Country: New Zealand
Lingwa: Ingliż
Sors: Medsafe (Medicines Safety Authority)
Peginterferon beta-1a 94ug; ; Peginterferon beta-1a 63ug
Biogen NZ Biopharma Ltd
Peginterferon beta-1a 94 µg
Solution for injection
Active: Peginterferon beta-1a 94ug Excipient: Arginine hydrochloride Glacial acetic acid Polysorbate 20 Sodium acetate trihydrate Water for injection Active: Peginterferon beta-1a 63ug Excipient: Arginine hydrochloride Glacial acetic acid Polysorbate 20 Sodium acetate trihydrate Water for injection
Prescription
Biogen Inc
Plegridy is indicated for the treatment of relapsing forms of Multiple Sclerosis
Package - Contents - Shelf Life: Syringe, glass, 1 x 63 mcg, 1 x 94 mcg, each fitted into a pen device - 2 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days from date of manufacture stored at or below 25°C protect from light - Syringe, glass, 1 x 63 mcg, 1 x 94 mcg - 2 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days from date of manufacture stored at or below 25°C protect from light
2015-01-05
PLEGRIDY 1 PLEGRIDY ® 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. 1. WHY AM I USING PLEGRIDY? PLEGRIDY contains the active ingredient peginterferon beta‐1a (rch). PLEGRIDY is used to treat people with relapsing forms of Multiple Sclerosis (MS). For more information, see Section 1. Why am I using PLEGRIDY? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PLEGRIDY? Do not use if you have ever had an allergic reaction to PLEGRIDY 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 PLEGRIDY? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with PLEGRIDY 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 PLEGRIDY? • PLEGRIDY dose is gradually increased. The recommended starting dose is a single injection of PLEGRIDY 63 micrograms, followed by a single injection of PLEGRIDY 94 micrograms two weeks later. Full dose is 125 micrograms. • PLEGRIDY is injected under the skin (subcutaneously) every 14 days (two weeks). More instructions can be found in Section 4. How do I use PLEGRIDY? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PLEGRIDY? THINGS YOU SHOULD DO • Remind any doctor, dentist, MS nurse or pharmacist you visit that you are using PLEGRIDY. • Tell your doctor if you are pregnant or plan to become pregnant, or if you want to breastfeed. • If you are about to have any blood tests, tell your doctor that you are using PLEGRIDY, as it may interfere with the results of some tests. THINGS YOU SHOULD NOT DO • Do not stop using this medicine unless your doctor tells you to. • Do not use PLEGRIDY if you have severe depression or Aqra d-dokument sħiħ
PLEGRIDY DS - Oct 2023 Page 1 of 17 NEW ZEALAND DATA SHEET 1. PRODUCT NAME PLEGRIDY ® peginterferon beta-1a (rch) 63 microgram/0.5 mL and 94 microgram/0.5 mL solution for injection (Titration pack) PLEGRIDY ® peginterferon beta-1a (rch) 125 microgram/ 0.5 mL solution for injection (Administration pack) 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. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PLEGRIDY is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS) (see Section 5.1). 4.2 DOSE 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 DS - Oct 2023 Page 2 of 17 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 mic Aqra d-dokument sħiħ