TEMGESIC Solution for injection (2020)

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Περιεχόμενα

1. Name of the medicinal product

Temgesic Injection 1ml.

2. Qualitative and quantitative composition

Each ml contains buprenorphine hydrochloride 324 µg, equivalent to 300 µg buprenorphine base. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection.

4.1. Therapeutic indications

As a strong analgesic for the relief of moderate to severe pain.

4.2. Posology and method of administration

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with buprenorphine in order to minimise the risk of addiction and drug ...

4.3. Contraindications

Hypersensitivity to the active substance or to other opiates or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Temgesic occasionally causes significant respiratory depression and, as with the other strong centrally acting analgesics, care should be taken when treating patients with impaired respiratory function ...

4.5. Interaction with other medicinal products and other forms of interaction

Temgesic should be used cautiously when co-administered with serotonergic medicinal products, such as MAO inhibitors, selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake ...

4.6. Pregnancy and lactation

Pregnancy Temgesic is not recommended for use during pregnancy. Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. If opioid use is required ...

4.7. Effects on ability to drive and use machines

Ambulant patients should be warned not to operate machinery until they are certain they can tolerate Temgesic. This medicine can impair cognitive function and can affect a patients ability to drive safely. ...

4.8. Undesirable effects

Nausea, vomiting, dizziness, sweating and drowsiness have been reported and may be more frequent in ambulant patients. Hallucinations and other psychotomimetic effects have occurred although more rarely ...

4.9. Overdose

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur. The expected symptoms ...

5.1. Pharmacodynamic properties

Buprenorphine is a µ (mu) opioid partial agonist and k (kappa) antagonist. It is a strong analgesic of the partial agonist (mixed agonist/antagonist) class.

5.2. Pharmacokinetic properties

Buprenorphine is readily available by i.v. or i.m. routes; the relative bioavailability i.m. to i.v. was 1.07. Peak plasma levels are achieved within a few minutes of i.m. administration and after 10 minutes ...

5.3. Preclinical safety data

No preclinical findings of relevance to the prescriber have been reported.

6.1. List of excipients

Glucose monohydrate Hydrochloric acid Water for injections

6.2. Incompatibilities

None stated.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 30°C. Store in the original package in order to protect from light.

6.5. Nature and contents of container

Sealed Type 1 glass ampoules. <u>Pack size:</u> five ampoules containing 1 ml.

6.6. Special precautions for disposal and other handling

Administration by i.m. or slow i.v. injection.

7. Marketing authorization holder

Indivior UK Limited, The Chapleo Building, Henry Boot Way, Priory Park, Hull, HU4 7DY, United Kingdom

8. Marketing authorization number(s)

PL 36699/0006

9. Date of first authorization / renewal of the authorization

03/10/1977 / 17/05/2002

10. Date of revision of the text

24/11/2020

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