ACIDO 100 mg /Ml Injectable Solution
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Інструкція із застосування AKIDO TRANEXAMIKO AUROBINDO
Зміст інструкції
Acido Tranexamico Aurobindo 100 mg/ml solution for injection
Generic medicine
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 your doctor or nurse.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet:
- 1. What Acido Tranexamico Aurobindo is and what it is used for
- 2. What you need to know before you are given Acido Tranexamico Aurobindo
- 3. How to use Acido Tranexamico Aurobindo
- 4. Possible side effects
- 5. How to store Acido Tranexamico Aurobindo
- 6. Contents of the pack and other information
1. What is Acido Tranexamico Aurobindo and what is it used for
Acido Tranexamico Aurobindo contains tranexamic acid, which belongs to a group of medicines
called antihemorrhagics, antifibrinolytics, amino acids.
This medicine is used in adults and children starting from one year of age for the prevention and
treatment of bleeding due to a process that inhibits blood coagulation called
fibrinolysis.
The specific indications are:
- heavy menstrual bleeding in women;
- gastrointestinal bleeding;
- bleeding disorders of the urinary tract, following surgery on the prostate or surgical procedures on the urinary tract;
- surgery on ears, nose or throat;
- surgery on the heart, abdomen or gynecological surgery;
- bleeding following treatment with other medicines to dissolve blood clots.
2. What you need to know before you are given Acido Tranexamico Aurobindo
Do not take Acido Tranexamico Aurobindo:
- if you are allergicto tranexamic acid or any of the other ingredients of this medicine (listed in section 6);
- if you have a disease that leads to the formation of blood clots;
- if you have a condition called “consumption coagulopathy” in which the blood begins to form clots in different parts of the body;
- if you have kidney problems;
- if you have had seizures in the past.
Due to the risk of cerebral edema and seizures, intrathecal and intraventricular injection and
intracerebral application are not recommended.
If you think any of these conditions apply to you, or if you have any other doubts, talk to your doctor before
taking this medicine.
Warnings and precautions
Talk to your doctor or nurse before taking Acido Tranexamico Aurobindo if you suffer from any of the
following conditions. This will help them decide if this medicine is suitable for you:
- if you have blood in your urine, which could lead to an obstruction of the urinary tract;
- if you are at risk of developing blood clots;
- if you have excessive clots or bleeding throughout the body (disseminated intravascular coagulation), this medicine may not be suitable for you, unless you have acute severe bleeding and blood tests have shown that the process that inhibits blood clotting, called fibrinolysis, is activated;
- if you have had seizures this medicine should not be given to you. The doctor will need to use the minimum possible dose to avoid seizures due to treatment with this medicine;
- if you are undergoing prolonged treatment with this medicine, attention should be paid to possible disturbances of color vision and, if necessary, treatment should be discontinued. In case of prolonged use of this medicine, regular ophthalmological visits are recommended (including eye examinations including visual acuity, color vision, fundus examination, visual field, etc.). In case of pathological ophthalmological changes, in particular with retinal diseases, the doctor must decide, after consulting a specialist, on the need for prolonged use of this medicine in your case.
Other medicines and Acido Tranexamico Aurobindo
Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other
medicines.
In particular, you should tell them if you are taking:
- other medicines that promote blood clotting called antifibrinolytics;
- medicines that prevent blood clotting called thrombolytics;
- oral contraceptives.
Pregnancy, breastfeeding and fertility
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.
Tranexamic acid is excreted in breast milk. Therefore, the use of this medicine is not recommended
during breastfeeding.
Driving and using machines
No studies have been performed on the ability to drive vehicles and use machines.
3. How to use Acido Tranexamico Aurobindo
This medicine will be administered to you with a slow injection into a vein.
The doctor will decide the appropriate dose for you and how long you will need to take it.
Use in children
If this medicine is administered to a child starting from one year of age, the dose will be calculated based on
the child's weight. The doctor will decide the appropriate dose for the child and how long they will need to take it.
Use in the elderly
It is not necessary to reduce the dose unless there is evidence of renal insufficiency.
Use in patients with kidney problems
If you have kidney problems, the dose of tranexamic acid will be reduced based on a blood test (serum
creatinine level).
Use in patients with liver damage
It is not necessary to reduce the dose.
Method of administration
This medicine must be administered slowly into a vein.
It must not be injected into a muscle.
If you are given more Acido Tranexamico Aurobindo than the recommended dose
If you are given more tranexamic acid than the recommended dose, a
temporary drop in blood pressure may occur. Inform your doctor or pharmacist immediately.
If you have any doubts about the use of this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects reported with this medicine are:
The following side effects have been observed with this medicine:
Common: may affect up to 1 in 10 people
- effects on the stomach and intestines: nausea, vomiting, diarrhoea.
Uncommon: may affect up to 1 in 100 people
- effects on the skin: rash.
Not known: frequency cannot be estimated based on the available data
- illness with hypotension (low blood pressure), in particular if the injection was administered too quickly;
- blood clots;
- effects on the nervous system: convulsions;
- effects on the eyes: vision disorders including altered colour vision;
- effects on the immune system: allergic reactions.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Acido Tranexamico Aurobindo
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and label after Scad.
The expiry date refers to the last day of that month. The pharmacist will check the expiry date
before giving you the injection.
This medicine does not require any special storage conditions.
Once opened: Use immediately. Discard any unused quantity.
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 Acido Tranexamico Aurobindo contains
- The active ingredient is tranexamic acid. Each ml of solution contains 100 mg of tranexamic acid. Each vial of 5 ml solution contains 500 mg of tranexamic acid. Each vial of 10 ml solution contains 1000 mg of tranexamic acid.
- The other component is water for injections.
Description of the appearance of Acido Tranexamico Aurobindo and package contents
Solution for injection.
Type I clear glass vial containing 5 ml or 10 ml of solution for injection. To facilitate breaking, the
vials may have a “single break point” or may be “marked”. The vials are contained in
a pre-printed box.
Pack sizes:
5 ml:1, 5, 6, 10 and 100 vials in a box.
10 ml:5 and 10 vials in a box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914, Malta
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD
United Kingdom
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Belgium: Tranexaminezuur AB 100 mg/ml solution for injection
Italy: Acido Tranexamico Aurobindo
Germany: Tranexamsäure PUREN 100 mg/ml Injektionslösung
Netherlands: Tranexaminezuur Aurobindo 100 mg/ml, solution for injection
Portugal: Ácido Tranexâmico Generis
Spain: Ácido Tranexámico Aurovitas 100 mg/ml solución inyectable EFG
United Kingdom: Tranexamic acid 100 mg/ml solution for injection
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THE FOLLOWING INFORMATION IS INTENDED EXCLUSIVELY FOR PHYSICIANS OR
HEALTHCARE PROFESSIONALS:
Dosage in adults
Unless otherwise prescribed, the following doses are recommended:
- 1. standard treatment of local fibrinolysis: from 0.5 g (1 vial of 5 ml) to 1 g (1 vial of 10 ml or 2 vials of 5 ml) of tranexamic acid via slow intravenous injection (= 1 ml/minute) two or three times a day.
- 2. standard treatment of generalized fibrinolysis:
1 g (1 vial of 10 ml or 2 vials of 5 ml) of tranexamic acid via slow intravenous injection (= 1
ml/minute) every 6-8 hours, equivalent to 15 mg/kg body weight.
Use in children
If Acido Tranexamico Aurobindo 100 mg/ml solution for injection is administered to children from one year
of age, the dose will be based on the child's weight. The doctor will decide the correct dose for the child and for
how long it should be used.
In children from 1 year of age, for the current approved indications, the dosage is around 20 mg/kg/day.
Use in the elderly
It is not necessary to reduce the dose unless there is proven renal insufficiency.
Use in patients with renal problems
In case of renal insufficiency which may entail a risk of accumulation, the use of tranexamic acid is
contraindicated in patients with severe renal impairment. For patients with mild to
moderate renal insufficiency, the dose of tranexamic acid must be reduced based on the level of serum creatinine.
Use in patients with hepatic impairment
No dosage adjustments are necessary.
Method of administration
Acido Tranexamico Aurobindo 100 mg/ml solution for injection must be injected
slowly (= 1 ml/minute) only.
Acido Tranexamico Aurobindo 100 mg/ml solution for injection must not be injected into the muscle.
| Serum creatinine | l Intravenous dose | Administration | |
| micromoles/l | mg/10 ml | ||
| from 120 to 249 | a from 1.35 to 2.82 | 10 mg/kg body weight | Every 12 hours |
| from 250 to 500 | t from 2.82 to 5.65 | 10 mg/kg body weight | Every 24 hours |
| > 500 | I > 5.65 | 5 mg/kg body weight | Every 24 hours |
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- Країна реєстрації
- Лікарська формаInjectable solution, 100 MG/ML
- Код АТХB02AA02
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до AKIDO TRANEXAMIKO AUROBINDOЛікарська форма: Film-coated tablet, 500 MGДіюча речовина: Транексамовая кислотаВиробник: APC PHARMLOG SP. Z O.O.Потрібен рецептЛікарська форма: Injectable solution, 500 MG/5 MLДіюча речовина: Транексамовая кислотаПотрібен рецептЛікарська форма: Coated granules in a sachet, 1000 MGДіюча речовина: Транексамовая кислотаВиробник: CEMAG CAREПотрібен рецепт
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Часті запитання
AKIDO TRANEXAMIKO AUROBINDO потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у AKIDO TRANEXAMIKO AUROBINDO — Транексамовая кислота. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
AKIDO TRANEXAMIKO AUROBINDO виробляється компанією Eugia Pharma (Malta) Limited. 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 AKIDO TRANEXAMIKO AUROBINDO 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 AKIDO TRANEXAMIKO AUROBINDO 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 (Транексамовая кислота) включають AKIDO TRANEXAMIKO APK PARMLOG, AKIDO TRANEXAMIKO BIOINDUSTRIA L.I.M., NEXAG. 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.
