Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
urapidil
EVER Neuro Pharma GmbH
urapidil
5mg/ml
solution for i/v injection
Prescription
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 Read the complete document