Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
azacitidine, Quantity: 100 mg
Juno Pharmaceuticals Pty Ltd
Injection, powder for
Excipient Ingredients: mannitol
Intravenous Infusion, Subcutaneous
1 vial
(S4) Prescription Only Medicine
Azacitidine is indicated for the treatment of patients with: ? Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS), ? Chronic Myelomonocytic Leukemia [CMMoL (10%-29% marrow blasts without Myeloproliferative Disorder)], ? Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation Classification (WHO), in whom allogenic stem cell transplantation is not indicated.
Visual Identification: White to off white lyophilized cake or powder in 30 mL Type-I clear glass vial, grey rubber stopper and flip off seal; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-10-21
Azacitidine 1 AZACITIDINE MSN 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 AZACITIDINE MSN? Azacitidine MSN contains the active ingredient azacytidine, which prevents the growth of cancer cells. For more information, see Section 1. Why am I using Azacitidine MSN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE AZACITIDINE MSN? Do not use if you have ever had an allergic reaction to azacitidine or any of the ingredients listed at the end of the CMI. 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 Azacitidine MSN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Azacitidine MSN 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 AZACITIDINE MSN? Your doctor will choose the correct dose of Azacitidine MSN for you. Azacitidine MSN will be given to you as an injection under the skin (subcutaneously i.e. under the skin on your thigh, abdomen or upper arm) or as an intravenous infusion by a doctor or a nurse. More instructions can be found in Section 4. How do I use Azacitidine MSN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING AZACITIDINE MSN? THINGS YOU SHOULD DO • Remind any other doctors, dentists, and pharmacists who are treating you that you are being treated with Azacitidine MSN. • Tell your doctor immediately if you stop passing urine or if you are passing less urine than normal. • If you become pregnant while taking this medicine, tell your doctor immediately. • Keep all your doctor's appointments so that your progress can be checked. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how Azacitidine MSN affects you. L Citiți documentul complet
Azacitidine MSN PI Ver 2.0 1 AUSTRALIAN PRODUCT INFORMATION –AZACITIDINE MSN (AZACITIDINE) 1. NAME OF THE MEDICINE Azacitidine 2. QUALITIATIVE AND QUANTITATIVE COMPOSITION Azacitidine MSN is supplied in a sterile powder form for reconstitution as a suspension for subcutaneous injection or intravenous infusion. Vials contain 100 mg of azacitidine. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder for injection. White to off-white, sterile lyophilised powder in a 30 mL glass vial. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azacitidine MSN is indicated for the treatment of patients with: • Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS), • Chronic Myelomonocytic Leukemia [CMMoL (10%-29% marrow blasts without Myeloproliferative Disorder)], • Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation Classification (WHO), in whom allogenic stem cell transplantation is not indicated. 4.2 DOSE AND METHOD OF ADMINISTRATION Azacitidine MSN treatment should only be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Patients should be premedicated for nausea and vomiting. Injectable azacitidine should not be used interchangeably with oral azacitidine due to differences in the exposure, dose and schedule of treatment (see Section 5.2 [Pharmacokinetic Properties]). Healthcare professionals are recommended to verify drug name, dose, and administration route. RECOMMENDED DOSAGE IN ADULTS: First Treatment Cycle The recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75 mg/m 2 of body surface area given subcutaneously or by intravenous infusion, daily for seven days, followed by a rest period of 21 days (28-day treatment cycle). Azacitidine MSN PI Ver 2.0 2 Subsequent Treatment Cycles Cycles should b Citiți documentul complet