Pethidine Injection BP Solution for Injection 5%w/v (50mg/ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PETHIDINE HYDROCHLORIDE

Available from:

Macarthys Laboratories Limited Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom

ATC code:

N02AB02

INN (International Name):

PETHIDINE HYDROCHLORIDE 5 % (W/V)

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

PETHIDINE HYDROCHLORIDE 5 % (W/V)

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2007-04-29

Patient Information leaflet

D03933
D03933
WHAT IS IN THIS LEAFLET
1. What Pethidine Injection is and what it is used for
2. Before you are given Pethidine Injection
3. How Pethidine Injection will be given
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 is a drug with powerful pain relieving properties.
Pethidine Injection is used for the relief of moderate to severe
pain and is used for pain relief during labour. It may also be
used to stop you from feeling pain before and during an
operation and to provide continuous pain relief if needed
2. BEFORE YOU ARE GIVEN PETHIDINE INJECTION
YOU SHOULD NOT BE GIVEN PETHIDINE INJECTION IF:
• you are allergic (hypersensitive) to Pethidine Hydrochloride or
to any of the ingredients of this medicine (listed in section 6)
• you suffer from asthma, shallow breathing or other breathing
difficulties
• you are suffering from severe headaches or have suffered a
head injury
• you suffer from alcoholism
• you suffer from a convulsive disorder (fits) such as epilepsy
• you have any liver or kidney problems
• you are suffering from a condition known as delirium
tremens, caused by withdrawal from alcohol
• your heartbeat is faster than usual
• you suffer from a tumour of the adrenal gland known as
phaeochromocytoma
• you suffer from diabetes
• you are taking or have recently taken any drugs used to treat
depression known as Monoamine Oxidase Inhibitors (MAOI’s)
(see ‘Taking other medicines)
Patients in a coma should not be given this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before being given Pethidine
Injection if:
• are in shock, the symptoms of which include sweating, a fast
pulse and cold, clammy skin
• suffer from thyroid problems
• suffer from problems related to your adrenal gland (the
organ responsible for stress levels), including adrenocortical
insufficiency (a lack of the hormones produced by the adrenal
gland)
• suffer

Summary of Product characteristics

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pethidine 50mg/ml & 100mg/2ml Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pethidine Hydrochloride 5% w/v
(50mg in 1ml and 100mg in 2ml total volume)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for Injection
A clear colourless, particle free solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of moderate to severe pain.
Premedication.
Obstetric analgesia.
Enhancement of analgesia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_.
_For moderate or severe pain. _
Normal single dose (usually not to be repeated more often than 4
hourly)
By intramuscular or subcutaneous injection 25 - 100 mg.
Page 2 of 10
By slow intravenous injection 25 - 50 mg.
_For obstetric analgesia. _
By intramuscular or subcutaneous injection repeated 1 - 3 hours later.
50 -
100 mg.
Maximum of 400mg in 24 hours.
_As a premedication. _
By intramuscular injection one hour prior to the operation. 50 - 100mg
_For the enhancement of analgesia. _
By slow intravenous injection. 10 - 25mg as required.
_Elderly or debilitated patients. _
Initial doses should not exceed 25mg as this group of patients may be
specially
sensitive to the central depressant effect of the drug.
Paediatric population
_For moderate or severe pain. _
By intramuscular injection. 0.5 - 2 mg per Kg of body weight.
_As a premedication. _
By intramuscular injection one hour prior to the operation. 1 - 2 mg
per kg of
body weight.
Method of administration
Intramuscular, intravenous or subcutaneous injection
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed
in section 6.1
Severe respiratory depression, severe obstructive airways disease or
acute
asthma.
It should not be administered to patients with severe renal impairment
or
severe hepatic impairment.
Should be avoided in patients with acute alcoholism, delirium tremens,
raised intracranial pressure or in those with convulsive st