Χώρα: Νέα Ζηλανδία
Γλώσσα: Αγγλικά
Πηγή: Medsafe (Medicines Safety Authority)
Tramadol hydrochloride 100 mg/mL
Seqirus (NZ) Ltd
Tramadol hydrochloride 100 mg/mL
100 mg/mL
Oral solution
Active: Tramadol hydrochloride 100 mg/mL Excipient: Aniseed flavour (87122) Glycerol Mint oil, partially dementholised Polyethylene glycol hydrogenated castor oil Potassium sorbate Propylene glycol Purified water Saccharin sodium Sodium cyclamate Sucrose
Bottle, Metered Dose Pump, 30 mL
Prescription
Class C2 Controlled Drug
Proto Chemicals AG
Relief of moderate to severe pain.
Package - Contents - Shelf Life: Bottle, dropper, - 10 mL - 36 months from date of manufacture stored at or below 30°C protect from light
2003-12-18
TRAMAL ORAL DROPS 1 TRAMAL ORAL DROPS Tramadol hydrochloride: 100 mg is contained in each mL of the solution CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Tramal ® oral drops. 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 this medicine against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT TRAMAL ® ORAL DROPS IS USED FOR Tramal ® oral drops are used to relieve moderate to severe pain. This medicine belongs to a group of medicines called analgesics (pain relievers). Your doctor may have prescribed Tramal ® oral drops for another reason. Ask your doctor why this medicine has been prescribed for you. Tramal ® oral drops are not usually addictive. However, rarely, addiction to tramadol has been reported. This medicine is available only with a doctor’s prescription. NOTE: DO NOT GIVE THIS MEDICINE TO ANY CHILD BETWEEN THE AGES OF 2 AND 12 YEARS UNLESS YOUR DOCTOR TELLS YOU TO DO SO. BEFORE YOU USE TRAMAL ® ORAL DROPS _WHEN YOU MUST NOT USE _ _THIS MEDICINE_ DO NOT TAKE TRAMAL ® ORAL DROPS IF YOU: know you have an allergy to Tramal ® oral drops or any of the ingredients listed at the end of this leaflet. know you have an allergy to any other medicines known as opioid analgesics e.g. morphine or codeine. are taking medicine for depression containing a “monoamine oxidase inhibitor” (such as Nardil ® , Parnate ® ), or have taken one within the past two weeks. DO NOT TAKE TRAMAL ® ORAL DROPS AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it is after the expiry date, or the packaging is damaged, return it to your pharmacist for disposal. DO NOT GIVE TRAMAL ® ORAL DROPS TO CHIL Διαβάστε το πλήρες έγγραφο
1 NEW ZEALAND DATA SHEET TRAMAL ® CAPSULES TRAMAL ® SOLUTION FOR INJECTION TRAMAL ® SR TABLETS 1. PRODUCT NAME Tramal ® (tramadol hydrochloride) immediate release capsules 50 mg Tramal ® (tramadol hydrochloride) solution for injection 50 mg/mL, 100 mg/2mL Tramal ® SR tablets (tramadol hydrochloride) sustained release tablets) 50 mg, 100 mg, 150 mg, 200 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TRAMAL ® 50 MG CAPSULES ARE YELLOW-YELLOW CAPSULES CONTAINING: 50 mg tramadol hydrochloride. TRAMAL ® 50 MG AND 100 MG INJECTIONS CONTAIN: tramadol hydrochloride 50 mg/mL. TRAMAL ® SR SUSTAINED RELEASE TABLETS CONTAIN: tramadol hydrochloride in the following dose strengths: 50, 100, 150 and 200 mg. For full list of excipients, see section 6.1 LIST OF EXCIPIENTS. Tramal ® capsules, Tramal ® solution for injection, and Tramal ® SR tablets contain tramadol hydrochloride which is ( +) - _cis_-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)-cyclohexanol hydrochloride. Tramadol hydrochloride is an odourless, white to off-white crystalline powder WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, Tramal ® 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 Tramal ® 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 Tramal ® . 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 ( Διαβάστε το πλήρες έγγραφο