Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
lanreotide acetate, Quantity: 100 mg (Equivalent: lanreotide, Qty 90 mg)
Amdipharm Mercury Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; glacial acetic acid
Subcutaneous
1 prefilled syringe delivering 90mg lanreotide
(S4) Prescription Only Medicine
Mytolac is indicated for:,- the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory,- the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours,- the treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease.
Visual Identification: Pre-filled syringe containing white to pale yellow semi-solid formulation, practically free of foreign particles; Container Type: Syringe; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2022-08-10
Mytolac® 1 MYTOLAC® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING MYTOLAC? Mytolac contains the active ingredient lanreotide (as acetate). Mytolac is used for the: • treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy, or in patients who do not respond to therapy with medicines called dopamine agonists • treatment of symptoms associated with carcinoid syndrome, such as flushing and diarrhoea • treatment and control of the growth of some advanced tumours of the intestine and pancreas that cannot be removed by surgery (called gastroenteropancreatic neuroendocrine tumours or GEP-NETs) in adult patients. For more information, see Section 1. Why am I using Mytolac? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE MYTOLAC? Do not use if you have ever had an allergic reaction to lanreotide, somatostatin or medicines from the same family or any of the ingredients listed at the end of the CMI. Do not use Mytolac if you are breastfeeding. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Mytolac? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Mytolac and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE MYTOLAC? • Information on how to inject Mytolac can be found in the INSTRUCTIONS FOR ADMINISTRATION OF THE PRODUCT at the end of this leaflet. • For the treatment of acromegaly or the symptoms of carcinoid syndrome, the recommended starting dose is 60 mg to 120 mg injected every 28 days. • For the treatment of advanced tumours of the intestine and pancreas that cannot be removed by surgery (GE Baca dokumen lengkap
MYTOLAC ® 1 AUSTRALIAN PRODUCT INFORMATION MYTOLAC ® LANREOTIDE (AS ACETATE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Lanreotide acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lanreotide (as acetate) 60 mg, 90 mg and 120 mg solution for injection in a pre-filled syringe. Each pre-filled syringe contains a supersaturated solution of lanreotide acetate corresponding to 24.6 mg of lanreotide base per 100 mg of solution. Each syringe delivers an injection dose of 60 mg, 90 mg and 120 mg of lanreotide base, respectively. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection in a pre-filled syringe. It is a white to pale-yellow semi-solid formulation and is formulated as a prolonged-release solution of lanreotide acetate for deep subcutaneous injection. Prolonged release of the peptide is achieved by the physical nature of the supersaturated solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mytolac is indicated for: • the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory • the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours • the treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease. MYTOLAC ® 2 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE _Acromegaly: _ In patients receiving a somatostatin analogue for the first time, the recommended starting dose is 60 mg of lanreotide administered every 28 days. In patients previously treated with lanreotide microparticle formulation* once every 14 days, the initial dose of Mytolac should be 60 mg every 28 days; in patients previously treated with lanreotide microparticle formulation once every 10 days, the initial dose of Mytolac should be 90 mg every 28 days, and in patients treated with lanreotide microparticle formulation once every 7 d Baca dokumen lengkap