KONAKION MM PAEDIATRIC 2 MG/0.2ML

Active substance: VITAMIN K1

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KAU-Nr.

1562

Genisys-No.

10144320

Printing Colour:

Pantone Black

Format:

280x630 mm

Folding Format:

70x105 mm

Type Size

10,5 pt

Drawing Norm

17.10.2011

make-up Code

GB

COE/CMO

FY

Checked and
approved

Date

Signature

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

Patient Information Leaflet

Konakion MM
®

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

10144320 GB FY 1212.1075

INFORMATION FOR HEALTHCARE PROFESSIONALS

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

Please read all of this leaflet
carefully before your baby or
child is given this medicine.

3. How Konakion MM
Paediatric is given

● 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.
Prevention of vitamin K deficiency
bleeding

Healthy babies delivered at or
nearly full term

In this leaflet:

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.

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

Premature babies or full term
babies at special risk of bleeding

1. What Konakion MM
Paediatric is and what it is
used for

● 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.

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.

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 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.

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

Treatment of too much blood
thinning medicine

Your child must not be given
Konakion MM Paediatric if they
are allergic (hypersensitive) to:

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.

● 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.

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.

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).

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

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

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 1, 5 or 10 ampoules. Not all pack
sizes may be marketed.

PACKS CONTAIN PLASTIC ORAL DISPENSERS.
NOT TO BE USED FOR INJECTIONS.
Posology and method of administration
Konakion MM Paediatric 2 mg/ 0.2 ml 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:
● 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 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
2.5 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.
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 baby Dose of vitamin K at birth Injection volume
1 kg
1.5 kg
2 kg
2.5 kg
Over 2.5 kg

0.4 mg
0.6 mg
0.8 mg
1 mg
1 mg

0.04 ml
0.06 ml
0.08 ml
0.1 ml
0.1 ml

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.
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.
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.

Method of administration
Konakion MM Paediatric can be administered by intramuscular
or intravenous injection or by oral administration depending on
the indication.

Konakion MM Paediatric is
essentially ‘sodium free’ as it contains
less than 1 millimole sodium
(2.64 mg in each millilitre).

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.
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.

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24.01.2013 08:23:44

KAU-Nr.

1562

Genisys-No.

10144320

Printing Colour:

Pantone Black

Format:

280x630 mm

Folding Format:

70x105 mm

Type Size

10,5 pt

Drawing Norm

17.10.2011

make-up Code

GB

COE/CMO

FY

Checked and
approved

Date

Signature

This information is intended for medical or
healthcare professionals only:

Patient Information Leaflet

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.

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.

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.

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

Ampoule and dispenser

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.

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 January 2013

Picture 1
- 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.

A reaction where the injection
was given
Rarely this may be severe. Signs
include redness, swelling, pain and it
may cause a scar.

- Shake the ampoule until the liquid
is in the bottom of the ampoule.
Do not use it if it looks cloudy.

If any of the side effects become
serious or troublesome, or if you notice
any side effects not listed in this
leaflet, please tell your doctor, nurse
or midwife.

To open the ampoule

5. How Konakion MM
Paediatric is stored

Picture 2
- 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).

● 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.

- 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).

Picture 3
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.

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.

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.

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’).

Picture 4
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.

Konakion MM Paediatric is supplied
in amber coloured glass ampoules in
packs of 1, 5 or 10 with plastic oral
dispensers. Not all pack sizes may be
marketed.

If your baby gets more Konakion
MM Paediatric than they should

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

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
January 2013

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.

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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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