PRILOTEKAL 2% Injectable solution
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Інструкція із застосування PRILOTEKAL
Зміст інструкції
Prilotekal 20 mg/ml injectable solution
prilocaine hydrochloride
Read this leaflet carefully before you are given this medicine
because 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.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Prilotekal is and what it is used for
- 2. What you need to know before you are given Prilotekal
- 3. How to use Prilotekal
- 4. Possible side effects
- 5. How to store Prilotekal
- 6. Contents of the pack and other information
1. WHAT IS PRILOTEKAL AND WHAT IS IT USED FOR
Prilotekal 20 mg/ml injectable solution is a local anesthetic belonging to the amide category
and is an injectable solution. Prilotekal injectable solution is used in adults to anesthetize
(put to sleep) specific parts of the body and to prevent pain during surgical procedures.
Prilotekal is injected into the lower part of the spine. This quickly stops pain
from the waist down for a limited period of time (short-duration surgical procedures).
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN THIS MEDICINE
PRILOTEKAL
Prilotekal must not be given to you
- if you are allergic (hypersensitive) to prilocaine hydrochloride, to another local anesthetic of the amide type or to any of the other ingredients of this medicine (listed in section 6),
- if you have severe problems with heart conduction,
- if you suffer from severe anemia,
- if you have heart failure,
- if you have cardiogenic and hypovolemic shock,
- if you suffer from congenital or acquired methemoglobinemia,
- if you have general or specific contraindications for the subarachnoid anesthesia technique. Prilotekal must not be administered into a blood vessel.
Prilotekal must not be used in children under 6 months of age.
Warnings and precautions
If you suffer from any of these disorders, discuss it with your doctor beforeyou are given
this medicine.
- If you have ever had an adverse reaction to an anesthetic
- If you have a skin infection at or in the area where the injection is planned
- If you suffer from any of the following disorders:
- diseases of the central nervous system, such as meningitis, poliomyelitis and problems affecting the spinal cord due to anemia
- severe headache
- brain tumors, spinal cord tumors or other types
- spinal tuberculosis
- recent spinal trauma
- very low blood pressure or reduced blood volume
- problems with blood coagulation
- acute porphyria
- fluid in the lungs
- septicemia (blood poisoning)
- If you suffer from a heart condition (e.g., partial or complete heart block, heart failure, arrhythmia)
- If you have problems with the liver or kidneys
- If you suffer from neurological problems such as multiple sclerosis, hemiplegia, paraplegia or neuromuscular disorders
- If your general condition is compromised. Spinal anesthesia should only be performed by a doctor with the necessary knowledge and experience. The doctor in charge is responsible for taking the necessary measures to avoid injection into a blood vessel and is able to recognize and treat adverse effects.
Children and adolescents
The use of Prilotekal is not recommended in children and adolescents. The safety and efficacy of Prilotekal
have not been demonstrated in the pediatric population. No data are available.
The use of Prilotekal is contraindicated in children under 6 months of age due to the high risk of developing
methemoglobinemia
Other medicines and Prilotekal
Tell your doctor if you are taking, have recently taken or might take any other
medicines, including those available without a prescription. In particular, if you are taking any medicine for
irregular heartbeat (Class III antiarrhythmics) and for pain relief.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor who will decide whether to give you injectable prilocaine. Prilocaine
should not be administered for local or regional anesthesia during labor.
It is not known whether prilocaine passes into breast milk. Breastfeeding can be resumed approximately 24 hours
after treatment.
Driving and operating machinery
Do not drive vehicles, or use tools or machinery, because Prilotekal may temporarily interfere
with reactions and muscle coordination.
Prilotekal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose (maximum dose equal to 4 ml of
Prilotekal injectable solution), i.e. essentially “sodium-free”.
3. HOW TO USE PRILOTEKAL
This medicine will be administered to you by your doctor, who will decide what the right dose is for you. The recommended dose in adults is 40-60 mg of prilocaine hydrochloride (2-3 ml of Prilotekal); the maximum dose is 80 mg of prilocaine hydrochloride (4 ml of Prilotekal).
The doctor will administer Prilotekal in the lower part of your spine, while you are sitting or lying down.
The use of hyperbaric prilocaine hydrochloride is not recommended in children and adolescents. The safety and efficacy of Prilotekal in the pediatric population have not been verified.
The use of Prilotekal is contraindicated in children under 6 months of age due to the high risk of developing methemoglobinemia.
A reduced dose is indicated in patients with compromised general conditions and with concomitant established pathologies (e.g. vascular occlusion, arteriosclerosis, diabetic polyneuropathy, impairment of hepatic or renal function).
In case of impairment of hepatic and renal function, a lower dosage range is recommended.
Hyperbaric prilocaine hydrochloride is injected via the spinal route.
Equipment, medications and personnel capable of handling an emergency must be immediately available. In rare cases, severe reactions have been reported following the use of local anesthetics, even in the absence of individual hypersensitivity in the patient's history.
If you receive more Prilotekal than you should
The doctor who will administer Prilotekal will be experienced in the use of spinal local anesthetics, so it is unlikely that you will be given an excessive dose. However, if the dose is accidentally injected directly into the bloodstream, problems with vision or hearing, muscle spasms, tremors, chills, seizures (convulsions), and loss of consciousness may develop, for a short period. Every time Prilotekal is administered, equipment to intervene in case of overdose must be available.
If you have any doubts about the use of this product, ask your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS
Like all medicines, Prilotekal can cause side effects, although not everybody gets them.
As with all local anesthetics, a sudden drop in blood pressure and a slowing of the heart rate may occur.
You may experience nausea, low blood pressure, or a slow heartbeat. Other possible effects are headache after surgery, vomiting, and difficulty urinating.
The following are possible side effects:
Very common: may affect more than 1 in 10 people
Low blood pressure, feeling unwell (nausea)
Common: may affect up to 1 in 10 people
Paresthesia, dizziness, vomiting
Uncommon: may affect up to 1 in 100 people
Convulsions, circumoral paresthesia, loss of consciousness, agitation, feeling of numbness of the
tongue, speech disorders, hearing problems, tinnitus, visual disturbances, back pain, temporary
muscle weakness, slow heartbeat, increased blood pressure.
Rare: may affect up to 1 in 1000 people
Methemoglobinemia, cyanosis. Anaphylactic shock, anaphylactic reactions, allergic reactions, itching.
Arachnoiditis, neuropathy, peripheral nerve injury.
Diplopia. Cardiac arrest, irregular heartbeat. Respiratory depression.
It is unlikely that Prilotekal injectable solution will cause serious side effects, except in the event
that it is accidentally injected via the wrong route or used together with other local anesthetics. If this
happens, numbness of the tongue, lightheadedness, dizziness, tremors and convulsions may occur. In
extremely rare cases, prilocaine has been associated with heart attacks, difficulty breathing, loss of
sensation in the lower body and allergic reactions, which can cause skin rashes,
swelling or very low blood pressure.
A rare but serious side effect of spinal anesthesia is high or total spinal block, with
consequent cardiovascular and respiratory depression.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects you can help provide more information on the safety of
this medicine.
5. HOW TO STORE PRILOTEKAL
Keep this medicine out of the sight and reach of children.
Do not use Prilotekal after the expiry date which is stated on the vial label and the outer
pack, after Exp. The expiry date refers to the last day of that month.
Do not store Prilotekal at a temperature above 25 °C. Do not refrigerate. Store in the
original packaging, to protect the medicine from light.
The medicine must be used immediately after first opening.
Do not use Prilotekal if you notice that the solution is not clear and free from suspended particles.
Any unused medicinal product remaining should be discarded. Since the use of the medicine is limited to hospital
use, the disposal of residues is carried out directly by the hospital. This will help to
protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What Prilotekal contains
The active ingredient is prilocaine hydrochloride.
1 ml of injectable solution contains 20 mg of prilocaine hydrochloride (corresponding to 2%).
1 vial of 5 ml solution contains 100 mg of prilocaine hydrochloride.
The other ingredients are:
Anhydrous glucose
Sodium hydroxide 1 N (for pH correction)
Water for injections
Description of the appearance of Prilotekal and contents of the pack
Injectable solution. Clear and colourless solution.
Prilocaine hydrochloride 2% hyperbaric is available in clear, colourless type I glass vials.
Pack of 10 vials, each containing 5 ml of injectable solution
Marketing Authorisation Holder and Manufacturer
- B. Braun Melsungen AG Carl-Braun-Straße, 1 34212 Melsungen Germany
Sirton Pharmaceuticals S.P.A.
Piazza XX Settembre 2
22079 Villa Guardia
Italy
Sintetica GmbH
Albersloher Weg 11
- 48155 - Münster Germany
This medicinal product is authorised in the Member States of the EEA with the following names:
| Member States | F Product Name |
| Austria | l Takipril hyperbar 2% Injektionslösung |
| Germany | e Takipril |
| Italy | d Prilotekal |
| Spain | a Takipril hiperbàrica 20mg/ml soluciòn inyectable |
| England | n Prilotekal 20mg/ml solution for injection |
| Belgium | a i l Takipri Hyperbar 20 mg/ml Oplossing voor injectie Takipri Hyperbar 20 mg/ml Solution injectable a Takipri Hyperbar 20mg/ml Injektionslösung |
| Bulgaria | t Takipril 20mg/ml Инжекционен разтвор |
| Czech Republic | I Takipri 20mg/ml Injekční roztok |
| Denmark | a i Takipril 20mg/ml Injektionsvæske, opløsning |
| z Finland | Takipril 20mg/ml Injektioneste, liuos |
| n e France | Baritekal 20mg/ml Solution injectable |
| g Hungary | Prilotekal 20mg/ml oldatos injekció |
| A Luxembourg | Takipri Hyperbar 20 mg/ml Solution injectable |
| Netherlands | Prilotekal 20mg/ml Oplossing voor injectie |
| Member States | Product Name |
| Norway | Takipril 20mg/ml injeksjonsvæske, opløsning |
| Poland | c Prilotekal |
| Romania | a Prilotekal 20mg/ml Soluţie injectabilă |
| Slovakia | m Prilotekal 20mg/ml Injekčný roztok |
| Sweden | r a Takipril 20mg/ml Injektionsvätska, lösning |
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The following information is intended for healthcare professionals only.
The SmPC is added at the end of the printed PIL as a detachable section.
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- Країна реєстрації
- Лікарська формаInjectable solution, 2%
- Код АТХN01BB04
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до PRILOTEKALЛікарська форма: Injectable solution, 40 MG/ML + 10 MICROGRAMMI/MLДіюча речовина: articaine, combinationsВиробник: PIERREL S.P.A.Рецепт не потрібенЛікарська форма: Injectable solution, 40 MG/ML + 10 MICROGRAMMI/MLДіюча речовина: articaine, combinationsВиробник: GIOVANNI OGNA E FIGLI S.R.L.Потрібен рецептЛікарська форма: Injectable solution, 40 MG/ML + 5 MICROGRAMMI/MLДіюча речовина: articaine, combinationsВиробник: OMNIA S.R.L.Потрібен рецепт
Аналоги PRILOTEKAL в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог PRILOTEKAL у Польща
Аналог PRILOTEKAL у Іспанія
Лікарі онлайн щодо PRILOTEKAL
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на PRILOTEKAL 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
PRILOTEKAL потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у PRILOTEKAL — Прилокаин. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
PRILOTEKAL виробляється компанією B. BRAUN MELSUNGEN AG. 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 PRILOTEKAL 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 PRILOTEKAL 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 (Прилокаин) включають ARTIKAINA KON ADRENALINA PIERREL, ARTIKAINA ONYA, ARTIN. 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.
