Pethidine Hydrochloride 50mg/ml Solution for injection (2ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PETHIDINE HYDROCHLORIDE

Available from:

Mercury Pharmaceuticals (Ireland) Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

ATC code:

N02AB02

INN (International Name):

PETHIDINE HYDROCHLORIDE 50 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

PETHIDINE HYDROCHLORIDE 50 mg/ml

Prescription type:

POM

Therapeutic area:

ANALGESICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2007-04-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PETHIDINE HYDROCHLORIDE 50MG/ML SOLUTION FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is Pethidine Hydrochloride 50mg/ml Solution
for Injection but will
be referred to as “Pethidine Injection” throughout the remainder
of this leaflet.
WHAT IS IN THIS LEAFLET
1. What Pethidine Injection is and what it is used for
2. What you need to know before you are given Pethidine Injection
3. How Pethidine Injection is given to you
4. Possible side effects
5. How to store Pethidine Injection
6. Contents of the pack and other information
1. WHAT PETHIDINE INJECTION IS AND WHAT IT IS USED FOR
Pethidine Injection is a type of medicine called an opioid analgesic.
The word opioid means
a substance similar to opium, for instance strong pain relievers such
as morphine or codeine.
An analgesic is a medicine that can be used to relieve pain.
Pethidine Injection is used to relieve moderate to severe pain,
including pain associated with
childbirth, before an operation and as a medicine given before
administration of an anaesthetic.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PETHIDINE INJECTION
YOU SHOULD NOT BE GIVEN PETHIDINE INJECTION
• if you are allergic to pethidine hydrochloride or any of the other
ingredients in this medicine
(listed in section 6)
• if you have any problems that affect your breathing including
chronic bronchitis or asthma,
shallow breathing or other breathing difficulties
• if you are taking monoamine oxidase inhibitors (MAOIs) or have
been taking them within
the last two weeks. MAOIs (e.g. phenelzine, moclobemide, isocarboxazid
selegiline and
rasagiline) are medicines used to

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pethidine Hydrochloride 50mg/ml Solution for Injection (2ml)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 50mg of Pethidine Hydrochloride.
Each 2ml of solution contains 100mg of Pethidine Hydrochloride.
Excipient with known effect
None
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (Injection)
A clear colourless, sterile solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an analgesic in the relief of moderate to severe pain.
As an adjunct in anaesthesia.
For preoperative medication
During labour
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual dose is 25 to 100mg intramuscularly or subcutaneously or 25
to
50mg by slow intravenous injection. Dosage may be repeated if required
every
4 hours.
_Elderly or debilitated patients _
In view of their greater sensitivity, the initial dose should not
exceed 25mg.
_Paediatric_
_population_
The usual dose is 0.5 to 2mg/kg body weight. Dosage may be repeated if
required every 4 hours.
The use of a small graduated syringe is recommended for the accurate
administration of dosages given to children. In the absence of
graduated
syringes, the solution should be diluted with Water for Injections
before
measuring the dose.
Method of administration
Pethidine Hydrochloride 50mg/ml Solution for Injection is for
administration
by subcutaneous, intramuscular or slow intravenous injection.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
•
Use of pethidine should be avoided in patients with diabetic acidosis
where
there is danger of coma
•
In comatose patients
•
Use of pethidine in patients with Phaeochromocytoma may result in
hypertensive crisis.
•
Use in patients who are receiving, or have within two weeks received,
monoamine oxidase inhibitors (including moclobemide, and the monoamine
B
inhibitors selegiline and rasagili