TREPULMIX Solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Trepulmix 1 mg/ml solution for infusion. Trepulmix 2.5 mg/ml solution for infusion. Trepulmix 5 mg/ml solution for infusion. Trepulmix 10 mg/ml solution for infusion.
Qualitative and quantitative composition
Trepulmix 1 mg/ml solution for infusion One ml of solution contains 1 mg treprostinil (as sodium salt). Each 10 ml vial of solution contains 10 mg treprostinil (as sodium salt). Excipients with known effect: ...
Pharmaceutical form
Solution for infusion. Clear colourless to slightly yellow solution, free from visible particles with a pH of 6.0–7.2 and an osmolality between 253 and 284 mOsm/kg.
Therapeutic indications
Trepulmix is indicated for the treatment of adult patients with WHO Functional Class (FC) III or IV and: inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or persistent or recurrent CTEPH ...
Posology and method of administration
Treatment with Trepulmix should be initiated and monitored only by clinicians experienced in the treatment of pulmonary hypertension. Treatment should be initiated under close medical supervision in a ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pulmonary veno-occlusive disease. Severe decompensated left heart failure. Severe hepatic impairment (Child-Pugh ...
Special warnings and precautions for use
General therapy The decision to initiate therapy with treprostinil should take into consideration the high probability that continuous infusion will have to be continued for a prolonged period. Thus the ...
Interaction with other medicinal products and other forms of interaction
Concomitant administration with diuretics, antihypertensive agents, or other vasodilators Concomitant administration of treprostinil with diuretics, antihypertensive agents or other vasodilators increases ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of treprostinil in pregnant women. Animal studies are insufficient with respect to effects on pregnancy (see section 5.3). Treprostinil should ...
Effects on ability to drive and use machines
Treprostinil has minor influence on the ability to drive and use machines at the initiation of treatment or dose adjustments. They may be accompanied by undesirable effects such as symptomatic systemic ...
Undesirable effects
Summary of safety profile In addition to local effects resulting from the administration of treprostinil by subcutaneous infusion such as infusion site pain and infusion site reaction, adverse reactions ...
Overdose
Symptoms of overdose with treprostinil include flushing, headache, hypotension, nausea, vomiting, and diarrhoea. Patients experiencing symptoms of overdose should, after consultation with their physician, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin ATC code: B01AC21 Mechanism of action Treprostinil is a prostacyclin analogue. It exerts a direct vasodilation ...
Pharmacokinetic properties
Distribution In humans, steady-state plasma concentrations are usually achieved within 15 to 18 hours of the initiation of either subcutaneous or intravenous infusion of treprostinil. Steady-state plasma ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction. In 13 and 26 week studies ...
List of excipients
Sodium citrate Hydrochloric acid Metacresol Sodium hydroxide Sodium chloride Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products.
Shelf life
Unopened vial: 3 years. After first opening: 30 days. During use with continuous subcutaneous infusion: Chemical, physical and microbial in-use stability of a single container (syringe) of undiluted Trepulmix ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For in-use storage times and conditions see section 6.3.
Nature and contents of container
Trepulmix 1 mg/ml solution for infusion: 10 ml type I clear glass vial sealed with a rubber teflon- coated stopper and fitted with a yellow cap. Trepulmix 2.5 mg/ml solution for infusion: 10 ml type I ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
SciPharm Sàrl, 7, Fausermillen, L-6689, Mertert, Luxembourg
Marketing authorization number(s)
EU/1/19/1419/001 EU/1/19/1419/002 EU/1/19/1419/003 EU/1/19/1419/004
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