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KONAKION MM PAEDIATRIC 2MG/0.2ML SOLUTION FOR INJECTION OR ORAL ADMINISTRATION

Active substance(s): PHYTOMENADIONE / PHYTOMENADIONE / PHYTOMENADIONE

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This information is intended for medical or healthcare professionals only:
The tear-off portion above is intended for the patient

Patient Information Leaflet

INFORMATION FOR HEALTHCARE PROFESSIONALS

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

®

Konakion MM
Paediatric 2mg/0.2ml
solution for injection or oral administration
Phytomenadione (vitamin K1)

(phytomenadione/vitamin K1)

Please refer to the Summary of Product Characteristics for full prescribing information

Please read all of this leaflet carefully before
your baby or child is given this medicine.
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 your
child. Do not pass it on to others. It may harm
them even if their symptoms are the same.
If any of the side effects become serious or
troublesome, or if you notice any side effects
not listed in this leaflet, please tell the doctor,
nurse or midwife.
The name of your medicine is ‘Konakion® MM
Paediatric 2mg/0.2ml solution for injection or oral
administration’ but will be referred to as Konakion
MM Paediatric throughout this leaflet.
In this leaflet:
1. What Konakion MM Paediatric is and what it
is used for
2. Before your baby or child is given Konakion
MM Paediatric
3. How Konakion MM Paediatric is given
4. Possible side effects
5. How Konakion MM Paediatric is stored
6. Further 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 K1. Konakion MM
Paediatric is 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 K1 with their
parent’s permission.
Babies and young children who may have
had too much of certain medicines to thin
their blood (called anticoagulants). Konakion
MM Paediatric is normally used to treat these
children after advice from a specialist
haematologist (blood doctor).
Konakion MM Paediatric works by helping your
body make blood clotting factors. These blood
clotting factors help stop bleeding.
2. Before your baby or child is given
Konakion MM Paediatric
Your child must not be given Konakion MM
Paediatric if they are allergic (hypersensitive)
to:
Phytomenadione or any of the other
ingredients of Konakion MM Paediatric (listed
in Section 6: Further information).
If you are not sure if this applies to your child, talk
to the doctor, nurse or midwife before they are
given Konakion MM Paediatric.
Take special care with Konakion MM
Paediatric
Check with your doctor, nurse or midwife before
your child has Konakion if:
They have a problem with the flow of bile in
their body (cholestatic disease). Bile is
important in helping the body to use some
vitamins.
Taking other medicines
Please tell your doctor, nurse or midwife if your
child is taking or has recently taken any other
medicines. This includes medicines that you buy
without a prescription and herbal medicines.
This is because Konakion MM Paediatric can
affect the way some medicines work. Also some
other medicines may affect the way Konakion
MM Paediatric works.
In particular, tell your doctor, nurse or midwife if
your baby or child is taking medicines to stop
their blood clotting (anticoagulants).
Important information about some of the
ingredients of Konakion MM Paediatric
Konakion MM Paediatric is essentially ‘sodium
free’ as it contains less than 1millimole sodium
(2.64mg in each millilitre).

3. How Konakion MM Paediatric is
given
Konakion MM Paediatric can be given to your
child by injection into a vein or muscle or by
mouth (orally). How it is given will depend upon
what the medicine is being used for and whether
your baby was born prematurely. The doctor will
decide how much Konakion MM Paediatric your
child needs.
Prevention of vitamin K
deficiency bleeding
Healthy babies delivered at or nearly full term
These babies will be given either:
A single injection (1mg) either at birth or soon
after, or
By mouth (oral) a first dose (2mg) at birth or
soon after. This is followed by a second 2mg
dose after 4 to 7 days and third 2mg dose at
1 month. In exclusively formula fed infants
the third oral dose can be omitted.
Premature babies or full term babies at
special risk of bleeding
These babies will be given Konakion MM
Paediatric as an injection at birth or soon
after.
More injections may be given later if your
baby is still at risk of bleeding.
Further doses:
Babies who are given vitamin K by mouth
and who are breast-fed (not given formula
milk) may need more doses of vitamin K by
mouth.
Bottle-fed babies given the two doses of
vitamin K by mouth may not need any more
doses of vitamin K. This is because it is
included in formula milk.
The instructions ‘How to give your baby Konakion
MM Paediatric by mouth’ are given later in this
section (section 3).
Treatment of vitamin K
deficiency bleeding (VKDB)
These babies will be given Konakion MM
Paediatric as an injection (usually 1mg).
More injections may be given later if your
baby is still at risk of bleeding. Some babies
may also need a blood transfusion.
Treatment of too much
blood thinning medicine
Treatment of children who have had too much
blood thinning medicine is usually decided by a
haematologist (blood doctor).
Konakion MM Paediatric will be given by
injection into one of your child’s veins
(IV injection).
The doctor will usually check your child’s
blood for the levels of clotting factors. This
check will be made 2 to 6 hours after giving
Konakion MM Paediatric.
If your child still does not have enough blood
clotting factors, the doctor may give
additional doses of Konakion MM Paediatric.
How to give your baby Konakion MM
Paediatric by mouth
If your baby was given Konakion MM Paediatric
by mouth at birth, you will be asked to give your
baby another 2mg dose. You will give them this
by mouth 4 to 7 days after birth.
If your baby is having breast milk and no formula
milk you may be asked to give your baby 2mg
doses once a month (by mouth).
The pictures in this leaflet show you how to give
the doses to your baby by mouth, using the
dispenser provided in the pack. If you are not
sure, or have any worries about doing this talk to
your health visitor, midwife, doctor or pharmacist.
1. Ampoule and
dispenser

2. To open the ampoule

Presentation

Picture 1

Picture 2
Please turn over

Presentation
Amber glass ampoules containing 0.2ml solution.
The solution is clear to slightly opalescent and
pale yellow in colour. Excipients are glycocholic
acid, lecithin, sodium hydroxide, hydrochloric acid
and water for injections. Konakion MM Paediatric
2mg/ 0.2ml is essentially ‘sodium free’ as it
contains less than 1mmol sodium (2.64mg per
1ml). Cartons of 5 ampoules.
PACKS CONTAIN PLASTIC ORAL
DISPENSERS. NOT TO BE USED FOR
INJECTIONS.
Posology and method of administration
Konakion MM Paediatric 2mg/ 0.2ml is for either
injection (intravenous or intramuscular) or oral
administration.
CAUTION: care is required when calculating
and measuring the dose in relation to the
baby’s weight (10 times dosing errors are
common).
Prophylaxis of vitamin K deficiency bleeding
(VKDB)
Healthy neonates of 36 weeks gestation and
older:
Either:
1mg administered by intramuscular injection
at birth or soon after birth
or
2mg orally at birth or soon after birth. The
oral dose should be followed by a further
dose of 2mg at 4-7 days of age. A further
2mg 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 2.5kg or greater, and term
neonates at special risk (e.g. prematurity,
birth asphyxia, obstructive jaundice, inability
to swallow, maternal use of anticoagulants or
anti-epileptics):
1mg IM or IV 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 weeks
gestation weighing less than 2.5kg: 0.4mg/kg
(equivalent to 0.04ml/kg) IM or IV at birth or soon
after birth. This parenteral dose should not be
exceeded. The amount and frequency of further
doses should be based on coagulation status.
There is evidence that oral prophylaxis is
insufficient in patients with underlying cholestatic
liver disease and malabsorption.
CAUTION: care is required when calculating and
measuring the dose in relation to the baby’s
weight (10 times dosing errors are common).
Dosing information for preterm babies at birth
for the prophylaxis of Vitamin K deficiency
bleeding
Weight of the Dose of vitamin Injection
baby
K at birth
volume
1kg
0.4mg
0.04ml
1.5kg
0.6mg
0.06ml
2kg
0.8mg
0.08ml
2.5kg
1mg
0.1ml
Over 2.5kg
1mg
0.1ml
Further oral doses in breast-fed infants have
been advised, but safety or efficacy data for
these additional doses is limited.
Therapy of early and/or late vitamin K
deficiency bleeding (VKDB)
Initially 1mg IV and further doses as required,
depending on clinical picture and coagulation
status. Konakion therapy may need to be
accompanied by a more immediate effective
treatment, such as transfusion of blood or blood
clotting factors to compensate for severe blood
loss and delayed response to vitamin K1.
Antidote therapy to anticoagulant drugs of the
coumarin type
There have been no dose ranging studies
performed to recommend a specific dose of
Konakion MM Paediatric used as an antidote to
anticoagulant drugs of the coumarin type in
infants and children. Suggested doses are
detailed below. Konakion MM Paediatric must be
administered by intravenous injection in these

patients. It is advisable that a haematologist is
consulted about appropriate investigation and
treatment in any infant or child in whom Konakion
MM Paediatric is being considered.
For patients on warfarin therapy, therapeutic
intervention must consider the reason for the
patient being on warfarin and whether or not
anticoagulant therapy has to be continued
(e.g. in a patient with mechanical heart valve or
repeated thrombo-embolic complications) as
vitamin K administration is likely to interfere with
anticoagulation with warfarin for 2 - 3 weeks.
For patients continuing to receive warfarin, the
suggested dose for the partial reversal of
anticoagulation is 30micrograms/kg administered
by IV injection. Konakion MM Paediatric is only
suitable for the administration of doses of
30micrograms/kg in children weighing over 13kg.
The suggested dose of vitamin K for patients
requiring a complete reversal of a warfarin
overdose is 250-300micrograms/kg administered
by IV injection. It should be noted that the earliest
effect seen with vitamin K treatment is at 4 to 6
hours and therefore, in patients with severe
haemorrhage, replacement with coagulation
factor concentrates may be indicated (discuss
with haematologist). Konakion MM Paediatric is
only suitable for the administration of doses of
250-300micrograms/kg in children weighing over
1.6kg. Prothrombin time should be measured 2 to
6 hours later and if the response has not been
adequate, Konakion MM Paediatric
administration may be repeated. Frequent
monitoring of vitamin K dependent clotting factors
is essential in these patients.
Method of administration
Konakion MM Paediatric can be administered by
intramuscular or intravenous injection or by oral
administration depending on the indication.
At the time of use, the ampoule contents should
be clear. Following incorrect storage, the
contents may become turbid or present a phaseseparation. In this case the ampoule must not be
used.
Parenteral use: For the administration of
injection volumes of 0.04ml (0.4mg) to 0.1ml
(1mg), 0.5ml syringes with 0.01ml gradations are
recommended. Undiluted Konakion MM
Paediatric is compatible with 0.5ml syringes
supplied by B.Braun.
Administration of Konakion MM Paediatric by
i.v. infusion is not recommended because
Konakion MM Paediatric must not be diluted or
mixed with other parenteral medications.
However, Konakion MM Paediatric may be
administered by injecting the dose into the lower
part of an infusion set containing 5% dextrose or
0.9% sodium chloride running at ≥ 0.7ml/minute,
see section, Incompatibilities.
Oral use: For oral administration, oral
dispensers are provided in the pack. After
breaking the ampoule open, 0.2ml of solution
should be withdrawn into the oral dispenser until
it reaches the mark on the dispenser (0.2ml =
2mg vitamin K). Drop the contents of the
dispenser directly into the baby’s mouth by
pressing the plunger.
Incompatibilities
Incompatibilities have been observed with diluted
Konakion MM solution and certain siliconised
syringes, therefore, Konakion MM Paediatric
must not be diluted before injection.
Do not dilute with sodium chloride containing
solutions as precipitation may occur.
Shelf life
Unopened: 3 years.
Special precautions for storage
Do not store above 25°C. Do not freeze.
Keep ampoules in the outer carton in order to
protect from light.
Do not use Konakion MM Pediatric if you notice
that the solution is cloudy or presents phase
separation.
PL 18799/2583
Leaflet Date – 06.06.2016


Picture 1 shows the ampoule (the small glass
container) and the dispenser. The part of the
dispenser which can be moved in and out is
called the plunger.
Shake the ampoule until the liquid is in the
bottom of the ampoule. Do not use it if it
looks cloudy.
Hold the bottom part of the ampoule between
the thumb and first finger of one hand. Make
sure the spot is facing towards your thumb
(see Picture 2).
Hold the top of the ampoule between the
thumb and first finger of your other hand.
Snap the top off by pushing away from the
side with the spot (see Picture 2).

5. How konakion MM Paediatric is
stored
Keep out of the sight and reach of children
Do not store above 25°C. Do not freeze.
Keep ampoules in the outer carton in order to
protect from light.
Do not use Konakion MM Pediatric if you
notice that the solution is cloudy or presents
phase separation.
Do not use Konakion MM Paediatric after the
expiry date printed on the carton or blister
foil.
Do not throw away any whole left over
ampoules. Instead, return them to your
pharmacist so that they can be disposed of
carefully. Only keep them if your doctor tells
you to.
6. Further information

Picture 3

Picture 4

3. Put the dispenser into the ampoule. The tip of
the dispenser should touch the bottom of the
ampoule (see Picture 3). Pull the plunger up
slowly to pull the medicine into the dispenser
until it is level with the second mark (2mg) on
the side of the dispenser.
The dispenser is designed to draw up the
right dose from the ampoule. There may be
some liquid left over in the ampoule even
after the right dose has been removed. This
is OK. Do not give your baby any extra liquid.
4. Put the dispenser into your baby’s mouth as
shown in Picture 4. Gently push the plunger
in, to give your baby the medicine.
If your baby gets more Konakion MM
Paediatric than they should
If your baby has had more Konakion MM
Paediatric than they should, talk to a doctor,
nurse or midwife. The following effects may
happen to your baby; jaundice (signs of which are
yellowing of the skin or the whites of the eyes),
tummy ache, constipation, soft stools (poo),
seeming unwell, being agitated (upset), a rash
and changes to how well their liver works (shown
up by blood tests).
If you forget to give your baby Konakion MM
Paediatric
If you forget to give your baby their dose of
Konakion MM Paediatric by mouth, talk to
your health visitor, midwife or doctor about
when to give the next dose.
Do not give your baby a double dose to make
up for a forgotten dose.
If someone else takes your baby’s Konakion MM
Paediatric by mistake, they should talk to a
doctor.
If you have any further questions on the use of
this medicine, ask your doctor, nurse or midwife.
4. Possible side effects
Like all medicines, Konakion MM Paediatric can
cause side effects, although not everyone gets
them.
The following side effects may happen with this
medicine:
Allergic reactions
The signs may include:
Swelling of your baby or child’s throat, face,
lips and mouth. This may make it difficult for
them to breathe or swallow.
Sudden swelling of your baby or child’s
hands, feet and ankles.
If your baby or child has an allergic reaction, tell
a doctor straight away.
A reaction where the injection was given
Rarely this may be severe. Signs include
redness, swelling, pain and it may cause a scar.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at:www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

What Konakion MM Paediatric contains
The active substance in Konakion MM Paediatric
2mg/0.2ml is vitamin K1 (phytomenadione).
Each 0.2ml ampoule of liquid medicine contains
2mg vitamin K1.
Other ingredients are glycocholic acid, sodium
hydroxide, lecithin, hydrochloric acid and water
for injections.
What Konakion MM Paediatric looks like and
contents of the pack
Konakion MM Paediatric is a slightly, opalescent
pale yellow liquid (‘solution for injection or oral
administration’).
Konakion MM Paediatric is supplied in amber
coloured glass ampoules in packs of 5 with
plastic oral dispensers.
Manufactured by: Roche Farma, S.A., C/Severo
Ochoa n°13, Poligono Industrial de Leganés,
28914 Madrid, Spain.
Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Konakion® MM Paediatric 2mg/0.2ml solution
for injection or oral administration
PL 18799/2583
Leaflet date: 06.06.2016

POM

KONAKION is a registered trademark of Roche
Products Limited

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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