Catapres 150micrograms/1ml solution for injection ampoules

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Clonidine hydrochloride

Disponibil de la:

Glenwood GmbH

Codul ATC:

C02AC01

INN (nume internaţional):

Clonidine hydrochloride

Dozare:

150microgram/1ml

Forma farmaceutică:

Solution for injection

Calea de administrare:

Intravenous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 02050200; GTIN: 5012816025523

Prospect

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 Raynaud’s disease (a problem wi

Caracteristicilor produsului

OBJECT 1
CATAPRES AMPOULES
Summary of Product Characteristics Updated 25-Sep-2017 | Boehringer
Ingelheim Limited
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 excipients, see 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 2nd or 3rd degree.
4.4 Speci