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VECURONIUM SUN 10 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): VECURONIUM BROMIDE / VECURONIUM BROMIDE / VECURONIUM BROMIDE

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Medicines which increase the effect of Vecuronium
- certain medicines used to make you sleep during surgery (anaesthetics; for example suxamethonium)
- certain medicines to treat bacterial infections (antibiotics; for example aminoglycosides, lincosamide and polypeptide
antibiotics, acylamino-penicillin antibiotics)
- medicines which increase the amount of urine (diuretics or water tablets)
- medicines used for the treatment of heart disease or high blood pressure (calcium channel blockers, beta-blockers and
quinidine)
- medicines used to treat mania, manic depressive illness or depression (lithium)
- certain medicines used to treat stomach ulcers, heartburn or acid reflux (cimetidine)
- some laxatives such as magnesium salts
- long-term concomitant use of certain anti-inflammatory medicines (corticosteroids)
- certain medicines for reducing pain (local anaesthetics; for example lidocaine)
- short-term concomitant use of certain medicines used for epilepsy (phenytoin).

Package leaflet: Information for the user

Vecuronium 10 mg powder for solution for injection/infusion
vecuronium bromide
Read all of this leaflet carefully before you are given 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, pharmacist or nurse. This includes any possible side effects not listed in
this leaflet. See section 4.

Medicines which decrease the effect of Vecuronium
- certain medicines used for epilepsy (for example phenytoin or carbamazepine)
- calcium chloride and potassium chloride.

What is in this leaflet
1. What Vecuronium is and what it is used for
2. What you need to know before you are given Vecuronium
3. How Vecuronium is used
4. Possible side effects
5. How to store Vecuronium
6. Contents of the pack and other information

Medicines with variable effect
- other muscle relaxants.
Effect of Vecuronium on other drugs
- Vecuronium may make certain anaesthetics (for example lidocaine) work more quickly.

1. What Vecuronium is and what it is used for

Your doctor will take this into account when deciding the correct dose of Vecuronium for you.

Vecuronium contains the active substance vecuronium bromide, which belongs to a group of medicines called muscle
relaxants.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor,
pharmacist or nurse for advice before you are given this medicine.

Muscle relaxants are used during an operation as part of a general anaesthetic. When you have an operation your
muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation. Vecuronium is used as
a muscle relaxant in adults, in children and adolescents (2-17 years) and in newborn babies and infants (0 days –
23 months).

Your doctor may still give you Vecuronium, but you need to discuss it first. Vecuronium may be given to you if you are
having a Caesarean section.
Driving and using machines
Do not drive or use machines until advised it is safe to do so. Because Vecuronium is given as part of a general
anaesthetic, you may feel tired, weak or dizzy for some time afterwards. Your anaesthetist will be able to advise you on
how long the effects are likely to last.

Normally, your nerves send messages called impulses to your muscles. Vecuronium acts by blocking these impulses so
that your muscles relax. Because your breathing muscles also relax, you will need help to breathe (artificial ventilation)
during and after your operation until you can breathe on your own again.
During the operation your doctor will keep a check on the effect of the muscle relaxant, and if necessary will give you
some more. At the end of surgery, the effects of the drug are allowed to wear off and you will start breathing on your
own. Sometimes the doctor will give you another drug to help speed this up.

3. How Vecuronium is used
Follow carefully all instructions given to you by your doctor or nurse. Check with your doctor or nurse if you are not sure.

2. What you need to know before you are given Vecuronium
You must not be given Vecuronium
- if you are allergic to vecuronium, the bromide ion or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Vecuronium
- if you are allergic to any muscle relaxants
- if you have reduced renal function or a renal disease
- if you have a heart disease or a disease affecting your blood circulation
- if you have an accumulation of fluid beneath the skin (for example swelling of the ankles)
- if you have a liver or a gallbladder disease
- if you have diseases affecting nerves and muscles (for example polio (poliomyelitis), myasthenia gravis, Eaton-Lambert
syndrome).

You may be given additional doses if they are needed. The dose that you receive will depend on various factors. These
include possible interactions with any other drugs you may have been given, the expected duration of the operation,
your age and the state of your health.
How Vecuronium is given
Vecuronium will be given to you by your doctor. Vecuronium is given intravenously (into a vein), either as single injections
or as a continuous infusion (a drip).
If you are given more Vecuronium than you should be
As your doctor will be monitoring your condition carefully it is unlikely that you will be given too much Vecuronium.
However if this happens, your doctor will keep you breathing artificially (on a ventilator) until you can breathe on your
own. It is possible to counteract the effects (too much) Vecuronium and speed-up your recovery by giving you a drug that
reverses the effect of Vecuronium. You will be kept asleep while this takes place.

Some conditions may influence the effects of Vecuronium, for example
- low potassium levels in the blood (hypokalaemia; caused for example by severe vomiting or by severe diarrhoea)
- high magnesium levels in the blood (hypermagnesaemia)
- low calcium levels in the blood (hypocalcaemia; caused by blood transfusion)
- low levels of proteins in the blood (hypoproteinaemia)
- loss of too much water from the body (dehydration; caused for example by being sick, diarrhoea or sweating)
- over-breathing (hyperventilation) leading to too little carbon dioxide in the blood (alkalosis)
- too much acid in the blood or body tissue (acidosis)
- an increased level of carbon dioxide in the blood (hypercapnia)
- general ill-health (cachexia)
- being very overweight (obesity)
- burns
- drop in body temperature (hypothermia) during anaesthesia.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If these side effects occur
while you are under anaesthetic, they will be seen and treated by your doctor.

Compatibility studies with other infusion
fluids have not been performed.

Compatibilities
When Vecuronium is reconstituted with
water for injections, the resultant solution
can be mixed with the following infusion
fluids, packed in PVC or glass, to a dilution up
to 40 mg/litre
- 0.9% NaCl solution
- 5% glucose solution
- Ringer's solution
- Ringer's glucose.

Alternatively, in order to obtain a solution
with a lower concentration Vecuronium may
be reconstituted with a volume up to 10 ml
of the following infusion fluids
- 5% glucose injection fluid
- 0.9% sodium chloride injection fluid
- lactated Ringer's solution
- lactated Ringer's injection and 5% glucose
- glucose 5% and 0.9% sodium chloride
injection
- water for injections.

Reconstitution
Addition of 5 ml water for injections results in
a solution of pH 4 and osmolality of 200
mOsm/kg containing 2 mg vecuronium
bromide per ml (2 mg/ml), each vial contains
10 mg vecuronium bromide which is
equivalent to 8.75 mg of vecuronium.

Vecuronium should be administered
following reconstitution. Vecuronium is
administered intravenously either as a bolus
injection or as a continuous infusion.

How to prepare and administer
Vecuronium

The following information is intended for
healthcare professionals only

vecuronium bromide

044BP2535A

Other medicines and Vecuronium
Tell your doctor or pharmacist if you are taking, have recently taken, or might take, any other medicines. Vecuronium may
affect other medicines or be affected by them.

The above-mentioned reconstituted solution
can also be injected in to the line of a
running infusion of the following fluids
- lactated Ringer's solution
- lactated Ringer's solution and 5% glucose
- glucose 5% and 0.9% sodium chloride
solution
- haemaccel
- dextran-40 5% in 0.9% sodium chloride
solution
- water for injections.

Uncommon/rare side effects (may affect up to 1 in 100 people)
- the drug is too effective, or not effective enough
- the drug works for longer than expected
- lowering of blood pressure (hypotension)
- increase in heart rate (tachycardia)
- delayed recovery from anaesthesia.

If you have any of the conditions listed above, your doctor will take them into account when deciding the correct dose of
Vecuronium for you.

Vecuronium 10 mg powder
for solution for
injection/infusion

430 mm

How much and when Vecuronium is given
Vecuronium can be used in adults and children of all ages. The dose will be determined by the doctor. You will be given
Vecuronium before or during a surgical procedure. The usual dose is 0.08 to 0.1 mg vecuronium bromide per kg body
weight and the effect will last for 24 to 60 minutes. During the procedure it will be checked whether Vecuronium is still
working.

350 mm
FONTS SPECIFICATION

Folding
350--3 zigzag--58.33 mm
430--8 zigzag--48mm

Patient info. Leaflet

Myriad Pro - 10 pt

Title and Title Heading

Myriad Pro - 13 pt and 11 pt

Body Text

Myriad Pro - 9 pt

Line Spacing 1.5 mm

Size: 350x430 mm
SUN EUROPE
EUUK - UNITED KINGDOM

Name of Product:
Vecuronium SUN 10 mg powder for solution for injection

AWS TYPE

Country

PIL

EUUK - UNITED KINGDOM

Language
English

Code

044BP2535A

Void artwork Code No:

CD-PDD-

Actual Size

350 x 430 mm

Reason:

REMARKS:

Location
SPIL - Halol

No. of Colors : 1
Specification / Type of paper
Color codes:
Super Fine 41 GSM ITC Paper

Folding
350--3 zigzag--58.33 mm
430--8 zigzag--48mm

BLACK

Prepared by

Artwork Prepared by :
Sun Pharmaceutical Industries Limited
Packaging Development Department [PDD]
SPIL - Vadodara
Checked by

Approved by

Approval History attached

Approved by RA

100

95

75

25

5

0

Vecuronium SUN 10 mg pwd for soln for inj-PIL-EUUK-350x430mm-29-09-16
29\09\2016 6:14:58 PM

Blank Area
Do not print here

Very rare side effects (may affect up to 1 in 10,000 people)
- allergic (hypersensitivity) reactions (such as rash, itching, difficulty in breathing or swelling of the face, lips, throat or
tongue)
- muscle weakness or paralysis
- failure of circulation (circulatory collapse and shock)
- excessive blushing
- tightness of the chest, associated with coughing, wheezing or breathlessness immediately after inhalation
(bronchospasm)
- rapid swelling under the skin (angioneurotic oedema)
- skin rash, sometimes with intense itching and hives
- rash or redness of the skin (erythematous rash)
- swelling of the face (face oedema)
- pain near the site of injection
- airway complication of anaesthesia
- prolonged muscle disorder usually seen after the use of Vecuronium in combination with steroids (corticosteroids
including an inflammatory effect) in severe ill patients (steroid myopathy).
Reporting of side effects
If you get any side effects, talk to your doctor , pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Vecuronium
Your doctor, pharmacist or nurse knows how to store Vecuronium properly.
Keep this medicine out of the sight and reach of children.
This medicine must not be used after the expiry date which is stated on the carton and vial after EXP. The expiry date
refers to the last day of that month.
Do not store above 25°C.
Chemical and physical in-use (i.e. following reconstitution) stability has been demonstrated for 24 hours at 15 to 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at
2 to 8°C.

6. Contents of the pack and other information
What Vecuronium contains
- The active substance is vecuronium bromide. Each vial contains vecuronium as 10 mg vecuronium bromide.
- The other ingredients are citric acid anhydrous, disodium phosphate anhydrous, mannitol (E421), sodium hydroxide
(for pH adjustment) and phosphoric acid concentrated (for pH adjustment).

430 mm

What Vecuronium looks like and contents of the pack
Vecuronium is a white to off-white lyophilised powder, for solution for injection/infusion.
Vecuronium is supplied in packs containing 1, 4, 10 or 20 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Suppliers LOGO / ID here

This medicinal product is authorised in the Member states of the EEA under the following names
Germany:
Vecuronium SUN 10 mg Pulver zur Herstellung einer Injektions/Infusionslösung
The Netherlands:
Vecuronium SUN 10 mg poeder voor oplossing voor injectie en intraveneuze infusie
United Kingdom
Vecuronium 10 mg powder for solution for injection/infusion

044BP2535A

This leaflet was last revised in September 2016.

350 mm

Folding
350--3 zigzag--58.33 mm
430--8 zigzag--48mm

Size: 350x430 mm
SUN EUROPE
[COMMON]

100

95

75

25

5

0

Vecuronium SUN 10 mg pwd for soln for inj-PIL-EUUK-350x430mm-29-09-16
29\09\2016 6:14:58 PM

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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