Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
remifentanil hydrochloride, Quantity: 2.194 mg
Apotex Pty Ltd
Remifentanil hydrochloride
Injection, powder for
Excipient Ingredients: glycine; hydrochloric acid
Intravenous Infusion
5 x 2 mg
(S8) Controlled Drug
Remifentanil is indicated:,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures, including cardiac surgery, in adults;,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical, but not cardiac procedures, in children aged 1?12 years;,- for continuation as an analgesic into the immediate post-operative period under the close supervision of medically-qualified persons trained in the use of anaesthetic agents, during transition to longer-acting analgesia following adult cardiac surgery ? when endotracheal intubation and controlled ventilation are anticipated;,- for provision of analgesia and sedation in mechanically-ventilated intensive care patients.
Visual Identification: White to off-white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2016-01-06
REMIFENTANIL APOTEX 1 REMIFENTANIL APOTEX _Remifentanil (as hydrochloride) _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about remifentanil. 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 BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Remifentanil APOTEX powder for injection. It contains the active ingredient remifentanil (as hydrochloride). Remifentanil is an anaesthetic used with other anaesthetic medicines, to produce and/or maintain heavy sleep during your operation. If you are a cardiac patient, it may also be used to help relieve any pain immediately following your operation. Remifentanil may also be used for patients in the Intensive Care Unit to maintain sedation and relieve pain. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS _ Remifentanil belongs to a group of medicines called opioids. It differs from other medicines in this group by its very quick onset and very short duration of action. As with other opioids, remifentanil can be addictive. This is unlikely to happen when remifentanil is only used during your operation. _USE IN CHILDREN _ This medicine should not be used in children less than 1 year old. BEFORE YOU ARE GIVEN THIS MEDICINE _WHEN YOU MUST NOT RECEIVE _ _IT _ YOU MUST NOT RECEIVE THIS MEDICINE IF YOU ARE HYPERSENSITIVE TO, OR HAVE HAD AN ALLERGIC Perskaitykite visą dokumentą
1 AUSTRALIAN PRODUCT INFORMATION REMIFENTANIL APOTEX (REMIFENTANIL HYDROCHLORIDE) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Remifentanil (as hydrochloride) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg, 2 mg or 5 mg remifentanil (as hydrochloride). EXCIPIENTS WITH KNOWN EFFECT Glycine For the full list of excipients see section 6.1 LIST OF EXCIPIENTS WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, Remifentanil APOTEX powder for injection 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 Remifentanil APOTEX powder for 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 Remifentanil APOTEX powder for 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. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients no Perskaitykite visą dokumentą