Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
mitomycin, Quantity: 10 mg
Omegapharm
Mitomycin
Injection, powder for
Excipient Ingredients: mannitol
Intravenous, Intravesical
1 vial
(S4) Prescription Only Medicine
Mitomycin is indicated in the palliative treatment of carcinoma of the stomach, pancreas, colon, lung (non-small cell), breast, cervix, head and neck, liver and bladder.
Visual Identification: blue violet cake or powder in amber glass vial; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-03-08
Version 1.1 Page 1 of 3 MITOMYCIN OMEGAPHARM Powder for injection, 2 mg/vial, 10 mg/vial and 20 mg/vial CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about Mitomycin Omegapharm but 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 treating you with Mitomycin Omegapharm against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING TREATED WITH MITOMYCIN OMEGAPHARM ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET, BECAUSE YOU MAY NEED TO READ IT AGAIN. WHAT MITOMYCIN OMEGAPHARM IS USED FOR Mitomycin Omegapharm contains mitomycin, which is an anti- cancer agent. It is used to treat cancer of the stomach, pancreas, colon, lung (non-small cell), breast, cervix, head and neck, liver and bladder. Mitomycin Omegapharm works by stopping cancer cells from growing. Ask your doctor if you have any question about why Mitomycin Omegapharm was prescribed for you. BEFORE YOU ARE GIVEN MITOMYCIN OMEGAPHARM _WHEN YOU MUST NOT BE GIVEN _ _MITOMYCIN OMEGAPHARM _ _ _ You must not take Mitomycin Omegapharm if you have a history of severe allergic reactions to mitomycin or to any of the ingredients listed at the end of this leaflet. Symptoms of a severe allergic reaction may include; chills, fever, fast heart beat, wheezing or coughing, difficulty breathing, dizziness, flushing, sweating and swelling of the face, tongue or other parts of the body. You must not take Mitomycin Omegapharm if you have any condition or any blood disorder which causes you to bleed very easily. _ BEFORE YOU ARE GIVEN MITOMYCIN _ _OMEGAPHARM _ You must tell your doctor if; you have ever had an allergic reaction to any medicine, or other substances such as food, preservatives or dyes. you have ever had a condition which caused you to bleed very easily. you have an infection now or had one recently. you have ever Lestu allt skjalið
MITOMYCIN OMEGAPHARM Mitomycin powder for injection, 2 mg/vial, 10 mg/vial and 20 mg/vial V2.0 Page 1 of 9 PRODUCT INFORMATION MITOMYCIN OMEGAPHARM NAME OF THE MEDICINE: MITOMYCIN OMEGAPHARM (mitomycin C) DESCRIPTION MITOMYCIN OMEGAPHARM is an antibiotic isolated from the broth of _Streptomyces caespitosus _ which has been shown to have anti-tumour activity. Mitomycin C is a blue-violet crystalline powder slightly soluble in water, freely soluble in dimethylacetamide, sparingly soluble in methanol, slightly soluble in acetone. The CAS number for Mitomycin C is 50-07-7. The structure is: [(1aS,8S,8aR,8bS)-6-Amino-8a-methoxy-5-methyl-4,7-dioxo-,1a,2,4,7,8,8a,8boctahydroazirino [2’,3’:3,4] pyrrolo[1,2-a]-indol-8-yl]methyl carbamate Molecular weight: 334.3 Molecular formula: C 15 H 18 N 4 O 5 MITOMYCIN OMEGAPHARM injection is available in single use vials. Each vial contains either 2 mg, 10 mg or 20 mg of mitomycin C. In addition each vial contains 4 mg, 20 mg or 40 mg respectively of mannitol. PHARMACOLOGY Mitomycin inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine correlates with the degree of mitomycin induced cross-linking. At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed. In humans, mitomycin is rapidly cleared from the serum after intravenous administration. Time required to reduce the serum concentration by 50 % after a 30 mg bolus injection is 17 minutes. After injection of 30 mg, 20 mg or 10 mg IV, the maximal serum concentrations were 2.4 microgram/mL, 1.7 microgram/mL and MITOMYCIN OMEGAPHARM Mitomycin powder for injection, 2 mg/vial, 10 mg/vial and 20 mg/vial V2.0 Page 2 of 9 0.52 microgram/mL respectively. Clearance is effected primarily by metabolism in the liver, but metabolism occurs in other issues as well. The rate of clearance is inversely proportional to the maximal serum concentration because, it is thought of saturation of the degradative pathways. Approximately 10 % of a dose of mitomycin is excreted unchanged in the ur Lestu allt skjalið