Інструкція із застосування ITTRIO (90Y) KITRATO KURIUM ITALY
Зміст інструкції
- Yttrium (Y) citrate Curium Italy 167, 200, 235, 280 or 336 MBq/mL
- yttrium (Y) citrate
- Yttrium (Y) citrate Curium Italy is used in adults for the treatment
Yttrium (Y) citrate Curium Italy 167, 200, 235, 280 or 336 MBq/mL
injectable suspension
yttrium (Y) citrate
Read this leaflet carefully before you are given 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 the nuclear medicine physician who will supervise the procedure.
- If any side effects occur, including any not listed in this leaflet, tell the nuclear medicine physician. See section 4.
Contents of this leaflet
- 1. What Yttrium (Y) citrate Curium Italy is and what it is used for
- 2. What you need to know before you are given Yttrium (Y) citrate Curium Italy
- 3. How Yttrium (Y) citrate Curium Italy is given
- 4. Possible side effects
- 5. How to store Yttrium (Y) citrate Curium Italy
- 6. Contents of the pack and other information
1. What is Yttrium (Y) citrate Curium Italy and what it is used for
This medicine is a radiopharmaceutical for therapeutic useonly.
The active ingredient is yttrium(Y) citrate.
Yttrium (Y) citrate Curium Italy is used in adults for the treatment
of the knee(radioisotopic synovectomy) in the presence of conditions
such as chronic inflammatory rheumatism arthritis, particularly rheumatoid
arthritis.
The use of Yttrium (Y) citrate Curium Italy involves exposure to a certain
amount of radioactivity. Your doctor and the nuclear medicine physician
have estimated that the clinical benefit obtained from the procedure with the
radiopharmaceutical outweighs the risk due to radiation.
2. What you need to know before you are given Yttrium (Y)
Curium Italy citrate
Yttrium (Y) citrate IBA must not be administered
- if you are allergic to Yttrium (Y) citrate Curium Italy or to any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or suspect you may be pregnant
- if you are breastfeeding
- if you have localised infections or skin diseases present at the injection site
- if you suffer from septic arthritis of the knee
- if you have a ruptured popliteal cyst
- if you are under 18 years of age.
Warnings and precautions
Take special care with Yttrium (Y) citrate Curium Italy
Contact your nuclear medicine doctor in the following cases:
- if you are a woman of childbearing potential (see section Pregnancy and breastfeeding),
- if you have a popliteal cyst that may rupture,
- if you have a severely damaged knee joint with destruction of bone tissue or loss of cartilage.
The doctor will inform you about any special precautions to be
taken after use of the product.
Children and adolescents
Yttrium (Y) citrate IBA must not be administered to children and
adolescents.
Inform your nuclear medicine doctor if you are under 18 years of age.
Other medicines and Yttrium (Y) citrate Curium Italy
Inform your nuclear medicine doctor if you are taking, have
recently taken or might take any other medicines, including those
available without a prescription, as they may affect the
quality of the results obtained with treatment with Yttrium (Y) citrate
Curium Italy.
Inform your nuclear medicine specialist if you have recently been
given a radiographic contrast agent, as it
is recommended to wait at least 8 days before
treatment.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a
pregnancy, or if you are breastfeeding, ask your nuclear medicine
doctor for advice before you are given this medicine.
Inform your nuclear medicine doctor before administration of
Yttrium (Y) citrate Curium Italy if there is a possibility that you are
pregnant, if you have missed a period or if you are breastfeeding.
If you have any doubts, it is important to consult your nuclear medicine
doctor who is supervising the procedure.
If you are a woman of childbearing potential, you must use an effective
contraceptive method before treatment and continue it for at least 4
months after treatment.
If you are pregnant or breastfeeding, this medicine must not be
administered.
If you are breastfeeding, you should consider the possibility of
reasonably delaying treatment until you have
finished breastfeeding.
Driving and using machines
The intra-articular injection of this medicine does not allow driving
vehicles and using machines as it must be followed by
immobilisation of the knee and bed rest for 2-3 days to
prevent extra-articular radiopharmaceutical spread.
Yttrium (Y) citrate Curium Italy contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose,
therefore it is practically sodium-free.
3. How Yttrium (Y) citrate Curium Italy is administered
There are strict laws regulating the use, handling and disposal of radiopharmaceuticals. Yttrium (Y) citrate Curium Italy must be used only in special controlled areas. This product must be handled and administered only by healthcare professionals prepared and qualified to use it, respecting safety criteria. These people will pay particular attention to the safe use of this product and will keep you informed of their actions. The nuclear medicine physician supervising the procedure will decide the amount of Yttrium (Y) citrate Curium Italy to use in your case. It will be the smallest amount necessary to achieve the desired effect. The amount to be administered, normally recommended for an adult, ranges from 185 to 220 MBq per knee(MBq: Megabecquerel is the unit used to express radioactivity).
If symptoms recur, the administration of the product can be
repeated after 6 monthsin the knee already treated.
Administration of Yttrium (Y) citrate Curium Italy and performance of the examination
The product is administered by injection into the knee, after removing any excess fluid from the joint.
Duration of the procedure
The nuclear medicine physician will inform you about the usual duration of the procedure.
After administration of Yttrium (Y) citrate Curium Italy, you must rest in bed for 2 or 3 dayswith absolute immobilizationof the knee to minimize the amount of product that could migrate outside the knee.
The nuclear medicine physician will inform you about any particular precautions you need to take after receiving this medicine. If you have any doubts about the use of this medicine, consult your nuclear medicine physician.
If you have been given more Yttrium (Y) citrate Curium Italy than you should
An overdose is unlikely as you will only receive a single dose of Yttrium (Y) citrate Curium Italy carefully controlled by the nuclear medicine physician supervising the procedure. However, in case of overdose, you will receive appropriate treatment which may include immobilization and cooling of the joint, removal of any effusion and intra-articular injection of a corticosteroid drug.
If you have any further questions about the use of Yttrium (Y) citrate Curium Italy, consult the nuclear medicine physician supervising the procedure.
4. Possible side effects
Like all medicines, this medicine can cause side effects
although not everybody gets them.
Common(may affect up to 1 in 10 people)
cases treated within 24 hours of the injection.
Uncommon(may affect up to 1 in 100 people)
- inflammation of the knee where the product was administered, which may occur after a few hours or a few days. The inflammation can be treated with an analgesic or a non-steroidal anti-inflammatory drug.
Not known(frequency cannot be estimated from available data)
- pain at the injection site
- secondary infection of the joint (infectious arthritis)
- blood cancer (myeloid leukemia)
- cancer of the lymph nodes or tissues (lymphoma)
- allergic reactions (hypersensitivity)
- skin death (skin necrosis)
- blackening of the skin (pigmentation disorders)
- destruction of knee bone tissue (osteonecrosis)
- inherited defects (cytogenetic abnormalities)
Carcinogenic (tumor) and leucemogenic (leukemia, blood cancer
affecting white blood cells) risk
Exposure to ionizing radiation is associated with the induction of tumors
and a potential development of inherited defects.
A single case of chronic myeloid leukemia (myeloid leukemia) and one case
of malignant inguinal lymphoma (lymphoma) occurred after treatment of
over 20,000 joints over a 20-year observation period.
However, the relationship of these diseases with radiosynoviarthrosis has not
been established.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your Nuclear Medicine doctor. You
can also report side effects directly through 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 Ittrio ( Y) citrato Curium Italy is stored
You must not store this medicine. This medicine is
stored under the responsibility of the specialist in appropriate premises. Radiopharmaceuticals will be stored in accordance with current national regulations
on radioactive materials.
The following information is intended only for the specialist.
The medicine must be stored in the original packaging at a
temperature not exceeding 25 °C.
After the first withdrawal from the vial, the medicine must be
stored in a refrigerator (2°- 8°C) and used within 8 hours.
Ittrio ( Y) citrato Curium Italy must not be used after the expiry date
indicated on the secondary packaging and on the vial.
6. Contents of the pack and other information
What Ittrio (Y) citrate Curium Italy contains
- The active substance is yttrium ( Y) citrate. One ml of suspension contains 167, 200, 235, 280 or 336 MBq of Yttrium ( Y) citrate at the date and time of calibration.
- The other components are: sodium chloride, water for injections, sodium hydroxide, nitric acid and sodium citrate.
Description of the appearance of Ittrio (Y) citrate Curium Italy and
contents of the pack
This medicine is presented in a glass vial containing a
white milky colloidal suspension. One vial contains from 0.3 to
10 mL of suspension.
Marketing authorisation holder and
manufacturer
Marketing authorisation holder
Curium Italy S.r.l.
Via Nicola Piccinni 2,
I-20131 Milano
Manufacturer
Cis bio international
R.N. 306 – Saclay
B.P. 32
F-91192 GIF-SUR-YVETTE CEDEX
More detailed information on this medicine is available on the website
------------------------------------------------------------------------------------------------
The following information is intended exclusively for doctors and
healthcare professionals:
The summary of product characteristics of Ittrio ( Y)
citrate Curium Italy is provided as a separate document, with the purpose of
providing healthcare professionals with further scientific and practical
information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.
- Країна реєстрації
- Лікарська формаInjectable suspension, 167 MBq/mL
- Код АТХV10AA01
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до ITTRIO (90Y) KITRATO KURIUM ITALYЛікарська форма: Infusion solution, 370 MBq/mLДіюча речовина: Лутеций (177Lu) оксодотреотидВиробник: ADVANCED ACCELERATOR APPLICATIONSПотрібен рецептЛікарська форма: Injectable or infusion solution, 1 000 MBq / mLДіюча речовина: lutetium (177Lu) vipivotide tetraxetanВиробник: NOVARTIS EUROPHARM LIMITEDПотрібен рецептЛікарська форма: Injectable solution, 2 to 4 GBqДіюча речовина: Самарий (153Sm) лексидронамВиробник: CIS BIO INTERNATIONALПотрібен рецепт
Аналоги ITTRIO (90Y) KITRATO KURIUM ITALY в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог ITTRIO (90Y) KITRATO KURIUM ITALY у Іспанія
Лікарі онлайн щодо ITTRIO (90Y) KITRATO KURIUM ITALY
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на ITTRIO (90Y) KITRATO KURIUM ITALY онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
ITTRIO (90Y) KITRATO KURIUM ITALY не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у ITTRIO (90Y) KITRATO KURIUM ITALY — yttrium (90Y) citrate colloid. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
ITTRIO (90Y) KITRATO KURIUM ITALY виробляється компанією CURIUM ITALY S.R.L.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування ITTRIO (90Y) KITRATO KURIUM ITALY з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати ITTRIO (90Y) KITRATO KURIUM ITALY у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (yttrium (90Y) citrate colloid) включають LUTATERA, PLUVIKTO, QUADRAMET. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















