KONAKION MM PAEDIATRIC INJECTION 2 mg0.2 ml

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

PHYTOMENADIONE

Disponibil de la:

ROCHE SINGAPORE PTE. LTD.

Codul ATC:

B02BA01

Dozare:

2 mg/0.2 ml

Forma farmaceutică:

INJECTION

Compoziție:

PHYTOMENADIONE 2 mg/0.2 ml

Calea de administrare:

INTRAVENOUS, INTRAMUSCULAR

Tip de prescriptie medicala:

General Sale List

Produs de:

CENEXI SAS

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

1997-07-23

Prospect

1
10126188 FE FY 1012.1072
KONAKION
®
 MM
2MG/0.2ML 
PAEDIATRIC
Phytomenadione
COMPOSITION
_Active ingredient: _phytomenadione (synthetic 
vitamin K
1
).
One amber glass ampoule contains 0.2 ml of a 
clear mixed-micelle solution of 2 mg vitamin 
K
1
 ( lling volume 0.3 ml) for oral or parenteral 
administration.
_Excipients_: glycocholic acid, sodium 
hydroxide, lecithin, hydrochloric acid, water 
for injection.
PROPERTIES AND EFFECTS
The presence of vitamin K
1
, the active 
ingredient of Konakion MM paediatric, is 
essential for the formation of prothrombin, 
factors VII, IX and X, and the coagulation 
inhibitors protein C and protein S in the body.
Vitamin K
1
 does not readily cross the placental 
barrier from mother to child and is poorly 
excreted in breast milk.
Lack of vitamin K
1
 leads to an increased 
tendency to hemorrhagic disease in the 
newborn. Vitamin K
1
 administration, which 
promotes synthesis of the above-mentioned 
coagulation factors by the liver, can reverse an 
abnormal coagulation status and bleeding due 
to vitamin K
1
 de ciency.
PHARMACOKINETICS
In the mixed-micelle solution, vitamin K
1
 is 
solubilized by means of a physiological 
colloidal system consisting of lecithin and bile 
acid.
_Absorption_
Vitamin K
1
 is absorbed from the small 
intestine. Absorption is limited in the absence 
of bile.
_Distribution_
Vitamin K
1
 accumulates predominantly in the 
liver. It is up to 90% bound to lipoproteins in 
the plasma and is stored in the body only for 
short periods of time.
_Metabolism_
Vitamin K
1
 is converted to more polar 
metabolites, such as phytomenadione-2,3-
epoxide.
_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.
INDICATIONS AND USAGE
_Documented indications_
Prophylaxis and treatment of haemorrhagic 
disease of the newborn.
DOSAGE AND ADMINISTRATION
_Prophylaxis_
For all healthy neonates:
2 mg oral

Caracteristicilor produsului

1
2-02-INF-KON-2018 08
KONAKION® MM
2 MG/ 0.2 ML
PAEDIATRIC
Phytomenadione
_______________________________________
C
OMPOSITION
_Active _
_ingredient_
:
phytomenadione
(synthetic
vitamin K
1
).
One amber glass ampoule contains 0.2 ml of a
clear mixed-micelle solution of 2 mg vitamin K
1
(filling
volume
0.3
ml)
for
oral
or
parenteral
administration.
_Excipients_
: glycocholic acid, sodium hydroxide,
lecithin, hydrochloric acid, water for injection.
P
ROPERTIES
, EFFECTS
The presence of vitamin K
1
, the active ingredient
of Konakion MM paediatric, is essential for the
formation of prothrombin, factors VII, IX and X,
and
the
coagulation
inhibitors
protein
C
and
protein S in the body.
Vitamin K
1
does not readily cross the placental
barrier
from
mother
to
child
and
is
poorly
excreted in breast milk.
Lack of vitamin K
1
leads to an increased tendency
to hemorrhagic disease in the newborn. Vitamin
K
1
administration, which promotes synthesis of
the above-mentioned coagulation factors by the
liver, can reverse an abnormal coagulation status
and bleeding due to vitamin K
1
deficiency.
_ _
I
NDICATIONS AND
U
SAGE
_Documented indications _
Prophylaxis
and
treatment
of
haemorrhagic
disease of the newborn.
D
OSAGE AND
A
DMINISTRATION
_Prophylaxis _
For all healthy neonates of 36 weeks gestation and
older:
1 mg administered by intramuscular injection at
birth or soon after birth or
2 mg orally at birth or soon after birth; the oral
dose should be followed by a further dose of 2 mg
at four to seven days of age. A further 2 mg oral
dose
should
be
given
1
month
after
birth.
In
exclusively formula-fed infants the third oral dose
can be omitted.
A single 1 mg (0.1 ml) dose intramuscularly is
recommended in children who are not assured of
receiving a second oral dose or, in the case of
breast-fed
children,
who
are
not
assured
of
receiving a third oral dose.
Preterm neonates of less than 36 weeks gestation,
weighing 2.5 kg or greater, and term neonates at
special
risk
(e.g.
prematurity,
birth
asphyxia,
obstructive
jaundice,
inabil