Skip to Content

KONAKION MM AMPOULES 10 MG/ML SOLUTION FOR INJECTION

Active substance(s): PHYTOMENADIONE

View full screen / Print PDF » Download PDF ⇩
Transcript
10165126 GB FY

Patient Information Leaflet

Konakion® MM Ampoules 10mg/ml
solution for injection

Phytomenadione (vitamin K1)
Please read all of this leaflet carefully before
you start taking this medicine.
● Keep this leaflet. You may need to read it
again.
● If you have any further questions, ask your
doctor or nurse.
● 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 or nurse.

Driving and using machines
Konakion MM is not likely to affect you being
able to drive or use any tools or machines. Talk
to your doctor if you notice any problems that
might affect driving, using tools or machines
while having Konakion.
Important information about some of the
ingredients of Konakion MM
Konakion MM is essentially ‘sodium (a type of
salt) free’ as it contains less than 1 mmol
sodium (2.64mg per 1ml).

In this leaflet:
1. What Konakion MM is and what it is used
for
2. Before you are given Konakion MM
3. How Konakion MM is given
4. Possible side effects
5. How to store Konakion MM
6. Further information

3. How Konakion MM is given
Konakion MM will be given to you by a doctor
or nurse. It will be given to you by injection
into a vein or through a small tube into one of
your veins (intravenous infusion).

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

Adults
● For people who are bleeding after taking
blood-thinning (anticoagulant) medicines, the
usual dose is 5 to 10 mg.
● For people who have severe bleeding the
Konakion dose (5 to 10 mg) is usually given
with a blood transfusion.
● For people with mild bleeding or at risk of
bleeding, the usual dose is 0.5 to 1 mg.
● If you need to have emergency surgery you
may be given 5 mg Konakion before surgery
to reverse the effects of blood-thinning
(anticoagulant) medicines.
● The maximum dose is usually no more than
40 mg Konakion in 24 hours.

Konakion MM contains a medicine called
phytomenadione. This is a man-made vitamin
called vitamin K1. Konakion MM is used for the
following:
● To prevent and treat bleeding after the use of
certain medicines to thin the blood (called
anti-coagulants).
● To treat children (aged 1 year and older) who
have liver disease or low levels of vitamin K
in their body because of illness. Konakion
MM is normally used to treat these children
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.

Your doctor will usually check your blood for
the levels of clotting factors, 3 hours after
having Konakion MM and, if you need them
give you more doses of Konakion MM.
Elderly
Because elderly adults are sometimes more
sensitive to Konakion MM your doctor may
decide to start you on a lower dose. This dose
may be increased or repeated if necessary.

2. 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.

Children (aged 1 to 18 years)
Konakion MM is normally used to treat children
following advice from a specialist haematologist
(blood doctor).
● The dose is usually no more than 5 mg.
● Some children may also need a blood
transfusion.
The doctor will usually check the child’s blood
for the levels of clotting factors, 2 to 6 hours
after they have Konakion MM and, if necessary,
give more doses of Konakion MM.

Take special care with Konakion MM
Check with your doctor or nurse before having
Konakion MM if:
● You have severe problems with your liver.
● You have an artificial heart valve.

If you are given more Konakion MM than you
should
Because Konakion MM is given by a doctor or
nurse, it is unlikely that you or your child will
be given too much or that you or your child will
miss a dose. However, if you are worried talk
to your doctor or nurse.

Taking other medicines
Please tell your doctor or nurse if you are taking
or have recently taken any other medicines.
This includes medicines that you buy without a
prescription and herbal medicines. This is
because Konakion MM can affect the way some
medicines work. Also some other medicines
may affect the way
Konakion MM works.
In particular, tell your
doctor or nurse if you are
taking medicines to stop
your blood clotting
(anticoagulants).

If you have any further
questions on the use of this
medicine, ask your doctor
or nurse.

4. Possible side effects

Pregnancy and breast-feeding
Talk to your doctor before having Konakion if
you are pregnant, think you are pregnant, or
breastfeeding. Your doctor will then decide if
you should receive Konakion.

Like all medicines Konakion MM may cause
side effects, although not everyone will get
them.
Please turn over

1

This information is intended for medical or healthcare professionals only:
The tear-off portion above is intended for the patient
INFORMATION FOR HEALTHCARE PROFESSIONALS
Konakion® MM Ampoules 10 mg/ ml
solution for injection
Phytomenadione (vitamin K1)
Please refer to the Summary of Product Characteristics for full prescribing information.
Presentation
Amber glass ampoules containing 1 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 Ampoules 10 mg/ ml are
essentially ‘sodium free’ as they contain less
than 1 mmol sodium (2.64 mg per 1 ml).
Cartons of 10 ampoules.

Reversal of anticoagulation prior to surgery:
For emergency surgery that can be delayed for
6-12 hours, 5 mg intravenous vitamin K1 can be
given. If surgery cannot be delayed, PCC can
be given in addition to intravenous vitamin K1
and the INR checked before surgery.
Use with anticoagulants other than warfarin:
The dosing recommendations above apply to
patients taking warfarin. There are limited data
regarding reversal of the effects of other
anticoagulants, such as acenocoumarol or
phenprocoumon. The half lives of these
anticoagulants are different to warfarin and
different doses of vitamin K1 may be required.

Therapeutic indication
Konakion MM is indicated as an antidote to
anticoagulant drugs of the coumarin type in the
treatment of haemorrhage or threatened
haemorrhage, associated with a low blood level
of prothrombin or factor VII.

Elderly
Elderly patients tend to be more sensitive to
reversal of anticoagulation with Konakion MM;
dosage in this group should be at the lower end
of the ranges recommended.

Posology and method of administration
Konakion MM Ampoules 10 mg/ ml is for
intravenous injection.

Children aged 1 to 18 years
It is advisable that a haematologist is consulted
about appropriate investigation and treatment in
any child in whom Konakion MM is being
considered.

Adults
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 (over at least 30 seconds) at a dose of
5 - 10 mg together with prothrombin complex
concentrate (PCC). Fresh frozen plasma (FFP)
may be used if PCC is not available. The
patient’s INR should be estimated three hours
later and, if the response has been inadequate,
the dose should be repeated. Not more than
40 mg of Konakion MM should be given
intravenously in 24 hours. Coagulation profiles
must be monitored on a daily basis until these
have returned to acceptable levels; in severe
cases more frequent monitoring is necessary.

For patients on warfarin therapy, therapeutic
intervention must take into consideration the
reason for the child being on warfarin and
whether or not anticoagulant therapy has to be
continued (e.g. in a child with mechanical heart
valve or repeated thromboembolic
complications) as vitamin K administration is
likely to interfere with anticoagulation with
warfarin for 2 – 3 weeks.
It should be noted that the earliest effect seen
with vitamin K treatment is at 4 – 6 hours and
therefore in patients with severe haemorrhage
replacement with coagulation factors may be
indicated (discuss with haematologist).

For full details of dose recommendations for
vitamin K1 therapy in patients with major and
life-threatening bleeding, please refer to the
Summary of Product Characteristics.

Dose of vitamin K
There are few data available regarding use of
Konakion MM in children over 1 year. There
have been no dose ranging studies in children
with haemorrhage. The optimal dose should
therefore be decided by the treating physician
according to the indication, clinical situation
and weight of the patient. Suggested dosages
based on clinical experience are as follows:

Less severe haemorrhage: An intravenous
injection of Konakion MM given slowly at a
dose of 0.5 – 1 mg. For full details of dose
recommendations for vitamin K1 therapy in
patients with asymptomatic high International
Normalised Ratio (INR) with or without mild
haemorrhage, please refer to the Summary of
Product Characteristics.
1

10165126_148x594_NF4.indd 1

Please turn over

05.05.2015 15:27:51

The following side effects may happen with this
medicine:
Allergic reactions
The signs may include:
● Swelling of the throat, face, lips and mouth.
This may make it difficult to breathe or
swallow.
● Sudden swelling of the hands, feet and
ankles.
If you have an allergic reaction, tell a doctor
straight away.
A reaction where the injection was given
The signs may include swelling and redness
along the vein where the medicine was given,
which is very tender or painful when touched.
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

5. How to store Konakion MM
● Your doctor or pharmacist is responsible for
storing Konakion MM. They are also
responsible for disposing of any unused
Konakion MM correctly.
● Keep out of the reach and sight of children.
● Do not use Konakion MM after the expiry
date printed on the pack.
● Konakion MM ampoules should be stored at
a temperature below 25°C.

6. Further information
What Konakion MM contains
The active substance in Konakion MM
Ampoules 10 mg/ml is vitamin K1
(phytomenadione). Each 1 ml of liquid
medicine contains 10 mg vitamin K1.
Other ingredients are glycocholic acid, sodium
hydroxide, lecithin, hydrochloric acid and water
for injections.
What Konakion MM looks like and contents
of the pack
Konakion MM is a slightly opalescent, pale
yellow liquid (‘solution for infusion’). This
liquid will be further diluted to make it weaker
before it is given to you.
Konakion MM is supplied in amber coloured
glass ampoules in packs of 10.
Marketing Authorisation Holder and
Manufacturer
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom
This leaflet was last revised in May 2015

2

Children with major and life-threatening
bleeding: a dose of 5 mg vitamin K1 i.v. is
suggested (together with PCC if appropriate, or
FFP if PCC is not available).
Children with asymptomatic high International
Normalised Ratio (INR) with or without mild
haemorrhage: i.v. vitamin K1 at doses of
30 micrograms/kg have been reported to be
effective in reversing asymptomatic high (>8)
INR in clinically well children.
INR should be measured 2 to 6 hours later and
if the response has not been adequate, the dose
may be repeated. Frequent monitoring of
vitamin K dependent clotting factors is essential
in these patients.
Neonates and babies
Konakion MM Paediatric 2 mg/0.2 ml should
be used in these patients.
Method of administration - Instructions for
infusion in adults
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.
Konakion MM Ampoules are for intravenous
injection and should be diluted with 55ml of 5%
glucose before slowly infusing the product.
The solution should be freshly prepared and
protected from light. Konakion MM Ampoule
solution should not be diluted or mixed with
other injectables, but may be injected into the
lower part of an infusion apparatus.
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.
This leaflet was last revised in May 2015

2

10165126_148x594_NF4.indd 2

10165126 GB FY

05.05.2015 15:27:51

Expand view ⇕

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.

Hide