Plegridy

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Peginterferon beta-1a 94ug;  ; Peginterferon beta-1a 63ug

可用日期:

Biogen NZ Biopharma Ltd

INN（国际名称）:

Peginterferon beta-1a 94 µg

药物剂型:

Solution for injection

组成:

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

处方类型:

Prescription

厂商:

Biogen Inc

疗效迹象:

Plegridy is indicated for the treatment of relapsing forms of Multiple Sclerosis

產品總結:

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

授权日期:

2015-01-05

资料单张

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

产品特点

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