Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
baclofen, Quantity: 0.05 mg
Medsurge Pharma Pty Ltd
Baclofen
Injection, solution
Excipient Ingredients: sodium chloride; water for injections
Intrathecal
1 ampoule
(S4) Prescription Only Medicine
Baclofen solution for intrathecal injection is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.
Visual Identification: Colourless, clear solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-08-07
CMI EDITION 4.0 OCTOBER 2020 1 BACTHECAL _BACLOFEN _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bacthecal. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP-TO-DATE INFORMATION ON THE MEDICINE. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you having Bacthecal against the benefits they expect it will give you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT BACTHECAL IS USED FOR Bacthecal is used to reduce tension in your muscles which causes spasms. These spasms happen in various illnesses such as multiple sclerosis, cerebral palsy and other diseases or injuries of the spinal cord or brain. Because this medicine reduces spasms and the pain that goes with them, it helps to make you more mobile. This helps you to manage your daily activities and makes physiotherapy easier. Bacthecal belongs to a group of medicines called muscle relaxants. It contains the active ingredient, baclofen, in the form of an ampoule for injection. It is used when medicines taken by mouth do not work well enough or when they cause too many side effects. The solution in the ampoule is injected into your back (spinal cord) using a special pump. From the pump, a constant amount of baclofen goes into your spinal cord through a tiny tube. This medicine can be used for adults and for children aged four years or older. 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 purpose. This medi Baca dokumen lengkapnya
BACTHECAL PRODUCT INFORMATION Edition 4.0 – October 2020 Page 1 of 25 AUSTRALIAN PRODUCT INFORMATION BACTHECAL BACLOFEN (0.05MG/ML, 0.5MG/ML, 2MG/ML) SOLUTION FOR INTRATHECAL INJECTION AMPOULE 1 NAME OF THE MEDICINE Baclofen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Baclofen 0.05mg/1mL (0.05mg/mL) Baclofen 10mg/20mL (0.5mg/mL) Baclofen 10mg/5mL (2mg/mL) It contains no preservatives. For the full list of excipients, see _Section 6.1 List of excipients_. 3 PHARMACEUTICAL FORM Solution for intrathecal injection and intrathecal infusion. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Baclofen solution for intrathecal injection is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses. 4.2 D OSE AND METHOD OF ADMINISTRATION Baclofen solution for intrathecal injection is intended for administration in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, in implantable pumps suitable for continuous administration of baclofen solution into the intrathecal space. For patients with spasticity due to head injury, it is recommended not to proceed to long- term baclofen solution for intrathecal injection therapy until the symptoms of spasticity are stable (i.e. at least one year after the injury). BACTHECAL PRODUCT INFORMATION Edition 4.0 – October 2020 Page 2 of 25 Establishment of the optimum dose schedule requires that each patient undergoes an initial screening phase with test doses by intrathecal bolus, followed by a very careful individual dose titration prior to maintenance therapy. This is due to the great variability in the effective individual therapeutic dose. Patients must be monitored closely in a fully equipped and staffed environment during the screening phase and dose-titratio Baca dokumen lengkapnya