REMODULIN 5 MGML

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

TREPROSTINIL AS SODIUM

Tilgængelig fra:

RAFA LABORATORIES LTD

ATC-kode:

B01AC21

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

TREPROSTINIL AS SODIUM 5 MG/ML

Indgivelsesvej:

S.C, I.V

Recept type:

Required

Fremstillet af:

UNITED THERAPEUTICS CORP., USA

Terapeutisk gruppe:

TREPROSTINIL

Terapeutisk område:

TREPROSTINIL

Terapeutiske indikationer:

Remodulin is indicated as a continuous subcutaneous infusion or intravenous infusion for the treatment of primary pulmonary arterial hypertension and pulmonary arterial hypertension associated with connective tissue disorders. Pulmonary hypertension associated with congenital systemic to pulmonary shunts.

Autorisation dato:

2022-10-31

Indlægsseddel

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is sold with a doctor's prescription only.
REMODULIN 2.5 MG/ML
REMODULIN 5 MG/ML
REMODULIN 10 MG/ML
Solution for subcutaneous or intravenous injection
ACTIVE INGREDIENT:
REMODULIN 2.5 MG/ML: Each ml contains 2.5 mg Treprostinil (as sodium).
REMODULIN 5 MG/ML: Each ml contains 5 mg Treprostinil (as sodium).
REMODULIN 10 MG/ML: Each ml contains 10 mg Treprostinil (as sodium).
For a list of additional ingredients, please see section 6.
See also 'Important information about some of the medicine's
ingredients' in section 2.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for treating your illness. Do not
pass it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is intended:
•
For treatment of primary pulmonary arterial hypertension.
•
For treatment of pulmonary arterial hypertension associated with
connective tissue
disorder.
•
For treatment of pulmonary hypertension resulting from a congenital
heart defect.
THERAPEUTIC GROUP:
Synthetic prostacyclin analog, platelet aggregation inhibitor.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other additional ingredients
this medicine contains (for a list of additional ingredients, please
see section 6).
•
The solution is not clear, if it is cloudy, if there is a change in
the solution color,
if the solution contains foreign particles and/or if there is any
defect in the vial.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
•
When Remodulin is administrated by intravenous infusion, there is a
risk of blood infection and
sepsis. This condition may be life threatening. Refer to a doctor or a
hospital emergency room

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