Treprostinil Reddy 5 mg/ml, oplossing voor infusie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

TREPROSTINIL NATRIUM SAMENSTELLING overeenkomend met ; ; TREPROSTINIL 5 mg/ml

INN (Algemene Internationale Benaming):

TREPROSTINIL NATRIUM SAMENSTELLING overeenkomend met ; ; TREPROSTINIL 5 mg/ml

farmaceutische vorm:

Oplossing voor infusie

Samenstelling:

METACRESOL ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507)

Toedieningsweg:

Subcutaan gebruik, Intraveneus gebruik

Autorisatie datum:

2022-04-14

Bijsluiter

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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Treprostinil Reddy 5 mg/ml, oplossing voor infusie
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains treprostinil sodium corresponding to 5 mg
treprostinil.
Each vial of 20 ml contains 100 mg treprostinil as treprostinil sodium
(sodium salt formed
_in situ _
during manufacture of the finished product).
Excipients with known effect:
Sodium: 78.4 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 255 and 305 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 in a
medica