Nimotop 0.02% solution for infusion 50ml vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nimodipine

Available from:

Bayer Plc

ATC code:

C08CA06

INN (International Name):

Nimodipine

Dosage:

200microgram/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060200; GTIN: 5010605174032 5010605174063

Patient Information leaflet

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Page 1 of 6
Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE USER
NIMOTOP
 0.02% 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 or pharmacist.
- This medicine has been prescribed for you only.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nimotop solution is and what it is used for
2.
What you need to know before you are given Nimotop solution
3.
How you are given Nimotop solution
4.
Possible side effects
5.
How to store Nimotop solution
6.
Contents of the pack and other information
_ _
_ _
1.
WHAT NIMOTOP SOLUTION IS AND WHAT IT IS USED FOR
Nimotop solution contains nimodipine, which belongs to a group of
medicines called _calcium _
_antagonists_.
NIMOTOP SOLUTION IS USED TO PREVENT CHANGES IN BRAIN FUNCTION AFTER
BLEEDING AROUND THE
BRAIN (_SUBARACHNOID HAEMORRHAGE)._
_ _
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2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NIMOTOP SOLUTION
_ _
DO NOT TAKE NIMOTOP SOLUTION
YOU SHOULD NOT BE GIVEN NIMOTOP SOLUTION:
_ _

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 ARE ALLERGIC TO NIMODIPINE or any of the ingredients of this
medicine (listed in
section 6).

TELL YOUR DOCTOR AND DO NOT TAKE NIMOTOP SOLUTION if any of these
apply to you.
_ _
WARNINGS AND PRECAUTIONS
Talk to your doctor or ph

Summary of Product characteristics

OBJECT 1
NIMOTOP 0.02% SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 10-Oct-2017 | Bayer plc
1. Name of the medicinal product
Nimotop 0.02% Solution for Infusion.
2. Qualitative and quantitative composition
A sterile solution containing 10 mg nimodipine in 50 ml vials of
aqueous alcoholic solvent (0.02%).
Excipients with known effect
Ethanol and sodium citrate
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Clear yellow sterile solution for intravenous use.
4. Clinical particulars
4.1 Therapeutic indications
Nimodipine 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 μg/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 μg/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.
Duration of treatment
_Aneurysmal subarachnoid haemorrhage_
Intravenous treatment should begin as early as possible after
neurological deficit occurs due to arterial
spasm, post subarachnoid haemorrhage. This should continue for at
least five days up to a maximum of
14 days.
In the event of surgical intervention during treatment, administration
of nimodipine should be continued
(dose as above) for at least five days.
Nimotop solution may be used with or without pre-treatment with
Nimotop tablets. In the event of
Nimotop tablets and Nimotop solution being administered sequentially
the total duration of treatment
should not exceed 21 days. Nimotop solution should not be administered
for longer than 1