DBL™ Pethidine Hydrochloride Injection

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pethidine hydrochloride 50 mg/mL; Pethidine hydrochloride 50 mg/mL

Available from:

Pfizer New Zealand Limited

INN (International Name):

Pethidine hydrochloride 50 mg/mL

Dosage:

50 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Pethidine hydrochloride 50 mg/mL Excipient: Water for injection Active: Pethidine hydrochloride 50 mg/mL Excipient: Sodium hydroxide Water for injection

Units in package:

Ampoule, glass, Type 1, (5 x 1mL), 5 mL

Class:

Class B3 Controlled Drug

Prescription type:

Class B3 Controlled Drug

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Therapeutic indications:

DBL Pethidine Hydrochloride Injection is indicated for administration as an anaesthetic adjunct and for obstetric analgesia. DBL Pethidine Hydrochloride Injection is also indicated for the short-term (24 to 36 hours) management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. It can be given via the following routes of administration – intramuscular (IM), subcutaneous (SC), slow intravenous (IV) bolus injection, intravenous infusion and patient-controlled analgesia (PCA).

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type 1, (5 x 1mL) - 5 mL - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, (5 x 1.5mL) - 7.5 mL - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, Type 1, (5 x 2mL) - 10 mL - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, Type 1, (50 x 1.5mL) - 75 mL - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1985-08-07

Summary of Product characteristics

Version: pfdpethi11122
Supersedes: pfdpethi10522
Page 1 of 23
NEW ZEALAND DATA SHEET
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, pethidine
should only be used in
patients for whom other treatment options, including non-opioid
analgesics, are ineffective,
not tolerated or otherwise inadequate to provide appropriate
management of pain (see
section 4.4 Special warnings and precautions for use).
_HAZARDOUS AND HARMFUL USE _
Pethidine poses risks of hazardous and harmful use which can lead to
overdose and death.
Assess the patient’s risk of hazardous and harmful use before
prescribing and monitor the
patient regularly during treatment (see section 4.4 Special warnings
and precautions for
use).
_LIFE-THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of pethidine.
Be aware of situations which increase the risk of respiratory
depression, modify dosing in
patients at risk and monitor patients closely, especially on
initiation or following a dose
increase (see section 4.4
Special warnings and precautions for use).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, _
_INCLUDING ALCOHOL _
Concomitant use of opioids with CNS depressants medicines, such as
other opioid
analgesics,
benzodiazepines,
gabapentinoids,
cannabis,
sedatives,
hypnotics,
tricyclic
antidepressants,
antipsychotics,
antihistamines,
centrally-active
anti-emetics,
general
anaesthetics, tranquilisers, or other CNS depressants, including
alcohol, may result in
profound sedation, respiratory depression, coma, and death. Limit
dosages and durations to
the minimum required; and monitor patients for signs and symptoms of
respiratory
depression and sedation. Caution patients not to drink alcohol while
using pethidine (see
section 4.4
Special warnings and precautions for use).
1.
PRODUCT NAME
DBL™ Pethidine Hydrochloride Injection 50 mg/mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Pethidine Hydrochloride Injec