البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
SATRALIZUMAB
ROCHE PHARMACEUTICALS (ISRAEL) LTD
L04AC19
SOLUTION FOR INJECTION
SATRALIZUMAB 120 MG / 1 ML
S.C
Required
HOFFMANN LA ROCHE LTD, SWITZERLAND
SATRALIZUMAB
Enspryng is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.
2022-02-01
INJECTING ENSPRYNG 13. Hold the barrel of the syringe between your thumb and forefinger. With the help of the other hand, pull the needle cap straight off. You may see a drop of liquid at the tip of the needle. This is normal and will not affect your dose )SEE FIGURE K(. • USE THE SYRINGE WITHIN 5 MINUTES OF REMOVING THE CAP, OTHERWISE THE NEEDLE MAY GET BLOCKED. • Do not remove the needle cap until you are ready to inject Enspryng. • Do not put the needle cap back on after it has been removed as it might damage the needle. • Do not touch the needle and do not allow it to come into contact with other surfaces after the needle cap has been removed. 14. Dispose of the needle cap immediately in the sharps container. See step 21 ”Disposing of Enspryng“. 15. Hold the barrel of the syringe with your thumb and forefinger. With the other hand, pinch the skin in the area which you cleaned )SEE FIGURE L(. 16. Use a fast and sharp movement to insert the needle at an angle between 45° and 90° )SEE FIGURE L(. • Do not change the injection angle during the injection. • Do not insert the needle again. 17. After the needle is inserted, release the pinched skin. 18. Slowly inject all of the medicine by gently pressing the plunger downward until it touches the activation guards )SEE FIGURE M(. 19. Gently release the plunger and allow the needle to exit the skin at the same angle at which it was inserted (SEE FIGURE N(. • NOW THE NEEDLE WILL BE COVERED BY THE AUTOMATIC NEEDLE GUARD. If the needle is not covered, carefully place the syringe in the sharps container to prevent injury. See step 21 ”Disposing of Enspryng“. TAKING CARE OF THE INJECTION SITE 20. A little bleeding may occur at the injection site. You can press with a cotton ball or gauze pad on the injection site until the bleeding stops, but DO NOT massage the area. If needed, a small bandage can be placed on the injection site. If the medicine comes into contact with the skin, wash the area with water. DISPOSING OF ENSPRYNG 21. Do not try to cover اقرأ الوثيقة كاملة
1 Enspryng PI_version 1 ENSPRYNG ® SATRALIZUMAB_ _ Solution for injection 1. NAME OF THE MEDICINAL PRODUCT Enspryng 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe (PFS) contains 120 mg of satralizumab in 1 mL. Satralizumab is_ _produced in Chinese hamster ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) Colourless to slightly yellow liquid. The solution has a pH of approximately 6.0 and an osmolality of approximately 310 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Enspryng is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of neuromyelitis optica (NMO) or NMOSD. Posology Enspryng can be used as a monotherapy or in combination with oral corticosteroids (OCs), azathioprine (AZA) or mycophenolate mofetil (MMF) (see section 5.1). The posology in adolescent patients ≥12 years of age with body weight ≥ 40 kg and adult patients is the same. 2 _Loading doses _ _ _ The recommended loading dose is 120 mg subcutaneous (SC) injection every two weeks for the first three administrations (first dose at week 0, second dose at week 2 and third dose at week 4). _ _ _Maintenance doses _ _ _ The recommended maintenance dose is 120 mg SC injection every four weeks. _Duration of treatment _ _ _ Enspryng is intended for long-term treatment. _ _ _Delayed or missed doses _ _ _ If an injection is missed, for any reason other than increases in liver enzymes, it should be administered as described in table 1. TABLE 1: RECOMMENDED DOSAGE FOR DELAYED OR MISSED DOSES LAST DOSE ADMINISTERED RECOMMENDED DOSAGE FOR DELAYED OR MISSED DOSES Missed a loading do اقرأ الوثيقة كاملة