מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
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
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Buprenorphine hydrochloride 0.324 mg/mL (equivalent to 0.3 mg/mL buprenorphine)
0.3 mg/mL
Solution for injection
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
Ampoule, glass, 1mL, 1 mL
Class C4 Controlled Drug
Class C4 Controlled Drug
Indivior UK Limited
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.
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
1979-05-23
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 קרא את המסמך השלם
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 קרא את המסמך השלם