DICYNONE 250 Solution for injection Ref.[28188] Active ingredients: Etamsylate

Source: Υπουργείο Υγείας (CY)  Publisher: OM PHARMA S.A., R. da Indústria, 2 – Quinta Grande, 2610-088 Аmadora Portugal

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 vascularised tissues: E.N.T., gynaecology, obstetrics, urology, odontostomatology, ophthalmology, plastic and reconstructive surgery.

In paediatrics

Prevention of periventricular haemorrhages in premature babies.

4.2. Posology and method of administration

Adults

Presurgical: 1-2 ampoules i.v. (250-500 mg) 1 hour before surgery.

Persurgical: 1-2 ampoules i.v. Repeat the dosage if necessary.

Postsurgical: 1-2 ampoules (250-500 mg) every 4-6 hours as long as the risk of bleeding persists.

Emergency cases, according to the severity of the case: 1-2 ampoules i.v. or i.m. every 4-6 hours as long as the bleeding risk persists.

Local treatment: soak a swab with the contents of one ampoule and apply to haemorrhagic area, or in the tooth socket after dental extraction. The application may be repeated if necessary; it may be associated with oral or parenteral administration.

Children

Half the adult dose.

Neonatology

10 mg per kg body weight (0,1 ml = 12,5 mg) injected intramuscularly within 2 hours of birth then every 6 hours for 4 days.

Special population

Clinical studies have not been performed in patients presenting hepatic or renal impairment. Consequently, caution is required when administering Dicynone 250 to these patients.

4.9. Overdose

No case of overdose has been reported. In case de overdosage, a symptomatic treatment should be initiated.

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.

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