Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
baclofen, Quantity: 2 mg/mL
Boucher & Muir Pty Ltd
Baclofen
Injection, solution
Excipient Ingredients: sodium chloride; water for injections
Intrathecal
1 ampoule
(S4) Prescription Only Medicine
SINTETICA BACLOFEN INTRATHECAL 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: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-03-10
SINTETICA BACLOFEN INTRATHECAL _INTRATHECAL INJECTION_ _Baclofen_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you are given Sintetica Baclofen Intrathecal. This leaflet answers some common questions about Sintetica Baclofen Intrathecal. It does not contain all the available information. The most up- to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au. Reading this leaflet 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 giving you Sintetica Baclofen Intrathecal 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 want to read it again. WHAT SINTETICA BACLOFEN INTRATHECAL IS USED FOR Sintetica Baclofen Intrathecal 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. Sintetica Baclofen Intrathecal belongs to a group of medicines called muscle relaxants. It contains the active ingredient, baclofen, in a solution for injection or infusion. 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 canal) using a special pump. From the pump, a constant amount of baclofen goes into the space surrounding your spinal cord through a tiny tube. This medicine can be used for adults and for children aged four years or older. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. S Citiți documentul complet
SINTETICA BACLOFEN INTRATHECAL 1 AUSTRALIAN PRODUCT INFORMATION SINTETICA BACLOFEN INTRATHECAL BACLOFEN SOLUTION FOR INTRATHECAL INJECTION 1 NAME OF THE MEDICINE Baclofen. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sintetica Baclofen Intrathecal contains 50 microgram baclofen per 1 mL ampoule (50 microgram/mL), 10 mg baclofen per 20 mL ampoule (500 microgram/mL), 10 mg baclofen per 5 mL ampoule (2 mg/mL) and 40 mg baclofen per 20 mL ampoule (2 mg/mL). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Sintetica Baclofen Intrathecal is a solution for intrathecal injection and intrathecal infusion. It is a clear, colourless solution. Sintetica Baclofen Intrathecal does not contain preservatives. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sintetica Baclofen Intrathecal 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 DOSE AND METHOD OF ADMINISTRATION Sintetica Baclofen Intrathecal 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 Sintetica Baclofen Intrathecal therapy until the symptoms of spasticity are stable (i.e. at least one year after the injury). SINTETICA BACLOFEN INTRATHECAL 2 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 clos Citiți documentul complet