CYTOFLAVIN

देश: इंडोनेशिया

भाषा: इंडोनेशियाई

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

सक्रिय संघटक:

SUCCINIC ACID, NICOTINAMIDE, INOSINE, RIBOFLAVIN SODIUM PHOSPHATE

थमां उपलब्ध:

PYRIDAM FARMA TBK - Indonesia

INN (इंटरनेशनल नाम):

SUCCINIC ACID, NICOTINAMIDE, INOSINE, RIBOFLAVIN SODIUM PHOSPHATE

डोज़:

1,00 G /0,10 G /0,20 G /0,02 G

फार्मास्यूटिकल फॉर्म:

LARUTAN KONSENTRAT UNTUK INFUS

पैकेज में यूनिट:

DUS, 1 BLISTER @ 5 AMPUL @ 10 ML

द्वारा बनाया गया:

SCIENTIFIC TECHNOLOGICAL PHARMACEUTICAL FIRM "POLYSAN" LTD. - Russian Federation

प्राधिकरण की तारीख:

2022-04-18

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
(PRESCRIBING INFORMATION)
CYTOFLAVIN
®
(Inosine + Nicotinamide + Riboflavin sodium phosphate+ Succinic acid)
CONCENTRATE FOR SOLUTION FOR INFUSION
BRAND NAME: CYTOFLAVIN
®
DOSAGE FORM: concentrate for solution for infusion
COMPOSITION: each ampoule contains:
Active ingredients:
Succinic acid
– 1.00 g
Nicotinamide
– 0.10 g
Inosine
– 0.20 g
Riboflavin sodium phosphate
– 0.02 g
Excipients:
Meglumine
– 1.65 g
Sodium hydroxide
– 0.34 g
Water for injections
- up to 10 mL
DESCRIPTION: A clear yellow solution.
THERAPEUTIC CATEGORY: Other nervous system drugs
ATC CODE: N07XX
INDICATIONS
CYTOFLAVIN
®
is indicated for adults as adjunctive to standard therapy for the
treatment of:
1. Moderate acute ischemic stroke in the first 6-24 hours from the
onset of stroke.
2. Sequelae due to ischemic stroke that occurred in the previous 25-30
days.
ADMINISTRATION AND DOSAGE
IN ADULTS:
CYTOFLAVIN
®
is administered intravenously by drop infusion only. Prior to
administration, a
single dose of CYTOFLAVIN
®
(10 mL) must be diluted with 200 mL of 5 % glucose or 0.9 %
sodium chloride. Recommended infusion rate is 3 – 4 mL (60-80
drops/min).
1. In moderate acute ischemic stroke, CYTOFLAVIN
®
should be administered as early as
possible after the stroke onset at a single dose 10 mL at 8-12 h
intervals for 10 consecutive days.
2.
In
sequelae
due
to
ischemic
stroke
that
occurred
in
the
previous
25-30
days,
CYTOFLAVIN
®
is administered once a day at a single dose 10 mL and given for 10
consecutive
days.
CONTRAINDICATIONS
−
Known sensitization to any of the component of CYTOFLAVIN
®
,
−
Pregnancy,
−
Breastfeeding,
−
Childhood (age 0-18),
−
Not indicated to critically ill patients until the normalization of
central hemodynamic
parameters and/or if arterial oxygen partial pressure is below 60 mm
Hg.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The prepared solution of CYTOFLAVIN
®
is administered at infusion rate of 3-4 mL/min. If the
infusion rate is exceeded, adverse drug reactions th