Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
CLONIDINE HYDROCHLORIDE
Boehringer Ingelheim International GmbH
C02AC; C02AC01
CLONIDINE HYDROCHLORIDE
150 microgram(s)/millilitre
Solution for injection
Imidazoline receptor agonists; clonidine
Marketed
1979-04-01
PROFESSIONAL LEAFLET CATAPRES ® AMPOULES 150 MICROGRAMS IN 1 ML SOLUTION FOR INJECTION (clonidine hydrochloride) NAME OF THE MEDICINAL PRODUCT CATAPRES Ampoules 150 micrograms in 1 ml Solution for Injection QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml ampoule contains clonidine hydrochloride 150 micrograms. For excipients, see List of excipients. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution CLINICAL PARTICULARS _THERAPEUTIC INDICATIONS _ CATAPRES is indicated for the treatment of hypertensive crises. _POSOLOGY AND METHOD OF ADMINISTRATION _ _ADULTS, INCLUDING THE ELDERLY: _ In hypertensive crises 150 to 300 micrograms (1 to 2 ampoules) should be given by slow intravenous injection. This dose may be repeated up to a maximum 750 micrograms (5 ampoules) in a 24 hour period. Patients undergoing anaesthesia should continue their CATAPRES treatment before, during and after anaesthesia using oral or intravenous administration according to individual circumstances. Intravenous injection of CATAPRES should be given slowly over 10-15 minutes to avoid a possible transient pressor effect. CATAPRES injection solution is compatible with 0.9% sodium chloride solution and with 5% dextrose solution. _PAEDIATRIC POPULATION: _ There is insufficient evidence for the application of clonidine in children and adolescents younger than 18 years. Therefore the use of clonidine is not recommended in paediatric subjects under 18 years. _RENAL INSUFFICIENCY: _ Dosage must be adjusted • according to the individual antihypertensive response which can show high variability in patients with renal insufficiency • according to the degree of renal impairment _CONTRAINDICATIONS _ CATAPRES should not be used in children (please refer to Special warnings and precautions for use) or in patients with known hypersensitivity to the active ingredient or other components of the product, and in patients with severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of 2 nd or 3 rd degree. _SPECIAL WARNI Lire le document complet
Health Products Regulatory Authority 07 March 2019 CRN008KDC Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Catapres Ampoules 150 micrograms in 1 ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml ampoule contains clonidine hydrochloride 150 micrograms. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Catapres is indicated for the treatment of hypertensive crises. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, including the elderly: In hypertensive crises 150 to 300 micrograms (1 to 2 ampoules) should be given by slow intravenous injection. This dose may be repeated up to a maximum of 750 micrograms (5 ampoules) in a 24 hour period. Patients undergoing anaesthesia should continue their Catapres treatment before, during and after anaesthesia using oral or intravenous administration according to individual circumstances. Intravenous injection of Catapres should be given slowly over 10 – 15 minutes to avoid a possible transient pressor effect. Catapres injection solution is compatible with 0.9% sodium chloride solution and with 5% dextrose solution. _PAEDIATRIC POPULATION: _ There is insufficient evidence for the application of clonidine in children and adolescents younger than 18 years. Therefore the use of clonidine is not recommended in paediatric subjects under 18 years. _RENAL INSUFFICIENCY: _ Dosage must be adjusted - according to the individual antihypertensive response which can show high variability in patients with renal insufficiency - according to the degree of renal impairment 4.3 CONTRAINDICATIONS Catapres should not be used in children (please refer to section 4.4 Special Warnings and Precautions for Use) or in patients with known hypersensitivity to the active ingredient or other components of the product, and in patients with severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of 2 nd or 3 Lire le document complet