Pethidine Hydrochloride 50 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PETHIDINE HYDROCHLORIDE

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N02AB; N02AB02

INN (International Name):

PETHIDINE HYDROCHLORIDE

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Phenylpiperidine derivatives; pethidine

Authorization status:

Not marketed

Authorization date:

2006-02-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER PETHIDINE
HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION (INJECTION)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1. What Pethidine Hydrochloride Injection is and what it is used for
2. Before you are given Pethidine Hydrochloride Injection
3. How to use Pethidine Hydrochloride Injection
4. Possible side effects
5. How to store Pethidine Hydrochloride Injection
6. Further information
1. WHAT PETHIDINE HYDROCHLORIDE INJECTION IS AND WHAT IT IS USED FOR
Medicines that relieve pain are called analgesics. Pethidine is a
strong analgesic and it belongs to a group
of medicines known as opioid analgesics.
Pethidine Hydrochloride Injection may be used as an analgesic to
relieve moderate-to-severe pain. It may
be used before, during, or after surgery to relieve pain and it may be
used to relieve pain during labour.
2. BEFORE YOU ARE GIVEN PETHIDINE HYDROCHLORIDE INJECTION
YOU SHOULD NOT BE GIVEN PETHIDINE HYDROCHLORIDE INJECTION
•
if you have ever had an allergic reaction to pethidine hydrochloride
or any of the other ingredients used
in this product.
•
if you have severe breathing problems
•
if you are in a coma
•
if you are taking medicines called monoamine oxidase inhibitors for
depression or if you have taken
them within the last 14 days.
•
if you are taking selegiline (for treatment of Parkinson’s disease).
TAKE SPECIAL CARE WITH PETHIDINE HYDROCHLORIDE INJECTION
•
if you are feeling drowsy or confused
•
if you are feeling weak or run-down
•
if you have had an underactive thyroid or adrenal gland
•
if you suffer from kidney, l

Summary of Product characteristics

Health Products Regulatory Authority
10 February 2020
CRN008X01
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pethidine Hydrochloride 50 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 50 mg pethidine hydrochloride.
Each 2 ml of solution contains 100 mg pethidine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (Injection)
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an analgesic in the relief of moderate to severe pain.
For pre-operative medication and analgesia during anaesthesia.
As an analgesic during labour.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Pethidine Hydrochloride Injection 50 mg/ml is for administration by
subcutaneous, intramuscular or slow intravenous injection.
FOR PAIN RELIEF:
Adults:
The usual dose is 25 to 100 mg intramuscularly or subcutaneously or 25
to 50 mg by slow intravenous injection. Dosage may
be repeated if required every 4 hours.
Elderly:
In view of their greater sensitivity, the initial dose should not
exceed 25 mg.
Paediatric patients:
The usual dose is 0.5 to 2 mg/kg body weight intramuscularly. Dosage
may be repeated if required every 4 hours.
OBSTETRIC ANALGESIA
50-100 mg given by intramuscular or subcutaneous injection. Dose may
be repeated after one to three hours if necessary up to
a maximum of 400 mg in 24 hours.
PRE-ANAESTHETIC MEDICATION
Adults:
25 to 100 mg may be given intramuscularly or subcutaneously about one
hour before surgery.
Elderly:
In view of their greater sensitivity, the initial dose should not
exceed 25 mg.
Paediatric patients:
0.5 to 2 mg/kg body weight intramuscularly one hour before surgery.
Health Products Regulatory Authority
10 February 2020
CRN008X01
Page 2 of 5
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 b