DICYNONE 250 Solution for injection
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Περιεχόμενα
1. Name of the medicinal product
Dicynone 250.
2. Qualitative and quantitative composition
<u>Ampoule for injection:</u> Etamsylate 250 mg. Excipients with a know effect: antiox. (E223) 0.8 mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
4.1. Therapeutic indications
Dicynone 250 is indicated in adults, children and neonates. In surgery Prevention and treatment of pre-, per-, or postsurgical capillary haemorrhages in all delicate operations and in those affecting highly ...
4.2. Posology and method of administration
Adults <u>Presurgical:</u> 1-2 ampoules i.v. (250-500 mg) 1 hour before surgery. <u>Persurgical:</u> 1-2 ampoules i.v. Repeat the dosage if necessary. <u>Postsurgical:</u> 1-2 ampoules (250-500 mg) every ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Acute porphyria. Bronchial asthma, proven hypersensitivity to sulphites.
4.4. Special warnings and precautions for use
As parenteral administration of Dicynone 250 for injection may induce a drop in blood pressure, it is advised to carefully monitor patients suffering from blood pressure instability or hypotension (see ...
4.5. Interaction with other medicinal products and other forms of interaction
Thiamine (vitamin B<sub>1</sub>) is inactivated by the sulphite contained in Dicynone 250 for injection. If a perfusion with Dextran is necessary, Dicynone 250 must be injected first. At therapeutic doses, ...
4.6. Pregnancy and lactation
There are limited amount of data from the use of etamsylate in pregnant women. Animal experiments have not revealed any direct or indirect toxicity affecting pregnancy, embryonic development, foetal development ...
4.7. Effects on ability to drive and use machines
In adults, Dicynone 250 for injection has no effect upon driving capacity and managing of machines.
4.8. Undesirable effects
The side effects are classified according to the MedDRA convention by system organ class and by frequency as follows: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Rare ...
4.9. Overdose
No case of overdose has been reported. In case de overdosage, a symptomatic treatment should be initiated.
5.1. Pharmacodynamic properties
<u>Pharmacotherapeutic group:</u> Other systematic hemostatics <u>ATC code:</u> B02BX01 Etamsylate is a synthetic antihaemorrhagic and angioprotective drug acting on the first step of haemostasis (endothelium-platelet ...
5.2. Pharmacokinetic properties
After i.v. administration of 500 mg etamsylate, the maximum plasma level, i.e. 50 μg/ml, is reached after 10 minutes; plasma half-life is about 1,9 h. About 85% of the administered dose are excreted in ...
5.3. Preclinical safety data
Acute and chronic toxicity studies, foetotoxicity and mutagenicity studies on etamsylate have not revealed any toxic effect.
6.1. List of excipients
Sodium metabisulfite Sodium hydrogen carbonate Water for injection
6.2. Incompatibilities
No known up to now.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Protect the ampoules from light. Discard Dicynone 250 ampoules if the solution is coloured. Dicynone 250 ampoules should not be administered after the expiration date indicated on the package (EXP).
6.5. Nature and contents of container
Colourless glass-ampoules, glass type I. Packs of 4, 20, 100 ampoules. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special instructions.
7. Marketing authorization holder
OM PHARMA S.A., R. da Indústria, 2 – Quinta Grande, 2610-088 Аmadora Portugal
8. Marketing authorization number(s)
10494
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 18 July 2001
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