Pancuronium bromide 4mg/2ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pancuronium bromide

Available from:

Pfizer Ltd

ATC code:

M03AC01

INN (International Name):

Pancuronium bromide

Dosage:

2mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15010500; GTIN: 5015997897101

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANCURONIUM BROMIDE 2 MG/ML INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1.
What Pancuronium Bromide Injection is and what it is used for
2.
Before you use Pancuronium Bromide Injection
3.
How to use Pancuronium Bromide Injection
4.
Possible side effects
5.
How to store Pancuronium Bromide Injection
6.
Further information
1.
WHAT PANCURONIUM BROMIDE INJECTION IS AND WHAT IT
IS USED FOR
Pancuronium bromide is one of a group of medicines called
‘non-depolarising’
muscle relaxants.
Pancuronium Bromide Injection is used to relax muscles during surgery,
including
caesarean section and in intensive care.
2.
BEFORE YOU USE PANCURONIUM BROMIDE INJECTION
DO NOT USE PANCURONIUM BROMIDE INJECTION

if you have shown signs of hypersensitivity (severe allergy) to
pancuronium or
bromide in the past
Tell your doctor if the above applies to you before this medicine is
used.
TAKE SPECIAL CARE WITH PANCURONIUM BROMIDE 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:
myasthenia
gravis,
myasthenic syndrome (other neuromuscular diseases) or poliomyelitis

if you have fluid retention (you may have swelling around the ankles)

if you have jaundice
Tell your doctor if any of the above applies to you before this
medicine is used.
Page 2 of 5
Special care will also be taken in the elderly, newborn babies,
patients who are
dehydrated or in general poor health and patients who have blood
abnormalities, such
as altered calcium, magnesium, potassium and protein levels (the
doctor may do blood
tests to check for such abno

Summary of Product characteristics

OBJECT 1
PANCURONIUM BROMIDE 2 MG/ML INJECTION
Summary of Product Characteristics Updated 30-Mar-2017 | Hospira UK
Ltd
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.
ADULT:
Initial dose: 50-80 micrograms/kg (intubation accomplished within
150-120 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:
Doses of pancuronium in neonates up to one month of age must be
carefully individualised since neonates
are particularly sensit