TEMGESIC SUBLINGUAL TABLET 0.2 mg

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:

0.2 mg

Farmaceutski oblik:

TABLET

Sastav:

BUPRENORPHINE HCl EQV BUPRENORPHINE 0.2 mg

Administracija rute:

ORAL

Tip recepta:

Prescription Only

Proizveden od:

RECKITT BENCKISER HEALTHCARE (UK) LTD

Status autorizacije:

ACTIVE

Datum autorizacije:

1991-05-17

Svojstava lijeka

Page 1 of 8
1. NAME OF THE MEDICINAL PRODUCT:
TEMGESIC® 0.2 MG SUBLINGUAL TABLET
BRAND OF BUPRENORPHINE HYDROCHLORIDE
Indivior
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Buprenorphine hydrochloride 216 μg/tablet, equivalent to 200 μg
buprenorphine base.
3. PHARMACEUTICAL FORM:
Temgesic 0.2mg Sublingual Tablets are white to creamy white, circular,
biconvex tablets engraved on
one side with the letter L. Each Temgesic Sublingual Tablet contains
0.216 mg buprenorphine
hydrochloride, equivalent to 0.2 mg buprenorphine base.
The sublingual formulation is not designed to be split or broken.
4. CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
As a potent analgesic for use in moderate to severe pain.
4.2 POSOLOGY AND METHOD OF_ _ADMINISTRATION:
The tablet should not be chewed or swallowed as this will reduce
efficacy.
ADULTS AND CHILDREN OVER 12 YEARS OLD:
1 to 2 tablets (200 to 400 micrograms) to be dissolved under the
tongue (sublingually) every 6-8 hours
or as required. The recommended starting dose for moderate to severe
pain of the type typically
presenting in general practice is one to two tablets (200 to 400
micrograms) every 8 hours. There is no
indication that dosage needs to be modified for the elderly.
Temgesic Sublingual Tablets may be employed in balanced anaesthetic
techniques as a premedication
at a dose of 400 micrograms.
ELDERLY:
There is no indication that dosage needs to be modified for the
elderly.
CHILDREN UNDER 12 YEARS:
Temgesic Sublingual Tablets are suitable for use in children as
follows:
18-26 kg (35-55 lb): 100 micrograms (half a tablet)
25-37 kg (65-82.5 lb): 100-200 micrograms (half to one tablet)
37.5-50 kg (82.5-110 lb): 200-300 micrograms (one to one and a half
tablets)
There is no clinical experience in infants below the age of six
months.
Sublingual administration is not suitable for children under the age
of six years.
4.3 CONTRAINDICATIONS:
Patients with impaired respiratory functions. Patients with severe
hepatic impairment. Patients with
concurrently given MAO inhibitors. Pati