Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Baclofen 0.5 mg/mL
Medsurge Pharma Limited
10 mg/20mL
Solution for injection
Active: Baclofen 0.5 mg/mL Excipient: Sodium chloride Water for injection
Prescription
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.
Package - Contents - Shelf Life: Ampoule, glass, 20 mL Type 1 clear in outer cardboard carton - 1 dose units - 60 months from date of manufacture stored at or below 25°C. Do not freeze
2016-02-16
_MEDSURGE BACLOFEN INJECTION_ CMI NZ V2.0 (JANUARY 2022) 1 BACLOFEN INJECTION _BACLOFEN SOLUTION FOR INTRATHECAL INJECTION _ NEW ZEALAND CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Baclofen Injection. 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. YOU CAN ALSO DOWNLOAD THE MOST UP-TO-DATE LEAFLET FROM WWW.MEDSAFE.GOVT.NZ. 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 Baclofen Injection 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 BACLOFEN INJECTION IS USED FOR Baclofen Injection 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. Baclofen Injection 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 ad Preberite celoten dokument
BACLOFEN INJECTION NEW ZEALAND DATA SHEET Edition 3.0 (January 2022) Page 1 of 21 BACLOFEN INJECTION 1 PRODUCT NAME Baclofen Injection 0.05mg/1mL, solution for injection Baclofen Injection 10mg/5mL, solution for injection Baclofen Injection 10mg/20mL, solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Baclofen 0.05mg/1mL (0.05mg/mL) Baclofen 10mg/20mL (0.5mg/mL) Baclofen 10mg/5mL (2mg/mL) For the full list of excipients, see section _6.1 List of excipients_. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 Therapeutic 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 Dose and method of administration Method of administration Intrathecal administration of baclofen through an implanted delivery system should only be undertaken by physicians with the necessary knowledge and experience. Specific instructions for implanting, programming and/or refilling the implantable pump are given by the pump manufacturers, and must be strictly adhered to. Dose 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). 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 individ Preberite celoten dokument