Pancuronium Bromide 2mg/ml Injection

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

PANCURONIUM BROMIDE

Tilgjengelig fra:

Hospira UK Limited

ATC-kode:

M03AC01

INN (International Name):

PANCURONIUM BROMIDE

Legemiddelform:

SOLUTION FOR INJECTION

Sammensetning:

PANCURONIUM BROMIDE 2 mg/ml

Resept typen:

POM

Terapeutisk område:

MUSCLE RELAXANTS

Autorisasjon status:

Authorised

Autorisasjon dato:

2006-12-28

Informasjon til brukeren

Q63027
Artworker
I have checked that this artwork conforms with the information
received.
Signature: 
Date:                  /                     /
Proofer
I have given this artwork a final check and it conforms with the
information received.
Signature: 
Date:                  /                     /
Administrator
I have checked the paperwork and it conforms with the artwork and
information received.
Signature: 
Date:                  /                     /
Regulatory
I have checked this artwork against the registered text including
spelling, layout, size, colours, 
registration numbers and scientific equations, the name and address
and trademarks. Also 
for any possible changes to related items.
This artwork is in conformance with the Marketing Authorisation and
can now proceed to the 
printing stage.
I have also signed the Supplier’s Specification and where necessary
a Change Request form.
Signature: 
Date:                  /                     /
QA EMEA
I have checked the paperwork and it conforms with the artwork and
information received.
Signature: 
Date:                  /                     /
N.B.: Regulatory approval on text and layout. Production requirements
may be added via 
manufacturing site.
Copyright in this drawing, design and 
specification or artwork vests in Hospira 
UK Limited and must not be copied or 
reproduced without the express prior 
permission of Hospira UK Limited. Any 
unauthorised act in relation to this work will 
result in both civil and criminal liability.
Copyright © Hospira UK Limited  October 2007
HOSPIRA UK LIMITED - Draft artwork
Request Number: 
AM1323
Country: 
UK
Product Code(s): 
08971D-GB
Artworker: 
KN
Version Number: 
2
Drafted: 
25/04/08
Specification
OI Template: 
BPS-0059/2
Dimensions: 
148 x 420 mm
Template type: 
In-licence Leaflet
Container: 
Ampoule
Supplier: 
Hameln
Stock: 
N/A
Folded dimensions:  N/A 
Printed both sides: 
Yes

Preparatomtale

Page 1 of 9 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Pancuronium Bromide 2 mg/ml Injection 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each 1 ml contains 2 mg of pancuronium bromide. 

Each 2 ml ampoule contains 4 mg of pancuronium bromide. 

For excipients, see 6.1. 

3. 
PHARMACEUTICAL FORM 

Solution for injection 

4. 
CLINICAL PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

The  active  substance  of  pancuronium  bromide  is  an  amino  steroid  which  effectively  blocks 
transmission of motor nerve impulses to the striated muscle receptors. It is a non-depolarising 
neuromuscular  blocking  agent  with  a  long  duration  of  action  and  is  used  in  the  following 
indications: 

1. 
As an adjuvant in surgical anaesthesia to obtain relaxation of skeletal muscles in a wide 
range of surgical procedures. 

2.  
Use in intensive care as  a non-depolarising neuromuscular blocker for the treatment of 
various pathologies eg intractable status asthmaticus and tetanus. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Pancuronium should be administered intravenously. 

It is not recommended to be given by infusion. 

The  dosage  should  be  individualised  as  there  is  a  wide  variation  in  individual  response  to 
muscle relaxants. When determining the dose, the method of anaesthesia, expected duration of 
surgery,  potential  interaction  with  other  drugs  that  are  administered  before  and  during 
anaesthesia and the condition of the patient should be taken into account.   

The  use  of  a  peripheral  nerve  stimulator  is  recommended  for  monitoring  the  neuromuscular 
block and recovery. 

Page 2 of 9 

ADULT: