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KONAKION MM PAEDIATRIC 2 MG/0.2ML

Active substance(s): PHYTOMENADIONE / VITAMIN K1

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Patient Information Leaflet

10165127 GB FY

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

Konakion® MM
Paediatric 2 mg/0.2 ml

INFORMATION FOR HEALTHCARE PROFESSIONALS
Konakion® MM
Paediatric 2 mg/0.2 ml
solution for injection or oral administration
Phytomenadione (vitamin K1)

solution for injection or oral administration
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.

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.

Presentation
Amber glass ampoules containing 0.2 ml 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 2 mg/ 0.2 ml is essentially ‘sodium
free’ as it contains less than 1 mmol sodium
(2.64 mg per 1 ml). Cartons of 5 ampoules.

Prevention of vitamin K
deficiency bleeding

PACKS CONTAIN PLASTIC ORAL
DISPENSERS. NOT TO BE USED FOR
INJECTIONS.

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

Healthy babies delivered at or nearly full term
These babies will be given either:
● A single injection (1 mg) either at birth or
soon after, or
● By mouth (oral) a first dose (2 mg) at birth or
soon after. This is followed by a second 2 mg
dose after 4 to 7 days and third 2 mg dose at
1 month. In exclusively formula fed infants
the third oral dose can be omitted.

Posology and method of administration
Konakion MM Paediatric 2 mg/ 0.2 ml is for
either injection (intravenous or intramuscular) or
oral administration.

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.

Prophylaxis of vitamin K deficiency bleeding
(VKDB)
Healthy neonates 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.

3. How Konakion MM Paediatric is
given

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:

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.

● 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).

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 1 mg).
● More injections may be given later if your
baby is still at risk of bleeding. Some babies
may also need a blood transfusion.

Konakion MM Paediatric works by helping your
body make blood clotting factors. These blood
clotting factors help stop bleeding.

Treatment of too much
blood thinning medicine

2. Before your baby or child is given
Konakion MM Paediatric

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.

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.

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 2 mg 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 2 mg doses once a month (by mouth).

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.

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

In particular, tell your doctor, nurse or midwife if
your baby or child is taking medicines to stop
their blood clotting (anticoagulants).

2. To open the ampoule

Important information about some of the
ingredients of Konakion MM Paediatric
Konakion MM Paediatric is essentially ‘sodium
free’ as it contains less than 1 millimole sodium
(2.64 mg in each millilitre).
Picture 1
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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 30 micrograms/kg
administered by IV injection. Konakion MM
Paediatric is only suitable for the administration
of doses of 30 micrograms/kg in children
weighing over 13 kg.

CAUTION: care is required when calculating
and measuring the dose in relation to the
baby’s weight (10 times dosing errors are
common).

The suggested dose of vitamin K for patients
requiring a complete reversal of a warfarin
overdose is 250‑300 micrograms/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
250‑300 micrograms/kg in children weighing
over 1.6 kg. 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.

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 IM or IV at birth or soon after birth. The
amount and frequency of further doses should be
based on coagulation status.

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 phase-separation.
In this case the ampoule must not be used.

Preterm neonates of less than 36 weeks gestation
weighing less than 2.5 kg: 0.4 mg/kg (equivalent
to 0.04 ml/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.

Parenteral use: For the administration of
injection volumes of 0.04 ml (0.4 mg) to 0.1 ml
(1 mg), 0.5 ml syringes with 0.01 ml gradations
are recommended. Undiluted Konakion MM
Paediatric is compatible with 0.5 ml syringes
supplied by B.Braun.

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).

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 ≥ 0.7 ml/minute,
see section, Incompatibilities.

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
1 kg
0.4 mg
0.04 ml
1.5 kg
0.6 mg
0.06 ml
2 kg
0.8 mg
0.08 ml
2.5 kg
1 mg
0.1 ml
Over 2.5 kg
1 mg
0.1 ml

Oral use: For oral administration, oral
dispensers are provided in the pack. After
breaking the ampoule open, 0.2 ml of solution
should be withdrawn into the oral dispenser until
it reaches the mark on the dispenser (0.2 ml =
2 mg vitamin K). Drop the contents of the
dispenser directly into the baby’s mouth by
pressing the plunger.

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 1 mg 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.

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
Store below 25°C and protect from light. Do not
freeze.
Do not use if the solution is turbid.
Date of preparation of leaflet May 2015

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5. How Konakion MM Paediatric is
stored

– 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.

● Konakion MM Paediatric ampoules should be
stored in their original packaging to protect
them from light.
● Konakion MM Paediatric should be stored at a
temperature below 25°C.
● Keep out of the reach and sight of children.
● Do not use Konakion MM Paediatric after the
expiry date printed on the pack.
● 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.

– 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).

6. Further information
What Konakion MM Paediatric contains
The active substance in Konakion MM Paediatric
2 mg/0.2 ml is vitamin K1 (phytomenadione).
Each 0.2 ml of liquid medicine contains 2 mg
vitamin K1.
Picture 3

Other ingredients are glycocholic acid, sodium
hydroxide, lecithin, hydrochloric acid and water
for injections.

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 (2 mg)
on the side of the dispenser.

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.

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.

Marketing Authorisation Holder and
Manufacturer
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom

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).

This leaflet was last revised in May 2015

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 or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly (see details below).
By reporting side effects you can help provide
more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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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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