VESOXX

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

OXYBUTYNIN HYDROCHLORIDE

Disponível em:

PROPHARM LTD

Código ATC:

G04BD04

Forma farmacêutica:

SOLUTION FOR INTRAVESICAL

Composição:

OXYBUTYNIN HYDROCHLORIDE 1 MG / 1 ML

Via de administração:

INTRAVESICAL

Tipo de prescrição:

Required

Fabricado por:

KLOSTERFRAU BERLIN GMBH, GERMANY

Área terapêutica:

OXYBUTYNIN

Indicações terapêuticas:

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..

Data de autorização:

2023-09-27

Folheto informativo - Bula

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

Características técnicas

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