국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
remifentanil hydrochloride, Quantity: 1.097 mg (Equivalent: remifentanil, Qty 1 mg)
Aspen Pharmacare Australia Pty Ltd
Injection, powder for
Excipient Ingredients: glycine
Intravenous
5 x 1mg vial
(S8) Controlled Drug
Ultiva for Injection 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 to 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 drugs, during transition to longer acting analgesia following adult cardiac surgery-when endotracheal intubation and controlled ventillation are anticipated. For provision of analgesia and sedation in mechanically ventilated intensive care patients.
Visual Identification: White to off-white lyophilised powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Registered
1998-05-04
ULTIVA ® 1 ULTIVA ® FOR INJECTION _Remifentanil hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Ultiva. It does not contain all of 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 being given Ultiva against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ULTIVA IS USED FOR Ultiva 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. Ultiva may also be used for patients in the Intensive Care Unit to maintain sedation and relieve pain. Ultiva 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. Your doctor may have prescribed Ultiva for another reason. Ask your doctor if you have any questions about why Ultiva has been prescribed for you. As with other opioids, Ultiva can be addictive. This is unlikely to happen when Ultiva is only used during your operation. BEFORE YOU ARE GIVEN ULTIVA _WHEN YOU MUST NOT RECEIVE _ _ULTIVA _ YOU MUST NOT RECEIVE ULTIVA IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO REMIFENTANIL HYDROCHLORIDE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. YOU SHOULD NOT RECEIVE ULTIVA IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO OTHER PAIN-RELIEVING MEDICINES WHICH ARE SIMILAR TO FENTANYL AND WHICH ARE RELATED TO THE CLASS OF MEDICINES KNOWN AS OPIOIDS. Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash ("hives") or fai 전체 문서 읽기
1 AUSTRALIAN PRODUCT INFORMATION ULTIVA (REMIFENTANIL HYDROCHLORIDE) POWDER FOR INJECTION WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, ULTIVA 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 _ ULTIVA 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 ULTIVA. 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 not to drink alcohol while taking ULTIVA. 1 NAME OF THE MEDICINE Remifentanil hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Remifentanil hydrochloride – 1mg, 2mg and 5mg as remifentanil base. List of excipients: Glycine, Hydrochloric acid, Sodium hydroxide and water for injection For the full list of excip 전체 문서 읽기