SAPHNELO

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

ANIFROLUMAB

Disponibil de la:

ASTRAZENECA (ISRAEL) LTD

Codul ATC:

L04AA51

Forma farmaceutică:

CONCENTRATE FOR SOLUTION FOR INFUSION

Compoziție:

ANIFROLUMAB 150 MG/ML

Calea de administrare:

I.V

Tip de prescriptie medicala:

Required

Produs de:

ASTRA ZENECA AB., SWEDEN

Zonă Terapeutică:

ANIFROLUMAB

Indicații terapeutice:

Saphnelo is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.Limitations of UseThe efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.

Data de autorizare:

2022-04-28

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Technical Info
110027018
5530
AZL051A
110027018
26-12-2022
108079705/403130431 0020
Saphnelo Leaflet patient 300mg IL
SGK is a Matthews International Corporation
Black
PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
SAPHNELO
®
Concentrate for solution for intravenous infusion
Each vial (2 ml) contains:
Anifrolumab 300 mg (300 mg/2mL)
Each 1 ml contains: anifrolumab 150 mg (150 mg/mL)
For inactive ingredients in the medicine - please see section 6
“Further
Information”.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains concise information about the medicine. If you
have
any further questions, ask the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if it seems to you that their ailment is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
SAPHNELO is indicated for the treatment of adult patients with
moderate
to severe systemic lupus
erythematosus (SLE), who are receiving standard therapy.
Limitations of Use
The efficacy of SAPHNELO has not been evaluated in patients with
severe
active lupus nephritis or severe active central nervous system lupus.
Use of SAPHNELO is not recommended in these situations.
Therapeutic group
Selective immunosuppressants
Lupus is a disease of the immune system (the body system that
fights infection). When given together with other medicines for lupus,
SAPHNELO may help to reduce your lupus disease activity more than
other lupus medicines alone.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients of this medicine (see section 6).
Special warnings regarding the use of this medicine
Before treatment with SAPHNELO, tell the doctor if:
•
You think you have an infection or have infections that keep coming
back. You shou

Caracteristicilor produsului

1
FULL PRESCRIBING INFORMATION
1 NAME OF THE MEDICINAL PRODUCT
SAPHNELO® 300 MG CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate for solution for infusion contains 150 mg of
anifrolumab.
One vial of 2.0 mL of concentrate contains 300 mg of anifrolumab (150
mg/mL).
Anifrolumab is a human, immunoglobulin G1 kappa (IgG1κ) monoclonal
antibody produced in mouse myeloma
cells (NS0) by recombinant DNA technology.
For a full list of excipients, see section 11.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate) in a
single dose vial.
Clear to opalescent, colourless to slightly yellow, pH 5.9 solution.
4 INDICATIONS AND USAGE
SAPHNELO is indicated for the treatment of adult patients with
moderate to severe systemic lupus
erythematosus (SLE), who are receiving standard therapy. _[see_
_Clinical Studies (14)]_.
LIMITATIONS OF USE
The efficacy of SAPHNELO has not been evaluated in patients with
severe active lupus nephritis or severe
active central nervous system lupus. Use of SAPHNELO is not
recommended in these situations.
5 DOSAGE AND ADMINISTRATION
5.1 DOSAGE RECOMMENDATIONS
SAPHNELO must be diluted prior to intravenous administration _[see
Dosage and Administration (5.2)]_.
The recommended dosage of SAPHNELO is 300 mg, administered as an
intravenous infusion over a
30-minute period, every 4 weeks.
Missed dose
If a planned infusion is missed, administer SAPHNELO as soon as
possible. Maintain a minimum interval of
14 days between infusions.
5.2 INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION
SAPHNELO is supplied as a single-dose vial. Prepare the diluted
infusion solution using aseptic technique, by
the following procedure:
2
1.
Visually inspect the vial for particulate matter and discoloration.
SAPHNELO is a clear to opalescent,
colorless to slightly yellow, solution. Discard the vial if the
solution is cloudy, discolored or visible
particles are observed. Do not shake the vial.
2.
Withdraw and discard 2 mL of solution from