FOSAPREPITANT 150 mg Порошок Для Раствора Для Внутривенного Введения
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Инструкция по применению FOSAPREPITANT AKKORD
Содержание инструкции
Fosaprepitant Accord 150 mg powder for solution for infusion
Equivalent medicine
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.
- If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Fosaprepitant Accord is and what it is used for
- 2. What you need to know before you use Fosaprepitant Accord
- 3. How to use Fosaprepitant Accord
- 4. Possible side effects
- 5. How to store Fosaprepitant Accord
- 6. Contents of the pack and other information
1. What is Fosaprepitant Accord and what it is used for
Fosaprepitant Accord contains the active substance fosaprepitant which is converted into aprepitant in your body.
It belongs to a group of medicines called “neurokinin 1 (NK) receptor antagonists”. The
brain has a specific area that controls nausea and vomiting. Fosaprepitant Accord works by blocking the
signals sent to that area, thus reducing nausea and vomiting. Fosaprepitant Accord is used in
adults together with other medicinesto prevent nausea and vomiting caused by chemotherapy
(cancer treatment) containing cisplatin (highly emetogenic) and with
chemotherapy moderately emetogenic (such as cyclophosphamide, doxorubicin and
epirubicin).
2. What you need to know before using Fosaprepitant Accord
Do not use Fosaprepitant Accord:
- if you are allergic to fosaprepitant, to aprepitant or to polysorbate 80 or to any of the other ingredients (listed in section 6).
- with medicines that contain pimozide (a substance used for the treatment of psychiatric diseases), terfenadine and astemizole (used for hay fever and other allergies), cisapride (used for the treatment of digestive problems). Tell your doctor if you are taking these medicines as your therapy may need to be modified before starting to use Fosaprepitant Accord.
Warnings and precautions
Consult your doctor, pharmacist or nurse before using Fosaprepitant Accord.
Before treatment with this medicine, tell your doctor if you have a liver disease because the liver
is important for metabolizing the medicine within the body. Your doctor may therefore need to
check the condition of the liver.
Children and adolescents
Do not give Fosaprepitant Accord to children and adolescents under 18 years of age, because it has not been
studied in this population.
Other medicines and Fosaprepitant Accord
Fosaprepitant Accord can have effects on other medicines both during and after treatment with
Fosaprepitant Accord. There are some medicines that must not be taken with Fosaprepitant Accord
(such as pimozide, terfenadine, astemizole and cisapride) or that require a dose adjustment (see also “Do not use Fosaprepitant Accord”).
The effects of Fosaprepitant Accord or of other medicines could be affected if you use Fosaprepitant
Accord together with other medicines, including those listed below. Tell your doctor or pharmacist if you are
taking any of the following medicines:
- medicines for birth control that may include birth control pills, skin patches, implants and some intrauterine devices (IUDs) that release hormones; they may not work well when taken together with Fosaprepitant Accord. During treatment with Fosaprepitant Accord and up to 2 months after use of Fosaprepitant Accord, another or an additional non-hormonal method of birth control should be used,
- cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants),
- alfentanil, fentanyl (used for the treatment of pain),
- quinidine (used for the treatment of an irregular heartbeat),
- irinotecan, etoposide, vinorelbine, ifosfamide (medicines used for the treatment of cancer),
- medicines containing alkaloids derived from ergot such as ergotamine, dihydroergotamine (used for the treatment of migraine),
- warfarin, acenocoumarol (anticoagulants; blood tests may be required),
- rifampicin, clarithromycin, telithromycin (antibiotics used for the treatment of infections),
- phenytoin (a medicine used for the treatment of seizures),
- carbamazepine (used for the treatment of depression and epilepsy),
- midazolam, triazolam, phenobarbital (medicines used to calm or help sleep),
- St. John's wort (a herbal remedy used for the treatment of depression),
- protease inhibitors (used for the treatment of HIV infections),
- ketoconazole except for shampoo (used to treat Cushing's syndrome, characterized by excessive cortisol production by the body),
- itraconazole, voriconazole, posaconazole (antifungals),
- nefazodone (used for the treatment of depression),
- diltiazem (a medicine used for the treatment of high blood pressure),
- corticosteroids (such as dexamethasone),
- anti-anxiety medicines (such as alprazolam), and
- tolbutamide (a medicine used for the treatment of diabetes)
Tell your doctor if you are taking, have recently taken, or may take any other medicines
or herbal remedies.
Pregnancy and breastfeeding
You should not use this medicine during pregnancy unless it is strictly necessary. If you are
pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast milk,
ask your doctor for advice before taking this medicine.
For information on birth control, see “Other medicines and Fosaprepitant Accord”.
It is not known whether Fosaprepitant Accord is excreted in human milk; therefore, breastfeeding is not
recommended during treatment with this medicine. It is important that you tell your doctor if you
are breastfeeding or are thinking about breastfeeding before taking this medicine.
Driving and using machines
You should be aware that some people have dizziness or feel sleepy after using
Fosaprepitant Accord. If you feel dizzy or sleepy, you should avoid driving or using
machines after using this medicine (see “Possible side effects”).
Fosaprepitant Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically “sodium-free”.
3. How to use Fosaprepitant Accord
The recommended dose of Fosaprepitant Accord is 150 mg of fosaprepitant on Day 1 (day of
chemotherapy).
The powder is reconstituted and diluted before use. The infusion solution will be administered to you by a
healthcare professional, such as a doctor or nurse, through an intravenous infusion (drip) 30 minutes
before starting chemotherapy. The doctor will ask you to take other medications including a
corticosteroid (such as dexamethasone) and a “5-HT antagonist” (such as ondansetron) to prevent
nausea and vomiting. If you have any doubts, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.
Stop taking Fosaprepitant Accord and go immediately to a doctor if you notice any of the
following side effects, which may be serious, and for which you may need urgent
medical treatment:
- hives, skin rash, itching, difficulty breathing or swallowing, or a severe drop in blood pressure (frequency not known, cannot be defined based on available data); these are signs of an allergic reaction.
Other side effects that have been reported are listed below.
Common side effects (may affect up to 1 in 10 people) are:
- constipation, indigestion,
- headache,
- fatigue,
- loss of appetite,
- hiccups,
- increased levels of liver enzymes in the blood.
Uncommon side effects (may affect up to 1 in 100 people) are:
- dizziness, insomnia,
- acne, skin rash,
- anxiety,
- burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing gas,
- increased pain or burning when urinating,
- weakness, general feeling of discomfort,
- redness of face/skin, hot flushes,
- fast or irregular heartbeat, increased blood pressure,
- fever with increased risk of infection, decreased red blood cells,
- pain at the injection site, redness at the injection site, itching at the injection site, inflammation of the vein at the injection site.
Rare side effects (may affect up to 1 in 1,000 people) are:
- difficulty thinking, lack of energy, altered taste,
- skin sensitivity to the sun, excessive sweating, oily skin, skin lesions, itchy rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (a rare, serious skin reaction),
- euphoria (feeling of extreme happiness), disorientation,
- bacterial infection, fungal infection,
- severe constipation, stomach ulcer, inflammation of the small intestine and colon, mouth sores, intestinal gas,
- frequent urination, passing more urine than usual, presence of sugar or blood in the urine,
- chest discomfort, swelling, change in the way you walk,
- cough, mucus in the back of the throat, sore throat, sneezing, sore throat,
- eye secretion and itching,
- ringing in the ears,
- muscle spasms, muscle weakness,
- excessive thirst,
- slowed heartbeat, heart and blood vessel disease,
- decreased white blood cells, decreased sodium levels in the blood, weight loss,
- hardening at the infusion site.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more information
about the safety of this medicine.
5. How to store Fosaprepitant Accord
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 package and vial after SCAD.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
The reconstituted and diluted solution is stable for 48 hours at 20-25°C.
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 Fosaprepitant Accord contains
- The active ingredient is fosaprepitant. Each vial contains fosaprepitant dimeglumine equivalent to 150 mg of fosaprepitant. After reconstitution and dilution, 1 mL of solution contains 1 mg of fosaprepitant (1 mg/mL).
- The other ingredients are: disodium edetate (E386), polysorbate 80 (E433), anhydrous lactose, sodium hydroxide (E524) (for pH adjustment) and/or concentrated hydrochloric acid (E507) (for pH adjustment).
Description of the appearance of Fosaprepitant Accord and package contents
Fosaprepitant Accord is a solid lyophilized product of white to off-white color for infusion solution.
The powder is contained in a transparent glass vial with a rubber stopper and an aluminum seal
with an orange tear-off cap.
Each vial contains 150 mg of fosaprepitant. Pack size: 1 vial.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Marketing authorization holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturers:
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
Harrow, Middlesex
HA1 4HF
United Kingdom
or
LABORATORI FUNDACIÓ DAU
Pol. Ind. Consorci Zona Franca, c/ C, 12-14
Barcelona, 08040,
Spain
or
Wessling Hungary Kft.
Fòti ùt 56.,
Budapest 1047,
Hungary
---------------------------------------------------------------------------------------------------------------------------
The following information is directed only to healthcare professionals:
Instructions for reconstitution and dilution of Fosaprepitant Accord 150 mg
- 1. Inject 5 mL of sodium chloride 9 mg/mL (0.9 %) injectable solution into the vial. Ensure that the sodium chloride 9 mg/mL (0.9 %) injectable solution is added along the wall of the vial to prevent foam formation. Gently rotate the vial. Avoid shaking and spraying the sodium chloride 9 mg/mL (0.9 %) injectable solution into the vial.
- 2. Prepare an infusion bag filled with 145 mLof sodium chloride 9 mg/mL (0.9 %) injectable solution (for example, by removing 105 mL of sodium chloride 9 mg/mL (0.9 %) injectable solution from a 250 mL infusion bag of sodium chloride 9 mg/mL (0.9 %) injectable solution)
- 3. Withdraw the entire volume from the vial and transfer it to an infusion bag containing 145 mL of sodium chloride 9 mg/mL (0.9 %) injectable solution to obtain a total volume of 150 mL. Gently invert the bag 2–3 times (see “How to use Fosaprepitant Accord”). The final reconstituted and diluted solution is stable for 48 hours at 20-25°C.
Medicinal products for parenteral use must be visually inspected before administration to
check for particles or color changes where the solution and container allow.
The appearance of the reconstituted solution is identical to the appearance of the diluent.
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- Страна регистрации
- Форма выпускаPowder for intravenous infusion solution, 150 MG
- Код АТХA04AD12
- 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 FOSAPREPITANT AKKORDФорма выпуска: Hard capsule, 125 MG + 80 MGДействующее вещество: АпрепитантПроизводитель: TEVA B.V.Отпускается по рецептуФорма выпуска: Hard capsule, 80 MGДействующее вещество: АпрепитантПроизводитель: SINTESY PHARMA S.R.L.Отпускается по рецептуФорма выпуска: Hard capsule, 80 MGДействующее вещество: АпрепитантПроизводитель: MERCK SHARP & DOHME B.V.Отпускается по рецепту
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FOSAPREPITANT AKKORD требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество FOSAPREPITANT AKKORD — Апрепитант. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
FOSAPREPITANT AKKORD производится компанией ACCORD HEALTHCARE, S.L.U.. 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 FOSAPREPITANT AKKORD 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 FOSAPREPITANT AKKORD в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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Другие лекарства с тем же действующим веществом (Апрепитант) включают APREPITANT TEVA, ATANTO, EMEND. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
