Vabysmo

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Faricimab 120 mg/mL

Հասանելի է:

Roche Products (NZ) Ltd

Դոզան:

120 mg/mL

Դեղագործական ձեւ:

Solution for injection

Կազմը:

Active: Faricimab 120 mg/mL Excipient: Acetic acid Histidine Methionine Polysorbate 20 Sodium chloride Sucrose Water for injection

Ռեկվիզորի տեսակը:

Prescription

Թերապեւտիկ ցուցումներ:

Vabysmo is indicated for the treatment of: · Neovascular (wet) age-related macular degeneration (nAMD)

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Vial, glass, Type I glass vial, rubber stopper, aluminium seal and plastic flip-off cap - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Do not shake 24 hours not refrigerated stored at or below 25°C protect from light. Store at 20 to 25 deg C

Հաստատման ամսաթիվը:

2021-07-20

Տեղեկատվական թերթիկ

Vabysmo 20240110
1
VABYSMO®
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 BEING GIVEN VABYSMO?
VABYSMO contains the active ingredient faricimab. VABYSMO is used to
treat the following eye disorders:

neovascular (wet) age-related macular degeneration (nAMD)

diabetic macular oedema (DMO)
For more information, see Section 1. Why am I being given VABYSMO? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN VABYSMO?
You must not be given VABYSMO if you have ever had an allergic
reaction to faricimab or any of the ingredients listed at the end
of this CMI.
You must not be given VABYSMO if you have an infection in or around
your eye, or inflammation in your eye.
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 am
given VABYSMO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VABYSMO 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 IS VABYSMO GIVEN?

VABYSMO must be injected into your eye every month for the first 4
months. Thereafter, the frequency of the ongoing
injections will be determined by your doctor.
More instructions can be found in Section 4. How is VABYSMO given? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE I AM BEING GIVEN VABYSMO?
THINGS YOU
SHOULD DO

Tell your doctor if you experience any problems during the treatment.

Women who could become pregnant should use effective contraception
during treatment and for at
least 3 months after the last injection of VABYSMO.
DRIVING OR USING
MACHINES

You may not see as well after you are given VABYSMO and after the
associated eye examinations.
This is temporary. Do not drive or use machines until your eyesight
has r

Ապրանքի հատկությունները

Vabysmo 20240110
1
NEW ZEALAND DATA SHEET
VABYSMO
® (FARICIMAB)
1.
PRODUCT NAME
Vabysmo (faricimab) 120 mg/mL solution for injection for intravitreal
use.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 0.24 mL contains 28.8 mg of faricimab at a concentration
of 120 mg/mL. This
provides a usable amount to deliver a single dose of 0.05 mL solution
containing 6 mg of
faricimab.
Faricimab is a humanised bispecific antibody produced in mammalian
Chinese Hamster
Ovary (CHO) cell culture by recombinant DNA technology.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection for intravitreal use.
Clear to opalescent, colourless to brownish-yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vabysmo is indicated for the treatment of:
•
Neovascular (wet) age-related macular degeneration (nAMD)
•
Diabetic macular oedema (DMO).
4.2
DOSE AND METHOD OF ADMINISTRATION
For intravitreal injection only. Vabysmo must be administered by a
qualified physician
experienced in intravitreal injections. Each vial should only be used
for the treatment of a
single eye.
DOSAGE
_NEOVASCULAR (WET) AGE-RELATED MACULAR DEGENERATION (NAMD) _
The recommended dose for Vabysmo is 6 mg (0.05 mL) administered by
intravitreal injection
every 4 weeks for the first 4 doses. Thereafter, an assessment of
disease activity based on
anatomic and/or visual outcomes is recommended 20 – 24 weeks after
treatment initiation so
treatment can be individualised (“treat-and-extend” approach).
Based on these assessments,
in patients without disease activity, administration of Vabysmo every
16 weeks should be
considered. In patients with disease activity, treatment every 8 weeks
or 12 weeks should be
considered. If anatomic and/or visual outcomes change, the treatment
interval should be
adjusted accordingly, and interval reduction should be implemented if
anatomic and/or visual
Vabysmo 20240110
2
outcomes deteriorate (see section 5.1). There is limited safety data
on treatment