Catapres Ampoules 150 micrograms in 1 ml Solution for Injection

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

CLONIDINE HYDROCHLORIDE

Prieinama:

Boehringer Ingelheim International GmbH

ATC kodas:

C02AC; C02AC01

INN (Tarptautinis Pavadinimas):

CLONIDINE HYDROCHLORIDE

Dozė:

150 microgram(s)/millilitre

Vaisto forma:

Solution for injection

Gydymo sritis:

Imidazoline receptor agonists; clonidine

Autorizacija statusas:

Marketed

Leidimo data:

1979-04-01

Pakuotės lapelis

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

Prekės savybės

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