DBL™ Pethidine Hydrochloride Injection

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

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

Διαθέσιμο από:

Pfizer New Zealand Limited

INN (Διεθνής Όνομα):

Pethidine hydrochloride 50 mg/mL

Δοσολογία:

50 mg/mL

Φαρμακοτεχνική μορφή:

Solution for injection

Σύνθεση:

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

Μονάδες σε πακέτο:

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

Kατηγορία:

Class B3 Controlled Drug

Τρόπος διάθεσης:

Class B3 Controlled Drug

Κατασκευάζεται από:

Sanofi-Aventis Deutschland GmbH

Θεραπευτικές ενδείξεις:

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).

Περίληψη προϊόντος:

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

Ημερομηνία της άδειας:

1985-08-07

Αρχείο Π.Χ.Π.

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