Temgesic

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Buprenorphine hydrochloride 0.324 mg/mL equivalent to 0.3 mg/mL buprenorphine; Buprenorphine hydrochloride 0.324 mg/mL equivalent to buprenorphine 0.3 mg/mL

Dostępny od:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Nazwa):

Buprenorphine hydrochloride 0.324 mg/mL (equivalent to 0.3 mg/mL buprenorphine)

Dawkowanie:

0.3 mg/mL

Forma farmaceutyczna:

Solution for injection

Skład:

Active: Buprenorphine hydrochloride 0.324 mg/mL equivalent to 0.3 mg/mL buprenorphine Excipient: Glucose Hydrochloric acid Water for injection Active: Buprenorphine hydrochloride 0.324 mg/mL equivalent to buprenorphine 0.3 mg/mL Excipient: Glucose monohydrate Hydrochloric acid Water for injection

Sztuk w opakowaniu:

Ampoule, glass, 1mL, 1 mL

Klasa:

Class C4 Controlled Drug

Typ recepty:

Class C4 Controlled Drug

Wyprodukowano przez:

Indivior UK Limited

Wskazania:

TEMGESIC injection is indicated for the short-term (not more than one week) 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. TEMGESIC is not recommended for use in children. TEMGESIC does not have an approved role in opioid dependence rehabilitation programmes.

Podsumowanie produktu:

Package - Contents - Shelf Life: Ampoule, glass, 1mL - 1 dose units -   - Ampoule, glass, 1mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C

Data autoryzacji:

1979-05-23

Ulotka dla pacjenta

TEMGESIC INJECTION 1.0
1
TEMGESIC INJECTION
_Buprenorphine (as hydrochloride) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TEMGESIC. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking TEMGESIC
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING TEMGESIC, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TEMGESIC IS
USED FOR
TEMGESIC is a "pain killer". It is
used for the short term relief of
severe pain.
TEMGESIC belongs to a group of
medicines called opioid (narcotic)
analgesics.
Opioid analgesics act directly on the
brain and spinal cord to block the
sensation of pain.
Your doctor may have prescribed
TEMGESIC for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TEMGESIC
HAS BEEN PRESCRIBED FOR YOU.
TEMGESIC contains the active
ingredient, buprenorphine (as
hydrochloride). People who take
buprenorphine to relieve short term
pain do not usually become addicted
to it.
It is important that you discuss this
issue with your doctor.
BEFORE YOU ARE GIVEN
TEMGESIC
_WHEN YOU MUST NOT USE IT _
YOU SHOULD NOT BE GIVEN
TEMGESIC IF YOU ARE:
•
allergic to buprenorphine or to
any of the other ingredients in
this medicine (see Product
Description at the end of this
leaflet).
•
allergic to opioid (narcotic)
medicines.
•
pregnant.
•
breast-feeding.
•
a child.
•
suffering from severe or acute
respiratory disease
_BEFORE YOU ARE GIVEN _
_TEMGESIC _
YOU MUST TELL YOUR DOCTOR IF:
1.
you have been given TEMGESIC
(buprenorphine) before and had
any problems with it
2.
you have any allergies to
•
any ingredients in this medicine
(see Product Description at the
end of this leaflet).
•
other strong analgesics (pain
killers) eg. morphine
•
any other substances such as
foods, preservatives, or dyes.
W

Charakterystyka produktu

NEW ZEALAND DATA SHEET
Page 1 of 13
1
PRODUCT NAME
TEMGESIC INJECTION 300 micrograms/mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Buprenorphine (as hydrochloride) 300 micrograms/mL
Excipients with known effect: 55 mg glucose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection. Colourless liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TEMGESIC injection is indicated for the short-term (not more than one
week) 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.
TEMGESIC is not recommended for use in children.
TEMGESIC does not have an approved role in opioid dependence
rehabilitation programmes.
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, TEMGESIC
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 _
TEMGESIC 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 TEMGESIC. 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
benzodiazepi