KONAKION MM PAEDIATRIC 2 MG0.2 ML
देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
सूचना पत्रक
(PIL)
05-02-2017
उत्पाद विशेषताएं
(SPC)
19-09-2022
सार्वजनिक आकलन रिपोर्ट
(PAR)
19-09-2022
सक्रिय संघटक:
PHYTOMENADIONE
थमां उपलब्ध:
TZAMAL BIO-PHARMA LTD
ए.टी.सी कोड:
B02BA01
फार्मास्यूटिकल फॉर्म:
SOLUTION FOR INJECTION
रचना:
PHYTOMENADIONE 10 MG/ML
प्रशासन का मार्ग:
I.M, I.V, PER OS
प्रिस्क्रिप्शन प्रकार:
Required
द्वारा बनाया गया:
CHEPLAPHARM ARZNEIMITTEL GMBH, GERMANY
चिकित्सीय समूह:
PHYTOMENADIONE
चिकित्सीय क्षेत्र:
PHYTOMENADIONE
चिकित्सीय संकेत:
Prophylaxis and treatment of haemorrhoagic disease of the newborn.
प्राधिकरण की तारीख:
2022-04-30
सूचना पत्रक
ךיראת
:
2016
-
SEP
-
9
2 :םושירה רפסמו תילגנאב רישכתה םש
KONAKION MM PAEDIATRIC 2MG/0.2ML (01.5.952.7..511)
םושירה לעב םש :
ROCHE PHARMACEUTICALS (ISRAEL) LTD
! דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
PRECAUTIONS
Parenteral administration may be
associated with an increased risk of
kernicterus in premature infants
weighing less than 2.5 kg.
At the time of use, the mixed-micelle ampoule
solution must be clear in appearance. Parenteral
administration may be associated with an
increased risk of kernicterus in premature
infants weighing less than 2.5 kg.
PHARMACOKINETICS/
ELIMINATION
The half-life of vitamin K
1
in plasma
is about 1.5 to 3 hours. Vitamin K
1
is
excreted in the bile and urine as
glucuronide and sulphate conjugates.
The half-life of vitamin K
1
in plasma is about
70 hours. Vitamin K
1
is excreted in the bile
and urine as glucuronide and sulphate
conjugates.
PHARMACOKINETIC OF
ORAL VS. IV MIXED
MICELLAR VITAMIN K
PROPHYLAXIS IN
SPECIAL POPULATIONS
Infants with cholestatic liver disease
[…]
Median serum vitamin K
1
concentrations were similar in the oral
and intravenous groups at baseline
(0.92 vs. 1.15 ng/ml) rising to
approximately 10 times higher
concentrations six hours after
intravenous K
1
compared to oral
administration (139 ng/ml vs. 1.4
ng/ml).
[…]
Infants with cholestatic liver disease
[…]
Median serum vitamin K
1
concentrations were
similar in the oral and intravenous groups at
baseline (0.92 vs. 1.15 ng/ml) rising to
approximately 100 times higher concentrations
six hours after intravenous K
1
compared to
oral administration (139 ng/ml vs. 1.4 ng/ml).
[…] תושקובמה תורמחהה תונמוסמ ובש ,ןולעה
ב"צמ
בוהצ עקר לע
5
ונמוס תורמחה רדגב םניאש םייוניש
)ןולעב(
.טסקטה םוקימב םייוניש אלו יתוהמ ןכות
קר ןמסל שי .הנוש עבצב
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