KONAKION MM phytomenadione 10 mg/1 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phytomenadione, Quantity: 10 mg/mL

Available from:

Pharmaco Australia Ltd

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: hydrochloric acid; glycocholic acid; water for injections; lecithin; sodium hydroxide

Administration route:

Intravenous, Oral

Units in package:

5 x 1mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Haemorrhage or threatened haemorrhage as a result of severe "hypo-prothrombinaemia" (i.e. deficiency of coagulation factors II, VII, IX and X) due, for instance, to overdosage of anticoagulants of the dicoumarol type, or to other forms of hypovitaminosis K (e.g. obstructive jaundice, liver and intestinal disorders or prolonged administration of antibiotics, sulfonamides or salicylates).

Product summary:

Visual Identification: Clear to slightly opalescent liquid; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1997-10-08

Patient Information leaflet

KONAKION MM
®
1
KONAKION
® MM
_PRONOUNCED KOE-NAK-EE-ON _
_contains the active ingredient phytomenadione (also called Vitamin
K1) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about KONAKION MM.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you receiving
KONAKION MM against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT KONAKION MM
IS USED FOR
KONAKION MM contains the active
ingredient phytomenadione.
KONAKION MM is used to treat
excessive bleeding problems.
KONAKION MM belongs to a group
of medicines called Vitamin K.
Vitamin K substances are used to
treat excessive bleeding problems
and work by reversing some of the
causes of excessive bleeding. This
risk of bleeding is usually caused by
the use of too much medication to
prevent blood clots (also known as
anticoagulant medication).
There are many different types of
medicines used to treat bleeding
disorders. KONAKION MM
belongs to one of these groups.
Your doctor, however, may have
prescribed KONAKION MM for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY KONAKION
MM HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU RECEIVE
KONAKION MM
_WHEN YOU MUST NOT HAVE IT _
DO NOT HAVE KONAKION MM IF:
1.
YOU HAVE HAD AN ALLERGIC
REACTION TO KONAKION MM,
ANY OTHER TYPE OF VITAMIN K OR
ANY INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Some symptoms of an allergic
reaction may include:
•
Shortness of breath
•
Wheezing or difficulty
breathing
•
Swelling of the face, lips,
tongue, or other parts of the
body
•
Rash, itching or hives on the
skinIf you use this medicine
after the expiry date has
passed it may not work as
well
2.
YOU ARE PREGNANT OR PLAN TO
BECOME PREGNANT.
3.
THE AMPOULE IS DAMAGED OR
SHO

Summary of Product characteristics

2020-09 v2.0
1
AUSTRALIAN PRODUCT INFORMATION – KONAKION
® MM
(PHYTOMENADIONE (VITAMIN K
1
)) SOLUTION
1
NAME OF THE MEDICINE
Phytomenadione (Vitamin K
1
)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
KONAKION MM contains as the active ingredient phytomenadione (Vitamin
K
1
) which is 2-
methyl-3-phytyl-1,4-naphthaquinone. Phytomenadione is a clear, yellow,
very viscous,
odourless or nearly odourless oil with a molecular weight of 450.7. It
is insoluble in water,
soluble 1 in 70 in alcohol, more soluble in dehydrated alcohol;
soluble in benzene,
chloroform, ether and vegetable oils. It is stable in air but
decomposes on exposure to light.
The ampoule contains the active ingredient phytomenadione 10 mg/1 mL
in a mixed micelles
(MM) solution (the micelles are composed of glycocholic acid and
lecithin in an aqueous
solution).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Haemorrhage or threatened haemorrhage as a result of severe
"hypoprothrombinaemia" (i.e.
deficiency of coagulation factors II, VII, IX and X) due, for
instance, to overdosage of
anticoagulants of the dicoumarol type, or to other forms of
hypovitaminosis K (e.g.
obstructive jaundice, liver and intestinal disorders, or prolonged
administration of antibiotics,
sulfonamides or salicylates).
4.2
D
OSE AND METHOD OF ADMINISTRATION
KONAKION MM ampoules are for IV injection or oral use.
For important information about the expiry, refer to Section 6.3 Shelf
life.
Slow IV injection must be reserved for potentially fatal haemorrhage
due to overdosage of
anticoagulants of the coumarin and indandione series. There is
currently no data to advise on
the appropriate vitamin K
1
dosage in the event of an indandione overdose.
Excessive doses of KONAKION MM impede the resumption of anticoagulant
therapy
without offering any advantages.
2020-09 v2.0
2
If there is a recurrence of thrombosis while KONAKION MM is being
used, IV
administration of heparin is recommend