TEMGESIC INJECTION 0.3 mgml

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

BUPRENORPHINE HCl EQV BUPRENORPHINE

Dostupno od:

ZUELLIG PHARMA PTE. LTD.

ATC koda:

N02AE01

Doziranje:

0.3 mg/ml

Farmaceutski oblik:

INJECTION

Sastav:

BUPRENORPHINE HCl EQV BUPRENORPHINE 0.3 mg/ml

Administracija rute:

INTRAVENOUS, INTRAMUSCULAR

Tip recepta:

Prescription Only

Proizveden od:

RECKITT BENCKISER HEALTHCARE (UK) LTD

Status autorizacije:

ACTIVE

Datum autorizacije:

1991-05-17

Svojstava lijeka

Page 1 of 5
1. NAME OF MEDICINAL PRODUCT:
TEMGESIC® INJECTION 0.3MG/ML
BRAND OF BUPRENORPHINE HYDROCHLORIDE
Indivior
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Buprenorphine hydrochloride 324 μg/ml, equivalent to 300 μg
buprenorphine base.
3. PHARMACEUTICAL FORM:
Temgesic injection is a colourless, clear solution, essentially free
from particles. Each ml of Temgesic
Injection contains 0.324 mg buprenorphine hydrochloride equivalent to
0.3 mg buprenorphine base.
4. CLINICAL PARTICULARS:
It has been proposed that Temgesic exerts its analgesic effect via
high affinity binding to the opiate
receptors in the central nervous system. Temgesic is a partial agonist
at one subclass of opiate
receptors. _In vitro_ and _in vivo_ studies have shown that Temgesic
has a high affinity for the (subclass
and dissociates from this receptor slowly. It is believed that these
qualities of receptor bindings
contribute to the long duration of action and low level of physical
dependence seen with Temgesic.
4.1 THERAPEUTIC INDICATION:
As a potent analgesic for use in moderate to severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
ADULTS AND CHILDREN OVER 12 YEARS OLD: 1 to 2 ml (300 to 600
micrograms) by IM or slow IV
injection, every 6-8 hours or as required.
Temgesic injection may be employed in balanced anaesthetic techniques
as a premedication at a dose
of 300 micrograms intramuscularly or as an analgesic supplement at
doses of 300-450 micrograms
intravenously.
CHILDREN UNDER 12 YEARS:
Temgesic is suitable for use in children below 12 at a dose of 3 – 6
micrograms/kg of body weight
every 6 to 8 hours in refractory cases up to 9 micrograms/kg may be
administered.
There is no clinical experience in infants below the age of six
months.
Page 2 of 5
ELDERLY:
There is no indication that dosage needs to be modified for the
elderly.
4.3 CONTRAINDICATIONS:
Patients with impaired respiratory functions. Patients with impaired
liver functions. Patients with
concurrently given MAO inhibitors. Patients who are pregnant. Not to
be given t