Konakion MM paediatric

Country: Armenia

Bahasa: Inggeris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

phytomenadione

Boleh didapati daripada:

F. Hoffmann-La Roche Ltd.

INN (Nama Antarabangsa):

phytomenadione

Dos:

2mg/0,2ml

Borang farmaseutikal:

solution for injection/oral

Jenis preskripsi:

Prescription

Risalah maklumat

10178705 FE FY
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)

Ciri produk

Summary of Product Characteristics
Konakion MM 2 mg/0.2 ml paediatric
1
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.
Summary of Product Characteristics
Konakion MM 2 mg/0.2 ml paediatric
2
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 (