Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Pethidine hydrochloride 50 mg/mL; Pethidine hydrochloride 50 mg/mL
Pfizer New Zealand Limited
Pethidine hydrochloride 50 mg/mL
50 mg/mL
Solution for injection
Active: Pethidine hydrochloride 50 mg/mL Excipient: Water for injection Active: Pethidine hydrochloride 50 mg/mL Excipient: Sodium hydroxide Water for injection
Ampoule, glass, Type 1, (5 x 1mL), 5 mL
Class B3 Controlled Drug
Class B3 Controlled Drug
Sanofi-Aventis Deutschland GmbH
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).
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
1985-08-07
Version: pfdpethi10224 Supersedes: pfdpethi11122 Page 1 of 22 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). _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). _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). _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). 1. PRODUCT NAME DBL™ Pethidine Hydrochloride Injection 50 mg/mL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Pethidine Hydrochloride Injection is available as a 50 mg/1 mL, 75 mg/1.5 mL, and 100 mg/2 mL solution. For the full list of excipients, see section 6.1. Version: pfdpethi10224 Supersedes: pfdpethi Leggi il documento completo