Інструкція із застосування OFTASTERIL
Зміст інструкції
Oftasteril 50 mg/ml eye drops, solution
Iodopovidone
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, pharmacist or nurse.
- 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, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Oftasteril is and what it is used for
- 2. What you need to know before you use Oftasteril
- 3. How to use Oftasteril
- 4. Possible side effects
- 5. How to store Oftasteril
- 6. Contents of the pack and other information
1. What is Oftasteril and what is it used for
Oftasteril contains the active ingredient povidone-iodine, which belongs to the group of antimicrobial and antiseptic medicines and works by killing bacteria, spores, fungi and viruses. This medicine is used as a solution for preparing the surgical field (eyelids, eyelashes and cheeks) and for cleaning the eye (irrigation of the cornea, conjunctiva and palpebral fornices) in case of eye surgery.
2. What you need to know before you use Oftasteril
Do not use Oftasteril
- if you are allergic to povidone-iodine or any of the other ingredients of this medicine (listed in section 6);
- if the patient is a newborn up to one month of age;
- for administration by injection directly into the eye or around the eye (intraocular or periocular), the medicine is for external use only;
- if you are using eye drops that contain mercury-based preservatives;
- if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).
Warnings and precautions
This medicine will be administered to you by your doctor or trained personnel.
Consult your doctor, pharmacist or nurse before using Oftasteril.
Use this medicine with caution:
- if there are eye conditions that may promote the absorption of iodine into the blood;
- if you suffer from thyroid problems (due to the possibility of iodine absorption);
- if it is to be used in children under 30 months of age.
To maintain sterility, the sachet containing the vial should only be opened shortly before use; the vial is not externally sterile if the sachet containing it is open or damaged.
The product should be discarded after use, even if only partially used.
Children
Do not use this medicine in newborns up to one month of age.
Use this medicine with caution in children up to 30 months of age.
Other medicines and Oftasteril
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Avoid using Oftasteril together with other antiseptic or cleansing medicines.
Do not use Oftasteril together with other medicines that contain mercury-based preservatives or with sodium thiosulfate (iodine antidote).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist or nurse for advice before using this medicine.
Do not use Oftasteril during pregnancy unless absolutely necessary and always under the direct supervision of your doctor.
If you are breastfeeding, the use of this medicine may cause undesirable effects in the infant.
Therefore, consult your doctor who will assess whether to interrupt treatment with the medicine or discontinue breastfeeding.
Driving and operating machinery
Oftasteril does not impair the ability to drive vehicles and operate machinery.
OFTASTERIL contains phosphates
This medicine contains 1.5 mg of phosphate buffer per 1 ml. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may in very rare cases cause opaque spots on the cornea due to calcium accumulation during treatment.
3. How to use Oftasteril
This medicine will be administered to you by a doctor or another healthcare professional. If you have any doubts
consult your doctor, pharmacist or nurse.
If you use more Oftasteril than you should
This medicine will be administered to you by a doctor or another healthcare professional, it is unlikely that you
will be given an excessive dose. However, if you think that you have been given an excessive dose
or have accidentally ingested or inhaled the medicine, inform your doctor or nurse immediately who
will take appropriate precautions.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been reported for this medicine, except for rare cases of local sensitivity.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the
website 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 to store Oftasteril
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Store protected from light.
Dispose of the bottle after use even if it contains residual medicine.
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 Oftasteril contains
- The active ingredient is povidone-iodine. 100 ml of solution contains 5 g of povidone-iodine (0.5% available iodine).
- The other ingredients are: glycerol, citric acid, polysorbate 20, disodium phosphate, sodium chloride, sodium hydroxide, purified water.
Description of Oftasteril and contents of the pack
Pack containing 1 bottle of 3.5 ml.
The bottle is contained in a double sterile bag.
Marketing authorisation holder and manufacturer
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera, 26
80026 Casoria (NA)
Italy
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Oftasteril 50 mg/ml eye drops, solution
Iodopovidone
The following information is intended exclusively for doctors or healthcare professionals
Instructions for use
Taking advantage of the double packaging, transfer the product to the operating room using aseptic technique and use
as described.
Saturate the sterile cotton wool with the liquid contained in the vial and begin to prepare the eyelashes and
eyelid margins.
Repeat for the eyelids, cheeks and forehead in a circular manner until the entire surgical field is cleaned.
Repeat three times.
Position the blepharostat and irrigate the cornea, conjunctiva and palpebral fornices with the product. Wait two
minutes, then remove the Oftasteril from the ocular surface by irrigating the cornea, conjunctiva and palpebral
fornices with sterile polysaline solution.
After using the medicine, the single-dose vial must be discarded even if partially used.
Overdose
In case of ocular overdose, wash abundantly with sterile polysaline solution.
Ingestion or accidental inhalation of some disinfectants can have serious, sometimes fatal consequences.
In case of recent accidental ingestion of a considerable amount of Oftasteril, gastric lavage should be performed, otherwise
supportive therapies should be administered.
Interactions with other medicines and other types of interaction
Avoid the simultaneous use of other antiseptics and detergents.
Oftasteril should not be administered simultaneously with mercury derivatives and sodium thiosulfate
(the latter is in fact the antidote to iodine).
For further information, consult the Summary of Product Characteristics.
- Країна реєстрації
- Лікарська формаEye drops, solution, 50 MG/ML
- Код АТХS01AX18
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до OFTASTERILЛікарська форма: Not known, 1 MG/MLДіюча речовина: hexamidineВиробник: LABORATOIRES THEAПотрібен рецептЛікарська форма: Ophthalmic ointment, 30MGДіюча речовина: ацикловирВиробник: FARMIGEA S.P.A.Потрібен рецептЛікарська форма: Powder for injectable solution, 50 MGДіюча речовина: ЦефуроксимВиробник: LABORATOIRES THEAПотрібен рецепт
Аналоги OFTASTERIL в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог OFTASTERIL у Польща
Аналог OFTASTERIL у Іспанія
Аналог OFTASTERIL у Україна
Лікарі онлайн щодо OFTASTERIL
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на OFTASTERIL 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
OFTASTERIL потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у OFTASTERIL — Повидон-йод. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
OFTASTERIL виробляється компанією ALFA INTES INDUSTRIA TERAPEUTICA SPLENDORE 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 OFTASTERIL 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 OFTASTERIL 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 (Повидон-йод) включають TSAMIDINE, AKY, APROKAM. 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.
















