NIMBEX 2 мг/мл Инъекционный раствор
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Инструкция по применению NIMBEX
Содержание инструкции
Nimbex 2 mg/ml injectable solution/infusion, 5 mg/ml injectable solution/infusion
Cisatracurium
Read this leaflet carefully before you start to 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.
- If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.
Contents of this leaflet:
- 1. What Nimbex is and what it is used for
- 2. What you need to know before Nimbex is given to you
- 3. How Nimbex is used
- 4. Possible side effects
- 5. How to store Nimbex
- 6. Contents of the pack and other information
What Nimbex is and what it is used for
Nimbex contains a substance called cisatracurium. This substance belongs to a group of
medicines called muscle relaxants. Nimbex is used for:
- Relaxing the muscles during surgical operations in adults and children of at least 1 month of age, including heart surgeries
- To facilitate tracheal intubation, if a patient needs help with breathing
- To relax the muscles in patients in intensive care. Ask your doctor if you want more information about this medicine.
2. What you need to know before you are given Nimbex
Do not use Nimbex:
- if you are allergic to cisatracurium, or to other muscle relaxants or to any of the excipients of Nimbex (listed in section 6)
- if you have previously had an adverse reaction with the use of an anesthetic. If you think any of these conditions apply to you, do not take Nimbex. If you are not sure, talk to your doctor, nurse or pharmacist first. Take special care with NimbexBefore taking this medicine, talk to your doctor, nurse or pharmacist:
- If you have muscle weakness, pain or difficulty coordinating movements (myasthenia gravis) also check if: (only for 10 ml) You have neuromuscular diseases, such as muscle deterioration disease, paralysis, motor neuron disease or cerebral palsy
- If you have a burn that requires medical treatment. If you are not sure if anything of the above applies to you, ask your doctor, nurse or pharmacist before you are given Nimbex.
Other medicines and Nimbex
Tell your doctor if you are taking, have recently taken or might take any other medicines,
including those available without a prescription.
In particular, consult your doctor if you are taking any of these medicines:
- anesthetics (used to reduce pain and the sensation of pain during surgery)
- antibiotics (used to treat infections)
- medicines for irregular heartbeats (antiarrhythmics)
- medicines for high blood pressure
- diuretics, such as furosemide
- medicines for joint inflammation, such as chloroquine or penicillamines
- steroids
- medicines for convulsions (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
- anticholinesterases for the treatment of Alzheimer's disease such as donepezil.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine.
Driving and operating machinery
If you have been in hospital for only one day, your doctor will inform you about how long to wait before
leaving the hospital or driving a car. It may be dangerous to drive too soon after undergoing
surgery.
3. How Nimbex is administered
You should never expect to be able to administer this medicine to yourself. It will always be
administered to you by a qualified person to do so.
Nimbex can be administered:
- as a single injection into a vein (venous bolus injection)
- as a continuous infusion into a vein. In this way, the medicine is released slowly over a long period of time.
- The doctor will decide on the method of administration and the necessary dose. Which will depend on the following factors:
- body weight
- the amount and duration of muscle relaxant activity required
- the response to the medicine. This medicine should not be administered to children under 1 month of age.
If you receive more Nimbex than you should
Nimbex must always be administered under strict control. However, if you think that you have been
administered more than you should, talk to your doctor or nurse immediately.
If you have any doubts about the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, Nimbex can cause side effects, although not everybody gets them.
If you experience a side effect, speak to your doctor. This includes any possible side effect
not listed in this leaflet.
Allergic reactions (may affect less than 1 in 10,000 people)
If you have an allergic reaction, call your doctor or nurse immediately. Signs of allergy may include:
- sudden difficulty breathing, chest pain or chest tightness
- swelling of the eyelids, face, lips, mouth or tongue
- sudden skin rash or hives anywhere on the body
- collapse.
Talk to your doctor, nurse or pharmacist if you notice any of the following effects:
Common (may affect less than 1 in 10 people)
- decreased heart rate
- low blood pressure. Uncommon (may affect less than 1 in 100 people)
- skin rash or redness of the skin
- shortness of breath or cough. Very rare (may affect less than 1 in 10,000 people)
- muscle weakness or pain.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, nurse or pharmacist. You can also report side effects directly through the
national reporting system at “ www.agenziafarmaco.gov.it/it/responsabili ”..
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Nimbex
Keep Nimbex out of sight and reach of children.
Do not use Nimbex after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of the month.
Store in a refrigerator (2 C – 8 C). Do not freeze.
Store in the original container to protect the product from light.
If diluted, store the infusion solution between 2 C and 8 C and use within 24 hours. The infusion
solution must be discarded if not used within 24 hours.
Do not dispose of any medicine in wastewater. Ask your pharmacist or nurse how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Nimbex contains
- The active substance is cisatracurium 2 mg/ml or 5 mg/ml (as besilate).
- The excipients are benzenesulfonic acid (32% w/v) and water for injections.
Description of the appearance of Nimbex and contents of the pack
Nimbex 2 mg/ml solution for injection / infusion is available in:
- 2.5 ml in vials (glass) pack of 5 vials (each vial of 2.5 ml contains 5 mg of cisatracurium) 5 ml in vials (glass) pack of 5 vials (each vial of 5 ml contains 10 mg of cisatracurium) 10 ml in vials (glass) pack of 5 vials (each vial of 10 ml contains 20 mg of cisatracurium) 25 ml in vials (glass) pack of 2 vials (each vial of 25 ml contains 50 mg of cisatracurium)
Nimbex 5 mg/ml solution for injection / infusion is contained in a glass bottle of 30 ml. Each
bottle of 30 ml contains 150 mg of cisatracurium.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MAH:
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
24 Dublin
Ireland
Legal Representative and Sales:GlaxoSmithKline S.p.A. - Verona.
Manufacturer
GlaxoSmithKline Manufacturing S.p.A. - Strada Provinciale Asolana, n.90 - S. Polo di Torrile - Parma
(Italy)
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations :
Nimbex: UK, Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Netherlands,
Portugal, Spain
Nimbex 5mg <10 mg>:Germany
<-----------------------------------------------------------------------------------------------------------------------------
The following information is intended only for doctors or healthcare professionals:
This medicinal product is for single use.
Only use clear, colourless or slightly yellow or yellowish-green solutions.
The product must be visually inspected before use, and if the visual appearance is
changed or the container is damaged, the product must be discarded.
When diluted to concentrations between 0.1 and 2 mg/ml, Nimbex has been shown to be stable from a
chemical and physical point of view for 24 hours at 5° C and at 25° C in the following infusion solutions (both in polyvinyl chloride and polypropylene containers):
Sodium chloride 0.9% w/v
Glucose 5% w/v
Glucose with sodium chloride (respectively 4% w/v and 0.18% w/v)
Glucose with sodium chloride (respectively 2.5% w/v and 0.45% w/v)
This product does not contain preservatives; dilution should be done immediately before use,
otherwise see paragraph 5.
Nimbex has been shown to be compatible with the following drugs, commonly used in
perioperative settings, mixed under conditions simulating intravenous infusion administration through
a "Y" injection set: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride and
sufentanil citrate. When other drugs are administered, through the same needle or cannula, in addition to
Nimbex, it is important that each drug is flushed through with an adequate amount of a
suitable infusion solution (e.g. sodium chloride 0.9% w/v).
As with other drugs administered intravenously, if a small-caliber vein is chosen as the injection site, Nimbex must be injected into the vein with a liquid suitable for
intravenous administration, such as sodium chloride for intravenous injection (0.9% w/v).
Unused medicinal product or waste material derived from such medicinal product should be disposed of in accordance with
local regulations.
Nimbex 2 mg/ml solution for injection/infusion
Instructions for opening the vial (applicable only to the 2 mg/ml vial)
The vials are equipped with a safety pre-break system and must be opened as follows:
- hold the lower part of the vial with one hand as shown in figure 1;
- place the other hand on the top positioning the thumb above the coloured point and apply pressure as shown in figure 2.
Figure 1
Figure 2
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- Страна регистрации
- Форма выпускаInjectable solution, 2 MG/ML
- Код АТХM03AC11
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги NIMBEXФорма выпуска: Injectable or infusion solution, 2 MG/MLДействующее вещество: cisatracuriumПроизводитель: HIKMA FARMACEUTICA (PORTUGAL) S.A.Отпускается по рецептуФорма выпуска: Injectable or infusion solution, 2 MG/MLДействующее вещество: cisatracuriumПроизводитель: AS KALCEKSОтпускается по рецептуФорма выпуска: Injectable solution, 2 MG/MLДействующее вещество: cisatracuriumПроизводитель: MYLAN S.P.A.Отпускается по рецепту
Аналоги NIMBEX в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог NIMBEX в Испания
Аналог NIMBEX в Польша
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
NIMBEX не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество NIMBEX — cisatracurium. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
NIMBEX производится компанией ASPEN PHARMA TRADING LIMITED. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения NIMBEX с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить NIMBEX в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (cisatracurium) включают KISATRAKURIO IKMA, KISATRAKURIO KALKEKS, KISATRAKURIO MYLAN PARMA. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
