Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
fingolimod hydrochloride, Quantity: 560 microgram (Equivalent: fingolimod, Qty 500 microgram)
Teva Pharma Australia Pty Ltd
Capsule, hard
Excipient Ingredients: iron oxide yellow; titanium dioxide; Gelatin; sodium lauryl sulfate; pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
28 capsules, 30 capsules, 84 capsules, 7 capsules
(S4) Prescription Only Medicine
FINGOLIMOD-TEVA 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: Size 4 capsule, imprinted in black with 'TV 7820' on the yellow capsule cap and 'TV 7820' on the white opaque capsule body.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2023-01-16
FINGOLIMOD-TEVA F I N G O L I M O D - T E V A v 1 . 0 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. ▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING FINGOLIMOD-TEVA? FINGOLIMOD-TEVA contains the active ingredient fingolimod hydrochloride. FINGOLIMOD-TEVA is used in adults, children and adolescents (10 years of age and above) to treat relapsing forms of multiple sclerosis (MS). For more information, see Section 1. Why am I using FINGOLIMOD-TEVA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE FINGOLIMOD-TEVA? Do not use if you have ever had an allergic reaction to FINGOLIMOD-TEVA or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use FINGOLIMOD-TEVA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with FINGOLIMOD-TEVA and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE FINGOLIMOD-TEVA? • The usual dose for adults and children weighing over 40 kg is one capsule per day (0.5 mg of fingolimod). • The usual dose for children weighing 40 kg or less is one 0.25 mg capsule per day. More instructions can be found in Section 4. How do I use FINGOLIMOD-TEVA? in the full CMI. *0.25 mg capsules are available in other brands 5. WHAT SHOULD I KNOW WHILE USING FINGOLIMOD-TEVA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using FINGOLIMOD-TEVA. • Avoid becoming pregnant while taking FINGOLIMOD-TEVA • Tell your doctor about any changes in your vision THINGS YOU SHOULD NOT DO • You should not receive certain types of vaccin Lesen Sie das vollständige Dokument
Fingolimod-Teva v1.0 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-TEVA (FINGOLIMOD) CAPSULES 1 NAME OF THE MEDICINE Fingolimod. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each FINGOLIMOD-TEVA capsule contains 0.56 mg fingolimod hydrochloride (equivalent to 0.5 mg fingolimod). Excipient of known effect: Gelatin may contain residual sulfites. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM FINGOLIMOD-TEVA 0.5 mg capsule: A hard gelatin capsule, size 4, filled with white to off-white powder, imprinted in black, with “TV 7820” on the yellow capsule cap and “TV 7820” on the white opaque capsule body. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS FINGOLIMOD-TEVA 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 In adults the recommended dose of FINGOLIMOD-TEVA 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. _ Fingolimod-Teva v1.0 2 _*0.25 MG STRENGTH IS AVAILABLE IN OTHER BRANDS _ 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. FINGOLIMOD-TEVA 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 FINGOLIMOD-TEVA treatment, after the first dose, it is recommend Lesen Sie das vollständige Dokument