Cernevit

Patient Information Leaflet: Information for the Patient

CERNEVIT

Vitamin Solution
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of 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 information

1. What CERNEVIT is and what it is used for

CERNEVIT is a vitamin-containing solution administered to meet your nutritional needs or those of your child.
CERNEVIT is indicated to provide vitamins to adults and children over 11 years of age when oral intake is not possible or not sufficient (e.g. in case of inadequate nutrition, intestinal malabsorption, or need for non-oral nutrition).

2. What you should know before using CERNEVIT

CERNEVIT will not be administered to you/your child

• if you are allergic to one or more of the vitamins, soy proteins, peanut proteins, or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”)
• if you are pregnant (see section “Pregnancy and breastfeeding”),
• if the child is a newborn, infant, or under 11 years of age
• if you/your child has a condition characterized by excess of one of the vitamins (hypervitaminosis) contained in this medicine.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using CERNEVIT.
Your doctor may need to perform blood tests and appropriate monitoring if you or your child

• suffers from skin lesions (pressure ulcers), wounds, or burns;
• has undergone surgical removal of a portion of the intestine and suffers from disorders (short bowel syndrome);
• suffers from a severe lung disease (cystic fibrosis);
• is undergoing dialysis (a blood filtration system);
• has cancer;
• has kidney disease, especially if severe or if undergoing dial游戏副本

3. How to use CERNEVIT

Use this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor.
The dose will be determined by the doctor based on your weight and health condition or that of your
child.
You/your child will receive this medicine through an intravenous infusion or an
intramuscular injection.

Elderly patients
If you are elderly, the doctor will reduce the dose and/or extend the intervals between doses.

Use in children and adolescents
CERNEVIT must not be administered to children under 11 years of age.

If you/your child stops treatment with CERNEVIT
If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you or your child experience

• symptoms of an allergic reaction such as:
• difficulty breathing
• chest discomfort
• throat tightness
• hives, skin rash and redness of the skin
• stomach discomfort
• heart attack which may lead to death
• alteration in blood flow from the heart to the lungs (pulmonary insufficiency), treatment will be immediately discontinued.

The possible side effects are listed below by frequency:
Common (may affect up to 1 in 10 people)

• Pain at the injection/infusion site
  Not known (frequency cannot be estimated from the available data)
• Nausea, vomiting, diarrhoea
• Increased Vitamin A
• Increased retinol-binding protein
• Dysgeusia (metallic taste)
• Fast heartbeat (Tachycardia)
• Rapid breathing (Tachypnea)
• Changes in blood tests (Increased Transaminases, isolated increases in alanine aminotransferase, increased glutamate dehydrogenase, increased alkaline phosphatase in blood, increased bile acids, increased gamma-glutamyltransferase)
• Itching
• Fever
• Generalised pain
• Reactions at the infusion site, for example burning sensation, skin rash

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CERNEVIT

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the bag following EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CERNEVIT contains

• The active substances contained in each vial are:

• Other ingredients are glycocola, glycolic acid, lecithin from soy, sodium hydroxide, hydrochloric acid.

Description of the appearance of CERNEVIT and contents of the pack
CERNEVIT is a powder for injectable solution.
It is available in vials, with or without the BIOSET infusion set.
The following pack sizes are available:
1 or 10 vials with BIOSET
1 or 10 vials without BIOSET
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
BAXTER S.p.A.
Piazzale dell’Industria 20
00144 Rome, Italy

Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION – Idron, FRANCE
or
BAXTER S.A Lessines - BELGIUM
Valdepharm – Val de Reuil, Parc Industriel d’Incarville,
Parc de la Fringale – CS 10606, Val De Reuil Cedex, 27106
France

The following information is intended for medical or healthcare professionals only:
Precautions for use:
Deficiency of one or more vitamins should be corrected by specific supplementation.
CERNEVIT does not contain vitamin K. This must be administered separately if required.

Dosage, method and duration of administration
Adults and children over 11 years of age:
1 vial per day

Elderly:
Dosage adjustments should generally be considered in elderly patients (by reducing the dose and/or extending the intervals between doses).

Special dosage: When an increased intake of nutrients is required (e.g., severe burns), CERNEVIT may be administered at daily doses 2–3 times higher than normally used.

Overdose
Treatment of vitamin overdose generally consists of removing the excess vitamin and implementing other clinical measures as indicated below (reducing calcium intake, increasing diuresis, and rehydration).

Instructions for use

For intravenous use
Using a syringe, inject the contents of one solvent vial (5 ml of water for preparations for
injection) into the vial. Gently shake to dissolve the lyophilisate.
Slow I.V. injection or infusion in physiological saline, glucose solutions, etc.
CERNEVIT may be included in nutritional mixtures in combination with carbohydrates, lipids,
amino acids and electrolytes, provided compatibility and stability of each type of mixture have been verified.

For intramuscular use
Dissolve the lyophilisate in 2.5 ml of solvent (water for preparations for injection), as described above.

Special precautions

• Aseptic conditions must be maintained during reconstitution and when used as part of a parenteral nutrition mixture.
• Mix slowly to dissolve the lyophilized powder.
• Before transferring from the vial, CERNEVIT must be completely dissolved.
• Do not use the product until the reconstituted solution is clear and the original seal is intact.
• After adding CERNEVIT to a parenteral nutrition solution, check for any abnormal color change and/or formation of precipitates, insoluble complexes or crystals.
• Thoroughly mix the final solution when CERNEVIT is used in a parenteral nutrition mixture.
• Any unused portion of reconstituted CERNEVIT must be discarded and must not be stored for subsequent use.
• Parenteral nutrition drugs must be visually inspected for the presence of particles and abnormal discoloration before administration, whenever the solution and container permit.
• The use of an in-line filter is recommended during administration of all parenteral nutrition solutions.
• Cross-reactions between soy and peanut proteins have been observed. In addition to inspecting the solution, the infusion set and catheter should be periodically checked for precipitate formation. Cernevit (vial without BIO-SET) Using a syringe, inject the contents of one solvent vial (5 ml of water for preparations for injection) into the vial. Gently shake to dissolve the lyophilisate. Slow intravenous injection or infusion in physiological saline, glucose solutions, etc. Cernevit BIO-SET Cernevit BIO-SET allows direct reconstitution into bags equipped with an injection site (both single-chamber and multi-chamber bags). See Figure 1 Single-chamber bag:
  1. Remove the cap by twisting and pulling to break the safety ring;
  2. Connect the BIO-SET directly to the bag via the injection site;
  3. Activate the BIO-SET by applying light pressure on the transparent movable part of the BIO-SET. This action punctures the rubber stopper of the vial.
  4. Position the combined system (Cernevit BIO-SET + infusion bag) vertically with the bag on top. Gently press the bag several times to transfer the solution into the vial (approximately 5 ml). Shake the vial to reconstitute Cernevit.

5. Invert the combined system, bringing the bag downward. Gently press the infusion bag several times to push air into the headspace of the vial, thereby allowing solution transfer back into the bag.
6. Repeat steps 4 and 5 until the vial is empty.
7. Remove and discard the Cernevit BIO-SET. Multi-chamber bag: Reconstitution of Cernevit BIO-SET must be performed before activation of the multi-chamber bag (before opening the non-permanent membranes and before mixing the contents of each compartment).
8. Place the multi-chamber bag on a flat working surface;
9. Remove the cap of Cernevit BIO-SET by twisting and pulling to break the safety ring;
10. Connect the BIO-SET directly to the multi-chamber bag via the injection site;
11. Activate the BIO-SET by applying light pressure on the transparent movable part of the BIO-SET. This action punctures the rubber stopper of the vial;
12. Hold the vial vertically. Gently press the bag several times to transfer the solution into the vial (approximately 5 ml). Shake the vial to reconstitute Cernevit.
13. Invert the combined system, holding the vial vertically upside down. Gently press the infusion bag several times to push air into the headspace of the vial, allowing solution transfer back into the bag.
14. Repeat steps 5 and 6 until the vial is empty.
15. Remove and discard the Cernevit BIO-SET.
16. Finally, activate the multi-chamber bag. Warning: Ensure that during the entire reconstitution process the BIO-SET remains connected to the injection site.

Figure 1
RECONSTITUTION OF CERNEVIT BIO-SET WITH SINGLE-CHAMBER BAG

RECONSTITUTION OF CERNEVIT BIO-SET WITH MULTI-CHAMBER BAG