ENSPRYNG

Riik: Indoneesia

keel: indoneesia

Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Toimeaine:

SATRALIZUMAB

Saadav alates:

MENARINI INDRIA LABORATORIES - Indonesia

INN (Rahvusvaheline Nimetus):

SATRALIZUMAB

Annus:

120 MG

Ravimvorm:

INJEKSI

Ühikuid pakis:

DUS, 1 PREFILLED SYRINGE @ 120 MG/ 1 ML

Valmistatud:

CHUGAI PHARMA MANUFACTURING CO., LTD. - Japan

Loa andmise kuupäev:

2021-12-20

Toote omadused

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_______________________________________________________________
ENSPRYNG
®
Satralizumab
____________________________________________________________
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Enspryng is a recombinant humanized immunoglobulin G2 (IgG2)
monoclonal antibody against
the human interleukin-6 receptor (IL-6R), produced in Chinese hamster
ovary cells by recombinant
DNA technology (including a pH-dependent binding technology).
ATC code: L04AC19.
1.2
TYPE OF DOSAGE FORM
Ready-to-use sterile solution for subcutaneous (SC) injection in a
single-dose, prefilled syringe
(PFS) with needle safety device (NSD).
1.3
ROUTE OF ADMINISTRATION
Subcutaneous (SC) injection.
1.4
STERILE/RADIOACTIVE STATEMENT
Sterile product.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: satralizumab.
Excipients: L-histidine, L-aspartic acid, L-arginine, poloxamer 188,
and water for injection.
Enspryng solution for SC injection is a colorless to slightly yellow
liquid supplied in a PFS filled
with 1 mL of solution. Each PFS contains 120 mg of satralizumab.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Satralizumab (Enspryng) is indicated as monotherapy or in combination
with immunosuppressive
therapy (IST) for the treatment of neuromyelitis optica spectrum
disorders (NMOSD) in adult
patients who are anti aquaporin 4 (AQP4) seropositive.
2.2
DOSAGE AND ADMINISTRATION
GENERAL
Substitution by any other biological medicinal product requires the
consent of the prescribing
physician.
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The safety and efficacy of alternating or switching between Enspryng
and products that are
biosimilar but not deemed interchangeable have not been established.
Therefore, the benefit-risk of
alternating or switching needs to be carefully considered.
In order to prevent medication errors, it is important to check the
prefilled syringe label to ensure
that the drug being administered is Enspryng.
RECOMMENDED DOSAGE
Enspryng must be administered as a subcutaneous injection.
Enspryng can