País: Israel
Idioma: inglés
Fuente: Ministry of Health
OCTREOTIDE
NOVARTIS ISRAEL LTD
H01CB02
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
OCTREOTIDE 10 MG
INTRAGLUTEALLY
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
OCTREOTIDE
OCTREOTIDE
Treatment of acromegaly in: Patients already adequately controlled on standard doses of Sandostatin s.c. Patients in whom surgery or radiotherapy are inappropriate or ineffective, or who are in the latency period before radiotherapy becomes fully effective. Endocrine gastro-entero- pancreatic (GEP) tumors, carcinoid tumors.
2013-09-30
SAS LAR APL OCT22 V4 UK PIL July 2022 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only SANDOSTATIN ® LAR ® 10 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION Name and quantity of active ingredient: EACH VIAL OF POWDER CONTAINS 10 MG OCTREOTIDE (AS OCTREOTIDE ACETATE) SANDOSTATIN ® LAR ® 20 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION Name and quantity of active ingredient: EACH VIAL OF POWDER CONTAINS 20 MG OCTREOTIDE (AS OCTREOTIDE ACETATE) SANDOSTATIN ® LAR ® 30 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION Name and quantity of active ingredient: EACH VIAL OF POWDER CONTAINS 30 MG OCTREOTIDE (AS OCTREOTIDE ACETATE) Inactive ingredients and allergens: see section 6 ‘Additional information’. See also in section 2 ‘Important information about some of the ingredients of the medicine’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? SANDOSTATIN LAR is used: • to treat people with acromegaly: - whose illness is adequately controlled by standard doses of Sandostatin given by injection under the skin (subcutaneously) - when surgery or radiotherapy are inappropriate or ineffective - to cover the interim period until the radiotherapy becomes fully effective • to treat endocrine gastro-entero-pancreatic (GEP) tumors, carcinoid tumors THERAPEUTIC GROUP: somatostatin analogues SANDOSTATIN LAR is a synthetic compound derived from somatostatin. Somatostatin is normally found in the human body, where it inhibits the release of certain hormones such as growth hormone. SANDOSTATIN LAR has advantages over somatostatin; it is stronger and its effect Leer el documento completo
SAS LAR API OCT22 V4 PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Sandostatin LAR 10 mg powder and solvent for suspension for injection Sandostatin LAR 20 mg powder and solvent for suspension for injection Sandostatin LAR 30 mg powder and solvent for suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 10 mg, 20 mg or 30 mg octreotide (as octreotide acetate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for suspension for injection. Powder: White to white with yellowish tint. Solvent:Colourless to slightly yellow or brown solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of acromegaly in: Patients already adequately controlled on standard doses of sandostatin s.c. Patients in whom surgery or radiotherapy are inappropriate or ineffective, or who are in the latency period before radiotherapy becomes fully effective. Endocrine Gastro-Entero-Pancreatic (GEP) tumors, carcinoid tumors. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Sandostatin LAR may only be administered by deep intragluteal injection. The site of repeat intragluteal injections should be alternated between the left and right gluteal muscle (see 6.6 Instructions for use/handling). Posology _Acromegaly _ _ _ _For_ _patients who are adequately controlled_ with s.c. Sandostatin, it is recommended to start treatment with the administration of 20 mg Sandostatin LAR at 4-week intervals for 3 months. Treatment with Sandostatin LAR can be started the day after the last dose of s.c. Sandostatin. Subsequent dosage adjustment should be based on serum growth hormone (GH) and insulin- like growth factor 1/somatomedin C (IGF 1) concentrations and clinical symptoms. For patients in whom, within this 3-month period, clinical symptoms and biochemical parameters (GH; IGF 1) are not fully controlled (GH concentrations still above 2.5 microgram/L), the dose may be increased to 30 mg every 4 weeks. SAS LAR API OCT22 V4 For patients whose GH Leer el documento completo