important information for the patient.
CERNEVIT is a powder for solution for injection and infusion.
It contains 12 vitamins:
Active substances | Equivalent to | ||
retinol palmitate | 3500 IU | vitamin A | 3500 IU |
cholecalciferol | 220 IU | vitamin D3 | 220 IU |
DL-α-tocopherol | 10.20 mg | vitamin E | 11.20 IU |
ascorbic acid | 125 mg | vitamin C | 125 mg |
co-carboxylase tetrahydrate | 5.80 mg | vitamin B1 (thiamine) | 3.51 mg |
sodium phosphate riboflavin | 5.67 mg | vitamin B2 (riboflavin) | 4.14 mg |
pyridoxine hydrochloride | 5.50 mg | vitamin B6 (pyridoxine) | 4.53 mg |
cyanocobalamin | 6 µg | vitamin B12 | 6 µg |
folic acid | 414 µg | folic acid | 414 µg |
dexpanthenol | 16.15 mg | pantothenic acid | 17.25 mg |
biotin | 69 µg | biotin | 69 µg |
niacinamide | 46 mg | vitamin PP | 46 mg |
CERNEVIT provides vitamins to patients receiving parenteral nutrition (through an IV).
Before starting CERNEVIT, tell your doctor, pharmacist or nurse:
Tell your doctor or pharmacist about all medicines the patient is taking now or recently, and about medicines the patient plans to take, including those available without a prescription.
Be especially careful if the patient is taking any of the following types of medicines:
Laboratory test disturbances
Cernevit contains 69 micrograms of biotin per 5 ml. If the patient is to undergo laboratory tests, they must inform their doctor or laboratory staff that they have recently taken Cernevit, as biotin may interfere with the results of such tests. Depending on the test, the results may be falsely elevated or falsely low due to biotin. The doctor may order the patient to stop taking Cernevit before undergoing laboratory tests. It should also be remembered that other products that may be taken, such as multivitamin preparations or dietary supplements used to improve hair, skin and nails, may also contain biotin and affect laboratory test results. If the patient is taking such products, they should inform their doctor or laboratory staff.
If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
If necessary, this medicine may be given to a pregnant woman under strict adherence to indications and dosage to avoid overdose of vitamins.
Breastfeeding
Administration of CERNEVIT during breastfeeding is not recommended.
If the patient is breastfeeding and also receiving CERNEVIT, there is a risk of vitamin A overdose in the child.
Fertility
There is no available data on the effect of CERNEVIT on fertility in men or women.
CERNEVIT will be administered by medical staff. It is usually given as an intravenous infusion.
The recommended dose is 1 vial per day.
In this case, the symptoms of CERNEVIT overdose are mainly symptoms related to vitamin A overdose:
If any of the above overdose symptoms are observed, the doctor should be informed. The doctor may discontinue the CERNEVIT infusion.
In case of any further doubts related to the use of this medicine, the doctor, pharmacist or nurse should be consulted.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are common and occur in 1 to 10 out of 100 patients:
The following side effects are rare and occur in 1 to 10 out of 1000 patients:
The following side effects occur with an unknown frequency:
The doctor should be informed immediately if symptoms of an allergic reaction occur, such as respiratory disorders, chest pain, throat swelling, urticaria, rash, skin redness, abdominal discomfort. The doctor will discontinue the infusion and take necessary measures.
If side effects occur, the doctor or nurse should be consulted.
This includes any side effects not listed in this leaflet.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 181C
PL 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
email: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.
The medicine should be stored out of sight and reach of children.
Store at room temperature, i.e. between 15°C and 25°C. Protect from light.
Store in the outer carton.
After reconstitution, the product retains chemical and physical stability for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately after reconstitution.
Otherwise, the time and conditions of storage until use are the responsibility of the person administering the product, and storage should not exceed 24 hours at 2-8°C, unless reconstitution was performed under controlled and validated aseptic conditions.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
1 vial of 5 ml contains:
Active substances | Equivalent to | ||
retinol palmitate | 3500 IU | vitamin A | 3500 IU |
cholecalciferol | 220 IU | vitamin D3 | 220 IU |
DL-α-tocopherol | 10.20 mg | vitamin E | 11.20 IU |
ascorbic acid | 125 mg | vitamin C | 125 mg |
co-carboxylase tetrahydrate | 5.80 mg | vitamin B1 (thiamine) | 3.51 mg |
sodium phosphate riboflavin | 5.67 mg | vitamin B2 (riboflavin) | 4.14 mg |
pyridoxine hydrochloride | 5.50 mg | vitamin B6 (pyridoxine) | 4.53 mg |
cyanocobalamin | 6 µg | vitamin B12 | 6 µg |
folic acid | 414 µg | folic acid | 414 µg |
dexpanthenol | 16.15 mg | pantothenic acid | 17.25 mg |
biotin | 69 µg | biotin | 69 µg |
niacinamide | 46 mg | vitamin PP | 46 mg |
IU = International Units
mg = milligrams
The other ingredients are: glycine, soy phospholipids, glycocholic acid, sodium hydroxide and hydrochloric acid.
CERNEVIT contains 24 mg of sodium (1 mmol) per vial. This should be taken into account in patients on a controlled sodium diet.
CERNEVIT is supplied in brown glass vials. To prepare the infusion solution, medical staff may use the BIO-SET system, which facilitates the dissolution of CERNEVIT.
CERNEVIT is available in packs of 10 or 20 vials, with or without the BIO-SET system.
Not all pack sizes may be marketed.
Baxter Polska Sp. z o.o.
Kruczkowskiego 8
00-380 Warsaw
Baxter SA
Boulevard René Branquart 80
7860 Lessines, Belgium
To obtain more detailed information, please contact the representative of the marketing authorization holder.
Baxter Polska Sp. z o.o.
Kruczkowskiego 8
00-380 Warsaw
phone: (22) 488 37 77
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1 vial of 5 ml contains:
Active substances | Equivalent to | ||
retinol palmitate | 3500 IU | vitamin A | 3500 IU |
cholecalciferol | 220 IU | vitamin D3 | 220 IU |
DL-α-tocopherol | 10.20 mg | vitamin E | 11.20 IU |
ascorbic acid | 125 mg | vitamin C | 125 mg |
co-carboxylase tetrahydrate | 5.80 mg | vitamin B1 (thiamine) | 3.51 mg |
sodium phosphate riboflavin | 5.67 mg | vitamin B2 (riboflavin) | 4.14 mg |
pyridoxine hydrochloride | 5.50 mg | vitamin B6 (pyridoxine) | 4.53 mg |
cyanocobalamin | 6 µg | vitamin B12 | 6 µg |
folic acid | 414 µg | folic acid | 414 µg |
dexpanthenol | 16.15 mg | pantothenic acid | 17.25 mg |
biotin | 69 µg | biotin | 69 µg |
niacinamide | 46 mg | vitamin PP | 46 mg |
The excipients are: glycine, soy phospholipids, glycocholic acid, sodium hydroxide and hydrochloric acid
After reconstitution, the resulting solution is yellow-orange in color.
Only for adults and children over 11 years old
1 vial per day.
Administer by slow intramuscular or intravenous injection, or intravenously in the form of infusions.
Method of administration
After reconstitution: Inject slowly (at least 10 minutes; see section Warnings) intravenously or as an intravenous infusion in a solution of physiological saline or 5% glucose.
Administration can be continued throughout the period of parenteral nutrition. To meet nutritional needs and prevent deficiencies and potential complications arising from them
CERNEVIT can be added to nutritional mixtures containing carbohydrates, fats, amino acids and electrolytes, provided that compatibility and stability have been previously established for each preparation in the nutritional mixture.
Consider the total amount of vitamins from all sources, such as other forms of nutrition, administration of other vitamins or medicines containing vitamins as inactive ingredients (see section Interactions).
The patient's clinical condition and vitamin levels should be monitored to maintain their appropriate levels.
It should be taken into account that some vitamins, especially A, B and B, are sensitive to ultraviolet light (e.g. direct and indirect sunlight). Additionally, high oxygen content in the solution may increase the loss of vitamins A, B, C and E. These factors should be considered if appropriate vitamin levels are not achieved.
CERNEVIT should not be used:
Allergic reactions
If symptoms of an allergic reaction occur, the infusion or injection must be stopped immediately.
Vitamin A hypervitaminosis
Refeeding syndrome in patients receiving parenteral nutrition
Supplementation of nutrients in severely malnourished patients can cause a syndrome of related symptoms, characterized by the transfer of potassium, phosphorus and magnesium to the intracellular space, as anabolic processes predominate in the patient. There may also be a deficiency of thiamine and fluid retention in the body. Close monitoring and gradual increase in nutrient intake, avoiding overfeeding, can prevent these complications. In case of nutritional deficiencies, appropriate supplementation may be justified.
Sediment in patients receiving parenteral nutrition
Sedimentation in pulmonary vessels has been reported in patients receiving parenteral nutrition, including parenteral nutrition with vitamin supplementation. Some cases were fatal. Excessive addition of calcium and phosphate increases the risk of calcium phosphate sediment formation. Sedimentation has been reported even in the absence of phosphate salts in the solution. Sediment formation at a distance from the filter on the infusion line and the suspicion of sediment formation in the bloodstream have also been reported.
In addition to checking the solution, the infusion set and catheter should also be periodically checked for the presence of sediment.
If symptoms of respiratory function disorders occur, the infusion should be discontinued and the patient's clinical condition should be assessed.
Check if the container is damaged.
Work in aseptic conditions.
Do not store partially used vials; do not use if the color of the product after reconstitution is improper.
Liver
Use in patients with impaired liver function
Patients with impaired liver function may require individual vitamin supplementation.
Particular attention should be paid to preventing vitamin A toxicity, as liver disease is associated with increased susceptibility to toxic effects of vitamin A, especially in combination with chronic excessive alcohol consumption (see also "Vitamin A hypervitaminosis" and "Liver" above).
Use in patients with impaired renal function
Patients with impaired renal function may require individual vitamin supplementation, depending on the degree of renal impairment and the presence of concomitant diseases. In patients with severe renal failure, particular attention should be paid to maintaining adequate vitamin D levels and preventing toxic effects of vitamin A, which may occur in such patients even with low-dose vitamin A supplementation or in the absence of supplementation.
Vitamin B hypervitaminosis and toxicity (peripheral neuropathy, involuntary movements) have been reported in patients undergoing long-term hemodialysis who received parenteral multivitamin products containing 4 mg of pyridoxine administered three times a week.
General monitoring
In patients receiving parenteral multivitamin products for a long time as the only source of vitamins, the clinical condition and vitamin levels should be monitored to ensure proper supplementation, e.g.:
Deficiencies of one or more vitamins should be corrected through specific supplementation.
CERNEVIT does not contain vitamin K, which should be administered separately if necessary.
Use in patients with vitamin B deficiency
Before starting supplementation with CERNEVIT in patients at risk of vitamin B deficiency and when planning to administer CERNEVIT for several weeks, it is recommended to assess the vitamin B status.
After a few days of administration, both the level of cyanocobalamin (vitamin B) and folic acid in the product may be sufficient to cause an increase in red blood cells, reticulocytes and hemoglobin in some patients with vitamin B deficiency with megaloblastic anemia. This may mask a vitamin B deficiency.
Effective treatment of vitamin B deficiency requires higher doses of cyanocobalamin than are provided in CERNEVIT.
Supplementation with folic acid in patients with vitamin B deficiency who are not receiving vitamin B may not prevent the development or progression of neurological changes associated with vitamin B deficiency. It is even suggested that the patient's neurological condition may worsen.
When interpreting vitamin B levels, it should be taken into account that recent intake of vitamin B may result in a normal level despite a deficiency in tissues.
Disturbances of laboratory tests
Biotin may interfere with laboratory tests based on the interaction of biotin and streptavidin, leading to falsely lowered or elevated test results, depending on the test. The risk of interference is higher in children and patients with impaired renal function, and increases with higher doses. When interpreting laboratory test results, possible biotin interference should be taken into account, especially if there is a lack of consistency with the clinical presentation (e.g. thyroid test results mimicking those indicating Graves' disease in patients taking biotin without symptoms of this disease, or falsely negative troponin test results in patients taking biotin with myocardial infarction). In cases where interference is suspected, alternative tests that are not susceptible to biotin interference should be performed, if available. If laboratory tests are ordered for patients taking biotin, consultation with laboratory staff is recommended.
The presence of ascorbic acid in serum and urine may cause falsely high or low readings of glucose levels in some glucose measurement systems, including portable test strips and portable glucose meters. The technical data for each laboratory test should be consulted to determine potential disturbances caused by vitamins.
Concomitant use with antiepileptic drugs:
Due to the presence of folic acid, concomitant administration of CERNEVIT with antiepileptic drugs containing phenobarbital, phenytoin or primidone requires special caution.
Concomitant use with levodopa:
Due to the presence of pyridoxine in CERNEVIT, concomitant use with levodopa requires caution, as it may reduce the effectiveness of L-dopa. To prevent this interaction, a decarboxylase inhibitor, such as carbidopa, can be added.
Medicines that bind to acidic alpha-1-glycoprotein (AAG):
In an in vitro study using human serum, a concentration of glycocholic acid about 4 times higher than the concentration of glycocholic acid in serum, which could result from the injection of a bolus of CERNEVIT in an adult, increased the fraction of certain medicines binding to acidic alpha-1-glycoprotein (AAG) by 50-80%.
It is not known whether this effect is clinically significant if the amount of glycocholic acid contained in a standard dose of CERNEVIT (as a component of mixed micelles) is administered in a slow intravenous injection, slow intramuscular injection or infusion over a longer period.
Patients receiving CERNEVIT and medicines binding to AAG should be closely monitored for increased effects of these medicines. These include propranolol, prazosin and many others.
Interactions related to supplementation with other vitamins:
Certain medicines may interact with certain vitamins in doses significantly exceeding those contained in CERNEVIT. This should be taken into account in patients taking vitamins from multiple sources, and when this occurs, patients should be monitored for these interactions and appropriate action should be taken.
Acute or chronic overdose of vitamins (especially A, D and E) can cause symptomatic hypervitaminosis.
The risk of overdose is particularly high if the patient receives vitamins from multiple sources, and overall vitamin supplementation does not meet the individual needs of the patient, and in patients with increased susceptibility to hypervitaminosis (see section Special precautions for use).
The symptoms of CERNEVIT overdose are mainly due to vitamin A overdose.
Clinical symptoms of acute vitamin A overdose (doses exceeding 150,000 IU)
Clinical symptoms of chronic vitamin A overdose (long-term administration of higher than physiological doses of vitamin A in patients who do not require supplementation of vitamin deficiency)
Treatment of vitamin overdose usually involves discontinuing vitamin supplementation and other actions in accordance with clinical indications (such as limiting calcium intake, increasing diuresis and hydration).
Shelf life
2 years
Special precautions for storage
Store at room temperature, i.e. between 15°C and 25°C, protected from light.
Store in the outer carton.
After reconstitution, the product retains chemical and physical stability for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately after reconstitution.
Otherwise, the time and conditions of storage until use are the responsibility of the person administering the product, and storage should not exceed 24 hours at 2-8°C, unless reconstitution was performed under controlled and validated aseptic conditions.
Type and content of packaging
Brown glass vials containing 750 mg of powder, in a carton. Packs of 10 and 20 vials.
Brown glass vials containing 750 mg of powder, with the BIO-SET system, in a carton. Packs of 10 and 20 vials.
Not all pack sizes may be marketed.
Incompatibilities, instructions for disposal and preparation of the medicinal product for use (if applicable)
If necessary, refer to relevant references on compatibility and guidelines. This medicinal product must not be mixed with other medicinal products, except for those that have been shown to be compatible and stable. For further information, contact the marketing authorization holder.
Check the compatibility of solutions administered simultaneously through the same line.
CERNEVIT (vials without BIO-SET)
Using a syringe, inject 5 ml of water for injections or glucose 5% or 0.9% sodium chloride solution into the vial.
Gently mix to dissolve the powder.
The resulting solution is yellow-orange in color.
Dissolve the powder in 2.5 ml of water for injection as described above.
CERNEVIT BIO-SET
CERNEVIT with the BIO-SET system allows for direct dissolution of the preparation in bags (single and multi-chamber) with an injection port.
Single-chamber bag:
Multi-chamber bag:
The CERNEVIT preparation with the BIO-SET should be dissolved before activating the multi-chamber bag (before opening the breakable welds and before mixing all the chambers).
WARNING:
Be careful not to disconnect the BIO-SET from the injection port of the bag during the dissolution of the preparation.
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