KONAKION MM AMPOULES 10 MG/ML SOLUTION FOR INJECTION

Active substance: PHYTOMENADIONE

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Patient Information Leaflet

10135498 GB FY 1112.1076

Konakion®

MM
Ampoules 10 mg/ml
solution for injection

Phytomenadione (vitamin K1)

Please read all of this leaflet
carefully before you start taking this
medicine.

In this leaflet:

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).

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

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.

 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.

1. What Konakion MM is and
what it is used for
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 anticoagulants).
 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.

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 (2.64 mg per 1 ml).

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).
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 bloodthinning (anticoagulant) medicines.
 The maximum dose is usually no more
than 40 mg Konakion in 24 hours.

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.
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.
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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

Coagulation profiles must be monitored on a
daily basis until these have returned to
acceptable levels; in severe cases more
frequent monitoring is necessary.

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.

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.
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.

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.

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.

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

10135498 148x594.indd 1

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.

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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.

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.

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.

5. How to store Konakion MM

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.

 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

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.

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.

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

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.

4. Possible side effects
Like all medicines Konakion MM may
cause side effects, although not everyone
will get them.

Konakion MM is supplied in amber
coloured glass ampoules in packs of 10.

The following side effects may happen
with this medicine:

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

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.

This leaflet was last revised in July 2012

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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.

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.

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.

Neonates and babies
Konakion MM Paediatric 2 mg/0.2 ml
should be used in these patients.

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.

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 55 ml 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.

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).
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:

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 July 2012

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

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10135498 GB FY 1112.1076

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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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