Pancuronium Bromide 2 mg/ml Solution for Injection

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Pancuronium bromide

Dostupné z:

Pfizer Healthcare Ireland

ATC kód:

M03AC; M03AC01

INN (Medzinárodný Name):

Pancuronium bromide

Dávkovanie:

2 milligram(s)/millilitre

Forma lieku:

Solution for injection

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Other quaternary ammonium compounds; pancuronium

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

1991-03-07

Príbalový leták

Page 1 of 5
2019-0055386
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANCURONIUM BROMIDE 2 MG/ML SOLUTION FOR INJECTION
PANCURONIUM BROMIDE
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.
• If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Pancuronium Bromide Solution for Injection is and what it is
used for
2. What you need to know before you use Pancuronium Bromide Solution
for Injection
3. How to use Pancuronium Bromide Solution for Injection
4. Possible side effects
5. How to store Pancuronium Bromide Solution for Injection
6. Contents of the pack and other information
1. WHAT PANCURONIUM BROMIDE SOLUTION FOR INJECTION IS AND WHAT IT IS
USED FOR
Pancuronium bromide is one of a group of medicines called
‘non-depolarising’ muscle relaxants.
Pancuronium Bromide Solution for Injection is used to relax muscles
during surgery, including caesarean
section and in intensive care.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PANCURONIUM BROMIDE SOLUTION FOR
INJECTION
DO NOT USE PANCURONIUM BROMIDE SOLUTION FOR INJECTION
• if you are allergic to pancuronium bromide or any of the
ingredients of this medicine (listed in section 6).
• if you are using “depolarising” muscle relaxants, e.g.
suxamethonium at the same time.
WARNING AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST OR NURSE BEFORE USING
PANCURONIUM
BROMIDE SOLUTION FOR INJECTION

if you have kidney, liver, lung or heart disease

if you have high blood pressure

if you have cancer, particularly lung cancer

if you suffer from any of the following conditions: muscular
dystrophy, myasthenia gravis,
myasthenic syndrome (other neuromuscular

Súhrn charakteristických

Health Products Regulatory Authority
18 December 2020
CRN009ZDP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pancuronium Bromide 2 mg/ml Solution for 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.
Excipients with known effect:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless solution with a pH of 3.8 – 4.2.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pancuronium bromide is a neuromuscular blocking agent with a long
duration of action. It is used as an adjuvant in surgical
anaesthesia to obtain relaxation of the skeletal muscles in a wide
range of surgical procedures. It is also used as relaxant in
orthopaedic manipulations. Used in intensive care therapy for a
variety of pathologies e.g. intractable status asthmaticus and
tetanus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
THE USE OF A PERIPHERAL NERVE STIMULATOR IS RECOMMENDED FOR MONITORING
THE NEUROMUSCULAR BLOCK AND RECOVERY.
The following may be used as a guideline:
ADULT: Initial dose: 50-80 micrograms/kg (intubation within 150 to 120
seconds)
Or 80-100 micrograms/kg (intubation accomplished within 120-90
seconds).
Incremental doses: 10-20 micrograms/kg
PAEDIATRIC:
Initial dose: 60-100 micrograms/kg
Incremental doses: 10-20 micrograms/kg
NEONATES:
Initial dose: 30-40 micrograms/kg
Incremental doses: As neonates are sensitive this dose should be
adjusted according to the initial response but generally
incremental doses lie in the range 10 to 20 micrograms/kg.
Ifsuxamethonium is used for intubation, the administration of
pancuronium bromide should be delayed until the patient has
clinically recovered from the neuromuscular block induced by
suxamethonium.
Health Products Regulatory Authority
18 December 2020
CRN009ZDP
Page 2 of 7
Following the administration of suxamethonium, the dose of pancuronium
bromide may be considerably reduced: