ORAQIX Periodontal Gel, 20X1.7g

Instructions for use for ORAQIX Periodontal Gel, 20X1.7g

Field of use

• The medicine is used to prevent pain in your gums.
• The gel is used in adults to control pain during certain dental procedures, such as scaling and/or root planing (cleaning the parts of your teeth that your toothbrush cannot reach) and probing (examining your teeth and gums).

Active ingredients / ingredients / ingredients

42.5 mg lidocaine
42.5 mg prilocaine
Poloxamer 188 excipient (+)
Poloxamer 407 excipient (+)
Hydrochloric acid, concentrated excipient (+)
Water, purified excipient (+)

Contraindications

• The preparation must not be used:
  • if you are allergic (hypersensitive) to lidocaine, prilocaine or other comparable local anesthetics,
  • if you are allergic (hypersensitive) to another ingredient in the gel,
  • if your doctor has told you that you have congenital or acquired methemoglobinemia (a condition in which too much hemoglobin in your blood is converted into methemoglobin, which results in the blood no longer being able to supply enough oxygen to the tissues ),
  • if your doctor has told you that you have repeated episodes of porphyria (a metabolic disorder that affects blood formation) or that you may have hereditary porphyria.

dosage

• The application is carried out by a dentist or dental hygienist. Your dentist or dental hygienist will decide the dosage depending on how many teeth need to be treated.
• On average, one cartridge (1.7 g) or less is sufficient for one quadrant of teeth. The maximum recommended dose in one treatment session is five cartridges, i.e. H. 8.5 g gel containing 212.5 mg lidocaine base and 212.5 mg prilocaine base.
• The full effect occurs after about half a minute, and the dentist or dental hygienist can then begin further treatment. The effects should usually last around 20 minutes.
• Please talk to your dentist or dental hygienist if you have the impression that the effect of the product is too strong or too weak.
• You may be given other local anesthetics at the same treatment session.
• Frequent use of large quantities is not recommended.

 

• If you have been given more Oraqix than intended
  • If too high a dose of local anesthetic has been used (i.e. the gel in combination with another anesthetic), the following side effects may occur: numbness in the lips and around the mouth, nervousness, drowsiness, dizziness, tremor or occasionally blurred vision, sleepiness and unconsciousness. Other rarely observed effects include seizures, shortness of breath and a drop in blood pressure.
  • Too much prilocaine (the gel combined with another anesthetic that also contains prilocaine) can also cause methemoglobinemia. This is characterized by slate-gray cyanosis (a blue-gray discoloration of the lips and skin).
  • If you experience any of the above symptoms, notify your dentist, dental hygienist or family doctor immediately and go to the nearest hospital emergency department where the risk can be assessed and you will be given advice. You may need to remain under observation for several hours.

 

 

Intake

• The gel is applied inside the gum pocket using a dental syringe or with the dispenser and a blunt tip applicator.
• The gel must not be injected.
• The gel must be liquid when used. If it has taken the form of a gel, it must be stored in the refrigerator until it becomes a liquid again.
• At temperatures below 5 °C the gel may become cloudy. However, the gel becomes clear again by warming to room temperature. After use, the preparation takes the form of a gel.

 

Patient information

• Please speak to your dentist/dental hygienist if any of the following apply to you:
  • if you suffer from kidney or liver disease,
  • if you suffer from cardiac arrhythmias or conduction disorders,
  • if you suffer from mouth ulcers or an infection in your mouth,
  • if your doctor has told you that you suffer from glucose-6-phosphate dehydrogenase deficiency (a hereditary deficiency of an enzyme that is important for your body).
• The medicine should be used with particular caution:
  • Since there is no experience with the treatment of children and adolescents, the drug is not recommended for children under 18 years of age.
  • Do not let the medicine get into your eyes. If you accidentally get gel in your eyes, the eye must be immediately rinsed with water or saline and protected until sensation returns.
  • The gel may occasionally block all sensation in the treated areas. Be careful not to cause bite injuries. You should also avoid very hot drinks and foods until sensation has fully returned.
  • The medicine may affect tests for substances that are prohibited for athletes to take. This can lead to false-positive test results for these substances.

 

• Ability to drive and use machines:
  • It is not known whether the medicine has any effect on the ability to drive or use machines.

 

Pregnancy

• Before treatment, tell your dentist or dental hygienist whether you are pregnant, planning to become pregnant, or breastfeeding.
• The medicine should not be used during pregnancy unless your dentist considers it necessary.
• You can continue breastfeeding after treatment.

Hints

Miscellaneous

- The medicine must not be injected.
- When used, the medicine must be liquid.
- If the medicine has become gel-like, it must be stored in the refrigerator until it becomes liquid again.
- The medicine contains an active ingredient that can influence tests for substances that are prohibited for athletes. Using the medicine could lead to false-positive test results.
- If the medicine comes into contact with the eyes, they must be rinsed immediately with water or saline solution and protected until sensation returns.

Manufacturer:  DENTSPLY DeTrey GmbH, De-Trey-Straße 1