দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
idarubicin hydrochloride, Quantity: 1 mg/mL
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: glycerol; hydrochloric acid; water for injections
Intravenous
1 x 5mL vial
(S4) Prescription Only Medicine
Zavedos is indicated for use in acute myelogenous leukaemia (AML) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients. Zavedos capsules are indicated whenever the intravenous route is not considered suitable. Zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents.
Visual Identification: Plastic vials containing a red-orange, clear, mobile solution and practically free from particles.; Container Type: Vial; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
1999-08-19
ZAVEDOS ® _Idarubicin hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE TREATMENT WITH ZAVEDOS. This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ZAVEDOS against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. PLEASE KEEP THIS LEAFLET. You may need to read it again. WHAT ZAVEDOS IS USED FOR ZAVEDOS is used to treat a type of leukaemia in adults known as AML (acute myelogenous leukaemia). It works by stopping cancer cells from growing and multiplying. ZAVEDOS may be used alone or in combination with other chemotherapy. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ZAVEDOS HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. ZAVEDOS is only available with a doctor's prescription. It is not addictive. BEFORE TREATMENT WITH ZAVEDOS _WHEN ZAVEDOS MUST NOT_ _BE USED_ DO NOT TAKE ZAVEDOS IF YOU HAVE AN ALLERGY TO: • any medicine containing idarubicin hydrochloride • other similar medicines for cancer, e.g., daunorubicin, doxorubicin, epirubicin, mitoxantrone • any of the ingredients listed at the end of this leaflet Symptoms of an allergic reaction to ZAVEDOS may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THE MEDICINE IF YOU HAVE: • severe kidney problems • severe liver problems • severe heart problems including heart failure, abnormal heartbeat or a recent heart attack • a severe infection, with signs such as fever, severe chills, sore throat or mouth ulcers • reduced number of red or white blood cells or platelets • previously received the full course of treatment with the maximum সম্পূর্ণ নথি পড়ুন
Version: pfpzavea10122 Supersedes: pfpzavea10221 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION – ZAVEDOS (IDARUBICIN HYDROCHLORIDE) 1. NAME OF THE MEDICINE Idarubicin hydrochloride. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 5 mg/5 mL or 10 mg/10 mL of idarubicin hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM SOLUTION FOR INJECTION . Red-orange, clear, mobile solution, free from particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZAVEDOS is indicated for use in acute myelogenous leukaemia (AML) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients. ZAVEDOS may be used in combination chemotherapy regimens involving other cytotoxic agents. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE For induction therapy in adult patients with AML, the following dose schedules are recommended: ZAVEDOS 12 mg/m 2 daily for three days by slow (10-15 min) intravenous injection in combination with cytarabine 100 mg/m 2 daily given by continuous infusion for seven days. In patients with unequivocal evidence of leukaemia after the first induction course, a second course may be administered. Administration of the second course should be delayed in patients who experienced severe mucositis, until recovery from this toxicity has occurred, and a dose reduction of 25% is recommended. DOSAGE ADJUSTMENT HEPATIC AND RENAL IMPAIRMENT ZAVEDOS should not be administered in patients with severe renal and liver impairment (see Section 4.3 Contraindications). Dose adjustment should be considered in patients with moderate liver and renal impairment (refer to Sections 5.2 Pharmacokinetic properties and 4.4 Version: pfpzavea10122 Supersedes: pfpzavea10221 Page 2 of 14 Special warnings and precautions for use). With anthracyclines a 50% dose reduction is generally employed if bilirubin levels are in the range 20.4-51.0 micromoles/litre. All dosage schedules should take into account the haematological সম্পূর্ণ নথি পড়ুন