Patient Information Leaflet: Information for the user
Anectine 50 mg/ml Solution for Injection or Infusion
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, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
In this leaflet:
What Anectine is and what it is used for
What you need to know before you have Anectine
How to have Anectine
Possible side effects
How to store Anectine
Contents of the pack and other information
1. What Anectine is and what it is used for
Anectine contains a medicine called suxamethonium chloride. This belongs to a group of
medicines called muscle relaxants.
Anectine is used:
to relax muscles during operations on adults and children
to help insert a tube into the windpipe (endotracheal intubation), if a person needs help to
to reduce how strongly your muscles contract
Ask your doctor if you would like more explanation about this medicine.
2. What you need to know before you have Anectine
Do not use Anectine if:
you are allergic to suxamethonium chloride or any of the other ingredients of Anectine injection
(listed in section 6).
you or a family member have reacted badly to an anaesthetic before, such as a very high body
temperature (malignant hyperthermia) or a long pause in breathing (prolonged apnoea).
you have severe liver or kidney problems.
you have had a major accident, operation or severe burns within the last three months.
you have not been able to move for a long time such as to allow a broken bone to mend or a
long period of bed rest.
you have high levels of potassium in your blood (hyperkalaemia).
you have recently had an eye injury.
you suffer from a problem caused by too much pressure in your eye called ‘glaucoma’.
you or a family member have an inherited condition which effects the muscles such as
myotonia congenita or dystrophia myotonica.
you have a disease of the muscles or nerves, such as a muscle wasting disease, paralysis,
motor neurone disease, muscular dystrophy or cerebral palsy.
you have a genetic defect in an enzyme found in the liquid part of your blood (plasma
Anectine should not be given to you unless you are fully anaesthetised.
Do not use Anectine if any of the above apply to you. If you are not sure, talk to your doctor, nurse
or pharmacist before you have Anectine.
Warnings and precautions
Anectine should only be given to you by a person who is qualified to do so. It will not be used on
its own to put you asleep before an operation. It will be used in combination with other medicines.
Anectine rapidly decomposes in the body and this can lead to rapid recovery of muscle function.
Talk to your doctor, nurse or pharmacist before having Anectine if you have:
an allergy to any other muscle relaxants
tetanus, an infection which occurs through wound contamination.
tuberculosis or other severe or long standing infection
had any long standing illness which has left you weak
you are suffering from cancer
you are suffering from anaemia
you suffer from malnutrition
liver or kidney problems
auto-immune diseases, for example, multiple sclerosis
an underactive thyroid gland, a condition known as myxoedema
collagen diseases such as systemic lupus erythematosus, rheumatoid arthritis, rheumatic
fever, polymyositis, and dermatomyositis
muscle disease, for example, myasthenia gravis
recently had a blood transfusion or a heart-lung by pass
been in contact with insecticides
recently received radiation therapy
unexplained loss of weight
an imbalance in your body's blood chemistry
a bone injury or muscle tightness in the area of the injury
given birth in the last six weeks
If you are elderly (over 65 years) check with your doctor, nurse or pharmacist before having this
medicine as it may be linked to a temporary problem with the rate or rhythm of the heartbeat,
especially if you are also taking medicines similar to digitalis.
Care should be taken when using Anectine in newborn babies and children.
Other medicines and Anectine
Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any
other medicines. This includes medicines obtained without a prescription, including herbal
medicines. This is because these medicines can affect how well Anectine works or can cause side
In particular tell your doctor, nurse or pharmacist if you are taking any of the following:
anaesthetics, or other medicines used during surgery such as ketamine, pethidine,
pancuronium, morphine and morphine antagonists, halothane, enflurane, desflurane,
isoflurane, diethylether and methoxyflurane
medicines for raised pressure in the eye (glaucoma) such as ecothiophate eye drops
medicines for allergies such as diphenhydramine or promethazine
medicines for treating asthma and other breathing conditions such as terbutaline
medicines containing metoclopramide, used to treat and prevent feeling or being sick
medicines for treating cancer (cytotoxic drugs) such as cyclophosphamide, mechlorethamine,
triethylenemelamine and thio-tepa
medicines for treating mental illnesses, such as phenelzine, promazine, chloropromazine,
lithium carbonate or selective serotonin reuptake inhibitors
medicines containing magnesium such as indigestion medicines
medicines containing oestrogen such as oral contraceptive pills
medicines containing steroids
antibiotics such as aminoglycosides, clindamycin and polymyxins
medicines used to treat disturbances in heartbeat rhythm such as quinidine, procainamide,
verapamil, lidocaine, procaine and beta blockers (anti-arrhythmic drugs)
medicines used to treat myasthenia gravis such as neostigmine, pyridostigmine, edrophonium,
and tacrine hydrochloride
medicines used to treat Alzeimher’s disease such as physostigmine,
medicines used to control your heart such as digitalis
medicines used during surgery to control your blood pressure, such as trimetaphan, or to
reduce bleeding, such as aprotinin
medicines that can affect the way your body fights disease (immunosuppressants) such as
azathioprine. These can be used to stop your body rejecting a transplanted organ or for ‘auto-
immune’ diseases such as rheumatoid arthritis
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 or pharmacist for advice before taking this medicine.
Driving and using machines
Do not drive or operate machinery after having this medicine. Your doctor will tell you when it is
safe to do so again. It is recommended that you arrange for someone to accompany you home
from the hospital.
3. How to have Anectine
How your injection is given
You will never be expected to give yourself this medicine. It will always be given to you by a person
who is qualified to do so.
Anectine can be given;
as a single injection into your vein (intravenous bolus injection)
as a continuous infusion into your vein. This is where the drug is slowly given to you over a long
period of time.
In children, Anectine can also be given as a single injection into a muscle (intramuscular bolus
Your doctor will decide the way you are given the drug and the dose you will receive. It will depend
your body weight
the amount of muscle relaxation you require
your expected response to the medicine
If you receive more Anectine than you should
Anectine will always be given under carefully controlled conditions. However, if you think that you
have been given more than you should tell your doctor or nurse immediatley.
4. Possible side effects
Like all medicines, Anectine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Allergic reactions are very rare (they affect less than 1 in 10,000 people).
If you have an allergic reaction, tell your doctor or nurse straight away. The signs may include:
sudden wheeziness, chest pain or chest tightness
swelling of your eyelids, face, lips, mouth or tongue
a lumpy skin rash or ‘hives’ anywhere on your body
Very common (affects more than 1 in 10 people)
abdominal cramps or pain and a feeling of nausea or “fullness”
visible twitching of muscle under the skin
muscle pain after the operation – your doctor will monitor you for this
Common (affects less than 1 in 10 people)
raised pressure of fluid in the eye which may cause headache or blurred vision
speeding up or slowing down of your heart rate
high level of potassium in your blood
high/low blood pressure
protein in the blood or urine due to muscle damage
Rare (affects less than 1 in 1,000 people)
abnormal heart rhythm
heart problems including changes in the way in which your heart beats or your heart stopping
difficulty in breathing or temporary loss of breath
difficulty in opening your mouth
Very rare (affects less than 1 in 10,000 people)
high body temperature
Frequency not known
excessive production of saliva
breakdown of muscle fibres (rhabdomyolysis) which may make your muscles ache or feel
tender, stiff and weak. Your urine may also look dark or be red or cola coloured
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
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1
6762517. Website: www.hpra.ie; E-mail:email@example.com.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Anectine
Keep out of the sight and reach of children.
Do not use Anectine after the expiry date which is stated on the pack. The expiry date refers to
the last day of the month.
Anectine is supplied as a clear, colourless solution. Do not use if it looks different to normal.
Store in a refrigerator, between 2 and 8°C. Do not freeze.
Store in the original package to protect from light.
6. Contents of the pack and other information
What Anectine contains
The active substance is suxamethonium chloride.
The other ingredient is water for injections.
What Anectine looks like and contents of the pack
Anectine 50 mg/ml Solution for Injection or Infusion is supplied as a clear, colourless solution in a
neutral glass, 2 ml ampoule. Each 2 ml ampoule contains 100 mg Suxamethonium Chloride. Each
pack contains 5 ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest
Business Campus, Dublin 24, Ireland
Tel: +353 1 6 308 400 (Ireland)
Tel: +356 21 497 982 (Malta)
Manufacturer: GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana 90, 43056 San
Polo di Torrile, Parma, Italy.
Aspen Pharma Ireland Limited, One George’s Quay Plaza, Dublin 2, Ireland
This leaflet was last revised in February 2019
Anectine is a trade mark of the Aspen group.
© 2017 Aspen group of companies. All rights reserved.
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
(Please refer to the Summary of Product Characteristics for further information)
Anectine 50 mg/ml Solution for Injection or Infusion (suxamethonium
Anectine 50 mg/ml Solution for Injection or Infusion
Posology and method of administration
Instructions for use
The dose of Anectine Injection is dependent on age, body weight, the degree of muscle relaxation
required and the route of administration.
The usual method of Anectine Injection administration is by bolus intravenous injection.
Use by intravenous bolus injection
Dosage in adults: A single intravenous dose of suxamethonium chloride dihydrate of approximately
1mg/kg bodyweight will usually provide profound neuromuscular blockade and good conditions for
tracheal intubation within 30-60 seconds of its administration. The duration of clinically useful
neuromuscular relaxation produced by this dose is on average 2-6 minutes, although wide inter-
patient variability exists.
Larger single doses of Anectine Injection may slightly accelerate the speed at which
neuromuscular paralysis develops, and will produce longer durations of clinically useful muscle
relaxation but not in a direct dose-dependent manner; doubling the dose of Anectine Injection does
not necessarily double the duration of relaxation.
Supplementary intravenous doses of Anectine Injection of 50-100% of the initial dose may be
administered for the maintenance of muscle relaxation during short surgical or other procedures
performed under general anaesthesia, at intervals of 5-10 minutes as required. During
administration of Anectine Injection by repeated intravenous bolus injection, the total dose should
not exceed 500mg per hour.
Dosage in children: Compared with adults, infants and young children are more resistant to the
neuromuscular blocking effects of suxamethonium on a mg per kg bodyweight basis.
In neonates and infants, the recommended intravenous bolus dose of Anectine Injection is 2mg/kg
bodyweight. A dose of 1mg/kg bodyweight in an older child is recommended.
Dosage in the elderly: Dosage requirements of Anectine Injection in the elderly are comparable to
those of younger adults (see Dosage in adults).
Administration of Anectine Injection may be associated with transient cardiac arrhythmias; the
elderly may be more susceptible to such arrhythmias especially if digitalis-like drugs are also being
Use by intramuscular bolus dosing
Dosage in children: Anectine Injection may be administered intramuscularly at doses up to 4-
5mg/kg bodyweight in infants and up to 4mg/kg bodyweight in older children. The onset of clinically
useful neuromuscular relaxation following intramuscular administration of Anectine Injection is
apparent within about 3 minutes.
Not more than 150mg total dose should be given.
Use by intravenous infusion
Dosage in adults and children: For prolonged surgical procedures in adults and older children,
Anectine Injection may be administered by intravenous infusion as a 0.1% (1mg/ml) or 0.2%
(2mg/ml) solution of suxamethonium chloride dihydrate in sterile 5% glucose solution or sterile
0.9% w/v saline solution.
In adults, the initial rate of infusion of Anectine Injection should be 36 micrograms/kg/min to 57
micrograms/kg/min (2.15mg/kg/hr to 3.42mg/kg/hr). A proportionately lower initial infusion rate
based on bodyweight should be used in children. The infusion rate should thereafter be adjusted
in accordance with the response of each individual patient.
Dosage requirements of Anectine Injection may increase with time during intravenous infusion.
During administration of Anectine Injection by intravenous infusion, the total dose should not
exceed 500mg per hour.
Dosage in the elderly: In the absence of specific dosage studies for the elderly, refer to Dosage in
adults and children and Section 4.4 of the Summary of Product Characteristics.
Dosage in renal impairment: A normal single dose of Anectine Injection may be administered to
patients with renal insufficiency in the absence of hyperkalaemia. Multiples or larger doses may
cause clinically significant rises in serum potassium and should not be used.
Dosage in hepatic impairment: Termination of the action of suxamethonium is dependent on
plasma cholinesterase, which is synthesised in the liver. Although plasma cholinesterase levels
often fall in patients with liver disease, levels are seldom low enough to significantly prolong
Dosage in patient with reduced plasma cholinesterase: Patients with reduced plasma
cholinesterase activity may experience prolonged and intensified neuromuscular blockade
following administration of suxamethonium. In these patients it may be advisable to administer
reduced dosages of Anectine Injection.
Monitoring advice: Monitoring of neuromuscular function is recommended during infusion of
Anectine Injection or if Anectine Injection is to be administered in relatively large cumulative doses
over a relatively short period of time in order to individualise dosage requirements.
Symptoms and signs:
Apnoea and prolonged muscle paralysis are the main and serious effects of overdosage.
In such cases it is essential to maintain a patent airway together with assisted ventilation until
spontaneous respiration returns.
The decision to use neostigmine to reverse a phase II suxamethonium-induced block depends on
the judgement of the clinician in the individual case. Valuable information in regard to this decision
will be gained by monitoring neuromuscular function. If neostigmine is used its administration
should be accompanied by appropriate doses of an anticholinergic agent such as atropine.
Shelf life and special precautions for storage
Store between 2-8°C. Store in the original container. Do not freeze.
Instructions for use and handling
No special requirements for disposal. Any unused medicinal product or waste material should be
disposed of in accordance with local requirements
Anectine injection may be administered by intravenous infusion as a 0.1% (1mg/ml) or 0.2%
(2mg/ml) solution of suxamethonium chloride dihydrate in sterile 5% glucose solution or sterile
0.9% w/v saline solution.
Instructions to open the ampoule:
Ampoules are equipped with the OPC (One Point Cut) opening system and must be opened
following the below instructions:
Hold with the hand the bottom part of the ampoule.
Put the other hand on the top of the ampoule positioning the thumb above the coloured point