Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
fingolimod hydrochloride, Quantity: 560 microgram (Equivalent: fingolimod, Qty 500 microgram)
Sun Pharma ANZ Pty Ltd
Capsule, hard
Excipient Ingredients: polacrilin potassium; crospovidone; colloidal anhydrous silica; magnesium stearate; Gelatin; sodium lauryl sulfate; titanium dioxide; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
84 capsules, 28 capsules, 7 capsules
(S4) Prescription Only Medicine
FINGOLIMOD SUN is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.
Visual Identification: Hard gelatin, size 4 yellow cap & white body, axially imprinted with 064 on cap & body in black ink, filled with white to off-white granular powder.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-09-09
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/ reporting-problems. FINGOLIMOD SUN _Fingolimod hydrochloride _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fingolimod Sun. 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. Any 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 benefits he/she expects Fingolimod Sun will provide to you against the risks in deciding to prescribe this medicine for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FINGOLIMOD SUN IS USED FOR Fingolimod Sun contains the active substance fingolimod, which belongs to a group of medicines known as sphingosine 1-phosphate (S1-P) receptor modulators. Fingolimod Sun can alter the way the body's immune system works and is used in adults, *children and adolescents (10 years of age and above) to treat relapsing remitting multiple sclerosis (MS). MS is a long-term condition that affects the central nervous system (CNS), particularly how the brain and spinal cord work. In MS, inflammation destroys the protective cover around the nerves (called myelin) and stops the nerves from working properly. The cause of MS is unknown but it is thought that an abnormal response by the body's immune system plays an important part in the process which da Läs hela dokumentet
1 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION – FINGOLIMOD SUN (FINGOLIMOD) CAPSULES 1 NAME OF THE MEDICINE The active ingredient of FINGOLIMOD SUN is fingolimod. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fingolimod hydrochloride is a white to almost white crystalline powder which is freely soluble in water. Fingolimod is a base with pKa of 7.82. Therefore, it has high solubility at low pH and very low solubility at high pH (e.g. < 0.01 mg/mL at pH 6.8). Relevant distribution coefficients are 22.3 in _n_ -Octanol/water and 1290 in _n_ -Octanol/hydrochloric acid 0.1N. 0.5 mg hard capsules: Each FINGOLIMOD SUN capsule contains 0.56 mg fingolimod hydrochloride (equivalent to 0.5 mg fingolimod). For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM FINGOLIMOD SUN 0.5 mg capsule: hard gelatin capsules, size '4' yellow cap and white body, axially imprinted with '064' on cap and on body in black ink, filled with white to off-white granular powder. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS FINGOLIMOD SUN is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability. 4.2 D OSE AND METHOD OF ADMINISTRATION _*_ _Fingolimod SUN is unavailable in capsule strengths below 500 micrograms and therefore _ _only appropriate for use in paediatric patients weighing ≥ 40 kg. For paediatric patients _ _requiring treatment with lower strengths of fingolimod, other brands are available._ In adults the recommended dose of FINGOLIMOD SUN is one 0.5 mg capsule taken orally once daily. In *paediatric patients (10 years of age and above), the recommended dose is dependent on body weight: _Paediatric pa Läs hela dokumentet