AZEPTIL Solution for injection (2016)
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Περιεχόμενα
1. Name of the medicinal product
Azeptil 250mg/5ml solution for injection. Azeptil 500mg/5ml solution for injection.
2. Qualitative and quantitative composition
Azeptil 250mg/5ml solution for injection: Each ampoule contains 5ml of an aqueous solution containing 250mg tranexamic acid. Azeptil 500mg/5ml solution for injection: Each ampoule contains 5ml of an aqueous ...
3. Pharmaceutical form
Solution for injection. A clear colourless solution, pH 6.5 to 8.0.
4.1. Therapeutic indications
Prevention and treatment of haemorrhages due to general or local fibrinolysis in adults and children from one year. Specific indications include: Haemorrhage caused by general or local fibrinolysis such ...
4.2. Posology and method of administration
Posology Adults Unless otherwise prescribed, the following doses are recommended: <u>Standard treatment of local fibrinolysis:</u> 0.5 g (2 ampoules of 250mg/5 ml or 1 ampoule of 500mg/5 ml) to 1 g (4 ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Acute venous or arterial thrombosis (see section 4.4). Fibrinolytic conditions following consumption coagulopathy ...
4.4. Special warnings and precautions for use
The indications and method of administration indicated above should be followed strictly: Intravenous injections should be given very slowly Tranexamic acid should not be administered by the intramuscular ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Simultaneous treatment with anticoagulants must take place under the strict supervision of a physician experienced in this field. Medicinal products that act ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential have to use effective contraception during treatment. Pregnancy There is insufficient clinical data on the use of tranexamic acid in pregnant women. As a result, although ...
4.7. Effects on ability to drive and use machines
No studies have been performed on the ability to drive and use machines.
4.8. Undesirable effects
The ADRs reported from clinical studies and post-marketing experience are listed below according to system organ class. Tabulated list of adverse reactions Adverse reactions reported are presented in table ...
4.9. Overdose
Symptoms No case of overdose has been reported. Signs and symptoms may include dizziness, headache, hypotension, and convulsions. It has been shown that convulsions tend to occur at higher frequency with ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antihemorrhagics, Antifibrinolytics, Aminoacids <b>ATC code:</b> B02AA02 Tranexamic acid exerts an anti haemorrhagic activity by inhibiting the fibrinolytic properties ...
5.2. Pharmacokinetic properties
Absorption Peak plasma concentrations of tranexamic acid are obtained rapidly after a short intravenous infusion after which plasma concentrations decline in a multi-exponential manner. Distribution The ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction. Epileptogenic ...
6.1. List of excipients
Azeptil 250mg/5ml and 500mg/5ml solution for injection also contain propylene glycol, sodium metabisulfite (E223), sodium hydroxide and water for injection.
6.2. Incompatibilities
Solution for injection of tranexamic acid should not be added to blood for transfusion or to injections containing penicillin.
6.3. Shelf life
5 years. <u>After first opening:</u> the solution for injection is for single use only. Unused solution for injection must be discarded.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Azeptil 250mg/5ml and 500mg/5ml solution for injection are filled into brown glass type I ampoules. 5 ampoules are placed into a PVC case. Cases and leaflet in an outer carton. Boxes of ten ampoules are ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Azeptil 250mg/5ml solution for injection: 19835 Azeptil 500mg/5ml solution for injection: 19834
9. Date of first authorization / renewal of the authorization
Azeptil 250mg/5ml solution for injection: 19.12.2005/30.05.2012 Azeptil 500mg/5ml solution for injection: 19.12.2005/31.05.2012
10. Date of revision of the text
05/2016
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