Инструкция по применению PALONOSETRON DR. REDDY'S
Содержание инструкции
Palonosetron Dr. Reddy’s 250 microgram solution for injection
Equivalent medicinal product
Read this leaflet carefully before using 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, pharmacist or nurse.
- This medicine has been prescribed only for you. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
- If you do not feel better or if you feel worse, tell your doctor.
Contents of this leaflet:
- 1. What is Palonosetron Dr. Reddy’s and what it is used for
- 2. What you need to know before you use Palonosetron Dr. Reddy’s
- 3. How to use Palonosetron Dr. Reddy’s
- 4. Possible side effects
- 5. How to store Palonosetron Dr. Reddy’s
- 6. Contents of the pack and other information
1What is Palonosetron Dr. Reddy’s and what it is used for
Palonosetron Dr. Reddy’s belongs to a class of medicines known as serotonin (5HT) antagonists.
These medicines are able to block the action of serotonin, a chemical substance, which
can cause nausea and vomiting.
Palonosetron Dr. Reddy’s is used for the prevention of nausea and vomiting associated with
cancer chemotherapy in adults, adolescents and children over one month of age.
2What you need to know before you use Palonosetron Dr. Reddy’s
Do not use Palonosetron Dr. Reddy’s:
- if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Palonosetron Dr. Reddy’s
- If you have acute bowel obstruction or a history of recurrent constipation.
- If you are using Palonosetron Dr. Reddy’s in addition to other medicines that can cause an irregular heartbeat, such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone.
- If you have a personal or family history of heart rhythm disorders (prolongation of the QT interval).
- If you have other heart problems.
- If you have an imbalance of certain minerals in your blood, such as potassium and magnesium, which has not been treated.
The use of Palonosetron Dr. Reddy’s is not recommended in the days following chemotherapy, unless you
need to undergo another cycle of chemotherapy.
Other medicines and Palonosetron Dr. Reddy’s
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including:
- SSRIs(selective serotonin reuptake inhibitors) used to treat depression and/or anxiety, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
- SNRIs(serotonin-noradrenaline reuptake inhibitors) used to treat depression and/or anxiety, including venlafaxine, duloxetine.
Pregnancy
If you are or think you may be pregnant, your doctor will not give you Palonosetron Dr. Reddy’s
unless absolutely necessary.
It is not known whether Palonosetron Dr. Reddy’s causes harm when used during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine if you are or think you could
be pregnant.
Breastfeeding
It is not known whether Palonosetron Dr. Reddy’s passes into breast milk.
Ask your doctor or pharmacist for advice before using Palonosetron Dr. Reddy’s during
breastfeeding.
Driving and using machines
Palonosetron Dr. Reddy’s can cause dizziness or tiredness. If affected, do not drive vehicles and do
not use tools or machines.
Palonosetron Dr. Reddy’s containsless than 1 mmol of sodium (23 mg) per vial, therefore is
essentially “sodium-free”.
3How to use Palonosetron Dr. Reddy’s
A doctor or nurse will usually inject Palonosetron Dr. Reddy’s about 30 minutes before
the start of chemotherapy.
Adults
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The recommended dose of Palonosetron Dr. Reddy’s is 250 micrograms, given as a rapid injection into a vein.
Children and adolescents (from 1 month to 17 years of age)
The doctor will decide the dose based on body weight; however, the maximum dose is 1500
micrograms.
Palonosetron Dr. Reddy’s is given as a slow infusion into a vein.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.
4Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
gets them.
The possible side effects and their frequency are listed below:
Adults
Common (may affect up to 1 in 10 people):
- headache, dizziness, constipation and diarrhoea.
Uncommon (may affect up to 1 in 100 people):
- high or low blood pressure
- irregular heartbeat or reduced blood flow to the heart
- change in colour of the vein and/or enlargement of the veins
- exceptionally high or low levels of potassium in the blood
- high levels of sugar in the blood or presence of sugar in the urine
- low levels of calcium in the blood
- high levels of the pigment bilirubin in the blood
- high levels of certain liver enzymes
- euphoric mood or feeling anxious
- sleepiness or difficulty sleeping
- decreased or loss of appetite
- weakness, fatigue, fever or flu-like symptoms
- feeling of numbness, burning, itching or tingling on the skin
- itchy skin rash
- altered vision or eye irritation
- motion sickness
- ringing in the ears
- hiccups, flatulence, dry mouth or indigestion
- abdominal (stomach) pain
- difficulty urinating
- joint pain
- abnormalities in the electrocardiogram (prolongation of the QT interval)
Very rare (may affect up to 1 in 10,000):
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- Allergic reactions to Palonosetron Dr. Reddy’s. The signs can include:
- swelling of the lips, face, tongue or throat
- difficulty breathing or collapse. You may also notice a skin rash with bumps and itching (urticaria), burning or pain at the injection site.
Children and adolescents
Common (may affect up to 1 in 10 people):
- headache
Uncommon (may affect up to 1 in 100 people):
- dizziness
- jerky body movements
- irregular heartbeat
- cough or shortness of breath
- nosebleed
- itchy skin rash or urticaria
- fever
- pain at the infusion site
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor 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 Palonosetron Dr. Reddy’s
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 vial or the box after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
For single use only, any unused solution should be discarded.
6Contents of the pack and other information
What Palonosetron Dr. Reddy’s contains
The active ingredient is palonosetron (as hydrochloride).
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Each ml of solution contains 50 micrograms of palonosetron. Each vial of 5 ml of solution
contains 250 micrograms of palonosetron.
The other components are mannitol, sodium acetate trihydrate, water for injections and for
pH adjustment: sodium hydroxide and hydrochloric acid.
Description of the appearance of Palonosetron Dr. Reddy’s and contents of the pack
Palonosetron Dr. Reddy’s 250 micrograms injectable solution is a clear and colourless solution.
The product is packaged in a tubular glass vial of type I closed with a 20 mm bromobutyl rubber stopper and sealed with a 20 mm flip-off seal.
Available in packs of 1 vial containing 5 ml of solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Dr. Reddy’s S.r.l.
Via F. Wittgens, 3 – 20123 Milano (MI), Italy
Manufacturer:
betapharm Arzneimittel GmbH
Kobelweg 95
- D - 86156 Augsburg – Germany
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany Palonosetron beta 250 Mikrogramm Injektionslösung
Romania Palonosetron Dr. Reddy's 250 micrograme soluție injectabilă
Italy Palonosetron Dr. Reddy´s 250 microgrammi soluzione iniettabile
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- Страна регистрации
- Форма выпускаInjectable solution, 250 MICROGRAMS
- Код АТХA04AA05
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги PALONOSETRON DR. REDDY'SФорма выпуска: Injectable solution, 250 MCGДействующее вещество: palonosetronПроизводитель: HELSINN BIREX PHARMACEUTICALS LTDОтпускается по рецептуФорма выпуска: Injectable solution, 250 MICROGRAMSДействующее вещество: palonosetronПроизводитель: ACCORD HEALTHCARE, S.L.U.Отпускается по рецептуФорма выпуска: Injectable solution, 250 MICROGRAMSДействующее вещество: palonosetronПроизводитель: FRESENIUS KABI ITALIA S.R.L.Отпускается по рецепту
Аналоги PALONOSETRON DR. REDDY'S в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог PALONOSETRON DR. REDDY'S в Испания
Аналог PALONOSETRON DR. REDDY'S в Украина
Врачи онлайн по PALONOSETRON DR. REDDY'S
Обсудите применение PALONOSETRON DR. REDDY'S и возможные следующие шаги — по оценке врача.
Получите рецепт на PALONOSETRON DR. REDDY'S онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
PALONOSETRON DR. REDDY'S требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество PALONOSETRON DR. REDDY'S — palonosetron. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
PALONOSETRON DR. REDDY'S производится компанией DR. REDDY'S S.R.L.. 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 PALONOSETRON DR. REDDY'S 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 PALONOSETRON DR. REDDY'S 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 (palonosetron) включают ALOXI, PALONOSETRON AKKORD, PALONOSETRON FRESENIUS KABI. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















