Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
methylene blue, Quantity: 50 mg
Clinect Pty Ltd
Methylene blue
Injection
Excipient Ingredients: water for injections
Intravenous, Oral
5 ampoules
(S4) Prescription Only Medicine
PROVEBLUE is indicated: For the treatment of drug-induced methaemoglobinaemia. For the treatment of idiopathic methaemoglobinaemia (in which structural abnormality of haemoglobulin is not present). As a bacterial stain. As a dye in diagnostic procedures such as fistula detection. For the delineation of certain body tissues during surgery.
Visual Identification: A sterile, clear blue solution for injection in 10 mL glass type I ampoules; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-07-23
PROVEBLUE ® _50 MG/10 ML_ _methylene blue injection_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PROVEBLUE. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you being given PROVEBLUE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT PROVEBLUE IS USED FOR PROVEBLUE is used to treat abnormal blood pigment levels. These abnormal blood pigments do not carry oxygen properly. This medicine belongs to a group of medicines called dyes. PROVEBLUE is also used: • to stain bacteria to make them easier to see • as a visible dye to help in the diagnosis of a number of conditions • as a stain to dye certain body tissues during surgery 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. PROVEBLUE is not recommended for long-term use. The use of methylene blue in infants under 4 months of age is not recommended. Your doctor will discuss use of this medicine in infants younger than 4 months if needed. This medicine is only available with a doctor's prescription. BEFORE YOU ARE GIVEN PROVEBLUE _WHEN YOU MUST NOT BE GIVEN_ _IT_ • if your blood disorder has been caused by cyanide • if your blood disorder has been caused by chlorate poisoning YOU SHOULD NOT BE GIVEN PROVEBLUE IF YOU HAVE AN ALLERGY TO: • any medicine containing methylene blue • any other dyes Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin YOU SHOULD NOT BE GIVEN THIS MEDICINE IF YOU HAVE GLUCOSE-6- PHOSPHATE DEHYDROGENASE DEFICIENCY. This is an in Soma hati kamili
1 AUSTRALIAN PRODUCT INFORMATION - PROVEBLUE ® (METHYLENE BLUE SOLUTION FOR INJECTION) 1. NAME OF THE MEDICINE Methylene blue (also known as methylthioninium chloride) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PROVEBLUE ® injection is a sterile solution containing 50 mg methylene blue trihydrate (equivalent to 42.77 mg of methylene blue anhydrous) in water for injections to 10 mL. The pH of the solution ranges between 3.0 and 4.5. Methylene blue is a dark blue, crystalline powder with a copper-coloured sheen, or green crystals with a bronze-coloured sheen. It is slightly soluble in water and slightly soluble in ethanol. 3. PHARMACEUTICAL FORM PROVEBLUE ® is a clear blue solution and contains methylene blue trihydrate 50 mg/10 mL. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PROVEBLUE ® is indicated: • for the treatment of drug-induced methaemoglobinaemia • for the treatment of idiopathic methaemoglobinaemia (in which structural abnormality of haemoglobin is not present) • as a bacteriological stain • as a dye in diagnostic procedures such as fistula detection • for the delineation of certain body tissues during surgery. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE PROVEBLUE ® may be administered orally or by intravenous (IV) injection. In the treatment of acute methaemoglobinaemia, the IV route of administration is usually preferred because it provides a more rapid onset of effect. Adults and children: In the treatment of methaemoglobinaemia, methylene blue is administered intravenously as the 0.5 % solution in doses of 1 to 2 mg per kg bodyweight injected over a period of 5 minutes. A repeat dose may be given after one hour if required. A maximum dose of 7mg/kg bodyweight is recommended. The use of methylene blue is not recommended in infants under 4 months of age. A dose of 5 mg/kg diluted in 500 mL of glucose 5% infused over 1 hour has been used successfully to stain and identify the parathyroid glands. PROVEBLUE ® should not be diluted with sodium chloride 0.9% (saline) as precipitati Soma hati kamili