CRUSIA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ENOXAPARIN SODIUM

متاح من:

TZAMAL BIO-PHARMA LTD

ATC رمز:

B01AB05

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

ENOXAPARIN SODIUM 100 MG / 1 ML

طريقة التعاطي:

S.C, I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ROVI PHARMA INDUSTRIAL SERVICES S.A, SPAIN

المجال العلاجي:

ENOXAPARIN

الخصائص العلاجية:

Crusia is indicated in adults for:•Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery.•Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism.•Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE ikely to require thrombolytic therapy or surgery. Prevention of thrombus formation in extra corporeal circulation during haemodialysis.•Acute coronary syndrome:-Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.-Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

تاريخ الترخيص:

2019-11-05

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
Crusia
Solution for injection in a pre-filled syringe with a safety system
20 mg/0.2 ml, 40 mg/0.4 ml, 60 mg/0.6 ml, 80 mg/0.8 ml,
100 mg/1.0 ml
Crusia Forte
Solution for injection in a pre-filled syringe with a safety system
120 mg/0.8 ml, 150 mg/1.0 ml
Active ingredient and its quantity:
Each syringe of Crusia respectively contains:
Enoxaparin Sodium 20 mg, 40 mg, 60 mg, 80 mg or 100 mg
Each syringe of Crusia Forte respectively contains:
Enoxaparin Sodium 120 mg or 150 mg
For a list of inactive ingredients, please see section 6.
Read the entire leaflet carefully before using the medicine. Keep this
leaflet,
you may need to read it again. This leaflet contains concise
information about the
medicine. If you have any other questions, refer to the doctor or the
pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to others.
It may harm them even if it seems to you that their medical condition
is similar.
If a side effect worsens or if a side effect that is not mentioned in
this leaflet
appears, refer to the doctor or pharmacist.
Crusia/Crusia Forte is a biosimilar preparation. For additional
information about
biosimilar preparations refer to the Ministry of Health website:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosimilars.aspx
Please note, every time you collect the medicine at the pharmacy, it
is important
that you make sure you get the same medicine your attending specialist
doctor
prescribed for you. If the medicine you received looks different from
the one you
usually receive, or the directions for use have been changed,
immediately refer
to the pharmacist in order to confirm that you have been supplied with
the correct
medicine. Any switch or change in the dosage of a medicine containing
enoxaparin
sodium must be conducted by the attending specialist doctor only.
Please check
that the trade name of th

خصائص المنتج

PHYSICIAN'S PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
CRUSIA
CRUSIA FORTE
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
CRUSIA
_2,000 IU (20 mg) /0.2 mL _
Each pre-filled syringe contains enoxaparin sodium 2,000 IU anti-Xa
activity (equivalent to 20
mg) in 0.2 mL water for injections.
_4,000 IU (40 mg) /0.4 mL _
Each pre-filled syringe contains enoxaparin sodium 4,000 IU anti-Xa
activity (equivalent to 40
mg) in 0.4 mL water for injections.
_ _
_6,000 IU (60 mg) /0.6 mL _
Each pre-filled syringe contains enoxaparin sodium 6,000 IU anti-Xa
activity (equivalent to 60
mg) in 0.6 mL water for injections.
_ _
_8,000 IU (80 mg) /0.8 mL _
Each pre-filled syringe contains enoxaparin sodium 8,000 IU anti-Xa
activity (equivalent to 80
mg) in 0.8 mL water for injections.
_ _
_ _
_10,000 IU (100 mg) /1 mL _
Each pre-filled syringe contains enoxaparin sodium 10,000 IU anti-Xa
activity (equivalent to
100 mg) in 1 mL water for injections.
_ _
CRUSIA FORTE
_12,000 IU (120 mg) /0.8 mL _
Each pre-filled syringe contains enoxaparin sodium 12,000 IU anti-Xa
activity (equivalent to
120 mg) in 0.8 mL water for injections.
_ _
_ _
_15,000 IU (150 mg) /1 mL _
Each pre-filled syringe contains enoxaparin sodium 15,000 IU anti-Xa
activity (equivalent to
150 mg) in 1 mL water for injections.
_ _
For the full list of excipients, see section 6.1.
Enoxaparin sodium is a biological substance obtained by alkaline
depolymerization of heparin
benzyl ester derived from porcine intestinal mucosa.
3
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, colourless to pale yellow solution.
CRUSIA/CRUSIA FORTE
is a biosimilar medicinal product that has been demonstrated to be
similar
in quality, safety and efficacy to the reference medicinal product
Clexane. Please be aware of
any differences in the indications between the biosimilar medicinal
product and the reference
medicinal product. The biosimilar is not to be switched with the
reference medicinal product
unless specifically stated otherwise. More detailed informat