Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
bendamustine hydrochloride, Quantity: 25 mg
Janssen-Cilag Pty Ltd
Bendamustine hydrochloride
Injection, powder for
Excipient Ingredients: mannitol
Intravenous
1 vial
(S4) Prescription Only Medicine
First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C). Efficacy relative to first-line therapies other than chlorambucil has not been established. Previously untreated indolent CD20-positive, stage III-IV Non-Hodgkin?s lymphoma, in combination with rituximab. Previously untreated CD20-positive, stage III-IV Mantle Cell Lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation. Relapsed/Refractory indolent Non-Hodgkin?s lymphoma.
Visual Identification: White, microcrystalline lyophilisate; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-06-30
RIBOMUSTIN ® 1 RIBOMUSTIN® BENDAMUSTINE HYDROCHLORIDE Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about RIBOMUSTIN powder for injection. 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 RIBOMUSTIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WHILE BEING TREATED. You may need to read it again. What RIBOMUSTIN is used for RIBOMUSTIN belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. These medicines are used to kill cancer cells. RIBOMUSTIN is used for the treatment of certain types of cancer. RIBOMUSTIN is used alone (monotherapy) or in combination with other medicines for the treatment of the following forms of cancer: • Chronic lymphocytic leukaemia; • Indolent, Stage III-IV Non- Hodgkin's Lymphoma and Stage III-IV Mantle Cell Lymphoma. It is prescribed for patients who have not been previously treated. • Indolent Non-Hodgkins Lymphoma. It is prescribed for patients who have received one or more prior treatment and whose cancer is still progressing. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. Before you are given RIBOMUSTIN When you must not use it DO NOT USE RIBOMUSTIN IF YOU: • Are hypersensitive (allergic) to the active substance, bendamustine hydrochloride or any of the other ingredients listed at the end of this leaflet; • Are breastfeeding; • Have severe liver dysfunction (damage to the functional cells of the liver); • Have yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice); • Preberite celoten dokument
CCDS200921 1 RIBOMUSTIN bendamustine (210902) API RIBOMUSTIN ® BENDAMUSTINE HYDROCHLORIDE A USTRALIAN P RODUCT I NFORMATION 1. NAME OF THE MEDICINE Bendamustine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION RIBOMUSTIN contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. Bendamustine hydrochloride contains a mechlorethamine group and a benzimidazole heterocyclic ring with a butyric acid substituent. Bendamustine is soluble in water when at room temperature. It is administered by intravenous infusion after reconstitution with 10 mL (for the 25 mg vial) or 40 mL (for the 100 mg vial) water for injection and further dilution with physiological saline (0.9%). RIBOMUSTIN BENDAMUSTINE HYDROCHLORIDE 25 MG POWDER FOR INJECTION Each 25 mg vial contains 25 mg of bendamustine hydrochloride (equivalent to 22.7mg bendamustine) and 30 mg of mannitol. RIBOMUSTIN BENDAMUSTINE HYDROCHLORIDE 100 MG POWDER FOR INJECTION VIAL Each 100 mg vial contains 100 mg of bendamustine hydrochloride (equivalent to 90.8 bendamustine) and 120 mg of mannitol. The pH of the reconstituted solution is 2.5 - 3.5. For a full list of excipients, see SECTION 6.1. 3. PHARMACEUTICAL FORM Powder for injection, for intravenous infusion. RIBOMUSTIN is a white, microcrystalline lyophilisate powder for concentrate for solution for infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C). Efficacy relative to first- line therapies other than chlorambucil has not been established. Previously untreated indolent CD20-positive, stage III-IV Non-Hodgkin’s lymphoma, in combination with rituximab. Previously untreated CD20-positive, stage III-IV Mantle Cell Lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation. Relapsed/Refractory indolent Non-Hodgkin’s lymphoma. Product Information - Australia CCDS200921 2 RIBOMUSTIN bendamustine (210902) API 4.2 DOSE AND METHOD OF ADMINISTRATION For intravenous Preberite celoten dokument