Atracurium besilate 250mg/25ml solution for injection ampoules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Atracurium besilate

Inapatikana kutoka:

Actavis UK Ltd

ATC kanuni:

M03AC04

INN (Jina la Kimataifa):

Atracurium besilate

Kipimo:

10mg/1ml

Dawa fomu:

Solution for injection

Njia ya uendeshaji:

Intravenous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 15010500; GTIN: 5012617020116

Taarifa za kipeperushi

Atracurium 10 mg/ml Sol. for injection/infusion PIL - UK
item no: AAAF6972
print proof no: 5
origination date: 22.07.13
originated by: DR
revision date: 04.11.13
revised by: DR
dimensions: 148 x 520
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 22.07.13
supplier: Rotexmedica
technically app. date: 24.07.13
min pt size: 8.5pt
TECHNICAL APPROVAL
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AAAF6972
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ATRACURIUM 10MG/ML
SOLUTION FOR INJECTION/INFUSION
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AAAF6972
Atracurium besilate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING 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.
•
This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.
•
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.
•
The full name of this medicine is Atracurium
10mg/ml Solution for Injection/Infusion
but within the leaflet it will be referred to as
Atracurium.
W
HAT IS
IN THIS LEAFLET
1
WHAT ATRACURIUM IS AND WHAT IT IS
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU
USE ATRACURIUM
3
HOW TO USE ATRACURIUM
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE ATRACURIUM
6
CONTENTS OF THE PACK AND OTHER
IN
FOR
MATION
1
WHAT ATRACURIUM IS AND WHAT IT IS
USED FOR
Atracurium belongs to a group of medicines
called muscle relaxants. It is used to relax
muscles during surgery.
ATRACURIUM IS USED:
• during surgery, other procedures and in
intensive care
• during general anaesthesia to ease tracheal
intubation (a tube into the windpipe) and
controlled ventilation.
2
WHAT YOU NEED TO KNOW BEFORE YOU
USE ATRACURIUM
DO NOT USE ATRACURIUM
• if you allergic (hypersensitive) to atracurium,
cisatracurium

Tabia za bidhaa

OBJECT 1
ATRACURIUM 10MG/ML SOLUTION FOR
INJECTION/INFUSION
Summary of Product Characteristics Updated 21-Jan-2014 | Accord-UK Ltd
1. Name of the medicinal product
Atracurium 10mg/ml Solution for Injection/Infusion
2. Qualitative and quantitative composition
1 ml solution contains 10 mg of atracurium besilate.
One ampoule with 2.5 ml solution contains 25 mg atracurium besilate.
One ampoule with 5.0 ml solution contains 50 mg atracurium besilate.
One ampoule with 25.0 ml solution contains 250 mg atracurium besilate
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection and Concentrate for solution for infusion
Clear and colourless solution
4. Clinical particulars
4.1 Therapeutic indications
Atracurium besilate is used intravenously as an adjunct to general
anaesthesia, during surgical and other
procedures and in intensive care to facilitate tracheal intubation and
controlled ventilation.
4.2 Posology and method of administration
In common with all neuromuscular blocking agents, monitoring of
neuromuscular function is
recommended during the use of atracurium besilate injection, in order
to individualise dosage
requirements.
USE IN ANAESTHESIA
● _In adults: Use as an injection_
Atracurium besilate is administered by intravenous injection and must
not be applied intramuscularly.
_Relaxation_
The dosage range recommended for adults is 0.3 to 0.6 mg atracurium/kg
(depending on the duration of
full block required). This dose will provide adequate relaxation for
about 15 to 35 minutes.
_Intubation_
Endotracheal intubation can usually be accomplished within 90 seconds
from the intravenous injection of
0.5 to 0.6 mg atracurium/kg.
_Repeated dose_
Full block can be prolonged with supplementary doses of 0.1 to 0.2 mg
atracurium/kg. Generally, the first
maintenance dose is required 20 to 45 minutes after the initial bolus
dose, then typically at 15 to 25
minutes intervals, however, the need for maintenance doses should be
determined by the individual
patient's requirements and responses