Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
PASIREOTIDE AS EMBONATE
MEDISON PHARMA LTD
H01CB05
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
PASIREOTIDE AS EMBONATE 60 MG/VIAL
I.M
Required
RECORDATI RARE DISEASES, FRANCE
PASIREOTIDE
Signifor LAR is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.
2020-10-31
Signifor LAR 10 mg-20 mg-30 mg-40 mg-60 mg-PIL-1023-V1 Signifor LAR-10mg_20mg_30mg_40mg_60mg-PIL-ENG-D17-F Page 1 of 12 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only SIGNIFOR ® LAR 1 0 MG, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION The active ingredient and its quantity: Each vial of powder contains: 10 mg pasireotide (as pamoate) SIGNIFOR ® LAR 20 MG, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION The active ingredient and its quantity: Each vial of powder contains: 20 mg pasireotide (as pamoate) SIGNIFOR ® LAR 30 MG, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION The active ingredient and its quantity: Each vial of powder contains: 30 mg pasireotide (as pamoate) SIGNIFOR ® LAR 40 MG, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION The active ingredient and its quantity: Each vial of powder contains: 40 mg pasireotide (as pamoate) SIGNIFOR ® LAR 60 MG, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION The active ingredient and its quantity: Each vial of powder contains: 60 mg pasireotide (as pamoate) INACTIVE AND ALLERGENIC INGREDIENTS: see section 6 'Additional information' and section 2 'Important information about some of this medicine's ingredients'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Signifor LAR is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with other somatostatin analogues. It is also indicated for treatment of Cushing’s disease in adult patients for whom surgical treatment is not an option or for whom Lesen Sie das vollständige Dokument
Signifor LAR 10 mg-20 mg-30 mg-40 mg-60 mg-SPC-1023-V1 Page 1 of 19 1. NAME OF THE MEDICINAL PRODUCT Signifor LAR 10 mg Signifor LAR 20 mg Signifor LAR 30 mg Signifor LAR 40 mg Signifor LAR 60 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains: Signifor LAR 10 mg: 10 mg pasireotide (as pasireotide pamoate). Signifor LAR 20 mg: 20 mg pasireotide (as pasireotide pamoate). Signifor LAR 30 mg: 30 mg pasireotide (as pasireotide pamoate). Signifor LAR 40 mg: 40 mg pasireotide (as pasireotide pamoate). Signifor LAR 60 mg: 60 mg pasireotide (as pasireotide pamoate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for suspension for injection. Powder: slightly yellowish to yellowish powder. Solvent: clear, colourless to slightly yellow or slightly brown solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Signifor LAR is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue. Treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. The 60 mg strength is only to be used in the treatment of acromegaly. The 10 mg and 30 mg are only to be used in the treatment of Cushing’s disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Acromegaly _ The recommended initial dose for the treatment of acromegaly is 40 mg of pasireotide every 4 weeks. The dose may be increased to a maximum of 60 mg for patients whose growth hormone (GH) and/or insulin-like growth factor-1 (IGF-1) levels are not fully controlled after 3 months of treatment with Signifor LAR at 40 mg. Signifor LAR 10 mg-20 mg-30 mg-40 mg-60 mg-SPC-1023-V1 Page 2 of 19 Management of suspected adverse reactions or over-response to treatment (IGF-1 < lower limit of normal) may require temporary dose reduction of Signifor LAR. The dose may be decreased either temporarily or permanently. _Cushing Lesen Sie das vollständige Dokument