KONAKION MM INJECTION 10 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

PHYTOMENADIONE

Available from:

ROCHE SINGAPORE PTE. LTD.

ATC code:

B02BA01

Dosage:

10 mg/ml

Pharmaceutical form:

INJECTION

Composition:

PHYTOMENADIONE 10 mg/ml

Administration route:

INTRAVENOUS

Prescription type:

General Sale List

Manufactured by:

CENEXI SAS

Authorization status:

ACTIVE

Authorization date:

1996-01-27

Summary of Product characteristics

10_1-INF-KON-2018 12
C
OMPOSITION
Phytomenadione: synthetic vitamin K
1
.
P
ROPERTIES
, EFFECTS
Vitamin K
1
, the active ingredient of Konakion, is a coagulation-promoting
factor. As a component of a liver carboxylate system, it is involved
in the
carboxylation of the coagulation factors II (prothrombin), VII, IX and
X and of
the coagulation inhibitors protein C and protein S in the
postribosomal phase.
Anticoagulants of the dicoumarol type inhibit reduction of vitamin K
1
(quinone
form) to vitamin K
1
hydroquinone and also prevent the vitamin K
1
epoxide
which arises after the carboxylation reaction from being reduced to
the quinone
form.
Konakion is thus an antagonist of Marcoumar™ and similar
anticoagulants. It
does not, however, inhibit the action of heparin Liquemin™; for this
purpose
Protamine should be used.
In the mixed-micelles solution, vitamin K
1
is solubilized by means of a micelle
colloidal system consisting of lecithin and bile acid, based on a
physiological
principle also found in the human body. Owing to the absence of
organic
solvents, venous tolerance to Konakion mixed-micelle solution is good.
I
NDICATIONS
Hemorrhage
or
threatened
hemorrhage
as
a
result
of
severe
‘hypoprothrombinemia’ (i.e. deficiency of coagulation factors II,
VII, IX and X)
due, for instance, to overdosage of anticoagulants of the dicoumarol
type or their
combination with phenylbutazone, or to other forms of hypovitaminosis
K (e.g.
obstructive jaundice, liver and intestinal disorders, prolonged
administration of
antibiotics, sulfonamides or salicylates).
Hermorrhage in the newborn: prophylaxis and therapy.
_ _
_ _
D
OSAGE
Konakion MM ampoules are for i.v. injection or oral use.
The ampoule solution should not be mixed with other parenteral
medications,
but may be injected, where appropriate, into the lower part of the
infusion set.
Mild hemorrhage or
_tendency to hemorrhage_
: 5 – 10 drops of Konakion. A
second, possibly larger, dose should be given if there is no effect
within eight to
twelve hours.
_In general, t