REMODULIN 5 MGML

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
03-12-2020
Ciri produk Ciri produk (SPC)
11-08-2020
Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
11-08-2020

Bahan aktif:

TREPROSTINIL AS SODIUM

Boleh didapati daripada:

RAFA LABORATORIES LTD

Kod ATC:

B01AC21

Borang farmaseutikal:

SOLUTION FOR INJECTION

Komposisi:

TREPROSTINIL AS SODIUM 5 MG/ML

Laluan pentadbiran:

S.C, I.V

Jenis preskripsi:

Required

Dikeluarkan oleh:

UNITED THERAPEUTICS CORP., USA

Kumpulan terapeutik:

TREPROSTINIL

Kawasan terapeutik:

TREPROSTINIL

Tanda-tanda terapeutik:

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.

Tarikh kebenaran:

2022-10-31

Risalah maklumat

                                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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