Инструкция по применению KARBALU
Содержание инструкции
Carbaglu 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 may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
Contents of this leaflet
- 1. What Carbaglu is and what it is used for
- 2. What you need to know before you take Carbaglu
- 3. How to take Carbaglu
- 4. Possible side effects 5 How to store Carbaglu
- 6. Contents of the pack and other information
1. What is Carbaglu and what is it used for
Carbaglu 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 need treatment during hyperammonemia crises.
2. What you need to know before taking Carbaglu
Do not take Carbaglu
- if you are allergic to carglumic acid or any of the other ingredients of this medicine (listed in section 6). Do not take Carbaglu during breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Carbaglu.
Treatment with Carbaglu must 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 a
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 Carbaglu
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Carbaglu with food and drink
Carbaglu 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 Carbaglu on pregnancy and the fetus are unknown.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
The excretion of carglumic acid into breast milk has not been studied in women. However, since
carglumic acid has been shown to be present in the milk of lactating female rats, with
potential toxic effects for breastfed infants, if you are taking Carbaglu you must not breastfeed.
Driving and using machines
No effects on the ability to drive or operate machines are known.
3. How to take Carbaglu
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult 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.
Carbaglu 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, Carbaglu 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 Carbaglu than you should
Consult your doctor or pharmacist for advice.
If you forget to take Carbaglu
Do not take a double dose to make up for a missed dose.
If you stop taking Carbaglu
Do not stop taking Carbaglu without informing 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.
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 (the frequency cannot be estimated from the available data).
- Common: increased sweating
- Uncommon: bradycardia (decreased heart rate), diarrhea, 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 not listed here
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 Carbaglu
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the blister pack
after Exp.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
After opening the blister pack: do not refrigerate. Do not store at a temperature
above 30 ° C.
Keep the container tightly closed in order to protect the product from humidity.
Write the date of opening on the blister pack. Discard the product 3 months after the first
opening.
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. Contents of the pack and other information
What Carbaglu contains
- The active ingredient is carglumic acid. Each tablet contains 200 mg of carglumic acid.
- The other ingredients are microcrystalline cellulose, sodium lauryl sulfate, hypromellose, sodium croscarmellose, anhydrous colloidal silica, sodium stearylfumarate.
Description of the appearance of Carbaglu and contents of the pack
Carbaglu 200 mg tablets are elongated tablets with 4 dots imprinted and three scoring lines on the side.
Carbaglu is supplied in plastic containers of 5, 15 or 60 tablets with a child-resistant closure.
Marketing Authorisation Holder
Recordati Rare Diseases
Immeuble “Le Wilson”
70, avenue du Général de Gaulle
F-92800 Puteaux
France
Tel: + 33 1 4773 6458
Fax: + 33 1 4900 1800
Manufacturer
Recordati Rare Diseases
Immeuble “Le Wilson”
70 avenue du Général de Gaulle
F-92800 Puteaux
France
or
Recordati Rare Diseases
Eco River Parc
30, rue des Peupliers
F-92000 Nanterre
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.
Lietuva
Recordati AB.
Tel: + 46 8 545 80 230
Sweden
България
Recordati Rare Diseases
Тел.: +33 (0)1 47 73 64 58
France
Belgique/België/Belgien
Recordati
Tél/Tel: +32 2 46101 36
Luxembourg/Luxemburg
Recordati
Tél/Tel: +32 2 46101 36
Belgique/Belgien
Česká republika
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Magyarország
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Danmark
Recordati AB.
Tlf : +46 8 545 80 230
Sweden
Malta
Recordati Rare Diseases
Tel: +33 1 47 73 64 58
France
Deutschland
Recordati Rare Diseases Germany GmbH
Tel: +49 731 140 554 0
Nederland
Recordati
Tel: +32 2 46101 36
België
Eesti
Recordati AB.
Tel: + 46 8 545 80 230
Sweden
Norge
Recordati AB.
Tlf : +46 8 545 80 230
Sweden
Ελλάδα
Recordati Hellas
Τηλ: +30 210 6773822
Österreich
Recordati Rare Diseases Germany GmbH
Tel: +49 731 140 554 0
Germany
España
Recordati Rare Diseases Spain S.L.U.
Tel: + 34 91 659 28 90
Polska
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
France
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
Portugal
Jaba Recordati S.A.
Tel: +351 21 432 95 00
Hrvatska
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France
România
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Ireland
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Slovenija
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Ísland
Recordati AB.
Simi:+46 8 545 80 230
Sweden
Slovenská republika
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
France
Italia
Recordati Rare Diseases Italy Srl
Tel: +39 02 487 87 173
Suomi/Finland
Recordati AB.
Puh/Tel : +46 8 545 80 230
Sweden
Κύπρος
Recordati Rare Diseases
Τηλ : +33 1 47 73 64 58
France
Sverige
Recordati AB.
Tel : +46 8 545 80 230
Latvija
Recordati AB.
Tel: + 46 8 545 80 230
Sweden
United Kingdom (Northern Ireland)
Recordati Rare Diseases UK Ltd.
Tel: +44 (0)1491 414333
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu. In addition, links to other websites on rare diseases and related
therapeutic treatments are provided.

- 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 KARBALUФорма выпуска: Dispersible tablet, 200 MGДействующее вещество: Карглюмиковая кислотаПроизводитель: WAYMADE B.V.Отпускается по рецептуФорма выпуска: Dispersible tablet, 200 MGДействующее вещество: Карглюмиковая кислотаПроизводитель: EUROCEPT INTERNATIONAL B.V.Отпускается по рецепту
Аналоги KARBALU в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог KARBALU в Испания
Аналог KARBALU в Польша
Аналог KARBALU в Украина
Врачи онлайн по KARBALU
Обсудите применение KARBALU и возможные следующие шаги — по оценке врача.
Получите рецепт на KARBALU 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
KARBALU требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество KARBALU — Карглюмиковая кислота. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
KARBALU производится компанией RECORDATI RARE DISEASES SARL. 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 KARBALU 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 KARBALU 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, UKEDANE, AMVERSIO. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















