Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
peginterferon beta-1a, Quantity: 125 microgram
Biogen Australia Pty Ltd
peginterferon beta-1a
Injection, solution
Excipient Ingredients: sodium acetate trihydrate; water for injections; glacial acetic acid; arginine hydrochloride; polysorbate 20
Subcutaneous
2 pre-filled syringes, 6 pre-filled syringes
(S4) Prescription Only Medicine
PLEGRIDY is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS) (see CLINICAL TRIALS).
Visual Identification: A clear, colorless liquid, essentially free of visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-11-10
PLEGRIDY ® (PLEGG-RIH-DEE) _peginterferon beta-1a (rch)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Plegridy. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. This leaflet was last updated on the date at the end of this leaflet. SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THIS MEDICINE. You can also download the most up to date leaflet from: www.biogen.com.au/products/ plegridy-CMI.pdf All medicines have risks and benefits. Your doctor has weighed the risks of you taking Plegridy against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT PLEGRIDY IS USED FOR Plegridy is a prescription medicine used to treat people with relapsing forms of Multiple Sclerosis (MS). It is not known if Plegridy is safe and effective in people under 18 or over 65 years of age. The cause of MS is not yet known. MS affects the brain and spinal cord. In MS, the body's immune system reacts against its own myelin (the 'insulation' surrounding nerve fibres). In relapsing forms of MS, people have 'exacerbations' from time to time (e.g. blurred vision, weakness in the legs or arms, or loss of control of bowel or bladder function). They are followed by periods of recovery. Recovery may be complete or incomplete. If it is incomplete there is 'progression of disability'. Plegridy belongs to a group of medicines called interferons. The active substance in Plegridy is peginterferon beta-1a. Peginterferon beta-1a is a long-acting form of interferon. Interferons exist naturally in the body to help fight viral infections and regulate the body's immunity. Although the exact mechanism of action of interferons in MS is unknown, it is thought that Plegridy works by decreasing the unwanted immune reaction against myelin. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS Đọc toàn bộ tài liệu
PLEGRIDY PI 210930 (bdpplgr11021) 1 AUSTRALIAN PRODUCT INFORMATION PLEGRIDY (PEGINTERFERON BETA 1-A (RCH)) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Peginterferon beta-1a (rch) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled pen A single pre-filled syringe contains 0.5 mL of solution of PLEGRIDY containing 63 micrograms, 94 micrograms, or 125 micrograms of peginterferon beta-1a. The glass syringe is contained within a single-use, disposable, injection device (pre-filled pen). Pre-filled syringe A single pre-filled syringe contains 0.5 mL of solution of PLEGRIDY containing 63 micrograms, 94 micrograms or 125 micrograms of peginterferon beta-1a. PLEGRIDY also contains sodium acetate trihydrate, glacial acetic acid, L-arginine hydrochloride, and polysorbate 20 in water for injections. 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS PLEGRIDY is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS) (see Section 5.1). 4.2 D OSE AND METHOD OF ADMINISTRATION PLEGRIDY is administered subcutaneously using a single-use pre-filled pen or single-use pre- filled syringe. The recommended dosage of PLEGRIDY is 125 micrograms injected subcutaneously every 2 weeks. Treatment initiation It is generally recommended that patients start treatment with 63 micrograms at dose 1 (day 0), increasing to 94 micrograms at dose 2 (day 14), reaching the full dose of 125 micrograms by dose 3 (day 28) and continuing with the full dose (125 micrograms) every 14 days (2 weeks) thereafter (see Table 1). PLEGRIDY PI 210930 (bdpplgr11021) 2 TABLE 1: TITRATION SCHEDULE AT INITIATION DOSE TIME* AMOUNT (MICROGRAMS) PEN/SYRINGE LABEL Dose 1 Day 0 63 Orange Dose 2 Day 14 94 Blue Dose 3 Day 28 125 (full dose) Grey *Dosed every 14 days (2 weeks) A Titration Pack is available containing the 63 micrograms (dose 1, orange label) and 94 micrograms (dose 2, blue label) syringes/pens. It is recommended that a health care professional trains patients in the proper technique for self-adm Đọc toàn bộ tài liệu