Інструкція із застосування NOVASTAN
Зміст інструкції
- What is Novastan and what is it used for
- What you need to know before using Novastan
- How to use Novastan
- Possible side effects
- How to store Novastan
- Package Contents and Other Information
for infusion solution
argatroban monohydrate
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.
- If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Novastan is and what it is used for
- 2. What you need to know before you use Novastan
- 3. How to use Novastan
- 4. Possible side effects
- 5. How to store Novastan
- 6. Contents of the pack and other information
1. What is Novastan and what is it used for
Novastan is an anticoagulant (a medicine that helps prevent the formation of blood clots
in the blood). It works by blocking the action of thrombin, a substance present in the blood
that is important for coagulation.
Novastan is used to treat a condition called heparin-induced thrombocytopenia type II (HIT type II). If you have HIT type II, there is a risk that you may develop blood clots
in your blood that can cause heart attacks, strokes, breathing problems, and problems
with blood distribution in the limbs. Novastan can prevent these problems or prevent
their worsening.
2. What you need to know before using Novastan
Do not take Novastan
Novastan will not be prescribed to you:
- if you have significant bleeding.
- if you are allergic (hypersensitive) to argatroban or any of the excipients of Novastan.
- if you suffer from severe hepatic impairment.
Warnings and precautions
Novastan will be prescribed to you with caution:
- if you have an increased risk of bleeding
- if you have recently received injections or infusions with other anticoagulant medications, such as heparin
- if you suffer from a liver disease Children and adolescentsIt is not recommended to give this medicine to children or adolescents, as a safe or effective dose of Novastan has not been clearly established.
Other medicines and Novastan
Tell your doctor if you are taking or have recently taken any other medicines,
including those available without a prescription.
The combined use with other medicines to thin the blood or dissolve clots may
increase the risk of bleeding.
Since Novastan contains ethanol, this may affect the effect of other medicines based on
metronidazole (used for infections) or disulfiram (for alcoholism).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor for advice before taking this medicine.
As a precautionary measure, it is preferable to avoid the use of Novastan during pregnancy.
Breastfeeding should be avoided during treatment with Novastan.
See also “Novastan contains alcohol”.
Driving and operating machinery
Because Novastan contains alcohol, you should not drive vehicles or operate machinery during
treatment. See also “Novastan contains alcohol”.
Novastan contains alcohol
Before dilution, this product contains 400 mg/ml of alcohol (ethanol), at 50% of
volume, corresponding to 0.5% volume after dilution as indicated in the instructions.
The daily dose may contain up to 5 ml (4g) of alcohol, corresponding to 100 ml of beer or
40 ml of wine. This may be harmful to people who suffer from liver disorders, from
alcoholism or epilepsy, in case of brain injury or disease, for women during
pregnancy or breastfeeding, and for newborns. See also “Pregnancy, breastfeeding and
fertility”.
If you have an alcohol dependence, talk to your doctor before taking this medicine.
The amount of alcohol in this medicine does not appear to have an effect on adults and adolescents.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or
pharmacist if you are taking other medicines.
Because this medicine is usually administered slowly over several hours,
the effects of alcohol may be reduced.
Novastan contains sorbitol
This medicine contains 750 mg sorbitol per vial (2.5 ml) equivalent to 300 mg/ml.
Sorbitol is a source of fructose. If your doctor has diagnosed you with hereditary fructose
intolerance, a rare genetic disease, you should not take this medicine. Patients with
hereditary fructose intolerance are unable to metabolize fructose, the accumulation of which can
cause serious side effects.
Before taking this medicine, tell your doctor if you suffer from hereditary fructose
intolerance.
3. How to use Novastan
Novastan will always be administered by medical personnel. Novastan will be
administered intravenously (into a vein) in the form of a continuous infusion. The
doctor will determine the dosage and duration of your treatment.
4. Possible side effects
Like all medicines, Novastan can cause side effects, although not everyone
experiences them.
The most common side effects are bleeding.Significant bleeding can
occur in approximately 5% of patients, while minor bleeding can occur in approximately
39% of patients. You should immediately inform your doctorif you notice the appearance of any
of the following symptoms:
- bleeding or bruising
- presence of blood in the urine or stool
- vomiting or coughing up blood
- dark stools
- difficulty breathing
- cold sweat
- dry mouth
- pupil dilation and/or weak or rapid pulse.
These symptoms may be indicative of bleeding problems.
Common side effects( may affect up to 1 in 10 people) :
- anemia
- blood clot formation
- bleeding, including small skin and mucous membrane bleeding (purpura)
- nausea
Uncommon side effects( may affect up to 1 in 100 people):
- infections, such as urinary tract infections
- abnormal blood test results
- blood clot formation
- loss of appetite
- low blood sugar levels
- low blood sodium levels
- confusion
- dizziness
- fainting
- headache
- stroke
- muscle disorders
- speech difficulties
- vision problems
- deafness
- heart attack
- fluid presence in the pericardium
- altered heart rhythm
- tachycardia
- low blood pressure
- high blood pressure
- vein inflammation
- shock
- reduced oxygen supply to tissues
- difficulty breathing
- fluid collection around the lungs
- hiccups
- emission of blood with cough, vomiting or stool
- constipation
- diarrhea
- gastritis
- difficulty swallowing
- tongue disorders
- Impaired liver function
- jaundice (yellowing of the skin and eyes)
- altered blood values for liver function
- skin rash including urticaria
- itching
- increased sweating
- hair loss
- muscle weakness
- muscle pain
- impaired kidney function
- fever
- pain
- fatigue
- reactions at the site of administration
- leg edema
- increased exudate from wounds
- alteration of laboratory test results
Not known(frequency cannot be estimated based on available data)
- Cases of cerebral hemorrhage have been reported.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please inform your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at
http://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 to store Novastan
Keep this medicine out of the sight and reach of children.
Store the vial in the outer packaging to protect the medicine from light.
Do not refrigerate or freeze.
Once diluted, the solutions must not be exposed to direct sunlight.
Do not use the solution if it appears cloudy or if you notice the presence of suspended particles.
Diluted solution: chemical and physical stability has been demonstrated for up to 14 days from
dilution both at 25ºC and between 2°C and 8ºC in sodium chloride 9 mg/ml (0.9%) infusion
solution, in glucose 50 mg/ml (5%) infusion solution, or in an intravenous infusion compound
based on sodium lactate.
From a microbiological point of view, the product must be used immediately after
dilution. If not used immediately, the storage times and conditions
prior to use are the responsibility of the user and should normally not exceed 24
hours at a temperature between 2 and 8°C, unless the dilution has been carried out in
controlled and validated aseptic conditions.
Novastan must not be used after the expiry date that is stated
on the carton/vial after “Exp”. The expiry date refers to the last day of the
month.
6. Package Contents and Other Information
What Novastan contains
The active ingredient of Novastan is argatroban monohydrate 100 mg/ml.
1 ml of concentrate for solution for infusion contains 100 mg of argatroban monohydrate.
1 vial with 2.5 ml of concentrate for solution for infusion contains 250 mg of argatroban
monohydrate.
The other ingredients are anhydrous ethanol, sorbitol and water for injections.
Description of the appearance of Novastan and contents of the pack
This medicine is a clear to pale yellow concentrate for solution for infusion.
Each vial contains 2.5 ml of the solution and the vials are packaged in
cardboard cartons containing 1 or 6 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ethypharm, 194, Bureaux de la Colline, Bâtiment D, 92213 Saint-Cloud cedex, France.
Manufacturer
Tjoapack Netherlands B.V., Nieuwe Donk 9, Etten-Leur, 4879AC, Netherlands.
For further information contact:
Recordati Rare Diseases (Italy) s.r.l
Via M. Civitali 1
20148 Milan
This medicinal product has been authorised in the Member States of the EEA with the following names:
Denmark Novastan
Italy Novastan
Norway Novastan
Spain Arganova
Sweden Novastan
______________________________________________________________________________
The following information is intended for healthcare professionals only
Instructions for use, handling and disposal
Novastan must be diluted in a 9 mg/ml (0.9%) sodium chloride solution for
infusion, in a 50 mg/ml (5%) glucose solution for infusion, or in a
sodium lactate intravenous infusion preparation to a final concentration of
1 mg/ml. If the solution appears cloudy, or if you notice the presence of insoluble precipitate, the
vial should be discarded.
Each 2.5 ml vial must be diluted 1:100 in 250 ml of diluent. The vial is for single
use only. Use 250 mg (2.5 ml) for 250 ml of diluent or 500 mg (5 ml) for 500 ml of
diluent. The reconstituted solution must be mixed by repeatedly inverting the
bag or bottle for one minute. The diluted solution must be clear and practically
free from visible suspended particles. After preparation, the solution may show a
slight transient opacity due to the formation of microprecipitates which however
dissolve rapidly with mixing. The pH of the intravenous solution prepared
according to the instructions is 3.2 - 7.5.
Measures to protect from light such as the use of protective film for intravenous
lines are not necessary. No significant loss of product potency has been observed after simulated delivery of the solution through intravenous tubing.
Unused medicine and waste derived from this medicine must be disposed of in
accordance with local regulations.

- Країна реєстрації
- Лікарська формаConcentrate for infusion solution, 100 MG/ML
- Код АТХB01AE03
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до NOVASTANЛікарська форма: Hard capsule, 75 MGДіюча речовина: dabigatran etexilateВиробник: PHARMATHEN S.A.Потрібен рецептЛікарська форма: Hard capsule, 75 MGДіюча речовина: dabigatran etexilateВиробник: ADAMED S.R.L.Потрібен рецептЛікарська форма: Powder for concentrate and solution for infusion, 250 MGДіюча речовина: БивалирудинВиробник: ACCORD HEALTHCARE, S.L.U.Потрібен рецепт
Аналоги NOVASTAN в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог NOVASTAN у Іспанія
Лікарі онлайн щодо NOVASTAN
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на NOVASTAN 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
NOVASTAN потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у NOVASTAN — Аргатробан. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
NOVASTAN виробляється компанією ETHYPHARM. 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 NOVASTAN 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 NOVASTAN 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 (Аргатробан) включають ANDABRA, BIJETRA, BIVALIRUDINA AKKORD. 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.
















