Dicynone 250

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

etamsylate

Available from:

OM Pharma SA

INN (International Name):

etamsylate

Dosage:

125mg/ml

Pharmaceutical form:

solution for i/m and i/v injection

Prescription type:

Prescription

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DICYNONE® 250 INJECTABLE SOLUTION
COMPOSITION
Each ampoule contains
_Active substance: _Etamsylate
_Excipients: _Sodium Hydrogen Carbonate as PH regulator, Antioxidant
(E223): 0.8 mg, water for
injections q.s.p. 2 ml.
PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT
Injectable solution in an ampoule (2 ml).
Each ampoule contains 250 mg of etamsylate.
INDICATIONS
Prophylaxis of pre-, intra- or postoperative capillary bleeding in all
difficult operations or operations on
highly vascularised tissues: ENT, gynaecology, obstetrics, urology,
odonto-stomatology, ophthalmology
or plastic and reparative surgery.
Treatment of capillary bleeding or any origin and any localisation.
Prophylaxis of periventricular bleeding in premature infants.
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS AND ADOLESCENTS _
_Pre-operative: _1-2 ampoules of Dicynone®250 i.v. or i.m. one hour
before the intervention.
_Intra-operative: _1-2 ampoules i.v., to be repeated as required.
_Post-operative: _1-2 ampoules of Dicynone®250, tobe repeated every
4-6 hours for as long as
thehaemorrhagic risk lasts.
_In an emergency and depending on the severity ofthe case: _1-2
ampoules i.v. or i.m., to be repeatedevery
4-6 hours until the haemorrhagic risk disappears.
_Topical application: _wet a pad with the content ofone ampoule and
apply to the haemorrhagic areaor into
the cavity after tooth extraction. To berepeated if necessary.
Combination with oral orparenteral use is
possible.
_CHILDREN _
Half the adult dose.
_Newborns: _10 mg per kg body weight (0.1 ml = 12.5mg) as an
intramuscular injection in the first 2hours
after birth, then every 6 hours for 4 days.
_ _
_SPECIAL POPULATIONS _
Clinical studies have not been performed inpatients presenting hepatic
or renal impairment.Consequently,
caution is required when administeringDicynone®250 injectable
solution to these
patients.
CONTRAINDICATIONS
- Acute porphyria
- Bronchial asthma, confirmed hypersensitivity tosulphites
- Hypersensitivity to any o

Summary of Product characteristics

052013
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dicynone
®
250, solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 2 ml contains 250 mg of etamsylate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of pre-, intra- or postoperative capillary bleeding in all
difficult operations or operations on
highly vascularised tissues: ENT, gynaecology, obstetrics, urology,
odonto-stomatology, ophthalmology
or plastic and reparative surgery.
Treatment of capillary bleeding or any origin and any localisation.
Prophylaxis of periventricular bleeding in premature infants.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS AND ADOLESCENTS _
_Pre-operative: _1-2 ampoules of Dicynone
®
250 i.v. or i.m. one hour before the intervention.
_Intra-operative: _1-2 ampoules i.v., to be repeated as required.
_Post-operative: _1-2 ampoules of Dicynone
®
250, to be repeated every 4-6 hours for as long as the
haemorrhagic risk lasts.
_In an emergency and depending on the severity of the case: _1-2
ampoules i.v. or i.m., to be repeated_ _every
4-6 hours until the haemorrhagic risk disappears.
_ _
_Topical application: _wet a pad with the content of one ampoule and
apply to the haemorrhagic area
or into the cavity after tooth extraction. To be repeated if
necessary. Combination with oral or parenteral
use is possible.
_CHILDREN _
Half the adult dose.
052013
2
_Newborns: _10 mg per kg body weight (0.1 ml = 12.5 mg) as an
intramuscular injection in the first 2 hours
after birth, then every 6 hours for 4 days.
_SPECIAL POPULATIONS _
Clinical studies have not been performed in patients presenting
hepatic or renal impairment.
Consequently, caution is required when administering Dicynone
®
250 injectable solution to these patients.
4.3
CONTRAINDICATIONS
CONTRAINDICATIONS
- Acute porphyria
- Bronchial asthma, confirmed hypersensitivity to sulphites
- Hypersensitivity to any of