NOVOSEVEN RT

देश: इंडोनेशिया

भाषा: इंडोनेशियाई

स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

सक्रिय संघटक:

EPTACOG ALFA (ACTIVATED)

थमां उपलब्ध:

BETA PHARMACON - Indonesia

INN (इंटरनेशनल नाम):

EPTACOG ALFA (ACTIVATED)

डोज़:

1 MG

फार्मास्यूटिकल फॉर्म:

SERBUK INJEKSI

पैकेज में यूनिट:

DUS, 1 VIAL @ 1 MG + 1 PREFILLED SYRINGE PELARUT @ 1 ML

द्वारा बनाया गया:

NOVO NORDISK A/S - Denmark

प्राधिकरण की तारीख:

2018-11-21

उत्पाद विशेषताएं

STF AUG 2021
1 of 20
1.
NAME OF THE MEDICINAL PRODUCT
NOVOSEVEN
®
RT
1 MG (50 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
eptacog alfa (activated) 1 mg/vial (corresponds to 50 KIU/vial), 1
mg/ml after reconstitution
1 KIU equals 1,000 IU (International Units).
eptacog alfa (activated) is recombinant coagulation factor VIIa
(rFVIIa) with a molecular
mass of approximately 50,000 Daltons produced in baby hamster kidney
cells (BHK Cells)
by recombinant DNA technology.
After reconstitution, the product contains 1 mg/ml eptacog alfa
(activated) when
reconstituted with solvent.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White lyophilised powder. Solvent: clear colourless solution. The
reconstituted solution has
a pH of approximately 6.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NovoSeven
®
RT is indicated for the treatment of bleeding episodes and for the
prevention of
bleeding in those undergoing surgery or invasive procedures in the
following patient groups:

in patients with congenital haemophilia with inhibitors to coagulation
factors VIII or IX > 5
Bethesda Units (BU)

in patients with congenital haemophilia who are expected to have a
high anamnestic
response to factor VIII or factor IX administration

in patients with acquired haemophilia

in patients with congenital FVII deficiency

in patients with Glanzmann’s thrombasthenia with past or present
refractoriness to
platelet transfusions, or where platelets are not readily available.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of haemophilia and/or bleeding disorders.
DISETUJUI OLEH BPOM: 16/12/2022
ID EREG100383VR12200076
STF AUG 2021
2 of 20
POSOLOGY
_Haemophilia A or B with inhibitors or expected to have a high
anamnestic response _
Dose
NovoSeven
®
RT should be given as early as possible after the start of a blee