Země: Nizozemsko
Jazyk: nizozemština
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TREPROSTINIL NATRIUM SAMENSTELLING overeenkomend met ; ; TREPROSTINIL 10 mg/ml
TREPROSTINIL NATRIUM SAMENSTELLING overeenkomend met ; ; TREPROSTINIL 10 mg/ml
Oplossing voor infusie
METACRESOL ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507)
Subcutaan gebruik, Intraveneus gebruik
2022-04-14
1 PACKAGE LEAFLET: INFORMATION FOR THE USER TREPROSTINIL REDDY 1 MG/ML, OPLOSSING VOOR INFUSIE TREPROSTINIL REDDY 2,5 MG/ML, OPLOSSING VOOR INFUSIE TREPROSTINIL REDDY 5 MG/ML, OPLOSSING VOOR INFUSIE TREPROSTINIL REDDY 10 MG/ML, OPLOSSING VOOR INFUSIE treprostinil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What [Invented Name] is and what it is used for 2. Before you use [Invented Name] 3. How to use [Invented Name] 4. Possible side effects 5. How to store [Invented Name] 6. Contents of the pack and other information 1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR WHAT [INVENTED NAME] IS The active ingredient of [Invented Name] is treprostinil. Treprostinil belongs to a group of medicines which work in a similar way to the naturally occurring prostacyclins. Prostacyclins are hormone-like substances which reduce blood pressure by relaxing blood vessels, causing them to widen, which allows the blood to flow more easily. Prostacyclins can also have an influence in preventing blood from clotting. WHAT [INVENTED NAME] IS USED TO TREAT [Invented Name] is used to treat idiopathic or heritable pulmonary arterial hypertension (PAH) in patients with moderate severity of the symptoms. Pulmonary arterial hypertension is a condition where your blood pressure is too high in the blood vessels between the heart and the lungs, causing shortness of breath, dizziness, tiredness, fainting, palpitations or abnormal heartbeat, dry cough, chest pain and swollen ankles or legs. [Invented Name] is initially administered a Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Treprostinil Reddy 10 mg/ml, oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains treprostinil sodium corresponding to 10 mg treprostinil. Each vial of 20 ml solution contains 200 mg treprostinil as treprostinil sodium (sodium salt formed _in situ _ during manufacture of the finished product). Excipients with known effect: Sodium: 74.8 mg per 20 ml vial Metacresol: 60 mg per 20 ml vial For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion Appearance: Clear colourless to slightly yellow solution. pH value: Between 6.0 and 7.2. Osmolality: Between 230 and 270 mOsm/kg 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of idiopathic or heritable pulmonary arterial hypertension (PAH) to improve exercise tolerance and symptoms of the disease in patients classified as New York Heart Association (NYHA) functional class III. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION [Invented Name] is administered by continuous subcutaneous or intravenous infusion. Due to the risks associated with chronic indwelling central venous catheters including serious blood stream infections, subcutaneous infusion (undiluted) is the preferred mode of administration and continuous intravenous infusion should be reserved for patients stabilised with treprostinil subcutaneous infusion and who become intolerant of the subcutaneous route, and in whom these risks are considered acceptable. The treatment should be initiated and monitored only by clinicians experienced in the treatment of pulmonary hypertension. [Invented name] should be used undiluted if administered by continuous subcutaneous infusion; and should be diluted with sterile water injection or 0.9% (w/v) sodium chloride injection, if administered by continuous intravenous infusion. Please refer to the section 6.6. ADULTS Treatment initiation for patients new to prostacyclin therapy Treatment should be initiated under close medical supervision Přečtěte si celý dokument