Catapres Ampoules 150 micrograms in 1 ml Solution for Injection

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

CLONIDINE HYDROCHLORIDE

Διαθέσιμο από:

Boehringer Ingelheim Limited

Φαρμακολογική κατηγορία (ATC):

C02AC; C02AC01

INN (Διεθνής Όνομα):

CLONIDINE HYDROCHLORIDE

Δοσολογία:

0.15 micromole(s)

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Imidazoline receptor agonists; clonidine

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1979-04-01

Φύλλο οδηγιών χρήσης

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 WARNINGS AN

Αρχείο Π.Χ.Π.

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
rd
degree.
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