CISATRACURIO 2 mg /Ml Инъекционный Или Инфузионный Раствор

Сергей Ильясов

Сергей Ильясов — опытный врач-невролог и квалифицированный психиатр, предоставляющий онлайн-консультации для взрослых и подростков. Сочетая глубокую неврологическую экспертизу с современным психиатрическим подходом, он обеспечивает комплексную диагностику и эффективное лечение широкого спектра состояний, затрагивающих как физическое, так и психическое здоровье.

Доктор помогает пациентам в таких случаях:

Хронические головные боли (мигрень, головная боль напряжения), боли в спине, невропатические боли, головокружения, онемение конечностей, нарушения координации.
Тревожные расстройства (панические атаки, генерализованное тревожное расстройство), депрессия (в том числе атипичная и резистентная), нарушения сна (бессонница, сонливость, кошмары), стресс, выгорание.
Хронические болевые синдромы и психосоматические симптомы (например, синдром раздражённого кишечника на нервной почве, вегетососудистая дистония).
Поведенческие нарушения и трудности с концентрацией внимания у подростков (включая СДВГ, расстройства аутистического спектра), нервные тики.
Нарушения памяти, фобии, обсессивно-компульсивное расстройство (ОКР), эмоциональные качели, а также поддержка при посттравматическом стрессовом расстройстве (ПТСР).

Благодаря двойной специализации в неврологии и психиатрии, Сергей Ильясов предлагает интегрированную и доказательную помощь при сложных состояниях, требующих междисциплинарного подхода. Его консультации направлены на точную диагностику, разработку индивидуального плана лечения (включая фармакотерапию и психотерапевтические методики) и долгосрочную поддержку, адаптированную к уникальным потребностям каждого пациента.

Запишитесь на онлайн-консультацию с доктором Сергеем Ильясовым, чтобы получить квалифицированную помощь и улучшить своё самочувствие уже сегодня.

Записаться на онлайн-консультацию

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Инструкция по применению KISATRAKURIO KALKEKS

Содержание инструкции

Cisatracurio Kalceks 2 mg/mL injectable solution/infusion

Cisatracurio Kalceks 2 mg/mL injectable solution/infusion

Generic medicine

Read this leaflet carefully before you receive this medicine as it contains important
information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Cisatracurio Kalceks is and what it is used for
2. What you need to know before you receive Cisatracurio Kalceks
3. How Cisatracurio Kalceks is administered
4. Possible side effects
5. How to store Cisatracurio Kalceks
6. Contents of the pack and other information

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

Cisatracurio Kalceks contains a medicine called cisatracurium, which belongs to a group of
medicines called muscle relaxants.
Cisatracurio Kalceks is used:

to relax muscles during surgical procedures, including cardiac surgery, in adults and children over 1 month of age;
to facilitate the insertion of a tube into the trachea (tracheal intubation) if a person needs help breathing;
to relax the muscles of adults in intensive care.

If you would like more explanations about this medicine, please ask your doctor.

2. What you need to know before receiving Cisatracurio Kalceks

You must not receive Cisatracurio Kalceks

if you are allergic to cisatracurium, atracurium or benzenesulfonic acid or to any of the other ingredients of this medicine (listed in section 6).

If any of the above applies to you, tell your doctor or nurse before receiving Cisatracurio
Kalceks.

Warnings and precautions
Talk to your doctor or nurse before receiving Cisatracurio Kalceks:

if you have muscle weakness, fatigue or difficulty coordinating movements (myasthenia gravis);
if you have a neuromuscular disease, such as a disease that causes muscle atrophy, paralysis, motor neuron disease or cerebral palsy;
if you have a burn that requires medical treatment;
if you have a severe imbalance of acid-base and/or electrolyte balance;
if you have had an allergic reaction to any muscle relaxant administered during surgery in the past.

If you are not sure if any of the above applies to you, ask your doctor or nurse before receiving
Cisatracurio Kalceks.

Other medicines and Cisatracurio Kalceks
Tell your doctor if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines:

anaesthetics (used to reduce sensations and pain during surgical procedures);
some other medicines to relax muscles;
antibiotics (used to treat infections);
medicines for irregular heartbeat (antiarrhythmics);
medicines for high blood pressure;
diuretics such as furosemide;
medicines for joint inflammation, such as chloroquine or D-penicillamine);
steroids;
medicines for seizures (epilepsy), such as phenytoin or carbamazepine;
medicines for mental disorders, such as lithium or chlorpromazine (which can also be used for nausea);
medicines containing magnesium;
medicines for Alzheimer's disease (anticholinesterases, e.g. donepezil).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor for advice before receiving this medicine.

Driving and operating machinery
If your hospital stay lasts only one day, your doctor will tell you how long to wait before leaving the hospital
or driving. It may be dangerous to drive too soon after surgery.

3. How Cisatracurio Kalceks is administered

You should never administer the medicine to yourself, but will always receive it from a qualified person.
Cisatracurio Kalceks can be administered:

as a single injection into a vein (intravenous bolus injection);
as a continuous infusion into a vein. This means that the drug is administered slowly over a prolonged period.

The doctor will decide how to administer the drug and the dose. This will depend on:

body weight;
the extent and duration of muscle relaxation required;
your expected response to the medicine. Children under 1 month of age should not receive this medicine.

If you receive more Cisatracurio Kalceks than you should
This medicine will always be administered under carefully controlled conditions. However, if
you believe that you have been given an excessive amount, inform your doctor or
nurse immediately.

4. Possible side effects

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

Allergic reactions (may affect up to 1 in 10,000 people)
If you have an allergic reaction, tell your doctor or nurse immediately. Signs may
include:

sudden wheezing, chest pain or tightness in the chest;
swelling of the eyelids, face, lips, mouth or tongue;
skin rash with blisters or hives anywhere on the body;
collapse.

Tell your doctor or nurse if you notice any of the following effects:

Common (may affect up to 1 in 10 people)

decreased heart rate;
low blood pressure.

Uncommon (may affect up to 1 in 100 people)

skin rash or redness of the skin;
wheezing or cough.

Very rare (may affect up to 1 in 10,000 people)

muscle weakness or pain.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Cisatracurio Kalceks

Keep this medicine out of the sight and reach of children.
Store and transport in a refrigerator (2°C  8°C). Do not freeze.
Store in the original package to protect the medicine from light.
Shelf life after dilution
Chemical and physical stability in use has been demonstrated for 24 hours at a temperature of 2  8°C and 25°C.
From a microbiological point of view, unless the opening/dilution method precludes the risk of
microbial contamination, the medicine must be used immediately. If the medicine is not
used immediately, the storage times and conditions during use are the responsibility
of the user.
Do not use this medicine after the expiry date which is stated on the vial label and the carton
after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cisatracurio Kalceks contains

The active ingredient is cisatracurium (as besilate). Each mL of solution contains 2 mg of cisatracurium (as cisatracurium besilate). Each 2.5 mL vial contains 5 mg of cisatracurium. Each 5 mL vial contains 10 mg of cisatracurium. Each 10 mL vial contains 20 mg of cisatracurium.
The other ingredients are benzenesulfonic acid (for pH adjustment) and water for injections.

Description of the appearance of Cisatracurio Kalceks and contents of the pack
Clear, colorless to pale yellow solution, free from visible particles.
2.5 mL, 5 mL or 10 mL of solution in colorless glass vials, with OPC pre-break system.
The vials are marked with a specific color code ring for each volume.
Five vials are inserted in a PVC blister.
The blister is inserted in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AS KALCEKS
Krustpils iela 53, Rīga, LV  1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]

Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV  1057, Latvia

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Latvia Cisatracurium Kalceks 2 mg/ml šķīdums injekcijām/infūzijām
Austria Cisatracurium Kalceks 2 mg/ml Injektions-/Infusionslösung
Belgium Cisatracurium Kalceks 2 mg/ml, solution injectable/pour perfusion
Cisatracurium Kalceks 2 mg/ml, oplossing voor injectie/infusie
Cisatracurium Kalceks 2 mg/ml, Injektions-/Infusionslösung
Estonia Cisatracurium Kalceks
France CISATRACURIUM KALCEKS 2 mg/ml, solution injectable/pour perfusion
Hungary Cisatracurium Kalceks 2 mg/ml oldatos injekció/infúzió
Ireland Cisatracurium 2 mg/ml solution for injection/infusion
Italy Cisatracurio Kalceks
Lithuania Cisatracurium Kalceks 2 mg/ml injekcinis ar infuzinis tirpalas
Poland Cisatracurium Kalceks

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The following information is intended for healthcare professionals:

Incompatibilities
Since cisatracurium is stable only in acidic solutions, it should not be mixed in the same syringe or
administered simultaneously through the same needle with alkaline solutions (e.g. sodium thiopental).
Cisatracurium is not compatible with ketorolac trometamol injectable emulsion or propofol.

Instructions for use, disposal and handling
For single use only.
After opening the vial, the medicinal product must be used immediately.
The medicinal product must be visually inspected before use and must not be used if there are
visible signs of deterioration (e.g. particles).
Cisatracurium Kalceks diluted is physically and chemically stable for 24 hours at temperatures of

2  8°C and 25°C, at concentrations of 0.1 mg/mL in the following infusion fluids, when in contact with polypropylene or polycarbonate syringes, polyethylene or PVC tubing and polypropylene or PVC infusion bags:

sodium chloride 9 mg/mL (0.9%) solution for injection;
glucose 50 mg/mL (5%) solution for injection;
sodium chloride 1.8 mg/mL (0.18%) and glucose 40 mg/mL (4%) solution for injection;
sodium chloride 4.5 mg/mL (0.45%) and glucose 25 mg/mL (2.5%) solution for injection.

Cisatracurium has been shown to be compatible with the following commonly used perioperative drugs when
mixed under conditions simulating administration in an ongoing intravenous infusion via a
Y-site: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride and sufentanil
citrate.
If other drugs are to be administered through the same needle or cannula as cisatracurium, it is
recommended to flush the drug through by aspirating an adequate volume of suitable intravenous fluid,
e.g. sodium chloride 9 mg/mL (0.9%) solution for injection.
As with other intravenously administered drugs, when choosing a small-bore vein as the injection site, cisatracurium should be flushed through the vein with an adequate volume of suitable intravenous fluid, e.g. sodium chloride 9 mg/mL (0.9%) solution for injection.
Instructions for opening the vial

1) Turn the vial with the colored tip upwards. If there is solution in the upper part of the vial, gently tap with your finger to bring all the solution to the bottom of the vial.
2) Use both hands to open; holding the bottom of the vial in one hand, break off the top of the vial in the opposite direction to the colored point (see figures below).

Unused medicinal product and waste materials derived from such medicinal product should be disposed of in
accordance with local regulations.

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Страна регистрации
Италия
Форма выпуска
Injectable or infusion solution, 2 MG/ML
Код АТХ
M03AC11
Действующее вещество
cisatracurium
Отпускается по рецепту
Да
Производитель
AS KALCEKS
Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
Аналоги KISATRAKURIO KALKEKS
KISATRAKURIO IKMA
Форма выпуска: Injectable or infusion solution, 2 MG/ML
Действующее вещество: cisatracurium
Производитель: HIKMA FARMACEUTICA (PORTUGAL) S.A.
Отпускается по рецепту
KISATRAKURIO MYLAN PARMA
Форма выпуска: Injectable solution, 2 MG/ML
Действующее вещество: cisatracurium
Производитель: MYLAN S.P.A.
Отпускается по рецепту
NIMBEX
Форма выпуска: Injectable solution, 2 MG/ML
Действующее вещество: cisatracurium
Производитель: ASPEN PHARMA TRADING LIMITED
Отпускается без рецепта

Аналоги KISATRAKURIO KALKEKS в других странах

Лекарства с тем же действующим веществом, доступные в других странах.