Catapres Ampoules 150 micrograms in 1 ml Solution for Injection

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Clonidine hydrochloride

থেকে পাওয়া:

Glenwood GmbH

এটিসি কোড:

C02AC; C02AC01

INN (আন্তর্জাতিক নাম):

Clonidine hydrochloride

ডোজ:

150 microgram(s)/millilitre

ফার্মাসিউটিকাল ফর্ম:

Solution for injection

থেরাপিউটিক এলাকা:

Imidazoline receptor agonists; clonidine

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1979-04-01

তথ্য লিফলেট

UK_Catapres Ampoules
Page 1 / 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
CATAPRES
®
AMPOULES
150 MICROGRAMS IN 1 ML
SOLUTION FOR INJECTION
(clonidine hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
•
If any of the side effects gets troublesome or serious, or if you
notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What CATAPRES Ampoules are and what they are used for
2.
Before you receive CATAPRES Ampoules
3.
How CATAPRES Ampoules will be given
4.
Possible side effects
5.
How to store CATAPRES Ampoules
6.
Further information
1. WHAT CATAPRES AMPOULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is CATAPRES Ampoules 150 micrograms in 1 ml
Solution for Injection
(called CATAPRES Ampoules in this leaflet). Your medicine is a
solution for injection.
CATAPRES Ampoules contain a medicine called clonidine. This belongs to
a group of medicines
called antihypertensives.
CATAPRES is used to lower high blood pressure in cases of hypertensive
crisis (a rapid rise in blood
pressure that needs treating straight away).
2. BEFORE YOU RECEIVE CATAPRES AMPOULES
YOU SHOULD NOT BE GIVEN CATAPRES AMPOULES IF:
•
You are pregnant, likely to get pregnant or are breast-feeding
•
You are allergic (hypersensitive) to clonidine or any of the other
ingredients of CATAPRES
(see section 6: Further information)
•
You have a slow heart rate due to heart problems
•
You are under 18 years old
You should not receive this medicine if any of the above apply to you.
If you are not sure, talk to
your doctor or pharmacist before having CATAPRES Ampoules.
TAKE SPECIAL CARE WITH CATAPRES AMPOULES
Check with your doctor or pharmacist before having CATAPRES if:
•
You have R

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
18 July 2022
CRN00CXT3
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
r