CERNEVIT powder for injectable solution and for infusion

2. What you need to know before you are given Cernevit

DO NOTgive Cernevit:

• if you are allergic to the active substances or to any of the other ingredients of this medicine, in particular to thiamine (Vitamin B1) or to soy and peanut proteins (included in section 6).
• If you are under 11 years old.
• If you suffer from hypervitaminosis of any of the vitamins contained in Cernevit.
• If you have high levels of calcium in the blood (severe hypercalcemia), in the urine (severe hypercalciuria), any treatment, disease, and/or disorder leading to severe hypercalcemia and/or hypercalciuria (e.g., neoplasms, bone metastases, excess parathyroid hormone, granulomatosis [inflammatory tissue]... etc.),
• If you are taking vitamin A or vitamin A derivatives (retinoids).

Warnings and precautions

Consult your doctor or nurse before receiving Cernevit

• If you have liver disease.
• If you have kidney disease.
• If you have epilepsy.
• If you have Parkinson's disease
• If you are taking vitamins A, D, and E

Hypersensitivity reactions

Allergic reactions ranging from mild to severe have been reported to vitamins B1, B2, B12, folic acid, and soy lecithin contained in Cernevit.

Cross-allergic reactions have been observed between soy and peanut proteins.

If you show any symptoms of an allergic reaction, such as sweating, fever, chills, headache, skin rash, urticaria, skin redness, or difficulty breathing, inform your doctor or nurse immediately. The infusion will be stopped immediatelyand the necessary emergency measures will be taken.

Children

Cernevit must not be given to children under 11 years old.

Other medicines and Cernevit

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

You must not take medicines containing vitamin A or vitamin A derivatives (retinoids) during treatment with Cernevit, due to the risk of vitamin A hypervitaminosis (excess of vitamin A in the blood) (see section 3 "How to use Cernevit").

You should be careful if you are taking any of the following types of medicines:

• Levodopa (used to treat Parkinson's disease).
• Phenobarbital, Phenytoin, Fosphenytoin, Primidone, Carbamazepine, and/or Valproate (used to treat epilepsy).
• Acetylsalicylic acid at high doses (for pain and inflammation),
• Efavirenz, zidovudine (HIV treatment)
• Chloramphenicol, Trimethoprim, tetracyclines (for bacterial infections),
• Deferoxamine (for iron poisoning or overload)
• Ethionamide, Cycloserine, Isoniazid (for tuberculosis),
• Sulfasalazine (treatment for Crohn's disease)
• Pyrimethamine (anti-malarial and other infection medication),
• Fluoropyrimidines, Raltitrexed, Bexarotene (cancer treatments),
• Methotrexate, penicillamine (for rheumatoid arthritis)
• Triamterene, Hydralazine (for heart disease),
• Phenelzine (for depression),
• Theophylline (treatment for respiratory diseases and asthma),
• Warfarin (anticoagulant)

Your doctor may monitor the levels of these medicines in your blood and may need to adjust your dose when starting or stopping Cernevit.

Laboratory test interference

Ascorbic acid may interfere with blood and urine glucose tests. Consult your doctor if you need to have tests.

Cernevit contains 69 micrograms of biotin per vial. If you are going to have laboratory tests, you must inform your doctor or laboratory staff that you are receiving or have recently received Cernevit, as biotin may influence the results of these tests. Depending on the test, the results may show false elevations or false reductions due to biotin. Your doctor may indicate that you should stop receiving Cernevit before having laboratory tests. You should also be aware that other products you may be taking, such as multivitamin preparations or supplements for hair, skin, and nails, may also contain biotin and influence the results of laboratory tests. Inform your doctor or laboratory staff if you are taking this type of product.

Using Cernevit with food and drinks

You should ask your doctor what you can eat or drink.

Fertility, pregnancy, and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

You can receive Cernevit during pregnancy if required, provided that the instructions and doses are observed to avoid vitamin overdose.

Breastfeeding

Cernevit is not recommended if you are breastfeeding. If you breastfeed your baby while receiving Cernevit, there is a risk that your baby may have a vitamin A overdose.

Fertility

There is not enough data on the use of Cernevit regarding fertility in male or female patients.

Driving and using machines

There is no information on the effects of Cernevit on driving or using machines.

Excipient warnings

This medicine contains 24 mg of sodium (main component of cooking/table salt) per vial. This is equivalent to 1.2% of the maximum recommended daily sodium intake for an adult.

3. How Cernevit will be given to you

Cernevit will be given to you by a doctor or nurse, usually through an infusion into your vein.

The recommended dose is one vial per day.

If you receive more Cernevit than you should

If you receive too much Cernevit (overdose), or if it is given too quickly or too frequently, there may be an increase in vitamins A and D.

• Signs of sudden vitamin A overdose include:

• Gastrointestinal disorders (nausea, vomiting),
• nervous system disorders (headache, optic nerve inflammation, convulsions) due to increased pressure in the head,
• psychiatric disorders (irritability),
• skin disorders (skin peeling).

• Signs of long-term vitamin A overdose include:

• Headache due to increased pressure in the head,
• bony disorders (painful or mild swelling in the extremities).

If you notice any of these overdose symptoms, inform your doctor so that the Cernevit infusion can be stopped.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 915.620.420, indicating the medicine and the amount used.

Stopping the Cernevit infusion

Your doctor will decide when to stop the infusion.

If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common(may affect more than 1 in 10 people)

• Pain at the injection site.

Uncommon(may affect less than 1 in 100 people):

• Feeling unwell (nausea, vomiting)

Frequency not known(cannot be estimated from the available data)

• Allergic reactions, with breathing difficulties, chest pain, throat constriction, urticaria, rash, skin redness, abdominal discomfort, as well as cardiac arrest.
• Increased levels of vitamin A and vitamin A transport protein in the blood.
• Taste disturbance (metallic taste).
• Increased heart rate.
• Increased respiratory rate.
• Diarrhea.
• Increased levels of liver enzymes and bile acids.
• Itching (pruritus).
• Fever, general pain, reactions at the injection site, such as burning sensation and rash.

If you experience any symptoms of an allergic reaction, such as difficulty breathing, chest pain, throat constriction, urticaria, rash, skin redness, abdominal discomfort, inform a doctor immediately so that the infusion can be stopped and the necessary measures taken.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cernevit

Keep this medicine out of the sight and reach of children.

Store below 25°C and in the outer packaging to protect from light.

Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiry date is the last day of the month shown.

6. Contents of the pack and other information

Composition of Cernevit

• The active substances are:

One vial contains:

Retinol (Vitamin A) in the form of retinol palmitate 3500 IU

Colecalciferol (Vitamin D3) 220 IU

Alpha-tocopherol (Vitamin E) 11.20 IU

corresponding to DL-alpha-tocopherol 10.20 mg

Ascorbic acid (Vitamin C) 125 mg

Thiamine (Vitamin B1) 3.51 mg

in the form of Cocarboxylase tetrahydrate 5.80 mg

Riboflavin (Vitamin B2) 4.14 mg

in the form of Riboflavin phosphate sodium dihydrate 5.67 mg

Pyridoxine (Vitamin B6) 4.53 mg

in the form of Pyridoxine hydrochloride 5.50 mg

Cyanocobalamin (Vitamin B12) 6 micrograms

Folic acid (Vitamin B9) 414 micrograms

Pantothenic acid (Vitamin B5) 17.25 mg

in the form of Dexpantenol 16.15 mg

Biotin (Vitamin B8) 69 micrograms

Nicotinamide (Vitamin PP) 46 mg

The other ingredients are: glycine, glycolic acid, soy lecithin, sodium hydroxide, and hydrochloric acid.

Appearance of Cernevit and pack contents

Cernevit is a yellow-orange powder for solution for injection and infusion, presented in a topaz-colored glass vial.

Each carton contains 10 vials.

Marketing authorisation holder and manufacturers

Marketing authorisation holder:

Baxter S.L.

Polígono Industrial Sector 14, Pouet de Camilo, 2.

46394 Ribarroja del Turia (Valencia)

Spain

Manufacturer:

Baxter S.A.

Boulevard René Branquart, 80 7860 Lessines

Belgium

Date of last revision of this leaflet: December 2017

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Dosage and method of administration

Only for adults and children over 11 years:

1 vial/day.

Administration exclusively by intravenous route:

Method of administration: Follow the instructions for use and handling

After reconstitution: Administer by slow intravenous injection (at least 10 minutes, see warnings section) or by infusion using 0.9% saline or 5% glucose solution.

Administration can be continued through parenteral nutrition. Cernevit can be part of nutrient mixtures where carbohydrates, lipids, amino acids, and electrolytes are combined, after previously checking compatibility and stability in each case, to meet nutritional needs and prevent deficiencies or complications.

The total vitamins from all sources, both nutrition and other vitamin supplements or medications containing vitamins as inactive ingredients, should be taken into account.

The patient's clinical condition and vitamin levels should be monitored to ensure adequate levels are maintained.

It should be noted that some vitamins, especially A, B2, and B6, are sensitive to ultraviolet light (e.g., direct or indirect sunlight). Additionally, the loss of vitamins A, B1, C, and E may increase with higher oxygen levels in the solution. These factors should be considered if adequate vitamin levels are not achieved.

Special precautions for disposal and other handling

Hypersensitivity reactions

Allergic reactions ranging from mild to severe have been reported to vitamins B1, B2, B12, folic acid, and soy lecithin contained in Cernevit.

Cross-allergic reactions have been observed between soy and peanut proteins.

If you show any symptoms of an allergic reaction, such as sweating, fever, chills, headache, skin rash, urticaria, skin redness, or difficulty breathing, inform your doctor or nurse immediately. The infusion will be stopped immediatelyand the necessary emergency measures will be taken.

This medicine should not be mixed with other medicines unless compatibility and stability of the mixture have been demonstrated. In this case, contact Baxter for further information.

• Reconstitution should be carried out under aseptic conditions, as when used as part of a mixture in parenteral nutrition.
• Gently mix to dissolve the powder for solution for injection and infusion.
• Before transfer from the vial, Cernevit must be completely dissolved.
• Do not use the medicine unless the reconstituted solution is clear and the original seal is intact.
• After adding Cernevit to a parenteral nutrition solution or emulsion, check for any abnormal color change and/or the appearance of precipitates, insoluble complexes, or crystals.
• When Cernevit is used as an additive in parenteral nutrition, vigorously mix the final solution.
• Any unused portion of reconstituted Cernevit should be discarded and not stored for later mixing.
• Parenteral medicines should be inspected visually for particles and discoloration before administration, whenever the solution and container permit.
• The use of a final filter is recommended during the administration of all parenteral nutrition solutions.

The compatibility of solutions administered simultaneously through the same equipment should be reviewed.

Reconstitution

Using a syringe, inject 5 ml of water for injection or 5% glucose solution or 0.9% sodium chloride solution into the vial.

Gently mix to dissolve the powder.

The resulting solution is yellow-orange in color.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage conditions and times before use are the responsibility of the user and normally should not exceed 24 hours at 2°C to 8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.