Nimotop 0.02% w/v Concentrate for Solution for Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NIMODIPINE

Available from:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

ATC code:

C08CA06

INN (International Name):

NIMODIPINE 0.2 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

NIMODIPINE 0.2 mg/ml

Prescription type:

POM

Therapeutic area:

CALCIUM CHANNEL BLOCKERS

Authorization status:

Withdrawn

Authorization date:

2006-12-21

Patient Information leaflet

BP22036_REC30610
1
Package leaflet: Information for
the user
Nimotop 0.02% w/v Concentrate for
Solution for Infusion
nimodipine
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
- Keep this leaflet. You may need to
read it again.
- If you have any further questions,
ask your doctor, pharmacist or nurse.
-If you get any side effects, talk to your
doctor, pharmacist or nurse.
This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1.
What Nimotop is and what it is
used for
2.
What you need to know before
you are given Nimotop
3.
How you are given Nimotop
4.
Possible side effects
5.
How to store Nimotop
6.
Contents of the pack and other
information
1.
What Nimotop is
and what it is
used for
Nimotop contains nimodipine, which
belongs to a group of medicines called
calcium antagonists
.
Nimotop is used to prevent changes
in brain function after bleeding
around the brain (
subarachnoid
haemorrhage).
2. What you need to know before you
are given Nimotop
Do not take Nimotop
You will not be given Nimotop:

If you are allergic to nimodipine or
any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before taking Nimotop
Your doctor will take special care:

While you are having a heart
attack.

If you have had a heart attack
within the last month.

If you suffer from angina and
notice an increase in the frequency
and severity of attacks.

If you have fluid in the brain or
severely raised pressure in your
skull. Your doctor will be able to
advise you about this.

If you have low blood pressure.

If you have liver disease. You will
probably need to have your blood
pressure measured regularly.

If you have kidney problems
and/or you have been given drugs
which may alter kidney function (e.g.
aminoglycosides, cephalosporins,
furosemide). Your doctor may need
to monitor your kidney function
during treatme

Summary of Product characteristics

BP22036_REC30610
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nimotop 0.02% w/v Concentrate for Solution for Infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 ml vial contains 10 mg of nimodipine (0.2 mg/ml).
Excipients with known effect:
Each 50 ml vial also contains 10 g of ethanol (0.2 g/ml) and 23 mg of
sodium (as sodium citrate dihydrate). Please see
section 4.4 for further information.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
A clear, yellow solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Nimotop solution is indicated for the treatment of ischaemic
neurological deficits following aneurysmal subarachnoid
haemorrhage.
4.2
Posology and method of administration
Posology
Recommended dose - aneurysmal subarachnoid haemorrhage:
For the first two hours of treatment, 1 mg of nimodipine, i.e. 5 ml
Nimotop solution (about 15 micrograms/kg bw/h),
should be infused each hour via a central catheter. If it is well
tolerated, the dose should be increased after two hours
to 2 mg nimodipine, i.e. 10 ml Nimotop solution per hour (about 30
micrograms/kg bw/h), providing no severe
decrease in blood pressure is observed.
Patients of body weight less than 70 kg or with unstable blood
pressure should be started on a dose of 0.5 mg
nimodipine per hour (2.5 ml of Nimotop solution, or less if
necessary).
Aneurysmal subarachnoid haemorrhage
PROPHYLACTIC USE
Intravenous therapy should be started no later than 4 days after the
haemorrhage, and be continued during the period
of maximum risk of vasospasm, i.e. up to 10-14 days after the
haemorrhage. This should continue for at least five days
up to a maximum of 10-14 days.
If during prophylactic administration of Nimotop, the source of the
haemorrhage is treated surgically, intravenous
treatment with Nimotop should be continued post-operatively for at
least 5 days.
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After the end of the infusion therapy, it is