Konakion MM paediatric solution for injection/oral

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

phytomenadione

Available from:

F. Hoffmann-La Roche Ltd.

ATC code:

B02BA01

INN (International Name):

phytomenadione

Dosage:

2mg/0,2ml

Pharmaceutical form:

solution for injection/oral

Units in package:

(5) ampoules 0,2ml and dispenser

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-09-09

Patient Information leaflet

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
(filling 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
deficiency.
INDICATIONS AND USAGE
_Documented indications_
Prophylaxis and treatment of hemorrhagic disease of the newborn. DOSAGE AND ADMINISTRATION
_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 breastfed
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, inability
to swallow, maternal use of anticoagulants or antiepileptics): 1 mg
intramu

Summary of Product characteristics

October 2018
Product Information (FE)
Konakion MM 2 mg/0.2 ml paediatric
1
SUMMARY OF PRODUCT CHARACTERISTICS
KONAKION
® MM 2MG/0.2ML PAEDIATRIC
Phytomenadione
1.
NAME OF THE MEDICINAL PRODUCT
Konakion
®
MM 2mg/0.2ml paediatric
2.
QUALITATIVE AND QUANTITATIVE 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
(filling volume 0.3 ml) for oral or parenteral administration.
For a full list of excipients, see 6.1
3.
PHARMACEUTICAL FORM
Solution of 2 mg vitamin K
1
in ampules (filling volume 0.3 ml) for oral or parenteral
administration.
4.
CLINICAL PARTICULARS
_4.1_
_ _
THERAPEUTIC INDICATIONS
Prophylaxis and treatment of hemorrhagic disease of the newborn.
_4.2_
_ _
POSOLOGY AND METHOD OF ADMINISTRATION
_4.2.1 POSOLOGY _
_ _
_Prophylaxis _
For all healthy neonates of 36 weeks gestation and older:
1 mg administered by intramuscular injection at birth or soon after
birth
or
October 2018
Product Information (FE)
Konakion MM 2 mg/0.2 ml paediatric
2
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 breastfed
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, inability to
swallow, maternal use of anticoagulants or antiepileptics): 1 mg
intramuscularly or
intravenously at birth or soon after birth. The amount and frequency
of further doses
should be based on coagulation status.
Preterm neonates of less than 36 weeks gestation, weighing less than
2.5 kg: 0.4 mg/kg
(equivalent to 0