KONAKION MM PAEDIATRIC phytomenadione 2 mg/0.2 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:

Injection, solution

Composition:

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

Administration route:

Intravenous, Intramuscular, Oral

Units in package:

5 x 0.2mL ampoules

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Prophylaxis and treatment of haemorrhagic disease of the newborn. INDICATIONS AS AT 18 OCTOBER 2000: Prophylaxis and treatment of vitamin K deficiency bleeding (VKDB).

Product summary:

Visual Identification: Clear to slightly opalescent liquid, practically free from visible particles.; 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:

2000-02-07

Patient Information leaflet

KONAKION
®
MM PAEDIATRIC
1
KONAKION
® MM
PAEDIATRIC
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
Paediatric.
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 your baby receiving
KONAKION MM Paediatric against
the benefits they expect it will have
for them.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR BABY RECEIVING THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT KONAKION MM
PAEDIATRIC IS USED FOR
KONAKION MM Paediatric
contains the active ingredient
phytomenadione.
KONAKION MM Paediatric is used
to treat blood clotting problems.
KONAKION MM Paediatric belongs
to a group of medicines called
Vitamin K.
Vitamin K is used to prevent and
treat Vitamin K Deficiency Bleeding
(VKDB). This is when the newborn
or older babies bleed excessively as
the blood clotting system is not fully
developed. Vitamin K works by
reversing some of the causes of
excessive bleeding.
There are many different types of
medicines used to treat bleeding
disorders. KONAKION MM
Paediatric belongs to one of these
groups.
Your doctor, however, may have
prescribed KONAKION MM
Paediatric for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY KONAKION
MM PAEDIATRIC HAS BEEN
PRESCRIBED FOR YOUR BABY.
BEFORE KONAKION
MM PAEDIATRIC IS GIVEN
_WHEN YOUR BABY MUST NOT _
_HAVE IT _
DO NOT USE KONAKION MM
PAEDIATRIC IF:
1.
YOUR BABY HAS HAD AN ALLERGIC
REACTION TO KONAKION MM
PAEDIATRIC, ANY OTHER TYPE OF
VITAMIN K OR ANY INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
2.
THE AMPOULE IS DAMAGED OR
SHOWS SIGNS OF TAMPERING.
3.
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED.
If you use this medicine after the
expiry date has passed it may not
work as well.
4.
THE SOLUTION IS CLOUDY

Summary of Product characteristics

2019-09 v1.0
1
AUSTRALIAN PRODUCT INFORMATION – KONAKION
® MM
PAEDIATRIC (PHYTOMENADIONE (VITAMIN K
1
)) SOLUTION
1
NAME OF THE MEDICINE
Phytomenadione (Vitamin K
1
)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Konakion
®
MM Paediatric 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 2 mg/0.2 mL
in a mixed
micelles (MM) solution (the micelles are composed of glycocholic acid
and lecithin in an
aqueous solution). The formulation is available in two volumes,
phytomenadione
10 mg/1 mL (adult) and 2 mg/0.2 mL (paediatric).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Injection, solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prophylaxis and treatment of vitamin K deficiency bleeding (VKDB).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Konakion MM Paediatric may be given by intramuscular, oral or
intravenous routes. Care
should be taken to ensure the correct dose is given for the chosen
route of administration.
PROPHYLAXIS
_ALL HEALTHY NEONATES _
1 mg (0.1 mL) IM at birth is recommended.
Alternatively, 2 mg (0.2 mL) orally at birth, at the time of newborn
screening (3-5 days of
age) and at 4 weeks.
For predominately formula fed neonates the last oral dose may be
omitted.
2019-09 v1.0
2
_NEONATES WITH SPECIAL RISK FACTORS _
1 mg IM at birth is recommended in neonates with special risk factors.
If the neonate has
special risk factors and weighs less than 1.5 kg, then 0.5 mg (0.05
mL) is recommended (see
Section 4.4 Special warnings and precautions for use).
_The size and frequency of further doses should be based on clinical
groun