البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
OXYBUTYNIN HYDROCHLORIDE
PROPHARM LTD
G04BD04
SOLUTION FOR INTRAVESICAL
OXYBUTYNIN HYDROCHLORIDE 1 MG / 1 ML
INTRAVESICAL
Required
KLOSTERFRAU BERLIN GMBH, GERMANY
OXYBUTYNIN
Vesoxx is indicated for the suppression of neurogenic detrusor overactivity (NDO) in children from 6 years of age and adults, who are managing bladder emptying by clean intermittent catheterization (CIC), if they cannot be adequately managed by oral anticholinergic treatment due to lack of efficacy and/or intolerable side effects..
2023-09-27
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only VESOXX SOLUTION FOR INTRAVESICAL USE ACTIVE INGREDIENT oxybutynin hydrochloride 1 ml solution contains 1 mg oxybutynin hydrochloride. 1 pre-filled syringe contains 10 mg oxybutynin hydrochloride. Inactive ingredients and allergens in this medicine: see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information'. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Vesoxx is indicated for the suppression of neurogenic detrusor overactivity (NDO) in children from 6 years of age and adults, who are managing bladder emptying by clean intermittent catheterisation (CIC), if they cannot be adequately managed by oral anticholinergic agents due to lack of efficacy and/or intolerable side effects. THERAPEUTIC GROUP: Medicines for treatment of urinary frequency and urinary incontinence The medicine works by relaxing the muscles of the bladder, thereby stopping sudden muscle contractions (spasms). This helps control the release of urine. Vesoxx solution is intended for direct injection into the bladder (intravesical administration) through a tube called a catheter. Treatment with Vesoxx must be started and supervised by a doctor specialised in the treatment of overactive bladder due to neurological disorders. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: - You are sensitive (allergic) to oxybutynin hydrochloride (the active ingredient) or to any of the other ingredients in this medicine (see section 6). - You have a rare autoimmune disease calle اقرأ الوثيقة كاملة
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vesoxx 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 1 mg oxybutynin hydrochloride. One scaled prefilled ready-to-use syringe with 10 ml solution contains 10 mg oxybutynin hydrochloride. Excipient with known effect: sodium 3.56 mg/ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Intravesical solution. Clear, colourless solution with a pH of 3.6 to 4.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vesoxx is indicated for the suppression of neurogenic detrusor overactivity (NDO) in children from 6 years of age and adults, who are managing bladder emptying by clean intermittent catheterisation (CIC), if they cannot be adequately managed by oral anticholinergic treatment due to lack of efficacy and/or intolerable side effects. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Initial dose adjustment shall be done by a neuro-urologist under close urodynamic control. There are no fixed rules for the dose regimen as high interindividual differences in bladder pressure and doses required to improve neurogenic detrusor overactivity exist. The dose regimen (doses and timings) must therefore be determined individually according to the patient´s need. Individual dosages will be applied to control uro-dynamic parameters sufficiently (maximum detrusor pressure < 40 cm H 2 O) aiming at complete inhibition of neurogenic detrusor overactivity. In the course of intravesical oxybutynin therapy, urodynamic parameters shall be controlled in regular intervals as defined by the attending urologist. _Paediatric population _ The safety and efficacy of oxybutynin hydrochloride in children aged 0 to 5 years of age have not yet been established. _Dose recommendations in adolescents from 12 years and above, adults and elderly _ The dose recommendations have been calculated according to the body weight percentiles of the different age groups (table 1). _ _ _Table 1: Dose recommendations in adolescents from 12 years an اقرأ الوثيقة كاملة