Anectine 50mg/ml solution for injection or infusion

Main information

  • Trade name:
  • Anectine 50mg/ml solution for injection or infusion
  • Dosage:
  • 50 milligram(s)/millilitre
  • Pharmaceutical form:
  • Solution for injection/infusion
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Anectine 50mg/ml solution for injection or infusion
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Choline derivatives; suxamethonium

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Marketed
  • Authorization number:
  • PA1691/033/001
  • Authorization date:
  • 01-04-1979
  • Last update:
  • 21-03-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Patient Information Leaflet: Information for the user

Anectine 50 mg/ml Solution for Injection or Infusion

(suxamethonium chloride)

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

breathe

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

cholinesterase).

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:

blood poisoning

an allergy to any other muscle relaxants

tetanus, an infection which occurs through wound contamination.

tuberculosis or other severe or long standing infection

severe burns

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.

Children

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

effects.

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

injection).

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

a collapse

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

skin flushing

skin rash

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

beating

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

Ireland

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1

6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

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

chloride)

Pharmaceutical form

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

taken.

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

suxamethonium-induced apnoea.

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.

Overdose

Symptoms and signs:

Apnoea and prolonged muscle paralysis are the main and serious effects of overdosage.

Management:

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

18 months.

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

and press.