Oraverse 400 Micrograms/L.7 Ml Solution For Injection
Out of date information, search anotherPACKAGE LEAFLET
[Revised following MAH transfer - Clean version]
OraVerse® 400 micrograms / 1.7 ml solution for injection
Phentolamine mesilate
Read all of this leaflet carefully before being given this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your dentist or doctor.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your dentist or doctor.
In this leaflet:
1. What OraVerse is and what it is used for
2. Before you are given OraVerse
3. How to use OraVerse
4. Possible side effects
5. How to store OraVerse
6. Further information
1. WHAT ORAVERSE IS AND WHAT IT IS USED FOR
OraVerse contains a medicine called phentolamine mesilate.
OraVerse is used to reverse the numbness in the lip and tongue caused by the injection of a local anaesthetic associated with a vasoconstrictor (of catecholamine type) given for a routine dental procedure such as teeth cleaning, scaling and planing, cavity filling, crowns.
OraVerse increases blood flow in the blood vessels at the injection site. This accelerates the return of normal sensation in the lip and tongue enabling you to speak, drink liquids and avoid drooling.
OraVerse is for use in adults and in children 6 years of age and older and weighing at least 15 kg.
2. BEFORE YOU ARE GIVEN ORAVERSE You should not be given OraVerse
- If you are allergic (hypersensitive) to phentolamine mesilate or any of the other ingredients of OraVerse listed in Section 6 below.
Make sure you tell your dentist or doctor before being given OraVerse
- If you have, or if you have ever had any heart conditions.
- If you are at increased risk of bleeding.
- If you have any liver problems.
Notify your dentist or doctor immediately if you feel dizzy or have palpitations right after OraVerse injection. Contact your dentist or doctor immediately if you experience important oral bleeding after the dental procedure.
Children
OraVerse is not recommended for use in children under 6 years of age or weighing less than 15 kg.
Using other medicines
OraVerse is not known to affect, or be affected by any other medicines.
Please tell your dentist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, tell your dentist or doctor if you are taking anticoagulant medicines.
Using OraVerse with food and drink
Patients are advised not to eat or drink until oral feeling returns to normal.
Pregnancy and breast-feeding
Before you are given this medicine, tell your dentist or doctor if you are pregnant, planning to get pregnant, or if you are breast feeding. OraVerse is not recommended during pregnancy. OraVerse should not be used during breast feeding unless clearly necessary.
Driving and using machines
Your dentist or doctor will advise you when it is safe to drive and/or use machines.
Important information about some of the ingredients of OraVerse
This medicine contains less than 1 mmol sodium (23 mg) per cartridge, i.e. is essentially “sodium-free”.
3. HOW TO USE ORAVERSE
OraVerse should only be given to you by a dentist or a doctor. It will be given to you at the end of the dental procedure, when the numbing effect of the anaesthesia is no longer needed. It is injected in the mouth at the same location(s) and using the same technique(s) used for the injection of the local anaesthetic.
Use in adults
The recommended dose of OraVerse is based on a 1:1 ratio to the number of cartridges of local anaesthetic administered:
|
Amount of Local Anaesthetic Administered |
Amount of OraVerse |
|
A Cartridge |
A Cartridge |
|
1 Cartridge |
1 Cartridge |
|
2 Cartridges |
2 Cartridges |
The maximum dose is 2 cartridges of OraVerse.
Use in children
OraVerse is not recommended for use in children under 6 years of age or weighing less than 15 kg.
As for adult patients, the recommended dose of OraVerse in_children is based on a 1:1 ratio to the number of cartridges of local anaesthetic administered.
The maximum dose to be administered depends on the age and weight of the children:
|
Age |
Weight |
Maximum amount of OraVerse |
|
6-11 years |
15-30 kg |
A Cartridge |
|
6-11 years |
> 30 kg |
1 Cartridge |
|
> 12 years |
> 30 kg |
2 Cartridges |
Use in the elderly
Use of OraVerse for elderly persons is not expected to be different when compared to use for adults less than 65 years of age.
If you receive more OraVerse than you should
Your dentist or doctor will carefully calculate how much OraVerse you should receive.
It is unlikely that you will receive more OraVerse than you should. If this happens, your dentist or doctor will monitor and treat symptoms accordingly.
Signs of receiving too much OraVerse include: lowered blood pressure, abnormal heart rate, headache, being overly excited, eyesight problems, sweating, diarrhoea, vomiting and low blood sugar.
If you have any further questions on the use of this product, ask your dentist or doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, OraVerse can cause side effects, although not everybody gets them.
Common side effects (affects less than 1 person in 10)
■ Pain at the location of injection.
■ Pain at the location of the dental procedure.
■ Oral pain.
■ Slow heart rate.
■ Increased heart rate.
■ Headache.
■ High blood pressure.
Uncommon side effects (affects less than 1 person in 100)
■ Unusual or decreased sensations such as numbness, tingling, prickling, burning in the mouth area (paraesthesia).
■ Abdominal pain, diarrhoea, being sick (vomiting).
■ Pain in jaw.
■ Swelling of the face.
■ Itching.
■ Injection site reaction, tenderness.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your dentist or doctor.
5. HOW TO STORE ORAVERSE
Keep out of the reach and sight of children.
Do not use OraVerse after the expiry date which is stated on the carton and the cartridge after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not refrigerate or freeze.
Store in the original carton in order to protect from light.
This medicine must not be given to you if it is discoloured or if there are particles in it.
Medicines should not be disposed of via wastewater or household waste. Your dentist or doctor is responsible for disposing of any unused OraVerse correctly.
6. FURTHER INFORMATION What OraVerse contains
- The active substance is phentolamine mesilate. 1.7 ml of solution contains 400 micrograms phentolamine mesilate (235 micrograms/ml).
- The other ingredients are mannitol (E421), disodium edetate, sodium acetate trihydrate (E262i), acetic acid (E260) or sodium hydroxide (for pH adjustment), and water for injections.
What OraVerse looks like and contents of the pack
The solution for injection should be clear and colourless.
OraVerse comes in a glass cartridge, in pack-sizes of 10 or 50 cartridges.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Septodont Holding 58 rue du Pont de Creteil 94100 Saint-Maur-des-Fosses France
Manufacturer:
Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave F- 33565 Carbon Blanc Cedex France
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom, Germany, France, Spain: OraVerse
Italy: Oraverse
This leaflet was last approved in {MM/YYYY}.
5