50 mg / ml injection solution 
suxametoniumklorid

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Celocurin is and what it is used for 
2. What you need to know before you get Celocurin 
3. How to take Celocurin 
4. Possible side effects 
5. How to store Celocurin 
6. Contents of the packaging and other information 

1. What Celocurin is and what it is used for

Celocurin contains the active substance suxamethonium chloride. Suxamethonium chloride belongs to a group of medicines called peripherally acting muscle relaxants that work by relaxing muscles.

Celocurin is generally used in case of muscle relaxation and when short-term action is desired, but especially in:

  • electroshock treatment,
  • intubation in the trachea (when a tube is inserted into the trachea to create a safe airway),
  • restoration of misaligned bones or joints after fractures and dislocations
  • X-ray examinations.

Suxamethonium chloride contained in Celocurin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Celocurin

You should not take Celocurin:

  • if you have major burns
  • if you have major tissue damage
  • if you have kidney failure which results in increased levels of potassium in your blood
  • if you have severe long-term sepsis
  • if you have very high levels of potassium in your blood
  • if you are allergic to suxamethonium chloride
  • if you have the hereditary muscle disease familial malignant hyperthermia.

Warnings and cautions

The use of Celocurin increases the level of potassium in the blood, which can have serious consequences in sensitive patients. This can manifest itself as slow heart rate, heart rhythm disturbances, and low blood pressure, but also as high heart rate and high blood pressure.

Suxamethonium chloride in Celocurin may also cause increased secretion of saliva, mucus in the lungs, and gastric juice, redness of the skin, respiratory cramps, and shock .

In rare cases, the heart rhythm can be affected and cause cardiac arrest.

Severe muscle problems due to (muscle weakness, tenderness, or pain) ( rhabdomyolysis ) together with acute renal failure and reddish-brown urine (the color is caused by protein et myoglobin) have been reported.

Children and young people

There is an increased risk of severe muscle problems due to abnormal muscle breakdown (muscle weakness, soreness or pain) ( rhabdomyolysis ) followed by arrhythmias, cardiac arrest, and death in children and adolescents with undiagnosed skeletal muscle myopathy (muscle problems such as muscle weakness, muscle aches, muscle aches).

Other medicines and Celocurin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Celocurine and atracurium (a muscle relaxant) should not be given at the same time as the effect of atracurium is enhanced and the effect of Celocurin is shortened.

Combination with the following drugs may require dose adjustment as they potentiate and/or prolong the effect of Celocurin:

  • plasma cholinesterase inhibitors, such as bambuterol (used to treat asthma ), donepezil, galantamine, and rivastigmine (used to treat dementia),
  • azathioprine (used in transplantation and in autoimmune diseases),
  • ketamine (anesthetic, used for anesthesia).

Other drugs that can affect the effect of Celocurin are:

  • aminoglycoside is (a type of antibiotic ),
  • cyclophosphamide (used against cancer),
  • thiotepa (used for cancer),
  • metoclopramide (used to treat nausea and vomiting),
  • halothane (anesthetic, used for anesthesia)
  • lithium (used for mania and depression).

Pregnancy and breastfeeding

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.

Pregnancy

Celocurin can be broken down more slowly in the body during pregnancy. Suxamethonium chloride does not normally pass through the placenta in such large quantities that the fetus is affected, but in rare cases when the fetus is feared to have certain genetic predispositions (pseudocholinesterase deficiency), there is a risk of respiratory problems. Therefore, Celocurin should be used with caution during childbirth.

Breast-feeding

There is no information on whether suxamethonium chloride passes into breast milk.

Driving and using machines

No studies have been performed.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Celocurin contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per vial/vial, ie essentially ‘sodium-free’.

How to take Celocurin

Celocurin should only be given by doctors who are specially trained in the study of anesthesia methods. When Celocurin is given, respiratory aid and oxygen should always be available.

The dosage of Celocurin is specific to each patient and is determined by the doctor.

Celocurin should be given as an injection or infusion, ie through a needle that is inserted into one of your veins, but can in special situations be given as an injection into a muscle or into the cavity inside a skeletal bone.

If you take more Celocurin than you should

This is unlikely to happen because the dose you are given is monitored very closely.

However, if you accidentally take an overdose, you may experience respiratory arrest. In this case, the doctor immediately takes the necessary action.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 user in 10):

  • muscle soreness/pain

Common (may affect up to 1 in 10 people):

  • drop in blood pressure
  • heart rhythm disorders
  • slow heart rate
  • release of histamine
  • increased pressure in the eye (this condition is rapidly transient)
  • increase in potassium levels in the blood

Rare (may affect up to 1 in 1,000 people) :

  • cardiac arrest
  • acute allergic reaction ( anaphylactic reaction )
  • malignant hyperthermia (muscle disease)
  • respiratory cramps

Has been reported (occurs in an unknown number of users) :

  • severe muscle problems due to abnormal muscle breakdown (muscle weakness, tenderness or pain) ( rhabdomyolysis )
  • acute renal failure and reddish-brown urine (the color is caused by protein et myoglobin)

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Celocurin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C-8 ° C). Can be stored in emergency bags and emergency bags and is then durable for 2 months when stored at room temperature.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is suxamethonium chloride. 1 ml contains 50 mg of suxamethonium chloride.
  • The other ingredients are succinic acid, sodium hydroxide, and water for injections.

What the medicine looks like and the contents of the pack

Clear, uncolored liquid.

The ampoule is 10 x 2 ml

Vials 10 x 10 ml

Vial 1 x 10 ml

Marketing Authorisation Holder

Meda AB

Box 906

170 09 Solna

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

02200 Espoo

Finland

Muhammad Nadeem

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