Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
TOCILIZUMAB
ROCHE PHARMACEUTICALS (ISRAEL) LTD
L04AC07
SOLUTION FOR INJECTION
TOCILIZUMAB 162 MG / 0.9 ML
S.C
Required
HOFFMANN LA ROCHE LTD, SWITZERLAND
TOCILIZUMAB
- Actemra in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti rheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists. In these patients, Actemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. - Actemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. - Actemra in combination with methotrexate (MTX) in indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX - Actemra (tocilizumab) is indicated for the treatment of giant cell arteritis (GCA) in adult patients. - Actemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Actemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. - Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Actemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
2019-11-30
• Disinfect the selected injection site using an alcohol pad )see Fig. C(, to reduce the risk of infection. • Let the skin dry for approximately 10 seconds. • Be sure not to touch the disinfected area prior to the injection. Do not fan or blow on the disinfected area. STEP 5. REMOVE NEEDLE-CAP • Do not hold the syringe by the plunger while removing the needle-cap. • Hold the body of the syringe steadily with one hand and pull off the needle-cap with the other hand )see Fig. D(. If you cannot remove the needle-cap, you should ask for assistance. • Do not touch the needle or let it touch any surface. • You may notice a drop of liquid at the end of the needle. This is normal. • Throw the needle-cap into a closed and safe sharps container. NOTE: Once the needle-cap is removed, use the syringe immediately. • If the syringe was not used within 5 minutes, it should be disposed of in a closed safe sharps container and a new syringe should be used. If the needle-cap is removed for more than 5 minutes, it may be more difficult to perform an injection as the medicine can dry out and block the needle. • Never try to re-attach the needle-cap after removing it. STEP 6. GIVING THE INJECTION • Hold the syringe comfortably in one hand. • To make sure the needle can be inserted correctly under the skin, pinch a fold of loose skin at the disinfected injection site with your free hand. Pinching the skin is important to ensure that you inject into fatty tissue under the skin but not any deeper )into the muscle(. Injection into muscle could cause discomfort. • Do not hold or push on the plunger while inserting the needle into the skin. • Quickly and steadily insert the needle all the way into the pinched skin at a 45°-90° angle )see Fig. E(. It is important to choose the correct angle to ensure that the medicine is delivered into the fatty tissue under the skin, otherwise the injection could be painful and the medicine may not work. • Hold the syringe in position and let go of the pinched skin. • Slow Perskaitykite visą dokumentą
1 ACTEMRA 162 MG SC PI VER 11 ACTEMRA ® 162MG SC TOCILIZUMAB Solution for injection in pre-filled syringe 1. NAME OF THE MEDICINAL PRODUCT Actemra 162 mg S.C. solution for injection in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 162 mg of tocilizumab in 0.9 mL. Tocilizumab is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble and membrane-bound interleukin 6 receptors. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. A colourless to slightly yellowish solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Actemra, in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Actemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Actemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Actemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Actemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Actemra can Perskaitykite visą dokumentą