypersensitivity reaction develop.

Vitamin toxicity

• The patient’s clinical condition and blood levels of vitamins should be closely monitored to avoid overdose and toxic effects, especially vitamins A, D and E and especially in patients receiving vitamin supplementation from other sources or that use other agents that increase the risk of vitamin toxicity.
• Monitoring is particularly important in patients receiving long-term supplementation.

Hypervitaminosis A:

• The risk of hypervitaminosis A and toxicity of vitamin A (eg., Abnormalities of skin and bones, diplopia, cirrhosis) is increased, for example, in patients with protein malnutrition, kidney failure (even lack of vitamin A supplementation), hepatic insufficiency, short stature (eg, pediatric population) and in patients on chronic treatment.
• An acute liver disease in patients with liver stores of vitamin A saturated may lead to the manifestation of toxicity of vitamin A.

Hypervitaminosis D:

• Excessive vitamin D intake can cause hypercalcemia and hypercalciuria.
• The vitamin D toxicity risk is increased in patients with a disease and / or disorders causing hypercalcemia and / or hypercalciuria, or in chronic vitamin treatment in patients.

Hypervitaminosis E:

• Although very rare, excessive doses of vitamin E can lead to slow healing due to platelet dysfunction and blood clotting abnormalities.
• The risk of vitamin E toxicity is increased in patients with hepatic impairment, a bleeding disorder or treated with oral anticoagulants or with vitamin treatment on chronic patients.

Precautions for use

Liver effects:

• Monitoring of liver function parameters is recommended in patients receiving CERNEVIT. Particularly close monitoring is recommended in patients with hepatic jaundice or other signs of cholestasis.
• Elevations of liver enzymes have been reported in patients receiving CERNEVIT including isolated cases of increased alanine aminotransferase (ALT) levels in patients with inflammatory bowel disease (see Adverse effects).
• In addition, increased bile acid levels (individual and total bile acids, glycocholic acid) have been reported in patients receiving CERNEVIT.
• Due to the presence of glycocholic acid, repeated and prolonged administration in patients with significant hepatic jaundice or cholestasis biochemically requires attentive monitoring of liver function.
• Disorders of the Hepatobiliary cholestasis, hepatic steatosis, fibrosis and cirrhosis, which can lead to liver failure, as well as cholecystitis and biliary stones are known to develop in some patients on parenteral nutrition (particularly during parenteral nutrition supplemented with vitamin ). The etiology of these disorders is considered to be multifactorial and may vary depending on the patient. Patients who develop abnormal laboratory parameters or other signs of hepatobiliary disorders should be evaluated promptly by a hepatic disease physician to identify possible causes and factors as well as possible therapeutic and prophylactic interventions.

Use in patients with impaired liver function

• Patients with liver problems may require individualized vitamin supplementation.
• Particular attention should be paid to preventing vitamin A toxicity as the presence of liver disease is associated with increased susceptibility to vitamin A toxicity, especially in association with excessive alcohol consumption. and chronic (see also hypervitaminosis A and hepatic effects above).

Use in patients with impaired renal function

• Patients with impaired renal function may require individualized vitamin supplementation, depending on the degree of renal impairment and the presence of a concomitant medical condition. In patients with severe renal impairment, special care should be taken to maintain adequate vitamin D levels and to prevent any toxicity from vitamin A.

General surveillance

• The total amounts of vitamins from all sources, such as nutritional sources, other vitamin supplements, or medicinal products containing vitamins as excipients (see section Interactions with other medicinal products and other forms of interaction) should be taken into account. .
• The patient’s clinical condition and vitamin levels should be monitored to ensure that appropriate levels are maintained.
• The sensitivity of some vitamins, especially vitamins A, B2 and B6, to ultraviolet rays (eg, direct or indirect sunlight) should be taken into account. In addition, losses of vitamins A, B1, C and E can increase with high oxygen levels in the solution. These factors should be considered if adequate vitamin levels are not achieved.
• Patients receiving parenteral multivitamin solutions as the sole source of vitamins for an extended period of time should be monitored to verify the adequacy of supplementation, including:
  • Vitamin A in patients with pressure ulcers, wounds, burns, a short gut syndrome or cystic fibrosis
  • Vitamin B1 in dialysis patients
  •  Vitamin B2 in patients with cancer
  •  Vitamin B6 in patients with renal impairment
  • The vitamins individual requirements may be increased due to interactions with other drugs (see Interactions with other drugs and other forms of interaction).
• A deficiency in one or more vitamins must be corrected by specific supplementation.
• CERNEVIT does not contain vitamin K, this should be administered separately if necessary.
• Use in patients with vitamin B12 deficiency.
• Assessment of vitamin B12 levels is recommended before starting supplementation with CERNEVIT in patients at risk of vitamin B12 deficiency and / or when supplementation is planned over several weeks.
• After several days of treatment, the individual amounts of cyanocobalamin (vitamin B12) and folic acid contained in CERNEVIT may be sufficient to cause an increase in the number of red blood cells, reticulocytes, and hemoglobin values ​​in some patients with megaloblastic anemia associated with vitamin B12 deficiency. This may mask an existing vitamin B12 deficiency which requires greater intakes of cyanocobalamin than those provided by CERNEVIT.
• When interpreting vitamin B12 levels, the possibility that recent vitamin B12 intakes may lead to normal levels, despite tissue deficiency, should be taken into account.

Interactions with laboratory tests

• Biotin can interfere with lab tests based on a biotin / streptavidin interaction, causing either a false decrease or a false increase in results, depending on the test. The risk of interference is higher in children and patients with renal impairment and increases with higher doses. When interpreting the results of laboratory tests, consideration should be given to possible biotin interferences, especially if inconsistency with the clinical picture is observed (for example, results of thyroid tests mimicking the Graves’ disease in asymptomatic patients taking biotin or false negative troponin test results in patients with myocardial infarction taking biotin). Alternative tests not susceptible to biotin interference should be used, if available, in cases where interference is suspected. Laboratory personnel should be consulted when ordering laboratory tests in patients taking biotin.

Ascorbic acid may interfere with the blood and urine glucose control systems (see section Interactions with other medicines and other forms of interactions)

Geriatric use

• In general, dose adjustments in elderly patients should be considered (dose reduction and / or dose interval prolongation) due to the greater susceptibility of these patients to have impaired hepatic, renal or cardiac function, concomitant pathologies and drug treatments.

Sodium content

• CERNEVIT contains 24 mg sodium (1 mmol) per vial. This should be taken into account if patients are on a controlled sodium diet.
• Compatibility must be tested before mixing with other solutions for infusion and, in particular, when adding CERNEVIT to bags of binary mixtures of parenteral nutrition, combining glucose, electrolytes and a solution of amino acids, as well as ternary mixtures combining glucose, electrolytes, a solution of amino acids and lipids (see sections Incompatibilities and Instructions for use, handling and disposal).

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

• CERNEVIT can be prescribed during pregnancy if necessary, in accordance with the indication and dosages in order to avoid vitamin overdose.
• Ask your doctor or pharmacist for advice before taking any medicine.

Feeding with milk

• The use of CERNEVIT is not recommended during breast-feeding because of the risk of overdose of vitamin A in the newborn.
• Ask your doctor or pharmacist for advice before taking any medicine.

What happens if I overdose from CERNEVIT ?

• Acute or chronic overdose of vitamins (especially A, B6, D and E) can cause symptomatic hypervitaminosis.
• The risk of overdose is particularly high if the patient is receiving multiple sources of vitamins and the overall vitamin supplementation does not match the patient’s individual needs; as well as in patients with increased sensitivity to hypervitaminosis .
• The signs resulting from an overdose of CERNEVIT are mainly those resulting from the administration of excessive doses of vitamin A.

Clinical signs of acute A overdose (doses greater than 150,000 IU):

• Digestive disorders, headache, intracranial hypertension, papillary edema, psychiatric disorders, irritability, even convulsions, delayed generalized desquamation.

Clinical signs of chronic intoxication (prolonged intake of vitamin A at supra-physiological doses in a non-deficient subject):

• Intracranial hypertension, cortical hyperostosis of long bones and early epiphyseal fusion. The diagnosis is generally made on the observation of tender or painful subcutaneous swelling in the extremities of the limbs. X-rays show a thickening of the periosteum on the diaphyseal area of ​​the ulna, fibula, collarbones and ribs.

Clinical signs of neurotoxic effects:

• Hypervitaminosis and toxicity (peripheral neuropathy, involuntary movements) of pyridoxine (vitamin B6) have been reported in patients receiving high doses for a prolonged period, and in chronic hemodialysis patients receiving polyvitamins, intravenously, containing 4 mg of pyridoxine, administered three times per week.

What to do in the event of acute or chronic overdose:

• Treatment of an overdose of CERNEVIT consists of stopping the administration of CERNEVIT, and taking additional measures according to the patient’s clinical condition, such as reduction of calcium intake, increased diuresis and rehydration. .

What should I do if I miss a dose?

• Not applicable.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse for more information.

What happens if you stop taking CERNEVIT ?

• Not applicable.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse for more information.

What is  Forms and Composition ?

Appearance and shape

CERNEVIT: COMPOSITION

Active substances

A 5 ml vial contains:

• Retinol (Vitamin A): 3500 IU

As retinol palmitate

• Cholecalciferol (Vitamin D3): 220 IU
• Alpha-tocopherol (Vitamin E): 11,200 IU
• Quantity corresponding to LD alpha-tocopherol: 10.200 mg
• Ascorbic acid (Vitamin C): 125,000 mg
• Thiamine (Vitamin B1): 3,510 mg
• In the form of cocarboxylase tetrahydrate: 5.800 mg
• Riboflavin (Vitamin B2): 4,140 mg
• As riboflavin sodium phosphate dihydrate: 5.670 mg
• Pyridoxine (Vitamin B6): 4,530 mg
• As pyridoxine hydrochloride: 5,500 mg
• Cyanocobalamin (Vitamin B12): 0.006 mg
• Folic acid (Vitamin B9): 0.414 mg
• Pantothenic acid (Vitamin B5): 17,250 mg
• In the form of dexpanthenol: 16,150 mg
• Biotin (Vitamin B8): 0.069 mg
• Nicotinamide (Vitamin PP): 46,000 mg

Other components

• Glycine, glycocholic acid, soy lecithin, sodium hydroxide, hydrochloric acid.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.