Tachyben solution for i/v injection

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

urapidil

Verfügbar ab:

EVER Neuro Pharma GmbH

ATC-Code:

C02CA06

INN (Internationale Bezeichnung):

urapidil

Dosierung:

5mg/ml

Darreichungsform:

solution for i/v injection

Einheiten im Paket:

(5/1x5/) ampoules 5ml in blister

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2019-01-18

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tachyben 25 mg solution for injection/infusion
Tachyben 50 mg solution for injection/infusion
Tachyben 100 mg solution for injection/infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 5 mg urapidil.
5 ml ampoule contains 25 mg urapidil.
10 ml ampoule contains 50 mg urapidil.
20 ml ampoule contains 100 mg urapidil.
For the full list of excipients, see 6.1.
3. PHARMACEUTICAL FORM
25 mg/ 50 mg: Solution for injection/infusion, which could also be
diluted for infusion purposes.
100 mg:
Solution for injection/infusion, which could also be diluted for
infusion purposes
Clear, colourless solution with a pH of 5.6 to 6.6.
Free from visible particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertensive emergencies (e.g. a critical rise in blood pressure),
severe and very severe forms of
hypertensive disease, hypertension resistant to treatment.
Controlled lowering of blood pressure in hypertensive patients during
and/or after surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_For hypertensive emergencies, severe and very severe forms of
hypertension, and treatment resistant _
_hypertension_
Intravenous injection
10-50 mg urapidil is slowly administered by intravenous injection -
while constantly monitoring the
blood pressure. A fall in blood pressure can be expected within 5 min.
of administering the injection.
The injection of 10-50 mg urapidil can be repeated depending how the
blood pressure reacts.
Intravenous infusion or syringe pump are used to maintain the level of
blood pressure achieved by the
injection.
For instructions on dilution of the medicinal product before
administration, see section 6.6.
The maximum quantity compatible is 4 mg urapidil per ml of solution
for infusion.
Speed of administration: The infusion rate is determined from the
individual blood pressure situation._ _
Initial recommended maximum infusion rate: 2 mg/min.
Maintenance dose:_ _On average 9 mg/h, referring to 250 mg urapidil
added to 500 ml so