Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
tramadol hydrochloride, Quantity: 50 mg/mL
Sandoz Pty Ltd
Tramadol hydrochloride
Injection, solution
Excipient Ingredients: sodium acetate; water for injections
Intramuscular, Intravenous
5 ampoules
(S4) Prescription Only Medicine
Tramadol Sandoz injections are indicated for the short-term 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.
Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-11-29
TRAMADOL SANDOZ 1 TRAMADOL SANDOZ ® _tramadol hydrochloride injection _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tramadol Sandoz. 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 using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TRAMADOL SANDOZ IS USED FOR This medicine is used to relieve severe pain. It contains the active ingredient tramadol hydrochloride. Tramadol hydrochloride belongs to a group of medicines called opioid analgesics (pain relievers). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. Tramadol Sandoz is for use in adults and children over 12 years of age. It should not be used in children under the age of 12 years or following the removal of tonsils and/or adenoids in people under 18. BEFORE YOU USE TRAMADOL SANDOZ _WHEN YOU MUST NOT USE IT _ DO NOT USE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • tramadol hydrochloride, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description • any other similar medicines known as opioid analgesics, e.g. morphine, codeine. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue throat or other parts of the body • skin rash, itching or hives on the skin WARNING LIMITATIONS OF USE Tramadol Sandoz should only be used when your doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them. HAZARDOUS Läs hela dokumentet
220208-Tramadol Sandoz injection-pi Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION TRAMADOL SANDOZ ® (TRAMADOL HYDROCHLORIDE) INJECTION 1 NAME OF THE MEDICINE Tramadol hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL of Tramadol Sandoz injection contains 50 mg of tramadol hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tramadol Sandoz 50 mg/1 mL injection - Clear colourless liquid free from visible particles. Tramadol Sandoz 100 mg/2 mL injection - Clear colourless liquid free from visible particles. WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, Tramadol Sandoz injection should only be used in patients 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 Tramadol Sandoz injection 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 Tramadol Sandoz injection. 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 benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma and death. Lim Läs hela dokumentet