国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
fingolimod hydrochloride, Quantity: 0.56 mg (Equivalent: fingolimod, Qty mg)
Pharmacor Pty Ltd
Capsule, hard
Excipient Ingredients: magnesium stearate; calcium hydrogen phosphate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; iron oxide yellow; titanium dioxide; Gelatin
Oral
28, 84, 7
(S4) Prescription Only Medicine
AKM Fingolimod 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: White to off- white powder filled in size 4 hard gelatin capsules, with a white opaque body with two radial band imprinted with yellow ink and bright yellow cap imprinted with FIG 0.5 mg with black ink.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-08-18
*0.25 MG STRENGTH IS AVAILABLE IN OTHER BRANDS. AKM FINGOLIMOD Ver: 03 1 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. AKM FINGOLIMOD* _Fingolimod hydrochloride _ Consumer Medicine Information (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AKM Fingolimod. 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 AKM Fingolimod 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 AKM FINGOLIMOD IS USED FOR AKM Fingolimod contains the active substance fingolimod, which belongs to a group of medicines known as sphingosine 1-phosphate (S1-P) receptor modulators. AKM Fingolimod 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 forms of 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 b 阅读完整的文件
*0.25 MG STRENGTH IS AVAILABLE IN OTHER BRANDS. PHARMACOR FINGOLIMOD Ver: 03 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 AKM FINGOLIMOD CAPSULES* (Fingolimod hydrochloride) 1. NAME OF THE MEDICINE The active ingredient of AKM Fingolimod is fingolimod hydrochloride. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each AKM Fingolimod capsule contains 0.56 mg fingolimod hydrochloride (equivalent to 0.5 mg fingolimod) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM AKM Fingolimod 0.5 mg capsule: White to off- white powder filled in size 4 hard gelatin capsules, with a white opaque body with two radial band imprinted with yellow ink and bright yellow cap imprinted with "FIG 0.5 mg" with black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AKM Fingolimod 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 DOSE AND METHOD OF ADMINISTRATION In adults the recommended dose of AKM Fingolimod 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 patients with body weight ≤ 40 kg: one 0.25 mg capsule daily taken orally. _ • _Paediatric patients with body weight > 40 kg: one 0.5 mg capsule daily taken orally. _ PHARMACOR FINGOLIMOD Ver: 04 2 Paediatric patients who start on 0.25 mg capsules and subsequently reach a stable body weight above 40 kg should be switched to 0.5 mg capsules. AKM Fingolimod can be taken with or without food. If a dose is missed, treatment should be continued with the next dose as planned. On initiation of AKM Fingolimod treatment, after the first dose, it is re 阅读完整的文件