Temgesic 300 micrograms/ml, solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Buprenorphine hydrochloride

Available from:

Eumedica Pharmaceuticals GmbH

ATC code:

N02AE; N02AE01

INN (International Name):

Buprenorphine hydrochloride

Pharmaceutical form:

Solution for injection

Therapeutic area:

Oripavine derivatives; buprenorphine

Authorization status:

Not marketed

Authorization date:

2019-02-01

Patient Information leaflet

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1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEMGESIC INJECTION 1 ML
Buprenorphine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
because it
contains important information for you.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
-
If you get any of the side effects, talk to your doctor, pharmacist or
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Temgesic is and what it is used for
2.
What you need to know before you use Temgesic Injection
3.
How to use Temgesic Injection
4.
Possible side effects
5.
How to store Temgesic Injection
6.
Contents of the pack and other information
1.
WHAT TEMGESIC INJECTION IS AND WHAT IT IS USED FOR
Temgesic Injection 1 ml is a strong pain killer that helps lessen
moderate or severe pain.
2.
BEFORE YOU USE TEMGESIC INJECTION
DO NOT USE TEMGESIC
•
If you are allergic (hypersensitive) to buprenorphine (the active
ingredient in
Temgesic) or to other opiates or to any other component of the
product.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Temgesic Injection if
you have:
•
asthma or other breathing problems or are taking medicines which may
make your
breathing slower or weaker,
•
an addiction or have ever been addicted to medicines or substances,
•
problems with your liver, such as hepatitis,
•
any kidney disease,
•
low blood pressure,
•
recently suffered from head injury or brain disease,
•
thyroid problems,
•
adrenocortical disorder such as Addison’s disease,
•
a urinary disorder such as an enlarged prostate or narrowing of the
urethra.
•
prostatic disease,
•
are elderly
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2
•
a history of gallbladder disease
•
acute abdominal

Summary of Product characteristics

Health Products Regulatory Authority
06 April 2023
CRN00D9QJ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Temgesic 300 micrograms/ml, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains buprenorphine 300 micrograms (as hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless sterile solution for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a strong analgesic for the relief of moderate to severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children over 12 years: _1-2ml (300-600 micrograms of
buprenorphine) every 6-8 hours or as required.
_Children aged under 12 years: _3-6 micrograms/kg body weight every
6-8 hours. In refractory cases up to 9 micrograms/kg may
be administered.
There is no clinical experience in infants below the age of 6 months.
There is no evidence that dosage need be modified for the elderly.
However, elderly patients are likely to be more susceptible
to the adverse effects of Temgesic (see Section 4.8).
Temgesic Injection may be employed in balanced anaesthetic techniques
as a pre-medication at a dose of 300 micrograms i.m.,
or as an analgesic supplement at doses of 300-450 micrograms i.v.
_Special populations_
_Hepatic impairment_
As buprenorphine pharmacokinetics may be altered in patients with
hepatic impairment, lower initial doses and careful dose
titration in patients with hepatic impairment may be required (See
section 4.4).
_Renal Impairment_
Modification of the buprenorphine dose is not generally required for
patients with renal impairment. Caution is recommended
when dosing patients with severe renal impairment (CLcr < 30 ml/min),
which may require dose adjustment (See section 5.2).
_Method of administration_
Administration by i.m. or slow i.v. injection.
4.3 CONTRAINDICATIONS
Hypersensitivity to buprenorphine or to any of the excipients listed
in section 6.1.
Health Products Regulatory Authority
06 April