Konakion MM Ampoules 10 mg/ml Solution for Injection and Oral Solution

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Phytomenadione

MAH:

CHEPLAPHARM Arzneimittel GmbH

ATC_code:

B02BA; B02BA01

INN:

Phytomenadione

dosage:

10 milligram(s)/millilitre

pharmaceutical_form:

Solution for injection

prescription_type:

Product subject to prescription which may not be renewed (A)

therapeutic_area:

Vitamin K; phytomenadione

authorization_status:

Marketed

authorization_date:

1990-04-06

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KONAKION MM AMPOULES 10 MG/ML
SOLUTION FOR INJECTION AND ORAL SOLUTION
Phytomenadione (vitamin K
1
)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects talk to your doctor or nurse. This
includes any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Konakion MM is and what it is used for
2. What you need to know before you are given Konakion MM
3. How Konakion MM is given
4. Possible side effects
5. How to store Konakion MM
6. Contents of the pack and other information
1.
WHAT KONAKION MM IS AND WHAT IT IS USED FOR
Konakion MM contains a medicine called phytomenadione. This is a
man-made vitamin called vitamin K
1
.
Konakion MM is used for the following:
•
To prevent and treat severe bleeding after the use of certain
medicines to thin the blood (called
anticoagulants).
•
To treat children aged 1 year and older normally after advice from a
specialist haematologist (blood
doctor).
Konakion MM works by helping your body make blood clotting factors.
These blood clotting factors help
stop bleeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KONAKION MM
YOU MUST NOT BE GIVEN KONAKION MM IF YOU ARE ALLERGIC (HYPERSENSITIVE)
TO
PHYTOMENADIONE
or any of
the other ingredients of Konakion MM (listed in Section 6: Further
information).
If you are not sure if this applies to you, talk to your doctor or
nurse before having Konakion.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before having Konakion MM if:
•
You have severe problems with your liver.
•
You have an artificial heart valve.
OTHER MEDICINES AND KONAKION MM
Tell your doctor or nurse i

SPC

Health Products Regulatory Authority
10 October 2023
CRN00DR1D
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Konakion MM Ampoules 10 mg/ml Solution for Injection and Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 10 mg vitamin K1 (phytomenadione) per 1 ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection and oral solution.
The solution is clear to slightly opalescent, pale yellow in colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Konakion is indicated in the treatment of haemorrhage or threatened
haemorrhage associated with a low blood level of
prothrombin or factor VII. The main indication is:
As an antidote to anticoagulant drugs of the coumarin type.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Konakion MM ampoules are for intravenous injection or oral use. The
ampoule solution should not be diluted or mixed with
other parenteral medicines, but may be injected, where appropriate,
into the lower part of the infusion set (via Y-site or 3-way
tap), during continuous infusion of sodium chloride 0.9% or 5%
dextrose.
The dosage recommendations detailed in the tables below are provided
for therapeutic guidance only.
The dose selection for a specific patient should be based not only on
the INR value, but various other risk factors and clinical
determinants such as patient characteristics, comorbid conditions and
concomitant medications should also be appropriately
considered. Hence the actual dose selection should be at the
discretion of the treating physician.
_ADULTS: AS AN ANTIDOTE TO ANTICOAGULANT DRUGS_
Severe or life-threatening haemorrhage, e.g. during anticoagulant
therapy: The coumarin anticoagulant should be withdrawn
and an intravenous injection of Konakion MM given slowly in a dose of
5-10 mg together with fresh frozen plasma (FFP) or
prothrombin complex concentrate (PCC). The dose of vitamin K1can be
repeated as needed. The prothrombin level should be
estimated three hours later and, if the