PROSPECTO: INFORMATION FOR THE USER

Cernevit powder for injectable solution and for infusion

Vitamins

Read this prospectus carefully before starting to use this medication, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experienceadverse effects, consult yourdoctor, pharmacist, ornurse even if they are not listed in this prospectus. See section 4.

This medication is called “Cernevitpowder for injectable solution and for infusion”, but it will be referred to as “Cernevit” in the rest of this prospectus.

1.What is Cernevit and how it is used

2.What you need to know before Cernevit is administered to you

3.How Cernevit will be administered to you

4.Possible adverse effects

5.Storage of Cernevit

6.Contents of the package and additional information

Cernevitis a powder for solution for injection or infusion.

It contains 12 vitamins:

Cernevitis a multivitamin in the form ofpowder for injectable solution and for infusionthat allows for an equilibrated association of all essential water-soluble and fat-soluble vitamins for the metabolism of adults and children over 11 years old, with the exception of vitamin K when reconstituted.

Cernevitis used to provide the corresponding vitamins to meet the daily needs of adults and children over 11 years old in situations that require a vitamin supplement by parenteral route, that is, when oral intake is contraindicated, not possible, or insufficient.

You should not be administeredCernevit:

• if you are allergic to the active ingredients or to any of the other components of this medication, particularly to thiamine (Vitamin B1) or to soy and peanut proteins (included in section 6).
• If you are under 11 years old.
• If you have a vitamin overdose of any of the vitamins contained inCernevit.
• If you have severe high calcium levels in the blood (hypercalcemia), urine (hypercalciuria), any treatment, disease, and/or disorder that leads to severe hypercalcemia and/or hypercalciuria (e.g., neoplasias, bone metastases, excessive parathyroid hormone, granulomatosis [inflammatory tissue] ... etc.),
• If you are taking vitamin A or derivatives of vitamin A (retinoids).

Warnings and precautions

Consult your doctor or nurse before receivingCernevit

• 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.

Allergic reactions

Mild to severe allergic reactions have been reported to vitamins B1, B2, B12, folic acid, and soy lecithin contained in Cernevit.

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

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 stoppedimmediatelyand emergency measures will be taken.

Children

Cernevitcannot be administered to children under 11 years old.

Other medications and Cernevit

Inform your doctor or nurseif you are taking, have taken recentlyor may need totake any other medication.

You should not take medications that contain vitamin A or derivatives of vitamin A (retinoids) during treatment with Cernevit, due to the risk of vitamin A overdose (excessive 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 medications:

• Levodopa (used to treat Parkinson's disease).
• Fenobarbital, Phenitoine, Fosphenitoine, Primidona,Carbamacepinaand/orValproato(used to treat epilepsy).
• High doses of acetylsalicylic acid(for pain and inflammation),
• Efavirez, zidovudine (HIV treatment)
• Cloranfenicol, Trimetoprima, tetracyclines (for bacterial infections),
• Deferoxamina(for iron poisoning or overload)
• Etionamida, Cicloserina, Isoniacida (for tuberculosis),
• Sulfasazolina (treatment for Crohn's disease)
• Pirimetamina(medication against malaria and other infections),
• fluoropirimidinas, Raltitrexed, Bexaroteno (cancer treatments),
• Metotrexato, penicilamina (for rheumatoid arthritis)
• Triamtereno, Hidralacina (for heart diseases),
• Fenelcina (for depression),
• Theophylline (treatment for respiratory diseases and asthma),
• Warfarin (anticoagulant)

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

Laboratory test interferences

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

Cernevit contains 69 micrograms of biotin per vial. If you are to have laboratory tests, you should inform your doctor or the laboratory staff that you are receiving or have recently received Cernevit, as biotin may affect the results of these tests. Depending on the test, the results may show false elevations or false reductions due to biotin. Your doctor will be able to tell you to stop receiving Cernevit before having the laboratory tests. You should also know that other products you may be taking, such as multivitamin preparations or hair, skin, and nail supplements, may also contain biotin and affect the results of laboratory tests. Inform your doctor or the laboratory staff if you are taking these types of products.

Use ofCernevitwith food and beverages

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

Fertility, pregnancy, and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor beforeusing this medication.

Pregnancy

You can receiveCernevitduring pregnancy, if necessary, always following the indications and doses to avoid vitamin overdose.

Breastfeeding

The use ofCernevitis not recommended if you are breastfeeding. If you are breastfeeding while receivingCernevit, there is a risk that your baby may have a vitamin A overdose.

Fertility

There are no sufficient data on the use of Cernevit with regard to fertility in male or female patients.

Driving and operating machinery

There is no information on the effects of Cerneviton driving or operating machinery.

Warnings about excipients

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

Cernevit will be administered 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 Cernevit Than You Should

If you receive an excessive amount of Cernevit (overdose), or if it is administered too quickly or too frequently, it may cause an increase in vitamins A and D.

• Signs of sudden overdose of vitamin A include:

• Gastrointestinal disturbances (nausea, vomiting),
• neurological disturbances (headache, optic nerve inflammation, seizures) due to increased intracranial pressure,
• psychiatric disturbances (irritability),
• skin disturbances (skin peeling).

• Signs of long-term overdose of vitamin A include:

• Headache due to increased intracranial pressure,
• bone disturbances (painful or tender swelling in the extremities).

If you notice any of these overdose symptoms, inform your doctor so they can stop the infusion of Cernevit.

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

Stopping the Cernevit Infusion

The doctor will decide when to stop the infusion.

If you have any other questions about using this product, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent(may affect more than 1 in 10 people)

• Pain at the injection site.

Infrequent(may affect fewer than 1 in 100 people):

• Unpleasant sensation (nausea, vomiting)

Unknown frequency(unknown number of people affected)

• Allergic reactions, with difficulty breathing, 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.
• Alteration of taste (metallic taste).
• Accelerated heart rate.
• Accelerated respiratory rate.
• Diarrhea.
• Increased levels of liver enzymes and bile acids.
• Pruritus (itching).
• Fever, generalized 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, report to a doctor immediately so that the infusion can be stopped and appropriate measures taken.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult with your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication

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

Storebelow 25°C andin the outer packagingtoprotect it from light

Do not use this medicationafter the expiration date that appears on the vialand on the box afterexp. The expiration date is the last day of the month indicated.

Composition ofCernevit

- The active principles are:

One vial contains:

Retinol (Vitamin A) in the form of retinol palmitate3500 UI

Colecalciferol (Vitamin D3)220 UI

Alpha-tocopherol (Vitamin E)11.20 UI

corresponding to DL-alpha-tocopherol10.20 mg

Ascorbic acid (Vitamin C)125 mg

Thiamine (Vitamin B1)3.51 mg

in the form of Cocarboxylase tetrahydrate5.80 mg

Riboflavin (Vitamin B2)4.14 mg

in the form of riboflavin sodium phosphate dihydrate5.67 mg

Pyridoxine (Vitamin B6)4.53 mg

in the form of pyridoxine hydrochloride5.50 mg

Cyanocobalamin (Vitamin B12)6 micrograms

Folic acid (Vitamin B9)414 micrograms

Pantothenic acid (Vitamin B5)17.25 mg

in the form of D-pantothenol16.15 mg

Biotin (Vitamin B8)69 micrograms

Nicotinamide (Vitamin PP)46 mg

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

Aspect and contents of the packaging

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

Each box contains 10 vials

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Baxter S.L.

Polígono Industrial Sector 14,Pouet de Camilo, 2.

46394 Ribarroja del Turia (Valencia)

Spain

Responsible for manufacturing:

Baxter S.A.

Boulevard René Branquart, 80 7860 Lessines

Belgium

Date of the last review of this leaflet: December 2017

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Dosage and method of administration

Only for adults and children over 11 years old:

1 vial/day.

Exclusively administered by intravenous route:

Administration method:Follow the following use and handling instructions

After reconstitution: Administer by slow intravenous injection (minimum 10 minutes, see warnings section) or in infusion through a 0.9% sodium chloride solution or 5% glucose solution.

The administration may be continued through parenteral nutrition. Cernevit may be part of nutrient mixtures in which glucose, lipids, amino acids, and electrolytes are associated, after having previously checked the compatibility and stability in each case, to meet nutritional needs and prevent deficiencies or complications.

It should be taken into account the total vitamins from all sources, both from nutrition, as well as other vitamin supplements or medications that contain vitamins as inactive ingredients.

The patient's clinical status and vitamin levels must 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, vitamin loss 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 manipulationsand hypersensitivity reactions

Hypersensitivity reactions

Severe allergic reactions have been reported to vitamins B1, B2, B12, folic acid, and soy lecithin contained in Cernevit.

Cross-allergies between soy and peanut proteins have been observed.

If you experience 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 stoppedimmediatelyand emergency measures will be taken.

This medicationshould not be mixedwith other medicationsunless compatibility andstability of the mixture have been demonstrated.In this case,contact Baxterfor additional information.

• The reconstitution should be carried out in aseptic conditions, as when it is used as part of parenteral nutrition.
• Mix gently to dissolve thepowder for injectable solution and for infusion.
• Before transferring from the vial, Cernevit must be completely dissolved.
• Do not use the medication unless the reconstituted solution is transparent and the original seal is intact.
• After adding Cernevit to a parenteral nutrition solution or emulsion, check if there is any abnormal color change and/or the appearance of precipitates, insoluble complexes, or crystals.
• When Cernevit is used as an additive in parenteral nutrition, mix the final solution vigorously.
• Any unused portion of Cernevit reconstituted solution must be discarded and not stored for later mixing.
• Parenteral medications should be visually inspected for particles and discoloration before administration, whenever possible.
• It is recommended to use a final filter during the administration of all parenteral nutrition solutions.

The compatibility of the solutions administered simultaneously through the sameequipmentshould 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.

Mix gently 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 will not exceed 24 hours at 2 °C to 8 °C, unless the reconstitution has been carried out in controlled and validated aseptic conditions.