Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOSTRIDIUM BOTULINUM TOXIN TYPE A
SUNWARD PHARMACEUTICAL SDN. BHD.
CLOSTRIDIUM BOTULINUM TOXIN TYPE A
1 Vials
MEDYTOX INC.
NEURONOX® INJECTION Clostridium botulinum toxin type A (50/100/200 units) 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Neuronox Injection is used for 2. How Neuronox Injection works 3. Before you use Neuronox Injection 4. How Neuronox Injection 5. While you are using it 6. Side effects 7. Storage and disposal of Neuronox Injection 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NEURONOX INJECTION IS USED FOR NO INDICATION REMARKS 1 Blepharo- spasm for the treatment uncontrolled contractions of the eye muscles/eye lids and surrounding facial are resulting from dry eyes for people 18 years of age and older. 2 Paediatric cerebral palsy indicated for the treatment in children 2 age and older for lack of flexibility of upward bending motions of ankle joint which due to impairment in the are of the brain. 3 Glabellar Wrinkles for the treatment for wrinkless that appear between eyebrows which refer as frown lines in adult over the age of 18 and below of the age 65 4 Muscle spasticity Upper limb spasticity associated with stroke in people 20 years of age and older HOW NEURONOX INJECTION WORKS The active ingredient in this medicine is Clostridium botulinum toxin type A. Botulinum toxin has the neurotransmitter effect as blocker to prevent acetylcholine which makes the muscle contract due to dystonia. This generates the treatment for overactive smooth muscles or abnormal activity of glands. BEFORE YOU USE NEURONOX INJECTION _- When you must not use it _ Do not use Neuronox Injection if:- you are hypersensitive to Clostridium botulinum toxin type A or other ingredients of this product. you have systemic neuromuscular junctional disorder you have respiratory dysfunction you are or think you may be pregnant, planning to become pregnant or if you are breastfeeding. _- Before you start to use it _ You should check with your doctor if :- you are immune-compromised patients you have Baca dokumen lengkapnya
NEURONOX ® Powder for Solution for Injection (_Clostridium botulinum _toxin type A) _ _ COMPOSITION Each vial contains [Neuronox ® 50Units] Active ingredient : Clostridium botulinum toxin type A 50 units(U) Stabilizer : Human serum albumin 0.25mg Isotonic agent : Sodium chloride 0.45mg [Neuronox ® ] Active ingredient : Clostridium botulinum toxin type A 100 units(U) Stabilizer : Human serum albumin 0. 5mg Isotonic agent : Sodium chloride 0.9mg [Neuronox ® 200Units] Active ingredient : Clostridium botulinum toxin type A 200 units(U) Stabilizer : Human serum albumin 1.0mg Isotonic agent : Sodium chloride 1.8mg * One unit(U) of N ® corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. DESCRIPTION Lyophilized white powder for injection in a colorless transparent glass vial. INDICATIONS AND USAGE NEURONOX ® is indicated for: Treatment of benign essential blepharospasm in adult patients. Treatment of equinus foot deformity due to spasticity in pediatric cerebral palsy patients 2 years of age and older. Treatment of upper limb spasticity associated with stroke in adult patients. Temporary improvement of glabellar lines ranging from moderate to severe associated with corrugators muscle and/or procerus muscle activities in adult patients below 65 years of age. DOSAGE AND ADMINISTRATION Route of administration: Intramuscular injection 1. Blepharospasm For blepharospasm, reconstituted NEURONOX ® (see Dilution Table) is injected using a sterile, 27 - 30 gauge needle without electromyographic guidance. The initial recommended dose is 1.25 - 2.5 U (0.05 mL to 0.1 mL volume at each site) injected into the medial and lateral pre-tarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid. In general, the initial effect of the injections is seen within three days and reaches a peak at one to two weeks post-treatment. Each treatment lasts approximately three months, following which the procedure can be repeated. At repeat treatment s Baca dokumen lengkapnya