Atracurium kalceks

Package leaflet: Information for the patient

Atracurium Kalceks, 10 mg/ml, solution for injection/infusion
Atracurii besilas
Please read carefully the entire leaflet before use, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents

1. What Atracurium Kalceks is and what it is used for
2. Important information before using Atracurium Kalceks
3. How to use Atracurium Kalceks
4. Possible side effects
5. How to store Atracurium Kalceks
6. Contents of the pack and other information

1. What Atracurium Kalceks is and what it is used for

Atracurium Kalceks belongs to a group of medicines commonly known as muscle relaxants.
Atracurium Kalceks is used during surgical procedures to relax skeletal muscles, to facilitate tracheal intubation and controlled ventilation. It is also used to facilitate mechanical ventilation in patients in intensive care units.

2. Important information before using Atracurium Kalceks

When not to use Atracurium Kalceks:

• if the patient is allergic to atracurium besilate, cisatracurium, or any of the other ingredients of this medicine (listed in section 6).

If this applies to the patient, inform the doctor before administering Atracurium Kalceks.

Warnings and precautions

Before starting treatment with Atracurium Kalceks, discuss with the doctor or nurse:

• if the patient has allergies or bronchial asthma;
• if the patient has ever had an allergic reaction to other medicines similar to Atracurium Kalceks that block nerve-to-muscle impulse transmission;
• if the patient is weakened, has muscle fatigue, or impaired movement coordination (myasthenia gravis);
• if the patient has a neuromuscular disorder;
• if the patient has heart disease or is sensitive to drops in blood pressure;
• if the patient has electrolyte imbalances (abnormal levels of ions such as sodium, potassium, or chloride in the blood);
• if the patient has recently suffered severe burns requiring medical treatment.

If any of the above conditions apply, inform the doctor.

Children

This medicine is not intended for children under 1 month of age.

Atracurium Kalceks and other medicines

Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Some medicines may affect the action of Atracurium Kalceks. Inform the doctor if the patient is taking any of the following medicines:

• anaesthetics (used to reduce consciousness and pain during surgery), such as halothane, isoflurane, enflurane, or ketamine;
• antibiotics (used to treat infections), such as aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin, and clindamycin;
• antiarrhythmics (used to treat heart rhythm disorders), such as propranolol, oxprenolol, calcium channel blockers, lidocaine, procainamide, and quinidine;
• diuretics (water pills), such as furosemide, mannitol, thiazide diuretics, and acetazolamide;
• magnesium salts (used to prevent magnesium deficiency);
• medicines used to treat psychiatric disorders, such as lithium or chlorpromazine;
• medicines used to treat high blood pressure (hypertension), such as trimethaphan, hexamethonium;
• medicines used to treat joint inflammation (rheumatic diseases), such as chloroquine and penicillamine;
• medicines used to treat Alzheimer's disease, such as donepezil;
• steroids (used to treat inflammation or asthma), such as prednisolone;
• medicines used to treat seizures (epilepsy), such as phenytoin.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine. The doctor will weigh the benefits against the risks before administering Atracurium Kalceks.

Atracurium Kalceks may be used to maintain muscle relaxation during caesarean section.

Driving and operating machinery

Atracurium Kalceks has a major influence on the ability to drive and operate machinery. Consult with the doctor to determine when it is safe to resume driving and operating machinery.

Do not drive or operate machinery if the patient feels unwell.

3. How to use Atracurium Kalceks

Atracurium Kalceks is used during procedures where the patient is anaesthetised
(unconscious) or heavily sedated. This medicine will always be administered under the supervision
of an experienced physician.
What dose is given
The doctor will determine the correct dose of Atracurium Kalceks based on:

• the patient's body weight;
• the required extent and duration of muscle relaxation;
• the expected response (reaction) of the patient to the administration of the medicine.

How Atracurium Kalceks is administered
Atracurium Kalceks is given as a single intravenous injection or as an intravenous infusion
(usually by means of an infusion pump). In this case, the medicine is administered slowly over a defined
time period.
Instructions for opening the ampoule:

1. Position the ampoule so that the coloured dot is at the top. If any of the solution is in the upper
   part of the ampoule, gently tap the ampoule with your finger so that all the solution collects in the
   bottom part.
2. Use both hands to open: hold the lower part of the ampoule in one hand and with the other hand
   snap off the top part of the ampoule in the direction opposite to the coloured dot (see illustrations below).

Use in children
This medicine must not be used in children under 1 month of age.
Accidental overdose of Atracurium Kalceks
This medicine is administered only by appropriately trained doctors. Since the medicine is given to the
patient during a hospital stay, it is unlikely that the patient will receive too little or too much medicine. However, if the patient has any concerns, the doctor or medical staff should be informed immediately. In the event of an overdose, appropriate measures will be initiated immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following adverse reactions, contact a doctor immediately:

• severe allergic reaction – the patient may develop sudden, itchy rash, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), the patient may feel faint;
• shock;
• heart failure;
• cardiac arrest.
  The adverse reactions listed above are very rare. The patient may require immediate medical assistance.

If the patient experiences any of the following adverse reactions, inform the doctor as quickly as possible:

Common adverse reactions (may occur in up to 1 in 10 patients):

• low blood pressure (hypotension), usually mild and transient;
• skin flushing.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• breathing difficulties and wheezing (bronchospasm).

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• seizures;
• muscle disorders (myopathy), muscle weakness.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform the doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Atracurium Kalceks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label after:
"EXP" and on the cardboard box after: "Expiry date (EXP)". The expiry date refers to the last
day of the stated month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original packaging to protect from light.
For single use only. After opening, the medicine should be used immediately.
Before use, inspect the solution carefully. Use only clear solutions without visible particles.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Atracurium Kalceks contains

• The active substance is atracurium besilate. 1 ml of solution contains 10 mg of atracurium besilate. One vial (2.5 ml) contains 25 mg of atracurium besilate. One vial (5 ml) contains 50 mg of atracurium besilate.
• The other components are: benzenesulfonic acid (for pH adjustment), water for injections.

What Atracurium Kalceks looks like and contents of the pack
A clear, colourless to slightly yellow solution, free from visible particles.
2.5 ml or 5.0 ml solution in 5.0 ml vials made of colourless glass (type I).
Vials are packed in PVC blisters. The blister is packed in a cardboard box.
Pack sizes: 1 or 5 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AS KALCEKS
Krustpils iela 71E
1057 Rīga
Latvia
Tel.: +371 67083320
E-mail: [email protected]

Manufacturer
Akciju sabiedrība “Kalceks”
Krustpils iela 71E
1057 Rīga
Latvia

This medicinal product is authorised in the European Economic Area and the United Kingdom under the following names:
Bulgaria Atracurium Kalceks 10 mg/ml инжекционен/инфузионен разтвор
Belgium Atracurium Kalceks 10 mg/ml solution injectable/pour perfusion
Atracurium Kalceks 10 mg/ml oplossing voor injectie/infusie
Atracurium Kalceks 10 mg/ml Injektions-/Infusionslösung
Czech Republic Atracurium Kalceks
Estonia Atracurium besilate Kalceks
France ATRACURIUM KALCEKS 10 mg/ml, solution injectable/pour perfusion
Hungary Atracurium besilate Kalceks 10 mg/ml oldatos injekció/infúzió
Ireland Atracurium besilate 10 mg/ml solution for injection/infusion
Latvia Atracurium besilate Kalceks 10 mg/ml šķīdums injekcijām/infūzijām
Lithuania Atracurium besilate Kalceks 10 mg/ml injekcinis ar infuzinis tirpalas
Malta Atracurium Kalceks 10 mg/ml solution for injection/infusion
Netherlands Atracurium Kalceks 10 mg/ml oplossing voor injectie/infusie
Poland Atracurium Kalceks
Romania Atracurium Kalceks 10 mg/ml soluție injectabilă/perfuzabilă
Slovakia Atracurium Kalceks 10 mg/ml injekčný/infúzny roztok
Spain Besilato de Atracurio Kalceks 10 mg/ml soluciόn inyectable y para perfusiόn
EFG
Sweden Atracurium Kalceks 10 mg/ml injektions-/infusionsvätska, lösning
United Kingdom (Northern Ireland) Atracurium besilate 10 mg/ml solution for injection/infusion

Information intended exclusively for healthcare professionals:

For single use only. After opening, the medicinal product should be used immediately.
From a microbiological standpoint, the medicinal product should be used immediately unless the
method of dilution excludes the risk of microbiological contamination. If not used immediately, the
user is responsible for the storage time and conditions.
Atracurium besylate undergoes inactivation at high pH; therefore, it must not be mixed in the same
syringe with thiopental or other alkaline medicinal products.
When a small-caliber vein is selected as the injection site, the vein should be flushed with
isotonic sodium chloride solution after administration of Atracurium Kalceks. When Atracurium Kalceks and other anesthetic medicinal products are administered through a permanently placed needle or cannula, the line should be flushed with an appropriate volume of isotonic sodium chloride solution after each medicinal product is injected.
Since Atracurium Kalceks is a hypotonic solution, it must not be administered through a cannula used for blood transfusion.
Atracurium Kalceks may be diluted with the following infusion fluids.

After dilution with one of the mentioned fluids so that the concentration of atracurium besilate is 0.5 mg/ml or higher, the resulting solutions are stable in daylight as indicated above, provided they are stored at a temperature below 25°C.