Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
cisatracurium besilate, Quantity: 2.68 mg/mL (Equivalent: cisatracurium, Qty 2 mg/mL)
Aspen Pharmacare Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; benzenesulfonic acid
Intravenous
5 x 2.5mL
(S4) Prescription Only Medicine
Nimbex injection is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as adjunct to general anaesthesia, or sedation in the Intensive Care Unit.
Visual Identification: Colourless to pale yellow or greenish yellow solution, practically free from visible particulate matter.; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
1996-09-13
1 NIMBEX ® INJECTION _CISATRACURIUM BESILATE_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NIMBEX. It does not contain all of the available information. Reading this leaflet does not take the place of talking to your doctor or pharmacist. Taking any medicine involves some risk. It is possible that all risks associated with this medicine might not have been detected, despite proper testing. Only your doctor or pharmacist is able to weigh up all of the relevant facts, and you should consult them if you have any queries. IF YOU HAVE ANY CONCERNS ABOUT THE USE OF NIMBEX ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS INFORMATION. You may want to read it again. This leaflet provides information about NIMBEX. The statements that are made in this leaflet cannot be applied to any other medicine, even those that are similar or appear to contain the same ingredients. WHAT NIMBEX IS USED FOR NIMBEX is used to relax the body’s muscles. NIMBEX will normally be given to you when you are in surgery, or during other medical procedures. NIMBEX is only used in conjunction with an anaesthetic, so you will be asleep during the procedure. IF YOU HAVE ANY QUESTIONS ABOUT WHY NIMBEX IS USED ASK YOUR DOCTOR. _HOW DOES NIMBEX WORK?_ Cisatracurium besilate (the active ingredient in NIMBEX) belongs to a group of medicines called “neuromuscular blockers”. NIMBEX works by blocking the effects of one of the body’s chemical messengers called acetylcholine. Acetylcholine is involved in muscle contraction. By relaxing your body’s muscles NIMBEX makes it easier for you to be kept asleep (under anaesthesia) or sedation. Your doctor will be able to provide you with more information. BEFORE YOU USE NIMBEX NIMBEX IS NOT SUITABLE FOR EVERYONE. BEFORE NIMBEX IS USED MAKE SURE THAT YOUR DOCTOR KNOWS IF: 1. YOU ARE ALLERGIC TO: • cisatracurium besilate, atracurium or benzenesulfonic acid. • any other muscle relaxants. 2. YOU ARE PREGNANT OR BREASTFEEDING. 3. YOU SUFFER FROM MYASTHENIA GRAV Prečítajte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION NIMBEX (CISATRACURIUM BESILATE) INJECTION 1 NAME OF THE MEDICINE Cisatracurium besilate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nimbex injection is supplied in two strengths, either 2 mg or 5 mg of cisatracurium besilate per mL. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Nimbex injection is a colourless to pale yellow or greenish solution, practically free from visible particulate matter. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Nimbex injection is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the intensive care unit. 4.2 D OSE AND METHOD OF ADMINISTRATION Nimbex injection contains no antimicrobial preservative and is intended for single patient use. _ _ USE BY INTRAVENOUS BOLUS INJECTION DOSAGE IN ADULTS _Tracheal intubation_. The recommended intubation dose of Nimbex injection for adults is 0.15 mg/kg bodyweight. This dose produces good to excellent conditions for tracheal intubation 120 seconds following injection. Higher doses will shorten the time to onset of neuromuscular block. The following table, Table 1, summarises mean pharmacodynamic data when Nimbex injection was administered at doses of 0.1 to 0.4 mg/kg bodyweight to healthy adult patients during opioid (thiopentone/fentanyl/midazolam) or propofol anaesthesia. 2 TABLE 1 INITIAL NIMBEX INJECTION DOSE (MG/KG BODYWEIGHT) ANAESTHETIC BACKGROUND TIME TO 90% T 1 ® SUPPRESSION (MIN) TIME TO MAXIMUM T 1 ® SUPPRESSION (MIN) TIME TO SPONTANEOUS T 1 ® RECOVERY (MIN) 0.1 Opioid 3.4 4.8 45 0.15 Propofol 2.6 3.5 55 0.2 Opioid 2.4 2.9 65 0.4 Opioid 1.5 1.9 91 ® Single twitch response as well as the first component of the Train-of-Four response of the adductor pollicis muscle following the supramaximal electrical stimulation of the ulnar nerve Enflurane or isoflurane anaesthesia may Prečítajte si celý dokument