KONAKION MM PAEDIATRIC 2 MG0.2 ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PHYTOMENADIONE

Available from:

TZAMAL BIO-PHARMA LTD

ATC code:

B02BA01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

PHYTOMENADIONE 10 MG/ML

Administration route:

I.M, I.V, PER OS

Prescription type:

Required

Manufactured by:

CHEPLAPHARM ARZNEIMITTEL GMBH, GERMANY

Therapeutic group:

PHYTOMENADIONE

Therapeutic area:

PHYTOMENADIONE

Therapeutic indications:

Prophylaxis and treatment of haemorrhoagic disease of the newborn.

Authorization date:

2022-04-30

Patient Information leaflet

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