powder for solution for injection or infusion 

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cernevit is and what it is used for 
2. What you need to know before using Cernevit 
3. How to use Cernevit 
4. Possible side effects 
5. How to store Cernevit 6. Contents of the pack 
and other ingredients information

1. What Cernevit is and what it is used for

Cernevit is a powder for solution for injection or infusion.

It contains 12 vitamins:

Retinol ( Vitamin A) Pyridoxine ( Vitamin B6) Ascorbic acid ( Vitamin C )
Thiamine ( Vitamin B1) Biotin ( Vitamin B8) Cholecalciferol ( VitaminD)
Riboflavin ( Vitamin B2) Folic acid ( Vitamin B9) Alpha-tocopherol ( Vitamin E)
Pantothenic acid ( VitaminB5) Cyanocobalamin ( Vitamin B12) Nicotinamide ( VitaminPP)

Cernevit is given as a vitamin supplement for intravenous nutrition (via a drip).

2. What you need to know before using Cernevit

Do not use Cernevit

  • if you are allergic to any of the active substances in this medicine, especially vitamin B1, or soy protein, or peanut protein (see section 6. Content declaration).
  • to children under 11 years.
  • if you already have excess vitamin in your blood of any vitamin found in Cernevit (hypervitaminosis) (see section 6).
  • if you have excess calcium in the blood (severe hypercalcemia ) or urine ( hypercalciuria ), or no treatment, disease and/or disorder can result in severe hypercalcemia and/or hypercalciuria (e.g. tumor you, bone metastases, excess of parathyroid hormone, granulomatosis ( inflammatory tissue ), etc.)
  • if you are taking vitamin A supplements or vitamin A derivatives ( retinoids ).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Cernevit:

  • if you have any liver disease
  • if you have any kidney disease
  • if you have epilepsy
  • if you have Parkinson’s disease.

Hypersensitivity s

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

Cross-allergic reactions between soybean protein and peanut protein have been observed.

Contact a doctor immediately if you get any symptoms of an allergic reaction such as sweating, fever, chills, headache, skin rash, hives, redness of the skin or difficulty breathing. The doctor will discontinue the infusion and take the necessary action.

Other medicines and Cernevit

Tell your doctor or pharmacist 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 hypervitaminosis (an excess of vitamin A in your blood) (see section 3 How to use Cernevit).

Impact on laboratory tests

Cernevit contains 0.069 mg biotin per 5 ml. If you are going to undergo laboratory tests, you must tell your doctor or laboratory staff that you are taking or have recently taken Cernevit, as biotin may affect the results of these tests. Depending on the test used, the results may be falsely elevated or falsely lowered due to biotin. Your doctor may ask you to stop taking Cernevit before the laboratory tests. You should also be aware that other products that you may be taking, such as multivitamins or hair, skin, and nail supplements, may also contain biotin and affect the results of laboratory tests. Tell your doctor or laboratory staff if you are taking such products.

Ascorbic acid can affect urine and blood glucose tests.

Cernevit with food, drink, and alcohol

There is no information on the effects of Cernevit with food, drink, or alcohol.

Fertility, pregnancy, and lactation

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Cernevit can if deemed necessary, be given to pregnant women. Your doctor will weigh the correct dosage to avoid overdosing on vitamins.

Breast-feeding

Cernevit is not recommended for breastfeeding women. If you are breast-feeding while you are taking Cernevit, there is a risk of vitamin A overdose in your baby.

Fertility

There are no data on the effect of Cernevit on male or female fertility .

Driving and using machines

There is no information on the effects of Cernevit on the ability to drive or handle other heavy machinery.

Cernevit contains excipients

Cernevit contains the excipient soy lecithin.

3. How to use Cernevit

Cernevit is given to you by healthcare professionals. Usually, you get Cernevit as an infusion in a friend.

The recommended dose is one vial (5 ml) per day.

If you use more Cernevit than you should 

In that case, the signs that you have received more Cernevit than you should usually depend on the content of vitamin A.

  • Signs of acute vitamin A overdose include:
    • gastrointestinal disorders (nausea, vomiting),
    • effects on the central nervous system (headache, swelling of the optic nerve, cramps) due to increased pressure in the head
    • psychiatric effect (irritability)
    • skin effects (delayed flaking of the skin).
  • Signs of prolonged vitamin A overdose include:
    • headache due to increased pressure in the head
    • bone effects (tender or painful swelling at the ends of the arms and legs).

Signs of nerve damage effects:

Pyridoxine – ( vitamin B6) hypervitaminosis (excess of pyridoxine in the blood) and damage caused by pyridoxine (disturbance of nerve function, involuntary movements) have been reported in patients who have taken high doses for a long period of time and in chronic hemodialysis (blood dialysis) where intravenous multivitamins containing 4 mg pyridoxine was given three times a week.

Tell your doctor if you notice any of these signs of overdose. Your doctor may then discontinue your infusion of Cernevit.

If you have any further questions on 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.

The following side effects have been reported with unknown frequency:

  • Serious and potentially life-threatening allergic reactions
  • Increased levels of liver enzymes.

If you show any symptoms of an allergic reaction such as sweating, fever, chills, headache, rash, hives, redness or difficulty breathing, contact a doctor immediately. The doctor will discontinue the infusion and take appropriate action.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Cernevit

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

Do not store above 25 ° C.

The vial should be stored in the outer carton.

After reconstitution, physicochemical stability has been demonstrated for 24 hours at 25 ° C. From a microbiological point of view, the product should be used immediately after reconstitution.

Shelf life and storage conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2 ° C -8 ° C unless reconstituted under aseptic conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are:

One vial (5 ml) contains:

Retinol ( Vitamin A)  
in the form of retinol palmitate 3500 IU
Cholecalciferol ( Vitamin D3) 220 IU
α-Tocopherol ( Vitamin E) 11.20 IU
in an amount corresponding to DL- α -Tocopherol 10.20 mg
Ascorbic acid ( Vitamin C ) 125 mg
Thiamine ( Vitamin B1) 3.51 mg
in the form of carboxylate tetrahydrate 5.80 mg
Riboflavin ( Vitamin B2) 4.14 mg
in the form of riboflavin sodium phosphate dihydrate 5.67 mg
Pyridoxine ( Vitamin B6) 4.53 mg
in the form of pyridoxine hydrochloride 5.50 mg
Cyanocobalamin ( Vitamin B12) 0.006 mg
Folic acid ( Vitamin B9) 0.414 mg
Pantothenic acid ( Vitamin B5) 17.25 mg
in the form of dexpantenol 16.15 mg
Biotin ( Vitamin B8) 0.069 mg
Nicotinamide ( Vitamin PP) 46 mg

IE = international units

mg = milligrams

  • The other ingredients are glycine, glycocholic acid, soy lecithin, sodium hydroxide, hydrochloric acid.
  • Cernevit contains 24 mg sodium (1 mmol) per vial. This should be considered by patients on a low-salt diet.

What the medicine looks like and the contents of the pack

Cernevit is an orange-yellow freeze-dried cake

Cernevit is supplied in brown vials.

A carton of 1, 10, or 20 vials is available.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer:

Baxter SA

Bd. R. Branquart 80

B-7860 Lessines, Belgium

Muhammad Nadeem

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