ORAQIX 25 мг/г Гель
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Инструкция по применению ORAQIX
Содержание инструкции
Oraqix 25/25 mg/g Periodontal Gel
lidocaine and prilocaine
Read this leaflet carefully before using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your dentist or dental hygienist.
- This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your dentist, your dental hygienist or your doctor.
Contents of this leaflet:
- 1. What Oraqix is and what it is used for
- 2. Before using Oraqix
- 3. How to use Oraqix
- 4. Possible side effects
- 5. How to store Oraqix
- 6. Further information
1. What is Oraqix and what is it used for
Oraqix is a gel that is used to prevent gum pain. Oraqix is used in adults for the
control of pain associated with some types of dental procedures, such as scaling and/or
root planing (cleaning of those portions of the teeth that a toothbrush cannot
reach) and probing (exploration of teeth and gums).
2. Before using Oraqix
Do not use Oraqix
- if you are allergic (hypersensitivity) to lidocaine, prilocaine or other similar local anesthetics;
- if you are allergic (hypersensitivity) to any of the other ingredients of the gel (see section 6, Further information);
- if your doctor has told you that you suffer from congenital or idiopathic methemoglobinemia (a condition in which an excessive amount of hemoglobin is converted into methemoglobin in the blood. If too much methemoglobin is produced, the blood has difficulty supplying oxygen to the tissues);
- if your doctor has told you that you are subject to recurrent episodes of porphyria or if there is a possibility that you have inherited porphyria (porphyrias are a group of diseases that alter the process of blood formation).
Inform your dentist/dental hygienist if you fall into any of the following cases:
- if you suffer from kidney or liver diseases;
- if you have an irregular heartbeat or heart conduction disorders;
- if you have ulcers or infections of the oral cavity;
- if your doctor has told you that you have a glucose-6-phosphate deficiency (an inherited condition that occurs when the body lacks the important enzyme for glucose-6- phosphate).
Take particular care with Oraqix
- The use of Oraqix in children and adolescents has not been evaluated; therefore, its use in people under 18 years of age is not recommended.
- Avoid getting Oraqix into your eyes. If the gel accidentally comes into contact with your eyes, wash them immediatelywith water or saline solution and protect them until sensitivity returns.
- Sometimes Oraqix can completely inhibit sensitivity in the treated areas. Be careful not to accidentally bite parts of your mouth. Also, avoid consuming very hot drinks and foods until sensitivity is fully restored.
- Oraqix may interfere with doping tests for the detection of illicit substances in athletes of both sexes, as it may give a false positive result for the presence of these substances.
Use of Oraqix with other medicines
Tell your dentist if you are taking:
- any other local amide-type anesthetic or products for the treatment of cardiac arrhythmias (antiarrhythmics, for example mexiletine), as these drugs in combination with Oraqix may increase the risk of adverse effects described in the section "if you use more Oraqix than you should";
- other drugs that can cause methemoglobinemia, such as certain types of antibiotics known as sulfonamides.
Inform your dentist/dental hygienist if you are taking or have recently taken any other
medicines, including those without a prescription.
Pregnancy and breastfeeding
If you are pregnant, planning a pregnancy or breastfeeding, tell your dentist or
dental hygienist before starting treatment with Oraqix.
- Oraqix must notbe used during pregnancy unless expressly recommended by your dentist.
- Breastfeeding can be continued after treatment with Oraqix.
Driving and using machines
Oraqix has no known effects on the ability to drive vehicles or operate machinery.
3. How to use Oraqix
Oraqix must be administered by a dentist or dental hygienist. The dose will be established by the
dentist or dental hygienist and will depend on the number of teeth to be treated.
- Oraqix Periodontal Gel is intended for use in adult patients.
- Oraqix must not be injected.
- Oraqix gel is applied to the gum with a dental syringe or by means of the Oraqix Dispenser and a blunt-tipped applicator.
- The maximum dose per single treatment is 5 cartridges.
- The full effect is achieved after approximately 30 seconds after which the dentist or dental hygienist can begin treatment. The effect normally lasts about 20 minutes.
- If you think that the effect of Oraqix is too strong or too weak, inform your dentist or dental hygienist.
- The administration of other local anesthetics is possible during the same treatment session.
- Frequent use of high quantities of Oraqix is not recommended.
If you use more Oraqix than you should
If you have been given an excessive amount of local anesthetic (for example Oraqix in association with
another anesthetic), the following side effects may occur: numbness of the lips and the
area around the mouth, nervousness, a feeling of dizziness, vertigo, motor uncertainty or, sometimes,
blurred vision, drowsiness, and loss of consciousness. Other rare effects reported are seizures,
shortness of breath and low blood pressure.
An excess of prilocaine (Oraqix in association with another anesthetic containing prilocaine) can
also cause methemoglobinemia (see section 2). This is characterized by slate-gray cyanosis (a gray-bluish discoloration of the lips and skin).
If you experience any of the symptoms described above, contact your dentist, dental hygienist or doctor; go
to the nearest emergency room for a risk assessment and consultation. It may
be necessary to remain under observation for a few hours.
4. Possible side effects
Like all medicines, Oraqix can cause side effects, although not everybody gets them.
Common side effects (affect up to 10% of treated patients):
- headache
- taste alteration
- reactions in the oral cavity (pain, burning, numbness of other parts of the mouth or lips, ulcers, irritation and redness).
Less common side effects (affect less than 1% of treated patients)
- allergic reactions that may include: skin redness, swelling of the throat, difficulty breathing and fever
- dizziness
- feeling of nausea
- difficulty breathing and cyanosis (grey-bluish discoloration of the lips and skin)
- burning sensation
- swelling at the application site
- An overdose of Oraqix may cause excitation or depression of the central nervous system and depression of cardiac conduction and cardiac function. If the appearance of these side effects causes concern, immediately seek hospital assistance.
If any of these side effects should worsen, for example if you have difficulty breathing
or swelling of the throat, or in the event of suspected anaphylactic reaction to the anesthetic, inform
your dentist or doctor immediately or go directly to the hospital. If dental problems occur while you are still at the clinic, or your doctor if they occur at home
when they appear.
5. How to store Oraqix
- Keep out of the sight and reach of children.
- Do not freeze.
- Do not use Oraqix after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help to protect the environment.
6. Further information
What Oraqix contains
The active ingredients are prilocaine (base) and lidocaine (base).
The excipients are: purified poloxamer 188, purified poloxamer 407, purified water and
diluted hydrochloric acid, used to adjust the pH.
Description of the appearance of Oraqix and contents of the pack
Oraqix is a periodontal gel. It presents as a clear, colourless gel in a single-use glass cartridge.
One gram of Oraqix Periodontal Gel contains 25 mg of lidocaine and 25 mg of prilocaine.
One cartridge contains 1.7 g of gel (42.5 mg of lidocaine and 42.5 mg of prilocaine).
Each pack contains 20 cartridges.
Marketing Authorisation Holder
DENTSPLY ITALIA S.r.l., Via A. Curtatone 3 - 00185 Roma, Italia
Tel: +39 06 72640360
Fax: +39 06 72640321
Email: [email protected]
Manufacturer
Recipharm Karlskoga AB, Björkbornsvägen 5, SE-691 33 Karlskoga Sweden
This medicinal product is authorised in the Member States of the EEA with the following
denominations:
MEMBER STATE NAME PRODUCT NAME
Austria Oraqix Parodontal-Gel
Lidocain und Prilocain
Denmark Oraqix periodontalgel
lidocain og prilocain
Finland Oraqix geeli ientaskuun
lidokaiini ja prilokaiini
Germany Oraqix Parodontal-Gel
Lidocain und Prilocain
Iceland Oraqix tannholdshlaup
lidókain og prilókain
Netherlands Oraqix periodontale gel
lidocaïne en prilocaïne
Norway Oraqix periodontalgel
lidokain og prilokain
Sweden Oraqix periodontalgel
lidokain och prilokain
Belgium Oraqix 25/25 mg Gel periodontal
Lidocaïne et Prilocaïne
Luxembourg Oraqix 25/25 mg Gel periodontal
Lidocaïne et Prilocaïne
Ireland Oraqix 25/25 mg per g Periodontal Gel
Lidocaine and Prilocaine
United Kingdom Oraqix 25/25 mg per g Periodontal Gel
Lidocaine and Prilocaine
France Oraqix gel périodontal
Lidocaïne et Prilocaïne
Portugal Oraqix Gel Periodontal
Lidocaína e Prilocaína
Spain Oraqix Gel Periodontal
Lidocaína y Prilocaína
Italy Oraqix 25/25 mg/g Gel Periodontale
Lidocaina e Prilocaina
To be torn off
…………………………………………………………………………………………………………
The following information is intended only for doctors and specialist personnel:
For more information on the use of Oraqix, please refer to the Summary of
Product Characteristics (SPC).
Method of administration
- Oraqix must not be injected.
- On average, one cartridge (1.7 g) or less of Oraqix is sufficient for the treatment of a dental quadrant. The maximum recommended dose of Oraqix per single treatment session is 5 cartridges, equivalent to 8.5 g of gel containing 212.5 mg of lidocaine base and 212.5 mg of prilocaine base.
- Upon administration, Oraqix must be in liquid form. If it has formed a gel, it should be stored in the refrigerator until it returns to a liquid state. The air bubble visible in the cartridge will move if the cartridge is tilted.
- The gel becomes opaque at temperatures below 5 C. It will return to its original appearance if warmed to room temperature. After administration, Oraqix appears in gel form.
- The cartridge and applicator are for single use only. They fit the Oraqix Dispenser.
- Apply Oraqix gel to the periodontal pockets using a dental syringe or the Oraqix Dispenser and the blunt-tipped applicator included in the pack, until the gel is visible at the gingival margin. Wait 30 seconds before starting treatment (a longer waiting time does not enhance the anaesthesia). The duration of anaesthesia, as assessed by probing depth, is approximately 20 minutes. If the effect of the anaesthesia begins to wear off, reapply Oraqix as needed.
- If further local anaesthesia is required in association with Oraqix, please refer to the SPC of each additional anaesthetic. Since systemic toxic effects are additive (see Sections 4.5 and 4.9 of the Oraqix SPC), it is not advisable to administer further local anaesthetics in the same treatment session if the amount of Oraqix administered corresponds to the maximum recommended dose of 5 cartridges.
- Avoid contact with Oraqix in order to avoid the development of possible allergies.
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- Страна регистрации
- Форма выпускаGel, 25 MG/G + 25 MG/G
- Код АТХN01BB20
- 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 ORAQIXФорма выпуска: Cream, 25 MG/G + 25 MG/GДействующее вещество: combinationsПроизводитель: ASPEN PHARMA TRADING LIMITEDОтпускается по рецептуФорма выпуска: Spray, 150 MG/ML / 50 MG/MLДействующее вещество: combinationsПроизводитель: RECORDATI IRELAND LTDОтпускается по рецептуФорма выпуска: Injectable solution, 40 MG/ML + 10 MICROGRAMMI/MLДействующее вещество: articaine, combinationsПроизводитель: PIERREL S.P.A.Отпускается без рецепта
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Аналог ORAQIX в Испания
Аналог ORAQIX в Польша
Аналог ORAQIX в Украина
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Часто задаваемые вопросы
ORAQIX требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ORAQIX — combinations. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ORAQIX производится компанией DENTSPLY SIRONA ITALIA S.R.L.. 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 ORAQIX 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 ORAQIX 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 (combinations) включают EMLA, FORTAKIN, ARTIKAINA KON ADRENALINA PIERREL. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
