Konakion MM Paediatric Ampoules 2 mg/ 0.2 ml oral solution or solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phytomenadione

Available from:

CHEPLAPHARM Arzneimittel GmbH

ATC code:

B02BA; B02BA01

INN (International Name):

Phytomenadione

Dosage:

2/0.2 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:

1995-04-20

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KONAKION MM PAEDIATRIC AMPOULES 2 MG/0.2 ML
ORAL SOLUTION OR SOLUTION FOR INJECTION
Phytomenadione (vitamin K
1
)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR BABY OR CHILD IS GIVEN
THIS MEDICINE, OR BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask the doctor, nurse or midwife.
•
This medicine has been prescribed for you or your child 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 or your child get any side effects, talk to your doctor, nurse
or midwife. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Konakion MM Paediatric is and what it is used for
2. What you need to know before you or your child is given Konakion MM
Paediatric
3. How Konakion MM Paediatric is given
4. Possible side effects
5. How to store Konakion MM Paediatric
6. Contents of the pack and other information
1.
WHAT KONAKION MM PAEDIATRIC IS AND WHAT IT IS USED FOR
Konakion MM Paediatric contains a medicine called phytomenadione. This
is a man-made vitamin called
vitamin K
1
. Konakion MM Paediatric is most commonly used for the following:
•
Babies who do not have enough vitamin K in their bodies. Giving
Konakion MM Paediatric
PREVENTS
and
TREATS
bleeding caused by a lack of vitamin K. This is called ‘vitamin K
deficiency bleeding’
(VKDB). This is a serious, but rare condition. All newborn babies are
given vitamin K
1
with their
parent’s permission.
Konakion MM Paediatric may also be used in adults and older children
when small amounts of vitamin K
are required, for the following:
•
To prevent and treat 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 Paediatric

Summary of Product characteristics

Health Products Regulatory Authority
10 October 2023
CRN00DR1D
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Konakion MM Paediatric Ampoules 2 mg/ 0.2 ml oral solution or solution
for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 2 mg phytomenadione in 0.2 ml.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution or solution for injection.
A clear to slightly opalescent pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Konakion MM Paediatric is indicated for the prophylaxis and treatment
of vitamin K deficiency bleeding (VKDB) in neonates
and infants.
Konakion MM Paediatric is further indicated for the treatment of
overdoses with anticoagulants of the coumarin type in adults
and older children (1 to 18 years) where small quantities of vitamin K
are required. This may also include the treatment of
haemorrhage or threatened haemorrhage, associated with a low blood
level of prothrombin or factor VII.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
PREVENTION AND TREATMENT OF VITAMIN K DEFICIENCY BLEEDING (VKDB) IN
NEONATES AND INFANTS
_ _
_PROPHYLAXIS OF VITAMIN K DEFICIENCY BLEEDING _
_Healthyneonates of 36 weeks gestation and older: _Either:
- 1 mg administered by intramuscular injection at birth or soon after
birth or
- 2 mg orally at birth or soon after birth. The oral dose should be
followed by a further dose of 2 mg at 4 - 7 days of age. A
further 2 mg oral dose should be given at 1 month after birth. In
exclusively formula fed infants the third oral dose can be
omitted.
_Preterm neonates of less than 36 weeks gestation weighing 2.5 kg or
greater, and term neonates at special risk (e.g. prematurity, _
_birth asphyxia, obstructive jaundice, inability to swallow, maternal
use of anticoagulants or antiepileptics)_:
1 mg by intramuscular or intravenous injection at birth or soon after
birth. The amount and frequency of further doses should
be based on coagulation status.
_Preterm neonates of less than 36 wee