Инструкция по применению UKEDANE
Содержание инструкции
Ucedane 200 mg dispersible tablets
Carglumic acid
Read this leaflet carefully before taking 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 Ucedane is and what it is used for
- 2. What you need to know before you take Ucedane
- 3. How to take Ucedane
- 4. Possible side effects 5 How to store Ucedane
- 6. Contents of the pack and other information
1. What is Ucedane and what is it used for
Ucedane can help to eliminate excessive levels of ammonia in the plasma (high level of
ammonia in the blood). Ammonia is particularly toxic to the brain and, in severe cases, can
lead to reduced levels of consciousness and coma.
Hyperammonemia (high level of ammonia in the blood) can be caused by:
- a lack of a specific liver enzyme, N-acetylglutamate synthase. Patients affected by this rare condition are unable to eliminate nitrogenous metabolic waste that forms after protein intake. This condition persists throughout the patient's life and therefore requires this treatment for life.
- isovaleric, methylmalonic or propionic acidemia. Patients affected by one of these forms of the disease require treatment during hyperammonemia crises.
2. What you need to know before taking Ucedane
Do not take Ucedane
- If you are allergic to carglumic acid or any of the other ingredients of Ucedane (listed in section 6). Do not take Ucedane during breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ucedane.
Treatment with Ucedane should begin under the supervision of a doctor experienced in the treatment of
metabolic disorders.
The doctor will need to assess individual responsiveness to carglumic acid before starting long-term
treatment.
The dose must be adjusted individually to maintain normal ammonia levels in the plasma.
The doctor may prescribe supplementary arginine or limit protein intake.
To monitor the disorder and response to treatment, the doctor may periodically subject you to
liver, kidney and heart function tests and blood tests.
Other medicines and Ucedane
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Ucedane with food and drink
Ucedane should be taken orally before meals or food intake.
The tablets must be dispersed in at least 5-10 ml of water and swallowed immediately.
The suspension has a slightly acidic taste.
Pregnancy and breastfeeding
The effects of Ucedane on pregnancy and the fetus are unknown.
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
Excretion of carglumic acid into breast milk has not been studied in women. However, since the presence
of carglumic acid has been demonstrated in the milk of lactating female rats, with potential toxic effects
for breastfed infants, if you are taking Ucedane you should not breastfeed.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery are known.
Ucedane contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per maximum daily dose, i.e. it is essentially
"sodium-free".
3. How to take Ucedane
Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Normal dosage:
The initial daily dose is, as a rule, 100 mg per kilogram of body weight, up to a
maximum of 250 mg per kilogram of body weight (for example, if you weigh 10 kg you should take 1 g
per day, i.e. 5 tablets).
For patients affected by N-acetylglutamate synthase deficiency, in the long term, the daily dose
normally varies from 10 mg to 100 mg per kilogram of body weight.
The doctor will establish the appropriate dose in order to maintain normal levels of ammonia in the blood.
Ucedane must be administered EXCLUSIVELY orally or via a feeding tube inserted into the
stomach (using a syringe, if necessary).
If the patient is in hyperammonemic coma, Ucedane should be administered by rapid injection
with a syringe through the inserted and used feeding tube.
Inform your doctor if you suffer from renal impairment, as in this case the daily dose
should be reduced.
If you take more Ucedane than you should
Consult your doctor or pharmacist for advice.
If you forget to take Ucedane
Do not take a double dose to make up for a missed dose.
If you stop taking Ucedane
Do not stop taking Ucedane without informing your doctor.
If you have any further questions on 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.
The following side effects have been reported with the following frequency: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon
(may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people),
very rare (may affect up to 1 in 10,000 people) and not known (frequency cannot be
estimated from the available data).
- Common: increased sweating
- Uncommon: bradycardia (decreased heart rate), diarrhoea, fever, increased transaminases (liver enzymes), vomiting
- Not known: skin rash
If any of these side effects gets worse, or if you notice any side effect
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ucedane
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the blister and on the package after
Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Ucedane contains
- The active ingredient is carglumic acid. Each tablet contains 200 mg of carglumic acid.
- The other ingredients are microcrystalline cellulose, anhydrous colloidal silicon dioxide, sodium stearylfumarate (see section 2 "Ucedane contains sodium"), mannitol, copovidone K28, crospovidone type B.
Description of the appearance of Ucedane and contents of the pack
Ucedane dispersible tablets are white, oval-shaped and biconvex, with three
grooves on both sides and the inscription “L/L/L/L” printed on one side.
The approximate dimensions of the tablets are 17 mm in length and 6 mm in width.
The tablet can be divided into four equal doses.
The tablets are supplied in aluminium/aluminium blisters packaged in a carton. The pack
contains 12 or 60 dispersible tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder
Eurocept International BV
Trapgans 5
1244 RL Ankeveen
The Netherlands
Manufacturer
Eurocept International BV
Trapgans 5
1244 RL Ankeveen
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.
België/Belgique/Belgien
Lucane Pharma
Tél/Tel: + 33 153 868 750
[email protected]
Lietuva
FrostPharma AB
Tel: +46 824 36 60
[email protected]
България
Lucane Pharma
Teл.: + 33 153 868 750
[email protected]
Luxembourg/Luxemburg
Lucane Pharma
Tél/Tel: + 33 153 868 750
[email protected]
Česká republika
Lucane Pharma
Tél/Tel: + 33 153 868 750
[email protected]
Magyarország
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
Danmark
FrostPharma AB
Tlf: +46 824 36 60
[email protected]
Malta
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
Deutschland
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
Nederland
Eurocept International BV
Tel: +31 35 528 39 57
[email protected]
EestiNorge
FrostPharma AB
Tlf: +46 824 36 60
[email protected]
FrostPharma AB
Tel: +46 824 36 60
[email protected]
Ελλάδα
Lucane Pharma
Τηλ: + 33 153 868 750
[email protected]
Österreich
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
España
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
Polska
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
France
Lucane Pharma
Tél: + 33 153 868 750
[email protected]
Portugal
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
Hrvatska
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
România
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
Ireland
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
Slovenija
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
Ísland
FrostPharma AB
Sími: +46 824 36 60
[email protected]
Slovenská republika
Lucane Pharma
Tel: + 33 153 868 750
[email protected]
Italia
Lucane Pharma
Tel: + 33 153 868 750
Suomi/Finland
FrostPharma AB
Puh/Tel: +46 824 36 60
[email protected]
Κύπρος
Lucane Pharma
Τηλ: + 33 153 868 750
[email protected]
[email protected]
Sverige
FrostPharma AB
Tel: +46 824 36 60
[email protected]
Latvija
FrostPharma AB
Tel: +46 824 36 60
[email protected]
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/.

- Страна регистрации
- Форма выпускаDispersible tablet, 200 MG
- Код АТХA16AA05
- 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 UKEDANEФорма выпуска: Dispersible tablet, 200 MGДействующее вещество: Карглюмиковая кислотаПроизводитель: WAYMADE B.V.Отпускается по рецептуФорма выпуска: Dispersible tablet, 200 MGДействующее вещество: Карглюмиковая кислотаПроизводитель: RECORDATI RARE DISEASES SARLОтпускается по рецепту
Аналоги UKEDANE в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог UKEDANE в Испания
Аналог UKEDANE в Польша
Аналог UKEDANE в Украина
Врачи онлайн по UKEDANE
Обсудите применение UKEDANE и возможные следующие шаги — по оценке врача.
Получите рецепт на UKEDANE онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
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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
UKEDANE требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество UKEDANE — Карглюмиковая кислота. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
UKEDANE производится компанией EUROCEPT INTERNATIONAL 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 UKEDANE 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 UKEDANE 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 (Карглюмиковая кислота) включают AKIDO KARLUMIKO WAYMADE, KARBALU, AMVERSIO. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















