Atracurium besilate 50mg/5ml solution for injection ampoules

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Atracurium besilate

Disponibil de la:

hameln pharma Ltd

Codul ATC:

M03AC04

INN (nume internaţional):

Atracurium besilate

Dozare:

10mg/1ml

Forma farmaceutică:

Solution for injection

Calea de administrare:

Intravenous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 15010500; GTIN: 5016386001116 5016386000287

Prospect

lowered. Ask your doctor if you have any further
questions.
OTHER MEDICINES AND ATRACURIUM
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines This is especially important with the
following medicines as they may interact with your
Atracurium:
- antibiotics (e.g. aminoglycosides, polymyxins,
spectinomycin,
tetracyclines,
lincomycin,
clindamycin and vancomycin)
- antiarrhythmic medicines (used to control the
rhythm of the heart e.g. lidocaine, procainamide,
quinidine)
- diuretics
(water
tablets,
e.g.
furosemide,
thiazides, acetazolamide and mannitol)
- medicines
used
to
control
blood
pressure,
angina or other heart problems (e.g. propranolol,
oxprenolol diltiazem, nicardipine, nifedipine and
verapamil)
- antiepileptic
medicines
(e.g.
carbamazepine,
phenytoin)
- drugs
used
to
treat
rheumatism
(e.g.
chloroquine, d-penicillamine)
- corticosteroids (used to treat inflammation)
- trimetaphan,
hexamethonium
(used
to
lower
blood pressure during surgery)
- dantrolene (a muscle relaxant)
- magnesium sulphate
- ketamine (an anaesthetic drug)
- lithium,
chlorpromazine
(treatment
of
mental
illness)
- quinine (treatment of malaria or leg cramps)
It may still be all right for you to be given Atracurium
and your doctor will be able to decide what is
suitable for you.
PREGNANCY AND BREAST-FEEDING
Atracurium
should
not
be
given
to
pregnant
women unless medically justified. Mothers should
stop breast-feeding for 24 hours after receiving
Atracurium. If you are pregnant or breast-feeding,
think you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice
before taking this medicine.
DRIVING AND USING MACHINES
After you have been given Atracurium, you must
not drive, operate machinery, or work in dangerous
situations. You should not go home alone and
should not drink ALCOHOL UNTIL FULLY RECOVERED.
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

Caracteristicilor produsului

OBJECT 1
ATRACURIUM BESILATE 10MG/ML SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 05-Feb-2016 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Atracurium besilate 10 mg/ml solution for injection
2. Qualitative and quantitative composition
1 ml solution contains 10 mg 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.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection or infusion
The product is a clear and colourless solution with a pH of 3.25 –
3.65 and an osmolality of 10 - 30
mOsmol/kg.
4. Clinical particulars
4.1 Therapeutic indications
Intravenous use during surgical and other procedures and in intensive
care.
Atracurium besilate is used as an adjunct to general anaesthesia, to
facilitate tracheal intubation and
controlled ventilation.
4.2 Posology and method of administration
As with all neuromuscular blocking agents, monitoring of neuromuscular
function is recommended
during the use of atracurium besilate in order to individualise dosage
requirements.
• _Use as an injection in adults_
Atracurium besilate 10 mg/ml solution for injection is administered by
intravenous injection and must not
be administered intramuscularly.
_Relaxation_
The dosage range recommended for adults is 0.3 to 0.6 mg atracurium
besilate/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 besilate /kg.
_Repeated dose_
Full block can be prolonged with supplementary doses of 0.1 to 0.2 mg
atracurium besilate /kg.
Generally, the first maintenance dose is required 20 to 45 minutes
after the initial bolus injection, then
typically at 15 to 25 minute intervals, however, the need for
maintenance doses should be determined by
the individual patien