KONAKION MM PAEDIATRIC 2 MG0.2 ML

Israel - English - Ministry of Health

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Active ingredient:
PHYTOMENADIONE
Available from:
TZAMAL BIO-PHARMA LTD
ATC code:
B02BA01
Pharmaceutical form:
SOLUTION
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 number:
105 47 28944 00
Authorization date:
2012-04-30

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

in plasma

is about 1.5 to 3 hours. Vitamin K

excreted in the bile and urine as

glucuronide and sulphate conjugates.

The half-life of vitamin K

in plasma is about

70 hours. Vitamin K

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

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

compared to oral

administration (139 ng/ml vs. 1.4

ng/ml).

[…]

Infants with cholestatic liver disease

[…]

Median serum vitamin K

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

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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