Konakion MM

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Phytomenadione 10 mg/mL

Available from:

Pharmaco (NZ) Ltd

INN (International Name):

Phytomenadione 10 mg/mL

Dosage:

10 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Phytomenadione 10 mg/mL Excipient: Glycocholic acid Hydrochloric acid Lecithin Sodium hydroxide Water for injection

Units in package:

Ampoule, 1mL, 5 dose units

Class:

General sale

Prescription type:

General sale

Manufactured by:

DSM Nutritional Products Ltd

Product summary:

Package - Contents - Shelf Life: Ampoule, 1mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1993-10-12

Patient Information leaflet

Konakion
®
CMI 190109
1
CONSUMER MEDICINE INFORMATION
KONAKION
® MM AND KONAKION
® MM PAEDIATRIC
PHYTOMENADIONE (VITAMIN K
1
)
10MG IN 1ML MIXED MICELLE (MM) SOLUTION FOR INJECTION OR ORAL USE
2MG IN 0.2ML MIXED MICELLE (MM) PAEDIATRIC SOLUTION FOR INJECTION OR
ORAL USE
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about KONAKION.
It does not contain all the available information.
It does not take the place of talking to your doctor, midwife or
pharmacist.
All medicines have risks and benefits. You, your doctor, midwife or
pharmacist must weigh the risks of
you or your baby receiving KONAKION against the benefits expected for
you or your baby.
IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR, MIDWIFE
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT KONAKION IS USED FOR
KONAKION contains the active ingredient phytomenadione, which is also
called vitamin K
1
.
KONAKION belongs to a group of medicines called haemostatic agents,
meaning they assist with
blood clotting problems.
KONAKION is used to prevent or treat blood clotting problems and works
by reversing some of the
causes of excessive bleeding.
In adults, this risk of bleeding is usually caused by too much
medication which prevents blood clotting
(known as anticoagulants) such as warfarin (Coumadin
®
, Marevan
®
). The risk of bleeding can also be
caused by diseases that cause low levels of vitamin K such as
jaundice, liver or intestinal disorders, or
prolonged use of some antibiotics or salicylates (such as aspirin).
In newborn babies, KONAKION MM Paediatric is used to prevent and treat
bleeding due to low levels
of Vitamin K.
ASK YOUR DOCTOR, MIDWIFE OR PHARMACIST IF YOU HAVE ANY QUESTIONS WHY
YOU OR YOUR BABY
SHOULD OR SHOULD NOT USE KONAKION.
BEFORE YOU OR YOUR BABY TAKES KONAKION
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE KONAKION IF:
Konakion
®
CMI 190109
2
1.
YOU OR YOUR BABY HAS HAD AN ALLERGIC REACTION TO KONAKION,
PHYTOMENADIONE OR ANY OTHER
TYPE OF VITAMIN K, OR ANY INGREDI

Summary of Product characteristics

NEW ZEALAND DATA SHEET
KONAKION001
11 Jan 2019
Page 1 of 9
KONAKION® MM 10MG/ML SOLUTION FOR INJECTION
KONAKION® MM PAEDIATRIC 2MG/0.2ML SOLUTION FOR INJECTION
Phytomenadione
1 PRODUCT NAME
Konakion® MM 10mg/mL solution for injection
Konakion® MM paediatric 2mg/0.2mL solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Konakion MM _
Each Konakion MM amber glass ampoule contains 10 mg phytomenadione in
1 mL of clear bile
acid/lecithin mixed-micelle (MM) solution (filling volume 1.15 mL) for
oral or intravenous (IV)
administration.
_Konakion MM paediatric _
Each Konakion MM paediatric amber glass ampoule contains 2 mg of
phytomenadione in 0.2 mL of
clear bile acid/lecithin mixed-micelle (MM) solution (filling volume
0.3 mL) for oral or parenteral
administration.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Clear to slightly opalescent liquid, practically free from particles.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Haemorrhage or risk of haemorrhage as a result of severe
‘hypoprothrombinaemia’ (i.e. deficiency
of clotting factors II, VII, IX and X) of various aetiologies,
including overdosage of coumarin-type
anticoagulants, their combination with phenylbutazone, and other forms
of hypovitaminosis K (e.g.
in obstructive jaundice as well as liver and intestinal disorders, and
after prolonged treatment with
antibiotics, sulphonamides or salicylates).
Prophylaxis and treatment of haemorrhagic disease in the newborn.
4.2
DOSE AND METHOD OF ADMINISTRATION
_ADULTS _
_STANDARD DOSAGE _
_Severe or life-threatening haemorrhage e.g.: during anticoagulant
therapy _
The coumarin anticoagulant should be withdrawn and an IV injection of
Konakion MM given slowly
(in at least 30 seconds) in a dose of 5-10 mg together with fresh
frozen plasma (FFP) or prothrombin
complex concentrate (PCC). The dose of vitamin K
1
can be repeated as needed.
NEW ZEALAND DATA SHEET
KONAKION001
11 Jan 2019
Page 2 of 9
_ _
_Dose recommendations for vitamin K_
_1 _
_therapy in patients with major and