CERNEVIT Порошок для инъекционного раствора

Содержание инструкции

1. CERNEVIT
   1. What is CERNEVIT and what is it 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. Content of the pack and other information

CERNEVIT

Vitamin Solution

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any undesirable effects occur, including those not listed in this leaflet, ask 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 is CERNEVIT and what is it used for

CERNEVIT is a solution containing vitamins that is administered to meet the nutritional needs of your/the child.
CERNEVIT is indicated to provide vitamins to adults and children over 11 years of agewhen oral intake is not possible or is insufficient (e.g. in case of inadequate nutrition,
intestinal absorption problems, need for non-oral nutrition).

2. What you need to know before using CERNEVIT

CERNEVIT will not be administered to you/your child

• if you are allergic to one or more vitamins, to soya proteins, to peanut proteins or to any of the other components 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 is under 11 years of age
• if you/your child has a condition characterized by an excess of one of the vitamins (hypervitaminosis) contained in this medicine.

Warnings and precautions
Consult your doctor, pharmacist or nurse before using CERNEVIT.
The doctor may need to perform blood tests and appropriate checks if you or your child

• suffer from skin lesions (pressure ulcers), wounds, burns;
• have undergone surgical removal of a portion of the intestine and suffer from disorders (short bowel syndrome);
• suffer from a severe lung disease (cystic fibrosis);
• are undergoing dialysis (a blood filtration system);
• have cancer;
• have a kidney disease, especially if severe or if you are undergoing dialysis (a blood filtration system);
• have a liver disease, especially if you have yellowing of the skin and eyes (jaundice). If the results of blood tests are not normal, the doctor may also prescribe a visit to a liver disease specialist (hepatologist).
• are taking other medicines (see “Other medicines and CERNEVIT”)
• suffer from vitamin B12 deficiency
• are undergoing parenteral nutrition (through a vein)
• suffer from an intestinal disease called inflammatory bowel disease. Inform the doctor if you suffer from any of the conditions listed above. In some cases the doctor may prescribe a personalized therapy. The doctor will check your vitamin levels in the blood to avoid an excessive dosage or if they will perform long-term treatment. Cross-reactions have been observed between soya proteins and peanut proteins. Blood tests If you/the child need to undergo blood tests, keep in mind that the administration of CERNEVIT may interfere with the method for measuring the amount of sugar in the blood (glycemia) or in the urine. Inform the laboratory staff of this. Children and adolescentsCERNEVIT cannot be administered to children under 11 years of age.

Other medicines and CERNEVIT
Inform your doctor if you or your child are taking, have recently taken or may
take any other medicine.
In particular, inform your doctor if you/your child are taking:

• medicines that can cause an increase in pressure inside the skull (pseudotumor cerebri), such as tetracyclines (antibiotics to treat infections)
• alcohol (chronic excessive consumption - see section “CERNEVIT with alcohol”)
• medicines to treat uncontrolled body movements (convulsions), such as phenobarbital, phenytoin, phosph phenytoin, and primidone
• aspirin, a medicine used as a pain reliever, anti-inflammatory and antipyretic (at high doses) or to reduce platelet function
• medicines to treat infections caused by the HIV virus (such as efavirenz and zidovudine, tipranavir oral solution, other protease inhibitors).
• chloramphenicol, trimethoprim and cyproheptadine, medicines to treat bacterial infections
• ethionamide and isoniazid, medicines to treat a tuberculosis infection (lung infections)
• deferoxamine, a medicine to treat iron poisoning
• medicines to treat tumors such as 5-fluorouracil, capecitabine, tegafur, methotrexate, raltitrexed
• sulfasalazine, a medicine to treat inflammation of the intestine
• pyrimethamine, a medicine to treat malaria and other infections such as toxoplasmosis
• triamterene, hydralazine, medicines to treat high blood pressure
• levodopa: a medicine to treat Parkinson's disease (a central nervous system disease that prevents movement control, which manifests for example with tremor, feeling of stiffness, slowing of movements, difficulty maintaining balance)
• penicillamine, a medicine to treat a metabolic disease (cystinosis)
• phenelzine: a medicine to treat depression
• retinoids, medicines to treat skin diseases
• theophylline, a medicine to treat asthma
• Vitamin K antagonists (e.g., warfarin), medicines that slow down the blood clotting process
• medicines that bind to a liver protein (alpha1-Acid Glycoprotein (AAG), such as propranolol and prazosin, which are used to treat high blood pressure
• vitamins

CERNEVIT with food, beverages and alcohol
Inform your doctor if you drink alcohol or tea or if you take other vitamins, as the substances contained in
these beverages/foods may alter the action of CERNEVIT

Fertility, pregnancy and breastfeeding
CERNEVIT will not be administered during pregnancy and breastfeeding.

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

Driving and operating machinery
CERNEVIT does not affect the ability to drive vehicles and operate machinery.

CERNEVIT contains soya and sodium
This medicine contains soya. If you are allergic to peanuts or soya, do not use this
medicine. This medicine contains 1 mmol (or 24 mg) of sodium per vial. To be taken into
consideration in people with reduced kidney function or who are following a low
sodium diet.

3. How to use CERNEVIT

Use this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor.
The dose will be established by the doctor based on the weight and health condition of you/your
child.
You/your child will receive this medicine via an intravenous infusion or an
intramuscular injection.
Elderly patients
If you are elderly, your doctor will reduce the dose and/or extend the intervals between doses.

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

If you/your child stop taking CERNEVIT
If you have any doubts about the use of 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 should experience

• the symptoms of an allergic reactionsuch as:
• difficulty breathing
• chest discomfort
• tightness in the throat
• hives, rash and redness of the skin
• discomfort in the epigastrium
• heart attack which can lead to death
• an alteration of blood flow from the heart to the lung (pulmonary insufficiency) the treatment will be immediately interrupted. Possible side effects are listed below according to the following frequency: common (may affect up to 1 in 10 people)
• Pain at the injection/infusion site not known (frequency cannot be estimated based on available data)
• Nausea, vomiting, diarrhea
• 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 the blood, Increased bile acids, Increased gamma-glutamyltransferase)
• Itching
• Fever
• Diffuse pain
• Reactions at the infusion site, for example, burning sensation, skin rash Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor. You can also report side effects directly through 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 sight and reach of children.
Do not store at a temperature above 25°C.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date which is reported on the bag after SCAD. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What CERNEVIT contains

• The active ingredients contained in each vial are:

• The other components are glycolic acid, glycolic acid, lecithin of soybean, 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 BIOSET infusion set
The following packs are available:
1 or 10 vials with BIOSET
1 or 10 vials without BIOSET
Not all packs may be marketed.

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

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

Dosage, method and duration of administration
Adults and children over 11 years of age:
1 vial per day
Elderly
In general, dosage adjustments should be considered in elderly patients (reducing the
dose and/or extending the intervals between dosages).
Special dosages: When an increased intake of nutrients is necessary (e.g. severe burns) CERNEVIT may be administered at daily doses 2-3 times
higher than those normally used.

Overdose
Treatment of vitamin overdose usually consists of eliminating the
vitamin and implementing other clinical measures as indicated below (reduction of calcium intake, increased diuresis and rehydration).

Instructions for use
For intravenous use
Using a syringe, inject the contents of a solvent vial (5 ml of water for injectable preparations) into the vial. Shake gently to dissolve the lyophilized powder.
Slow IV or infusion in physiological solution, glucose solution, etc.
CERNEVIT can be included in nutrient mixtures in association with carbohydrates, lipids,
amino acids, electrolytes, after verifying the compatibility and stability of each mixture.
For intramuscular use
Dissolve the lyophilized powder in 2.5 ml of solvent (water for injectable preparations), as described
above.

Special precautions

• Aseptic conditions must be followed during reconstitution and when used as part of a parenteral nutrition mixture.
• Mix slowly to dissolve the lyophilized powder.
• Before transfer from the vial, CERNEVIT must be completely dissolved.
• Do not use the product until the reconstituted solution is clear and if the original membrane is intact.
• After adding CERNEVIT to a parenteral nutrition solution, verify that there is no abnormal color change and/or appearance of precipitates, insoluble complexes or crystals.
• Mix the final solution meticulously when CERNEVIT is used in a parenteral nutrition mixture.
• Any unused portion of reconstituted CERNEVIT must be discarded and not stored for subsequent mixing.
• Parenteral nutrition drugs must be visually inspected for particles and for abnormal discoloration before administration, whenever the solution and container allow.
• The use of a final filter is recommended during the 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 also be checked periodically for precipitate formation. Cernevit (vial without BIO-SET) Using a syringe, inject the contents of a solvent vial (5 ml of water for injectablepreparations) into the vial. Shake gently to dissolve the lyophilized powder.Slow intravenous administration or infusion in physiological solution, glucose solution, etc.Cernevit BIO-SET Cernevit BIO-SET allows reconstitution directly into bagsequipped with an injection site (whether they are single or multi-compartment bags).See Figure 1 Single bag:
• 1. Remove the cap by rotating and pulling to break the safety ring;
• 2. Connect the BIO-SET directly to the bag through the injection site;
• 3. Activate the BIO-SET by applying slight pressure to the transparent mobile part of the BIO-SET. This action punctures the rubber stopper of the vial.
• 4. Place 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 (about 5 ml). Shake the vial to reconstitute Cernevit.

• 5. Invert the combined system, bringing the bag to the bottom. Gently press the infusion bag several times to push air into the headspace of the vial, thus allowing the solution to transfer into the bag.
• 6. Repeat steps 4 and 5 until the vial is empty.
• 7. Remove and discard the Cernevit BIO-SET. Multi-compartment bag: The reconstitution of Cernevit BIO-SET must be done before activating the multi-compartment bag (before opening the non-permanent membranes and before mixing the contents of each compartment).
• 1. Place the multi-compartment bag on a work surface;
• 2. Remove the cap of Cernevit BIO-SET by rotating and pulling to break the safety ring;
• 3. Connect the BIO-SET directly to the multi-compartment bag through the injection site;
• 4. Activate the BIO-SET by applying slight pressure to the transparent mobile part of the BIO-SET. This action punctures the rubber stopper of the vial;
• 5. Hold the vial vertically. Gently press the bag several times to transfer the solution into the vial (about 5 ml). Shake the vial to reconstitute Cernevit.
• 6. Turn the combined system over, holding the vial vertically. Gently press the infusion bag several times to push air into the headspace of the vial, thus allowing the solution to transfer into the bag.
• 7. Repeat steps 5 and 6 until the vial is empty.
• 8. Remove and discard the Cernevit BIO-SET.
• 9. Finally activate the multi-compartment bag. Caution: Make sure that during the entire reconstitution process the BIO-SET is always connected to theinjection site.

Figure 1

RECONSTITUTION OF CERNEVIT BIO-SET WITH SINGLE BAG

RECONSTITUTION OF CERNEVIT BIO-SET WITH MULTI-COMPARTMENT BAG