METHYLTHIONINIUM CHLORIDE PROVEBLUE Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Methylthioninium chloride Proveblue 5 mg/ml solution for injection.
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 ...
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.
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). ...
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 ...
Contraindications
Hypersensitivity to the active substance, or to any other thiazine dyes. Patients with Glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of haemolytic anaemia. Patients with nitrite-induced ...
Special warnings and precautions for use
General Methylthioninium chloride Proveblue must be injected very slowly over a period of 5 minutes to prevent high local concentrations of the compound from producing additional methaemoglobin. It imparts ...
Interaction with other medicinal products and other forms of interaction
Methylthioninium chloride should be avoided in patients receiving medicinal products that enhance serotonergic transmission because of the potential for serious CNS reactions, including potentially fatal ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of methylthioninium chloride in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is ...
Effects on ability to drive and use machines
Methylthioninium chloride has moderate influence on the ability to drive and use machines. Indeed, driving can be affected due to confusional state, dizziness and possibly eye disturbances. However, the ...
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions observed during clinical trials are dizziness, paraesthesia, dysgeusia, nausea, skin discoloration, chromaturia, sweating, injection ...
Overdose
Individuals without methaemoglobinaemia The administration of large intravenous doses (≥7 mg/kg) of Methylthioninium chloride Proveblue to individuals without methaemoglobinaemia induces nausea and vomiting, ...
Pharmacodynamic properties
Pharmacotherapeutic group: All other therapeutic products, antidotes ATC code: V03AB17 In vivo, in low concentration, methylthioninium chloride speeds up the conversion of methaemoglobin to haemoglobin. ...
Pharmacokinetic properties
After intravenous administration Methylthioninium chloride Proveblue is rapidly taken up by the tissues. It is also well absorbed by the oral route. The majority of the dose is excreted in the urine, usually ...
Preclinical safety data
Repeated dose toxicity One-month repeated dose toxicity in dogs showed no macroscopic toxic effects. Adverse reactions, seen at exposure levels similar to clinical exposure levels and with possible relevance ...
List of excipients
Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. It must especially not be mixed with sodium chloride 9 mg/ml (0.9%) solution for injection ...
Shelf life
Shelf life: 3 years. After opening or dilution: From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product must be used immediately. ...
Special precautions for storage
Do not refrigerate or freeze. Keep the ampoule in the original package in order to protect from light. For storage conditions of the diluted medicinal product, see section 6.3.
Nature and contents of container
Type I glass ampoules. Each carton contains a tray with 5 ampoules of 10 ml in blister. Each carton contains a tray with 5 or 20 ampoules of 2 ml in blister. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
For single use only. Methylthioninium chloride Proveblue may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population. Before any administration, ...
Marketing authorization holder
PROVEPHARM SAS, 22 rue Marc Donadille, 13013, Marseille, France
Marketing authorization number(s)
EU/1/11/682/001 EU/1/11/682/002 EU/1/11/682/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 06 May 2011 Date of latest renewal: 08 February 2016
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