Perovial® 0.8% 16mg/2m prefilled syringe, 1 ST

Perovial® 0.8% 16mg/2m prefilled syringe is a medical device for the treatment of acute Peyronie's disease.

PEROVIAL, thanks to the ability of hyaluronic acid {HA) to retain an extremely high amount of water, allows the softening of the plaque on the tunica albuginea of the penis and facilitates the correct healing process by combating the progression of the scar. In addition, due to the antioxidant action of HA, the pro-inflammatory action of free radicals is reduced.

PEROVIAL is indicated for the treatment of acute Peyronie's disease.

Dosage form

prefilled syringe

How to use

• Intrapenile treatment with PEROVIAL must be administered weekly for 10-12 weeks at the doctor's discretion. The volume of injections depends on the size of the plaque.
• Instructions: The application may only be carried out by qualified doctors. Please follow the instructions for use.
• Warnings and precautions: Do not inject intravascularly. In case of intravascular injection, see "Adverse reactions" section of these instructions for use. Do not inject PEROVIAL in patients with calcified plaque (chronic phase of IPP) or "hourglass" deformity detected by duplex Doppler ultrasound. Do not use in case of skin infection, foreskin infection or urethritis. Do not mix PEROVIAL with disinfectants such as quaternary ammonium salts or chlorhexidine as precipitates may form.
  
• Contraindications: Do not use PEROVIAL in case of known hypersensitivity or allergy to the components of the product. PEROVIAL must not be injected if the patient has an infection at the injection site.
  
• Interactions: There are currently no known interactions between PEROVIAL and other medications/treatments. In the case of therapies and/or medications taken in conjunction with treatment, consult a physician for further information.
  
• Adverse effects: Intrapenile infiltration of PEROVIAL may cause local adverse effects. Symptoms such as pain, warmth, redness, swelling, ecchymosis or haematoma may occur at the injection site during the application of PEROVIAL. They usually disappear again after a short time. Doctors must ensure that patients inform them of any side effects that occur after treatment. In the case of intravascular injection, apply a local, intensive massage to stimulate vasodilation and facilitate diffusion and subsequent degradation of the product. In the event of an incident, inform the manufacturer or the competent authority.
  

Ingredients

• Composition: Functional component per 2 ml - sodium hyaluronate 16 mg.
• Other components per 2 ml: sodium chloride 17 mg, sodium phosphate 0.410 mg, water for injection q.s. 2.0 ml.