Active ingredients: Cyanocobalamin, Folic acid, Nicotinamide
EPARGRISEOVIT adults 2500 mcg + 0.70 mg + 12 mg + 150 mg solution for injection
EPARGRISEOVIT children 1250 mcg + 0.35 mg + 6 mg + 75 mg solution for injection
Why is Epargriseovit used? What is it for?
Epargriseovit contains the active ingredients: cyanocobalamin (vitamin B12), folic acid (vitamin B9), nicotinamide (vitamin PP) and ascorbic acid (vitamin C).
This medicine is used for the treatment of:
- deficiencies in vitamins, especially vitamin B12 and folic acid, which can occur:
- in severe forms of weakening of the organism
- due to insufficient and inadequate nutrition during an illness (undernutrition)
- in the convalescence phase of an illness
- in any other condition that requires a supply of vitamins by injection into a vein
- anemias that respond to the administration of vitamin B12 and folic acid, such as anemias caused by:
- inadequate nutrition
- insufficient absorption of vitamins in the intestine
- chronic alcohol abuse (alcoholism)
- liver disease
- pregnancy
- a disease that causes chronic inflammation and, over time, deformations of the joints (rheumatoid arthritis)
- diseases in which medicines for seizures, malaria, infections and cancers are used
- trigeminal neuralgia
- diseases which cause inflammation or degeneration of the nerves (neuritis) and which respond to the administration of vitamin B12 and folic acid.
How Epargriseovit works
Epargriseovit is a "combination of cyanocobalamin, folic acid, nicotinamide and ascorbic acid.
Cyanocobalamin (vitamin B12) is essential for the normal growth of your body, for the formation of all blood cells (red blood cells, white blood cells, platelets), for the formation of the cells that line your oral cavity, your stomach , its intestines (gastrointestinal tract), its nasal passages, its bronchi and its lungs (airways) and for the normal development of nerve cells.
Folic acid (vitamin B9) is necessary for the normal performance of some important functions of cyanocobalamin.
Nicotinamide (vitamin PP) is essential for some functions of its metabolism.
Ascorbic acid (vitamin C) is essential for the development of your cartilage and bones, your teeth and for the healing of wounds. It is also important for the formation of red blood cells and for the functioning of your immune system.
Contraindications When Epargriseovit should not be used
Do not take Epargriseovit
If you or your child are allergic to any of the active substances: cyanocobalamin, folic acid, nicotinamide, ascorbic acid, or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Epargriseovit
Talk to your doctor or pharmacist before taking Epargriseovit. If you or your child suffer or have ever suffered from any of the following conditions please tell your doctor:
- Anemia, because not all forms of anemia benefit or can be treated with the vitamins contained in this medicine. Your doctor will assess your health and may decide that you or your child have some tests before prescribing this medicine. Your doctor will tell you how often these tests need to be done.
- Pernicious anemia. If you or your child have a form of anemia called pernicious anemia, your doctor may find it necessary to add vitamin B12 other than that contained in this medicine to your therapy. Your doctor will decide to add more vitamin B12 based on the results of the tests you or your child have performed.
Epargriseovit contains sodium hydrosulfite
Epargriseovit contains a substance called sodium hydrosulfite which can rarely cause severe hypersensitivity reactions and bronchospasm.
If you or your child have been diagnosed with "asthma," allergy or some form of hypersensitivity, talk to your doctor before taking this medicine.
Epargriseovit can color urine red. This is normal during treatment with this medicine and should not be considered abnormal.
Interactions Which drugs or foods can modify the effect of Epargriseovit
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Currently, there are no known medicines that cannot be taken together with Epargriseovit.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
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 using this medicine.
Currently, there are no known adverse effects following the administration of Epargriseovit during pregnancy or breastfeeding.
Driving and using machines
Epargriseovit does not affect the ability to drive or use machines. If in doubt, consult your doctor or pharmacist.
Epargriseovit contains sodium
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially sodium-free.
Dosage and method of use How to use Epargriseovit: Dosage
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Your doctor or the doctor treating your child will determine whether Epargriseovit can be given by injection through the vein in an arm (intravenously) or through a muscle, usually a buttock (intramuscular).
The recommended dose in adults is 2-3 doses per week of "Adult Epargriseovit". Your doctor will decide whether you should take 1 or 2 doses a day.
Use in children
The recommended dose in children is 2-3 doses per week of "Epargriseovit children", according to the doctor's judgment.
Instructions for Use
Epargriseovit contains two types of ampoules: ampoules containing a red liquid and ampoules containing a colorless liquid. At the time of use, the contents of both vials must be drawn into the same syringe.
To open, hold the vial vertically, making sure that the colored dot is in the position shown in the figure.
Push the top of the vial back as shown in the figure
Overdose What to do if you have taken an overdose of Epargriseovit
If you use more Epargriseovit than you should
In case of administration of an excessive amount of Epargriseovit, there are currently no known toxic effects of this medicine. If in doubt, consult your doctor or pharmacist.
If you forget to use Epargriseovit
If you have forgotten a dose of Epargriseovit, it can be given to you or your child as soon as you remember. Epargriseovit can be administered at any time of the day. Do not use a double dose to make up for a forgotten dose.
If you stop taking Epargriseovit
If you want to stop taking Epargriseovit, consult your doctor or pharmacist. There are no particular recommendations for stopping treatment with Epargriseovit.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Epargriseovit
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience the following side effect after taking Epargriseovit as it can be serious:
- rapid onset severe allergic reaction which can lead to death (anaphylactic shock).
The following undesirable effects have been reported in patients treated with Epargriseovit. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, talk to your doctor or pharmacist:
- decreased muscle strength (asthenia);
- fever;
- low blood pressure;
- increased breathing rate (tachypnea);
- skin rashes;
- itch;
- redness, swelling and pain at the injection site.
Reporting of side effects
If you get 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 national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine. .
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after "EXP". The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Epargriseovit contains
The active ingredients of Epargriseovit are cyanocobalamin, folic acid, nicotinamide and ascorbic acid. Adult Epargriseovit contains:
- Vial I (red): 2500 mcg of cyanocobalamin, 0.70 mg of folic acid, 12 mg of nicotinamide;
- Vial II (colorless): 150 mg of ascorbic acid.
Epargriseovit children contains:
- Vial I (red): 1250 mcg of cyanocobalamin, 0.35 mg of folic acid, 6 mg of nicotinamide;
- Vial II (colorless): 75 mg of ascorbic acid
The other ingredients of adult Epargriseovit are:
- Vial I (red): sodium tartrate, tartaric acid, sodium hydroxide, water for injections;
- Vial II (colorless): sodium hydrosulfite, sodium bicarbonate, water for injections.
The other ingredients of Epargriseovit children are:
- Vial I (red): sodium tartrate, tartaric acid, sodium hydroxide, water for injections;
- Vial II (colorless): sodium hydrosulfite, sodium bicarbonate, water for injections.
Description of the appearance of Epargriseovit and contents of the package
1 ml and 1.5 ml glass vials I (red) and II (colorless);
- Epargriseovit adults: box containing 6 ampoules I of 1 ml and 6 ampoules II of 1.5 ml;
- Epargriseovit children: box containing 6 ampoules I of 1 ml and 6 ampoules II of 1 ml.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
EPARGRISEOVIT
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Epargriseovit children
Vial I (red) contains: Active principles: cyanocobalamin 1250 mcg; folic acid 0.35 mg; nicotinamide 6 mg.
Vial II (colorless) contains: Active principle: ascorbic acid 75 mg.
Epargriseovit adults
Vial I (red) contains: Active principles: cyanocobalamin 2500 mcg; folic acid 0.70 mg; nicotinamide 12 mg.
Vial II (colorless) contains: Active principle: ascorbic acid 150 mg.
03.0 PHARMACEUTICAL FORM
Injectable solution
INTRAMUSCULAR AND INTRAMUSCULAR USE
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Vitamin deficiencies, with particular regard to those of vitamin B12 and folic acid in severe forms of organic wasting, undernutrition resulting from defying diseases in all cases in which parenteral administration of these components is necessary.
Adjuvant in states of anemia, sensitive to vitamin B12 and folic acid.
04.2 Posology and method of administration
Adults - Average dosage: 2-3 doses per week, in the opinion of the doctor, 1 or 2 doses per day can be administered.
Children - 2-3 doses of Epargriseovit children per week, according to medical judgment.
Epargriseovit can be administered intramuscularly, intravenously and in slow venous perfusions after dilution in 250-500 ml of physiological saline or glucose solution.
At the moment of use, draw the contents of both vials into the same syringe.
04.3 Contraindications
Known hypersensitivity to the components of the product.
04.4 Special warnings and appropriate precautions for use
Products containing folic acid or derivatives, especially if they also contain vitamin B12, should not be administered to anemic subjects except on the basis of investigations aimed at establishing the exact nature of the existing anemia.
The treatment must be carried out under haematological control.
In the case of pernicious anemia, supplementation of vitamin B12 may be necessary. In any case, it is necessary to check whether the quantitative composition of the combination is adequate for the individual therapeutic needs.
A non-targeted administration of the product to anemic subjects can lead to diagnostic errors. The product can color the urine red. This fact should not be considered an anomalous phenomenon.
The product contains sodium hydrosulfite; this substance can cause allergic reactions and severe asthmatic attacks in sensitive subjects and particularly in asthmatics.
04.5 Interactions with other medicinal products and other forms of interaction
They are not known.
04.6 Pregnancy and lactation
There are no known negative interferences.
04.7 Effects on ability to drive and use machines
The use of Epargriseovit does not alter the driving ability, nor the use of machinery.
04.8 Undesirable effects
Administration of the preparation, especially parenterally, can be followed by mostly general hypersensitivity reactions consisting of asthenia, fever, hypotension, tachypnea, skin rashes, itching. Anaphylactic shock may occur.
Redness, swelling and pain may occur at the injection site.
04.9 Overdose
There are no known manifestations of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Epargriseovit is a "combination of vitamin B12, folic acid, nicotinamide and vitamin C which catalyze fundamental biological processes in the body."
Vitamin B12 (cyanocobalamin) is involved in many cellular metabolic reactions. It is essential for normal growth, for hematopoiesis, for the reproduction of epithelial cells (including those of the gastrointestinal tract) and for the synthesis of myelin in the nervous system. Its coenzyme activity affects, among other things, the synthesis of acids. nucleic and proteins, the maintenance in reduced form of the sulfhydryl groups, the formulation of methionine, the metabolism of fats and carbohydrates, the conversion of methylmalonate to succinate.
Some important biochemical reactions catalyzed by vitamin B12 also require the simultaneous presence of folic acid.
The folic acid coenzymes participate in a large number of metabolic reactions characterized by the transfer of mono-carbon units, which are also necessary for the synthesis of purines.
The need for folate is therefore related to the degree of metabolic and cellular reproductive activity.
Ascorbic acid (vitamin C) is essential for the conversion of folic acid in its biologically active form, that is, in folinic acid, for the formation of collagen and intercellular substance and therefore for the development of cartilage, bones, teeth and for wound healing. Vitamin C also influences hemoglobin biosynthesis, erythrocyte maturation and some immunological reactions of the organism.
Nicotinamide (vitamin PP) is an essential component of the nucleotide coenzymes NAD and NADP which play an important role in many fundamental biochemical reactions and in particular in those of cellular redox systems.
05.2 Pharmacokinetic properties
NICOTINAMIDE. The intestinal absorption of nicotinamide is normally very efficient. In the organism it is converted into coenzymes and excreted mainly in the form of methylated derivatives.
CYANOCOBALAMINE. Administered orally, cyanocobalamin is absorbed in part by simple diffusion through the intestinal mucosa, in part after binding to intrinsic factor, glycoprotein with a molecular weight of 60,000. The cyanocobalamin intrinsic factor complex interacts with specific receptors of the ileum mucosa, determining the passage of the vitamin principle into the circulation. Cyanocobalamin then binds to plasma globulins, the transcobalamins, to be transported to the tissues and in particular to the liver. L " excretion occurs to a small extent through the bile and mainly by the kidney.
ASCORBIC ACID. Ascorbic acid is absorbed in the intestinal tract probably by diffusion and is converted in the tissues into coenzyme A.
Ascorbic acid is easily absorbed in the intestinal tract and is present in all fluids and tissues of the body. Elimination is predominantly urinary.
05.3 Preclinical safety data
In experimental animals, doses equivalent to a few tens of times the therapeutic dose did not cause mortality or variations in biochemical and morphological parameters.
From the complex of the data it can therefore be concluded that the compound is devoid of toxicity both following single and repeated administration.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
- Epargriseovit children
Vial I (red) contains: sodium tartrate; sodium hydroxide; water for injections.
Vial II (colorless) contains: sodium hydrosulfite; sodium bicarbonate; water for injections.
- Adult Epargriseovit
Vial I (red) contains: sodium tartrate; sodium hydroxide; water for injections.
Vial II (colorless) contains: sodium hydrosulfite; sodium bicarbonate; water for injections.
06.2 Incompatibility
They are not known.
06.3 Period of validity
24 months.
06.4 Special precautions for storage
Do not store above 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
1 ml and 1.5 ml neutral glass vials I (red) and II (colorless);
Epargriseovit children: scatola containing 6 ampoules I (red) and 6 ampoules II (colorless);
Epargriseovit adults: scatola containing 6 ampoules I (red) and 6 ampoules II (colorless);
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Pfizer Italia S.r.l. via Isonzo, 71 - 04100 Latina
08.0 MARKETING AUTHORIZATION NUMBER
- 6 vials I + 6 vials II - AIC 013092010
- 6 vials I + 6 vials II - AIC 013092022
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
May 31, 2005
10.0 DATE OF REVISION OF THE TEXT
January 2009
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