Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
bendamustine hydrochloride, Quantity: 25 mg
Juno Pharmaceuticals Pty Ltd
Injection, powder for
Excipient Ingredients: mannitol
Intravenous, Intravenous Infusion
1 vial; 5 vials
(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 patient?s ineligible for autologous stem cell transplantation.,Relapsed/Refractory indolent Non-Hodgkin?s lymphoma.
Visual Identification: white to off-white sterile lyophilized powder; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-09-23
BENDAMUSTINE JUNO _(Bendamustine hydrochloride) _ Consumer Medicine Information WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bendamustine JUNO 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 Bendamustine JUNO 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 BENDAMUSTINE JUNO IS USED FOR Bendamustine JUNO 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. Bendamustine JUNO is used for the treatment of certain types of cancer. Bendamustine JUNO 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 BENDAMUSTINE JUNO WHEN YOU MUST NOT US E IT DO NOT USE BENDAMUSTINE JUNO 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 eye Przeczytaj cały dokument
Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION – BENDAMUSTINE JUNO (BENDAMUSTINE HYDROCHLORIDE) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Bendamustine hydrochloride (as monohydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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%). BENDAMUSTINE JUNO BENDAMUSTINE HYDROCHLORIDE 25 MG (AS MONOHYDRATE) POWDER FOR INJECTION Each 25 mg vial contains 25 mg of bendamustine hydrochloride (equivalent to 22.7 mg bendamustine) and 40 mg of mannitol. BENDAMUSTINE JUNO BENDAMUSTINE HYDROCHLORIDE 100 MG (AS MONOHYDRATE) POWDER FOR INJECTION VIAL Each 100 mg vial contains 100 mg of bendamustine hydrochloride (equivalent to 90.8 mg bendamustine) and 160 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. BENDAMUSTINE JUNO is a white, microcrystalline lyophilisate powder for concentrate for solution for infusion. Page 2 of 28 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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. 4.2 D OSE AND METHOD OF ADMINISTRATION For intravenous infusion over 30 - 60 minutes (see SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION - SPECIAL PRECAUTIONS FOR DISPOSAL AND HANDLING). Infusion must be administered under the supervision of a physician qualified and experienced in th Przeczytaj cały dokument