Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
atracurium besilate, Quantity: 50 mg
Pfizer Australia Pty Ltd
Injection
Excipient Ingredients: benzenesulfonic acid; water for injections
Intravenous
5 x 5.0mL
(S4) Prescription Only Medicine
Atracurium Besylate Injection is indicated as an adjunct to general anaesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Visual Identification: A clear colourless to faint yellow solution free from visible particulates.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
1996-12-19
DBL™ ATRACURIUM BESYLATE INJECTION _Atracurium besilate (at-tra-CUR-ee-um)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you are given DBL Atracurium Besylate Injection (Atracurium), even if you have had this medicine before. This leaflet answers some common questions about DBL™ Atracurium Besylate Injection. 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 DBL Atracurium Besylate Injection against the benefits they expect it will have for you. IF YOU HAVE ANY QUESTIONS ABOUT DBL ATRACURIUM BESYLATE INJECTION, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. YOU MAY NEED TO READ IT AGAIN. WHAT IS DBL ATRACURIUM BESYLATE INJECTION USED FOR Atracurium (at-tra-CURE-ee-um) is a muscle relaxant medicine. It is usually used together with a general anaesthetic to assist the use of a mechanical ventilator. It is used prior to surgery to provide muscle relaxation during surgery or to provide muscle relaxation for medically assisted breathing. It will be given to you or your child when you/they are asleep during surgery. It works by blocking acetylcholine, one of the body’s chemical messengers. Acetylcholine is involved in muscle contraction. However, your doctor may have prescribed Atracurium Besylate Injection for another purpose. Ask your doctor if you have any questions about why it has been prescribed for you. This medicine is not addictive. BEFORE YOU ARE GIVEN DBL ATRACURIUM BESYLATE INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU SHOULD NOT BE GIVEN DBL™ ATRACURIUM BESYLATE INJECTION IF YOU ARE ALLERGIC TO • medicines containing atracurium besilate • medicines containing benzenesulfonic acid • other muscle relaxant medicines. If you have an allergic reaction you may have breathing difficulties, a skin rash, and swelling of the lips or tongue. IF YOU ARE NOT SURE WHETHER YOU SHOULD Lugege kogu dokumenti
Version: pfpatrai11021 Supersedes: pfpatrai10619 Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION – DBL™ ATRACURIUM BESYLATE (ATRACURIUM BESILATE) INJECTION 1. NAME OF THE MEDICINE Atracurium besilate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Atracurium Besylate Injection is a clear, colourless or faint yellow, sterile solution containing atracurium besilate 10 mg, in each mL of Water for Injections. The solution also contains benzenesulfonic acid to adjust the pH to 3.2 to 3.7. For the full list of excipients, see Section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM DBL Atracurium Besylate Injection is sterile solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Atracurium Besylate Injection is indicated as an adjunct to general anaesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE To avoid distress to the patient, DBL Atracurium Besylate Injection should not be administered before unconsciousness has been induced. DBL Atracurium Besylate Injection should not be mixed in the same syringe, or administered simultaneously through the same needle, with alkaline solutions (e.g. barbiturate solutions). INITIAL BOLUS DOSES FOR INTUBATION An atracurium besilate dose of 0.4 to 0.5 mg/kg (1.7 to 2.2 times the ED 95 ), given as an intravenous bolus injection, is the recommended initial dose for most patients. Following this dose, suitable conditions for non-emergency intubation can be expected within 2 to 2.5 minutes in most patients which is comparable to other drugs of this class. Maximum neuromuscular blockade is generally achieved approximately 3 to 5 minutes after administration. Under balanced anaesthesia, this initial dose usually results in complete neuromuscular blockade for about 20 to 35 minutes. Spontaneous recovery to 25% of control is generally achieved approximately 35 to 45 minutes after administration and complete recovery is usually achieved within Lugege kogu dokumenti