REMODULIN 10 MGML

Country: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

TREPROSTINIL AS SODIUM

Доступно од:

RAFA LABORATORIES LTD

АТЦ код:

B01AC21

Фармацеутски облик:

SOLUTION FOR INJECTION

Састав:

TREPROSTINIL AS SODIUM 10 MG/ML

Пут администрације:

S.C, I.V

Тип рецептора:

Required

Произведен од:

UNITED THERAPEUTICS CORP., USA

Терапеутска област:

TREPROSTINIL

Терапеутске индикације:

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.

Датум одобрења:

2021-01-31

Информативни летак

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

Карактеристике производа

Remodulin-DL- notif_July 2020-03
FULL PRESCRIBING INFORMATION
REMODULIN
® (TREPROSTINIL) SOLUTION FOR INJECTION
REMODULIN
® 2.5 MG/ML
REMODULIN
® 5 MG/ML
REMODULIN
® 10 MG/ML
SOLUTION FOR INJECTION
COMPOSITION: Remodulin is supplied in 20 mL vials in three strengths
containing 50mg, 100 mg
or 200 mg (2.5 mg/mL, 5 mg/mL or 10 mg/mL) of treprostinil (as
sodium).
For the full list of ingredients see section 11.
1. INDICATIONS AND USAGE
Remodulin® is indicated as a continuous subcutaneous infusion or
intravenous infusion for the
treatment of
• Primary pulmonary arterial hypertension
• Pulmonary arterial hypertension associated with connective tissue
disorders
• Pulmonary arterial hypertension associated with congenital
systemic to pulmonary shunts.
2. DOSAGE AND ADMINISTRATION
2.1 GENERAL
Remodulin can be administered without further dilution for
subcutaneous administration, or
diluted for intravenous infusion with Sterile Water for Injection or
0.9% Sodium Chloride Injection,
prior to administration.
2.2 INITIAL DOSE FOR PATIENTS NEW TO PROSTACYCLIN INFUSION THERAPY
Remodulin is indicated for subcutaneous (SC) or intravenous (IV) use
only as a continuous
infusion. Remodulin is preferably infused subcutaneously, but can be
administered by a central
intravenous line if the subcutaneous route is not tolerated because of
severe site pain or reaction.
The infusion rate is initiated at 1.25 ng/kg/min. If this initial dose
cannot be tolerated because of
systemic effects, reduce the infusion rate to 0.625 ng/kg/min.
2.3 DOSAGE ADJUSTMENTS
The goal of chronic dosage adjustments is to establish a dose at which
PAH symptoms are
improved, while minimizing excessive pharmacologic effects of
Remodulin (headache, nausea,
emesis, restlessness, anxiety and infusion site pain or reaction).
The infusion rate should be increased in increments of 1.25 ng/kg/min
per week for the first four
weeks of treatment and then 2.5 ng/kg/min per week for the remaining
duration of infusion,
depending on clinical response. Dosage adjustmen