Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
calcium folinate, Quantity: 10.8 mg/mL (Equivalent: folinic acid, Qty 10 mg/mL)
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid
Intravenous, Intramuscular
10 x 5mL ampoules, 5x 5mL ampoules
(S4) Prescription Only Medicine
Leucovorin Calcium Injection USP is indicated following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). It is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination.
Visual Identification: Clear yellowish solution; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
1997-11-12
LEUCOVORIN CALCIUM INJECTION _Calcium folinate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Leucovorin Calcium 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 benefits and risks. Your doctor has weighed the risks of you taking Leucovorin Calcium Injection against the benefits this medicine is expected to have for you. This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases, this leaflet may be given to you after the medicine has been used. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT LEUCOVORIN CALCIUM INJECTION IS USED FOR Leucovorin Calcium Injection contains calcium folinate. It belongs to a group of vitamins used as an antidote to the harmful effects of methotrexate therapy. Calcium folinate acts in the same way as folic acid which may be low in these patients. Leucovorin Calcium Injection may be used for the management of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed Leucovorin Calcium Injection. BEFORE YOU ARE GIVEN LEUCOVORIN CALCIUM INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT HAVE LEUCOVORIN CALCIUM INJECTION IF YOU HAVE AN ALLERGY TO: • any medicine containing leucovorin calcium (calcium folinate or folinic acid) • any of the ingredients listed at the end of this leaflet • any similar medicines. YOU MUST NOT BE GIVEN LEUCOVORIN CALCIUM IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • pernicious anaemia • any other megaloblastic anaemias which are due to a lack of Vitamin B12. _BEFORE YOU ARE GIVEN IT_ TELL YOUR DOCTOR IF: 1. YOU HAVE ANY ALLERGIES TO: - any other medicine - any other substances, such Läs hela dokumentet
Version pfpleuci11219 Supersedes: pfpleuci10313 Page 1 of 11 AUSTRALIAN PRODUCT INFORMATION – [LEUCOVORIN CALCIUM INJECTION (CALCIUM FOLINATE)] 1. NAME OF THE MEDICINE Calcium folinate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Calcium folinate as equivalent to folinic acid 50 mg/5 mL, 100 mg/10 mL, containing calcium folinate 54 mg in 5 mL (equivalent to 50 mg folinic acid) and 108 mg in 10 mL (equivalent to 100 mg folinic acid). Calcium folinate potency is usually expressed in terms of equivalent units of folinic acid. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Leucovorin Calcium Injection is a sterile, isotonic, clear, yellowish, preservative-free solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Leucovorin Calcium Injection is indicated following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). It is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE LABORATORY TESTS Patients treated with Leucovorin Calcium Injection following methotrexate therapy, including inadvertent overdose, or patients with impaired methotrexate elimination, should have serum creatinine and methotrexate concentrations determined at least once daily. Urine pH: in cases of methotrexate overdose or delayed excretion, monitor as appropriate to ensure maintenance of pH ≥ 7.0 Foods, drinks and drugs that may increase urinary acidity should be avoided during the therapy. LEUCOVORIN CALCIUM RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY The dose of Leucovorin Calcium Injection required depends on the amount of methotrexate administered and whether there is impaired methotrexate elimination. Table 1 provides dosing Version pfpleuci11219 Supersedes: pfpleuci10313 Page 2 of 11 guidelines for a methotrexate dose of 12 to 15 g/m 2 by intravenous infusion over 4 hours. Leucovorin Calcium Injection is commenced 24 hours after the start of the methotrexate infusion. TABLE Läs hela dokumentet