ARIKAYCE 590 mg Небулизаторная Дисперсия
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Инструкция по применению ARIKAYKE LIPOSOMIALE
Содержание инструкции
ARIKAYCE liposomal 590 mg dispersion for nebulizer
amikacin
Read this leaflet carefully before you start to use 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 pharmacist.
- This medicine has been prescribed for you only. 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 or pharmacist. See section 4.
Contents of this leaflet
- 1. What ARIKAYCE liposomal is and what it is used for
- 2. What you need to know before you use ARIKAYCE liposomal
- 3. How to use ARIKAYCE liposomal
- 4. Possible side effects
- 5. How to store ARIKAYCE liposomal
- 6. Contents of the pack and other information
- 7. Instructions for use
1. What is liposomal ARIKAYCE and what it is used for
ARIKAYCE liposomiale is an antibioticcontaining the active substance amikacin. Amikacin
belongs to a group of antibiotics called aminoglycosides, which stop the growth of
certain bacteria that cause infections.
ARIKAYCE liposomiale is used by inhalation for the treatment of lung infectioncaused by the
Mycobacterium aviumcomplex in adults with limited therapeutic options who do not suffer from
cystic fibrosis.
2. What you need to know before using ARIKAYCE liposomal
Do not use ARIKAYCEliposomal
- if you are allergic to amikacinor other aminoglycosides, to soyor to any of the otheringredientsof this medicine (listed in section 6)
- if you are taking other aminoglycosides (by mouth or by injection)
- if your kidney function is severely impaired.
Warnings and precautions
Talk to your doctor or pharmacist before using ARIKAYCE liposomal if:
- you use a bronchodilator (“symptomatic medicine”) for breathing problems, because you will be asked to use it before using ARIKAYCE liposomal;
- you have kidney problems; you may need to have a kidney test before starting treatment;
- you have hearing problems, ringing or buzzing in the ears(tinnitus) or problems with balance, including dizziness, lack of muscle coordination, vertigo or feeling faint. If you have hearing problems you may need to have a hearing test before starting treatment or during treatment itself;
- you suffer from other lung diseases;
- you have a disease that causes muscle weakness and fatigue, such as myasthenia gravis;
- you yourself have or if there is a maternal family history of mitochondrial mutation disease (a genetic disease) or hearing loss due to the use of antibiotics, it is recommended to inform your doctor or pharmacist before taking an aminoglycoside; certain mitochondrial mutations may increase the risk of hearing loss with this product. Your doctor may advise you to undergo genetic testing before administering ARIKAYCE liposomal.
Contact your doctor immediately if, while usingARIKAYCE liposomal, you experience any of the
following symptoms:
- loss of consciousness, rash, fever, worsening or new breathing problems;
- worsening of kidney problems;
- ear problems such as ringing in the ears or hearing loss. See section 4.
Children and adolescents
ARIKAYCE liposomal should not be given to children and adolescents under the age of
18 years.
Other medicines and ARIKAYCE liposomal
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Particular caution is required if you are taking other medicines, as some may interact with
ARIKAYCE liposomal, for example:
- diuretics such as ethacrynic acid, furosemide or mannitol
- other medicines that can have effects on the kidneys, hearing, balance or that can reduce muscle strength.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, the use of ARIKAYCE liposomal should be avoided. Ask your doctor or pharmacist for
advice before using this medicine.
If you become pregnant while using ARIKAYCE liposomal, tell your doctor. The doctor will decide whether
you should stop using ARIKAYCE liposomal.
It is not known whether amikacin passes into human breast milk. If you are breastfeeding, your doctor will tell you whether
you should stop breastfeeding or stop treatment with this medicine.
Driving and using machines
ARIKAYCE liposomal can cause dizziness and other vestibular disorders, such as vertigo and balance
problems. Do not drive or use machines while inhaling ARIKAYCE liposomal. For
any doubt, consult your doctor.
3. How to use ARIKAYCE liposomal
Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.
The recommended dose is one vialof ARIKAYCE liposomal to be inhaled through the mouth
once a day with the portable Lamira nebulizer. After 6 months of treatment, your doctor will tell you
whether to continue or stop therapy. The maximum duration of treatment is 18 months.
How to take ARIKAYCEliposomal
If you use a bronchodilator (“symptomatic medicine”), use it before taking ARIKAYCE
liposomal.
Each vial is for single use only.
- UseARIKAYCE liposomal onlywith the portable Lamira nebulizer and the aerosol head connected to a Lamira control unit. See section 7 for instructions on using the medicine with the Lamira nebulizer system.
- Do not useARIKAYCE liposomal with other types of portable nebulizers or aerosol heads.
- Do notpour other medicines into the portable Lamira nebulizer.
- Do notdrink the liquid contained in the vial.
How and when should you replace the portable Lamira nebulizer?
A portable Lamira nebulizer must be used for a 28-day treatment cycle. The
aerosol head should be replaced once a week. Each box of ARIKAYCE liposomal contains
4 aerosol heads. For advice on cleaning and storage, please refer to the manufacturer's instructions for use.
If you use more ARIKAYCE liposomal than you should
Immediately inform your doctor if you are concerned that you have used an excessive amount of this
medicine.
If you forget to use ARIKAYCEliposomal
If you forget to take the medicine, take it as soon as possible on the day of the missed dose.
Do not take more than one dose in a single day to make up for a missed dose.
If you stop using ARIKAYCEliposomal
If you decide to stop using ARIKAYCE liposomal for any reason, you must inform your
doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if:
- you develop hypersensitivity or severe allergic reactions while taking ARIKAYCE liposomal (e.g. with low blood pressure, loss of consciousness, severe skin rash or severe wheezing and shortness of breath). The frequency of these side effects is not known;
- your usual lung problems get worse or new breathing problems appear (e.g. shortness of breath or wheezing). This may be a sign of severe lung inflammation that requires treatment and may lead to discontinuation of ARIKAYCE liposomal. The frequency of these serious side effects is from common to very common.
Other side effects
Tell your doctor or pharmacist if you experience any of the symptoms listed below.
Very common side effects (may affect more than 1 in 10 people)
- Difficulty speaking
- Difficulty breathing
- Cough
- Coughing up blood
Common side effects (may affect up to 1 in 10 people)
- Infection causing worsening of lung conditions
- Increased mucus production with cough from the lungs
- Productive cough
- Wheezing
- Sore throat
- Throat pain
- Loss of voice
- Oral thrush (fungal infection)
- Mouth pain
- Changes in taste
- Lung inflammation
- Headache
- Dizziness
- Feeling unsteady
- Diarrhoea
- Nausea
- Vomiting
- Dry mouth
- Decreased appetite
- Itchy skin
- Deafness
- Tinnitus (ringing in the ears)
- Kidney problems, including impaired kidney function
- Joint pain
- Muscle pain
- Skin rash
- Fatigue
- Chest discomfort
- Fever
- Weight loss
- Uncommon side effects (may affect up to 1 in 100 people)
- Anxiety
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store ARIKAYCE liposomal
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 pack and on the
vial label after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze, discard vials that have been frozen.
Alternatively, ARIKAYCE liposomal can be stored at room temperature below
25 °C, but only for a maximum of 4 weeks. Once it reaches room temperature, any unused medicine must be discarded after 4 weeks.
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 ARIKAYCE liposomal contains
- The active ingredient is amikacin. Each vial contains amikacin sulfate equivalent to 590 mg of amikacin in liposomal formulation. The average dose released from each vial is approximately 312 mg of amikacin.
- The other ingredients are cholesterol, dipalmitoylphosphatidylcholine (DPPC), sodium chloride, sodium hydroxide and water for injections.
Description of the appearance of ARIKAYCE liposomal and package contents
ARIKAYCE liposomal is a milky nebulizer dispersion ranging in color from white to off-white contained in a glass vial with a rubber stopper and a metal crimp seal with a plastic snap-on cap.
The 28 vials are supplied in a carton for 28 days’ use; one vial per day. A carton of ARIKAYCE liposomal contains 4 inner cartons containing 7 vials and an aerosol head. The 28-day pack also contains 1 Lamira portable nebulizer.
Marketing Authorisation Holder
Insmed Netherlands B.V.
Stadsplateau 7
3521 AZ Utrecht
Netherlands
Manufacturer
Almac Pharma Services (Ireland) Ltd.
Finnabair Industrial Estate,
Dundalk, Co. Louth, A91 P9KD,
Ireland
Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, https://www.ema.europa.eu. Additionally, links to other websites on rare diseases and related therapeutic treatments are provided.
7. Instructions for Use
ARIKAYCE liposomal is for oral inhalation use with the Lamira nebulizer system.
Before using the Lamira nebulizer system, make sure you have read and understood the detailed information
provided in the complete instructions for use supplied with the Lamira nebulizer system.
These instructions contain more complete information on how to assemble, prepare,
use, clean and disinfect the Lamira nebulizer system.
Wash your hands with soap and water and dry them thoroughly.
Assemble the Lamira portable nebulizer and connect it to the control unit, as illustrated in the
complete instructions for use.
This medicine is a milky white liquid in a transparent vial. Do not use it if you notice
changes in color or floating particles in the vial.
Preparation of the medicine for use
- 1. It is recommended to remove the vial from the refrigerator at least 45 minutes before use, to bring it to room temperature. Do not use other medicines with the Lamira portable nebulizer.
- 2. Shake the vial of ARIKAYCE liposomal vigorously until the medicine appears homogeneous and well mixed.
- 3. Lift off the orange closure cap of the vial and set it aside (Figure 1).
Figure 1
- 4. Grasp the metal ring at the top of the vial and gently pull it downwards until one side detaches from the vial (Figure 2).
Figure 2
- 5. Pull off the metal band from the top of the vial with a circular motion until it is completely detached from the vial (Figure 3).
Figure 3
- 6. After detaching it, set the metal ring aside. Carefully remove the rubber stopper (Figure 4).
Figure 4
- 7. Pour the contents of the ARIKAYCE liposomal vial into the medicine reservoir of the Lamira portable nebulizer (Figure 5).
Figure 5
- 8. Close the medicine reservoir. (Figure 6).
Figure 6
- 9. Sit in a relaxed position keeping your shoulders straight. This will make inhalation easier and allow the medicine to reach your lungs better.
- 10. Take the mouthpiece in your mouth and breathe slowly and deeply. Then, inhale and exhale normally through the mouthpiece until the treatment is complete. The treatment should last about 14 minutes, but may take up to 20 minutes. Make sure to keep the Lamira portable nebulizer upright throughout the duration of the treatment (Figure 7).
Figure 7
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- Страна регистрации
- Форма выпускаNebulizer dispersion, 590 MG
- Код АТХJ01GB06
- 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 ARIKAYKE LIPOSOMIALEФорма выпуска: Injectable solution, 500 MG/2 MLДействующее вещество: amikacinПроизводитель: PHARMATEX ITALIA S.R.L.Отпускается по рецептуФорма выпуска: Infusion solution, 5 MG/MLДействующее вещество: amikacinПроизводитель: B. BRAUN MELSUNGEN AGОтпускается по рецептуФорма выпуска: Injectable or infusion solution, 125 MG/MLДействующее вещество: amikacinПроизводитель: NORIDEM ENTERPRISES LTDОтпускается по рецепту
Аналоги ARIKAYKE LIPOSOMIALE в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог ARIKAYKE LIPOSOMIALE в Испания
Аналог ARIKAYKE LIPOSOMIALE в Польша
Аналог ARIKAYKE LIPOSOMIALE в Украина
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
ARIKAYKE LIPOSOMIALE требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ARIKAYKE LIPOSOMIALE — amikacin. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ARIKAYKE LIPOSOMIALE производится компанией INSMED NETHERLANDS B.V.. 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 ARIKAYKE LIPOSOMIALE 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 ARIKAYKE LIPOSOMIALE 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 (amikacin) включают AMIKASIL, AMIKAKINA B. BRAUN, AMIKAKINA NORIDEM. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
