JORVEZA Oral suspension Ref.[116525] Active ingredients: Budesonide

The treatment with this medicinal product should be initiated by a gastroenterologist or a physician experienced in the diagnosis and treatment of eosinophilic esophagitis. Adult EoE patients may be treated with budesonide orodispersible tablets.

Posology

Induction of remission

Children 2 to 11 years of age:

The recommended daily dose is 1 mg budesonide to be administered as two separate doses per day: one dose of 2.5 mL suspension (corresponding to 0.5 mg budesonide) in the morning and one dose of 2.5 mL suspension (corresponding to 0.5 mg budesonide) in the evening.

Adolescents 12 to 17 years of age:

The recommended daily dose is 2 mg budesonide to be administered as two separate doses per day: one dose of 5 mL suspension (corresponding to 1 mg budesonide) in the morning and one dose of 5 mL suspension (corresponding to 1 mg budesonide) in the evening.

The usual duration of induction treatment is 12 weeks. For patients who are not appropriately responding within 12 weeks, the treatment can be extended to up to 24 weeks. Patients with long-standing or extensive disease and higher levels of disease activity have an increased likelihood of requiring an extended induction phase.

Maintenance of remission

Children 2 to 11 years of age:

The recommended daily dose is 0.5 mg budesonide to be administered as one dose of 2.5 mL suspension (corresponding to 0.5 mg budesonide) in the morning, depending on the individual clinical requirement of the patient.

A maintenance dose of 0.5 mg budesonide twice daily is recommended for patients with a long-standing disease history and/or high extent of oesophageal inflammation in their acute disease state, see also section 5.1.

Adolescents 12 to 17 years of age:

The recommended daily dose is 1 mg budesonide to be administered as one dose of 5 mL suspension (corresponding to 1 mg budesonide) in the morning, depending on the individual clinical requirement of the patient.

A maintenance dose of 1 mg budesonide twice daily is recommended for patients with a long-standing disease history and/or high extent of oesophageal inflammation in their acute disease state, see also section 5.1.

The duration of maintenance therapy is determined by the treating physician. Tapering of the dose is required after prolonged treatment. It is recommended to perform control endoscopies if symptoms persist or return. In addition, follow-up endoscopies are recommended in line with current clinical guidelines as symptoms may not reliably predict histological disease activity.

Special populations

Renal impairment

There are currently no data available from adult or paediatric patients with renal impairment. Because budesonide is not excreted via the kidneys, patients with mild to moderate impairment may be treated with caution with the same doses as patients without renal impairment. Budesonide is not recommended for use in patients with severe renal impairment.

Hepatic impairment

During treatment of patients with hepatic impairment with other budesonide containing medicinal products, budesonide levels were increased. However, no systematic study investigating different levels of hepatic impairment is available. Patients with hepatic impairment should not be treated (see section 5.2).

Method of administration

Oral use.

The oral suspension should be taken after a meal.

Only use the oral syringe provided as a measuring device to dose the oral suspension. Do not use any other measuring device.

The suspension must be shaken well before use. To open the bottle, the cap must be pushed down firmly whilst turning it anti-clockwise. The oral syringe must be inserted tightly into the bottle, while the plunger of the oral syringe must be completely pushed down. The bottle must be turned upside- down and the oral syringe held firmly whilst gently filling up the syringe to the required level. When finished, the bottle must be turned upright and the oral syringe gently removed by screwing it off the bottle. Immediately afterwards, the tip of the syringe must be placed in the patient's mouth and the plunger pressed all the way down. The patient should then completely swallow the suspension contained in the oral syringe. The cap must be screwed back onto the bottle. After each administration, the plunger must be removed from the barrel and both parts rinsed with cold water and allowed to air dry. The plunger must be inserted into the barrel before next use.

Drinking, eating or performing oral hygiene (e.g. brushing teeth and rinsing) should be avoided for at least 30 minutes after taking the oral suspension.

In case of short-term overdose no emergency medical treatment is required. There is no specific antidote. Subsequent treatment should be symptomatic and supportive.

2 years.

After first opening: use within 6 weeks.

Do not store above 25°C.

200 mL amber glass bottle of blow moulded type III glass.

Child-resistant closure:

White ribbed cap (PP) with a colourless screw closure (HDPE) and an internal colourless flow limiter (LDPE). After first opening, the flow limiter remains in the bottle neck and enables the insertion of the oral syringe to draw the suspension.

Syringe for oral administration:

CE-certified oral syringe consisting of a colourless barrel (PP) with a colourless screw closure (HDPE) and graduations for 2.5 mL and 5 mL, and a white plunger (HDPE).

Pack size:

One bottle containing 165 mL of oral suspension with one graduated oral syringe for oral administration.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.