Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
methylthioninium chloride
Provepharm SAS
V03AB17
methylthioninium chloride
All other therapeutic products
Methemoglobinemia
Acute symptomatic treatment of medicinal and chemical products- induced methaemoglobinaemia.Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).
Revision: 26
Authorised
2011-05-06
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ METHYLTHIONINIUM CHLORIDE PROVEBLUE 5 MG/ML SOLUTION FOR INJECTION methylthioninium chloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Methylthioninium chloride Proveblue is and what it is used for 2. What you need to know before you are given Methylthioninium chloride Proveblue 3. How Methylthioninium chloride Proveblue is given 4. Possible side effects 5. How to store Methylthioninium chloride Proveblue 6. Contents of the pack and other information 1. WHAT METHYLTHIONINIUM CHLORIDE PROVEBLUE IS AND WHAT IT IS USED FOR Methylthioninium chloride (also called methylene blue) belongs to a group of medicines called antidotes. Methylthioninium chloride Proveblue will be given to you or your child (0-17 years old) to treat problems with your blood resulting from exposure to some medicines or chemicals that can cause a disease called methaemoglobinaemia. In methaemoglobinaemia, your blood contains too much methaemoglobin (an abnormal form of haemoglobin that is not able to transport oxygen around your body effectively). This medicine will help your haemoglobin return to normal and restore the transport of oxygen in the blood. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN METHYLTHIONINIUM CHLORIDE PROVEBLUE _ _ YOU MUST NOT BE GIVEN METHYLTHIONINIUM CHLORIDE PROVEBLUE - if you are allergic to methylthioninium chloride or other thiazine dyes - if your body does not produce enough of the enzyme G6PD (glucose-6-phosphate dehydrogenase) - if your body does not produce enough of the enzyme NADPH (nicotinamide adenine dinucleotide phosphate) reductase - if your blood disorder has been caused b Lugege kogu dokumenti
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Methylthioninium chloride Proveblue 5 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 5 mg methylthioninium chloride. Each 10 ml ampoule contains 50 mg methylthioninium chloride. Each 2 ml ampoule contains 10 mg methylthioninium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) Clear dark blue solution with a pH value between 3.0 and 4.5 Osmolality is usually between 10 and 15 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute symptomatic treatment of medicinal and chemical products-induced methaemoglobinaemia. Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Methylthioninium chloride Proveblue is for administration by a healthcare professional. Posology _ _ _Adults _ _ _ The usual dose is 1 to 2 mg per kg body weight, i.e. 0.2-0.4 ml per kg body weight, given over a period of 5 minutes. A repeat dose (1 to 2 mg/kg body weight, i.e. 0.2-0.4 ml/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range. Treatment does not usually exceed one day. The maximum recommended cumulative dose for the course of treatment is 7 mg/kg and should not be exceeded, since Methylthioninium chloride administered above the maximum dose may cause methaemoglobinaemia in susceptible patients. In the case of aniline- or dapsone-induced methaemaglobinaemia, the maximum recommended cumulative dose for the course of treatment is 4 mg/kg (see section 4.4). Too limited data are available to support a continuous infusion dose recommendation. _ _ _ _ _ _ 3 Special populations _ _ _Elderly _ _ _ No dose adjustment is necessary. _Renal impairment _ _ _ In infants above 3 months, children and Lugege kogu dokumenti