देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Ganciclovir sodium 543mg equivalent to 500 mg ganciclovir
Pharmaco (NZ) Ltd
Ganciclovir sodium 543 mg (= 500 mg ganciclovir)
500 mg
Powder for infusion
Active: Ganciclovir sodium 543mg equivalent to 500 mg ganciclovir
Vial, glass, 5 dose units
Prescription
Prescription
Corden Pharma Colorado Inc
Iindicated for the prophylaxis of CMV infection and disease following bone marrow and solid organ transplantation in patients at risk of CMV disease.
Package - Contents - Shelf Life: Vial, glass, - 5 dose units - 36 months from date of manufacture stored at or below 30°C 12 hours reconstituted stored at or below 25°C
1990-06-21
CYMEVENE ® _contains the active ingredient_ _ganciclovir _ Cymevene ® 181205 1 CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cymevene. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Cymevene injection against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT CYMEVENE IS USED FOR Cymevene contains the active ingredient ganciclovir. Cymevene belongs to a class of medicines used to treat viral infections. It works by stopping certain viruses from growing in the body. Cymevene acts against a certain type of herpes virus called _cytomegalovirus_ or CMV. CMV causes infections mainly in people with poor immunity. Poor immunity can be caused by HIV/AIDS or some transplant medications. Cymevene helps control CMV eye infections in AIDS patients and in other patients who have poor immunity, which if left untreated can cause blindness. Cymevene is not a cure for CMV eye infections and is not effective against any underlying HIV infection. Cymevene may also be used to treat CMV lung infections in bone marrow transplant patients. Cymevene may also be used to prevent CMV infection and disease in patients following bone marrow or solid organ transplantation. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CYMEVENE HAS BEEN PRESCRIBED FOR YOU. Your doctor, however, may have prescribed Cymevene for another purpose. Cymevene is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN CYMEVENE Animal and other laboratory studies have shown Cymevene has caused infertility, birth defects and cancer. It is possible that these effects may also occur in humans. _WHEN YOU MUST NOT BE _ _GIVEN IT _ DO NOT USE CYMEVENE IF 1. YOU HAVE HAD पूरा दस्तावेज़ पढ़ें
NEW ZEALAND DATA SHEET Cymevene ® DS 181120 1 1. PRODUCT NAME Cymevene ® 500 mg powder for intravenous infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of ganciclovir (as ganciclovir sodium). After reconstitution with 10 mL of water for injections, each mL provides 50 mg of ganciclovir. Cymevene is available as the sterile lyophilised powder containing ganciclovir sodium 543 mg equivalent to ganciclovir 500 mg and sodium 43 mg (2 mEq). Excipients with known effect: approximately 43 mg (2 mEq) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for infusion) White to off-white solid cake. Ganciclovir, when formulated as monosodium salt in the intravenous (IV) dosage form, is a white to off-white lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cymevene (ganciclovir) administered as the IV infusion is indicated for the palliative treatment of confirmed sight-threatening cytomegalovirus (CMV) disease in AIDS and other severely immunocompromised individuals. It is indicated for the treatment of confirmed CMV pneumonitis in bone marrow transplant patients. It is also indicated for the prophylaxis of CMV infection and disease following bone marrow and solid organ transplantation in patients at risk of CMV disease. _NOTE:_ Cymevene (ganciclovir) is not indicated for congenital or neonatal CMV disease; nor for the treatment of CMV infection in non-immunocompromised individuals. 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL Cymevene must be reconstituted and diluted under the supervision of a healthcare professional and administered as an intravenous infusion (see section 4.2). Caution: Cymevene must only be administered by IV infusion over 1 hour, preferably via a plastic cannula, into a vein with adequate blood flow (intramuscular or subcutaneous injection may result in severe tissue irritation due to the high pH (~11) of ganciclovir NEW ZEALAND DATA SHEET Cymevene ® DS 181120 2 s पूरा दस्तावेज़ पढ़ें