Krajina: Indonézia
Jazyk: indonézština
Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SATRALIZUMAB
MENARINI INDRIA LABORATORIES - Indonesia
SATRALIZUMAB
120 MG
INJEKSI
DUS, 1 PREFILLED SYRINGE @ 120 MG/ 1 ML
CHUGAI PHARMA MANUFACTURING CO., LTD. - Japan
2021-12-20
_ _ _Page 1 of 23_ _______________________________________________________________ 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. _ _ _Page 2 of 23_ 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 Prečítajte si celý dokument