Oxybutynin Unimedic 0,5 mg/ml Intravesikal lösning

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

07-11-2018

Produktens egenskaper Produktens egenskaper (SPC)

19-02-2021

Aktiva substanser:
oxibutyninhydroklorid
Tillgänglig från:
Unimedic Pharma AB
ATC-kod:
G04BD04
INN (International namn):
oxibutyninhydroklorid
Dos:
0,5 mg/ml
Läkemedelsform:
Intravesikal lösning
Sammansättning:
oxibutyninhydroklorid 0,5 mg Aktiv substans
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Injektionsflaska, 10 x 20 ml
Bemyndigande status:
Godkänd
Godkännandenummer:
55089
Tillstånd datum:
2017-12-21

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

19-02-2021

Produktens egenskaper Produktens egenskaper - engelska

19-02-2021

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

21-12-2017

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Package leaflet: Information for the user

Oxybutynin Unimedic 0.5 mg/ml intravesical solution.

oxybutynin hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Oxybutynin Unimedicis and what it is used for

What you need to know before you use Oxybutynin Unimedic

How to use Oxybutynin Unimedic

Possible side effects

How to store Oxybutynin Unimedic

Contents of the pack and other information

1.

What Oxybutynin Unimedic is and what it is used for

Oxybutynin Unimedic is used to control an overactive bladder that makes you urinate very often

or causes incontinence (urine leakage). This can be caused by spina bifida or spinal injury.

Oxybutynin Unimedic contains the active substance oxybutynin that works by allowing the bladder

to expand and accommodate more urine before feeling the urge to urinate. Thereby the risk of

involuntary urine leakage is also reduced.

Oxybutynin Unimedic is given via catheter directly into the bladder, to patients suffering from severe

so called anticholinergic adverse events from taking oxybutynin as tablets (see section 4) and that are

already using catheter to empty the bladder, so called clean intermittent catheterisation (CIC).

Oxybutynin Unimedic is intended fo adults and children over the age of 5 years.

2.

What you need to know before you use Oxybutynin Unimedic

Do not use Oxybutynin Unimedic and tell your doctor

if you are allergic to oxybutynin or any of the other ingredients of this medicine (listed in

section 6).

If you have a rare condition called myasthenia gravis that makes the muscles in the body

become weak and tire easily.

If you have (narrow angle) glaucoma or shallow posterior eye chamber

If your intestines are obstructed, paralytic or not functioning well

If you suffer from a severe form of ulcerative colitis (inflammatory bowel disease) ileostomy

(surgical opening from the small intestine), colostomy (surgical opening from the large

intestine), toxic megalocolon (enlarged colon)

If you experience difficulties in urinating or incomplete bladder emptying during urination

If you have frequent urination at night caused by heart or kidney disease.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Oxybutynin Unimedic. Elderly persons and

children can be more sensitive to the effects of the medicinal product.

This medicinal product should be used with caution in

diseases of the nervous system (e.g. Parkinsons disease)

severe gastrointestinal conditions such as diaphragmatic hernia

liver or kidney disease

Oxybutynin may worsen the symptoms if you have

overactive thyroid gland (hypertyroidism)

certain coronary vascular diseases

high blood pressure

enlarged prostate

irregular or increased heart beat

Since treatment with oxybutynin may cause decreased perspiration, there is an increased risk of heat

exhaustion if you are exposed to high environmental temperatures.

Oxybutynin can cause a certain type of glaucoma. Immediately contact your doctor if you experience

pain in the eyes or sudden loss of visual acuity.

During long term treatment the risk of lower urinary tract infections is increased.

At urinary tract

infections during oxybutynin treatment antibiotic treatment should be initiated.

Proper dental care is important since treatment with oxybutynin increases the risk of caries due to

dryness of the mouth.

There is a risk that this type of medicines reduce the gastrointestinal movements, affects the attention

and causes symtoms such as anxiety, restlessness and sleeping difficulties. The risk is lower when

oxybutynin is given via catheter directly into the bladder compared to oral administration.

Children and adolescents

Oxybutynin Unimedic is not recommended for use in children under the age of 5 years.

In children on long term treatment with oxybutynin given via catheter into the urinary bladder, an

increased risk of lower urinary tract infections have been observed.

Other medicines and Oxybutynin Unimedic

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Oxybutynin can reduce the gastrointestinal movements and thereby affect the effect of other

medicines. Concomitant use with other medicines can also increase the effect of oxybutynin,

especially medicines with similar effects or medicines that inhibit the metabolism of oxybutynin. This

may increase the risk of dry mouth, constipation, and drowsiness.

Especially tell your doctor if you are using any of the following medicines:

phenothiazines, butyrophenones and clozapine (used to treat mental illness)

amantadine, biperiden and levodopa (used to treat Parkinson’s disease)

tricyclic antidepressants (used to treat depression)

quinine (used to treat malaria)

atropine (widens the pupil in the eye, muscle relaxant)

dipyridamole (reduces the risk of blood clots)

antihistamines (used to treat allergies)

itraconazole (used to treat fungal infections)

erythromycin (used to treat bacterial infections)

cholinesterase inhibitors (against dementia or certain muscle diseases)

Medicines for angina that should melt under the tongue may dissolve to a lesser extent under the

tongue due to mouth dryness. It is therefore recommended to moisten the mouth before taking such a

tablet.

Oxybutynin Unimedic with drink and alcohol

Avoid drinking grapefruit juice since this can affect the metabolism of oxybutynin.

Alcohol in combination with this medicine can enhance the drowsiness.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

Oxybutynin Unimedic is not recommended during pregnancy.

Oxybutynin Unimedic is not recommended during breast-feeding. Small amounts oxybutynincan be

excreted in the breast milk.

Driving and using machines

Oxybutynin Unimedic may cause drowsiness, vertigo or blurred vision. If this happens, driving or

using machinery should be avoided.

3.

How to use Oxybutynin Unimedic

This medicine is given to you by health care personnel, but if you or relative/caregiver have received

adequate training by competent health care personnel, you or your relative/caregiver can administer it

at home.

The bladder is emptied from urine via a catheter that is inserted in the urethra, so called clean

intermittent catheterisation (CIC). When the bladder is empty the oxybutynin solution and thereafter

the saline solution is injected into the bladder via the catheter while it is still in place. Thereafter the

catheter is removed. Emptying of the bladder should occur every 4 hours, via CIC.

The dosing is individual and depends on the medical condition and response to the medicine. To

ensure the complete dose reaches the bladder your doctor will decide upon a certain amount of the

saline solution to be inserted in the catheter after the medicine.

Adults

The dosing is individual and is decided by your doctor. The starting dose is 5 mg (10 ml) in the

bladder in the morning and evening. Provided that you can tolerate the side effects, the daily dose may

be increased to 5 mg (10 ml) three times a day or 10 mg (20 ml) twice a day to achieve adequate

effect.

Use in children and adolescents

Children over the age of 5 years: The dosing is individual and decided by the treating doctor.

The starting dose is 0.1 mg/kg in the bladder in the morning and evening. Provided the child can

tolerate the side effects the daily dose may be increased to 0.15 mg/kg twice daily to achieve adequate

effect. Not more than 5 mg should be administered per single dose.

Special populations

Elderly or patients with hepatic and renal insufficiency should be treated with caution. A lower dose

can be considered.

If you use more Oxybutynin Unimedic than you should

The urinary bladder should be emptied if too much medicine has been used.

To large amount of the medicine can give symptoms such as anxiety, restlessnes, confusion,

hallucinations, drowsiness, tachycardia, stomach discomfort, cramps, difficulties urinating, fever and

dehydration.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediately contact your doctor if you experience pain in the eyes or sudden blurred vision. These

can be symptoms of (narrow angle) glaucoma.

If urinary tract infection occurs, a doctor should be contacted and antibiotics given.

The undesirable effects are less pronounced when the medicine is given directly into the bladder

compared to oral administration.

Exact frequency of undesirable events, at intravesical administration, is not known.

Dose dependent so called anticholinergic side effects can occur. The following side effects might

occur with the frequency not known (cannot be estimated from the available data):

facial flushing

headache, dizziness, somnolence, drowsiness

tachycardia

dry skin

mouth dryness, constipation, abdominal discomfort, diarrhoea

urinary retention

anxiety, confusion, restlessness, disorientation, agitation

heat exhaustion due to decreased perspiration

dry eyes, blurred vision, narrow-angle glaucoma, light hypersensitivity

urinary tract infections

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects, you can help provide more information on the

safety of this medicine.

5.

How to store Oxybutynin Unimedic

Do not store above 25 °C.

Keep this medicine out of the sight and reach of children.

Opened package should be used immediately.

Do not use this medicine after the expiry date which is stated on the label after EXP.

The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

Declaration of content

1 ml solution contains 0.5 mg of the active substance oxybutynin hydrochloride

The other excipients are sodium chloride, hydrochloric acid (for pH adjustment), water for injections.

What Oxybutynin Unimedic looks like and contents of the pack

Clear colourless solution in a glass vial with a bromobutyl stopper and an aluminum cap.

Packaging size: 10x20 ml.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

Manufacturer:

Unimedic AB

Box 91

SE- 864 21 Matfors

This leaflet was last updated 2020-12-20

Detailed information on this medicinal product is available on the website of: {Name of MS/Agency}

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1.

NAME OF THE MEDICINAL PRODUCT

Oxybutynin Unimedic 0.5 mg/ml intravesical solution.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml solution contains 0.5 mg oxybutynin hydrochloride corresponding to 0.454 mg oxybutynin.

Excipient with known effect

The solution contains 3.5 mg (0.15 mmol) sodium per ml.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Intravesical solution.

Clear, colourless solution.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Treatment of frequency, urgency or urge incontinence as may occur in bladder overactivity due to

neurogenic bladder disorder (e.g. myelomeningocele or spinal injury), in situations where the

anticholinergic side effects with orally administered oxybutynin are not tolerated. The intravesical

solution should only be used when clean intermittent catheterisation (CIC) has already been

established.

Oxybutynin Unimedic is intended for adults and children over 5 years of age.

4.2

Posology and method of administration

This medicinal product is administered by health care personnel but can also be administered at home

by the patient or relative/caregiver. It is a requirement that the patient and relative/caregiver receive

adequate training by competent health care personnel, e.g. urologist or urotherapist prior to the first

administration.

Posology

Adults:

The dosing is individual with a starting dose of 5 mg (10 ml) intravesically in the morning and

evening. The dose can be adjusted after one week of treatment. Lowest effective dosing should be

chosen. The daily dose may be increased to between 5 mg (10 ml) x 3 and 10 mg (20 ml) x 2 to

achieve adequate effect, provided that side effects are tolerated.

Paediatric population

Children above 5 years:

The dosing is individual with a starting dose of 0.1 mg/kg intravesically in the morning and evening.

The dose can be adjusted after one week of treatment. Lowest effective dosing should be chosen. The

daily dose may be increased up to 0.15 mg/kg twice daily to achieve adequate effect, provided that

side effects are tolerated. Not more than 5 mg should be administered per single dose.

The safety and efficacy of oxybutynin hydrochloride in children below 5 years of age have not yet

been established.

Special populations

There is no data on intravesical use in the elderly or patients with hepatic and renal insufficiency. A

lower starting dose than recommended above should be considered to reduce the risk of adverse

events. Close monitoring of adverse events occurrence is advised when administering the product in

these populations (see sections 4.4 and 5.2).

Method of administration

For intravesical use. To ensure the complete dose reaches the bladder the volume of the catheter is

determined using a syringe to fill the catheter with saline solution. Register the volume required until

the solution reaches the end of the catheter. This volume of saline solution is added to the volume

oxybutynin solution prescribed for the treatment. After emptying of the bladder via clean intermittent

catheterisation (CIC), first the oxybutynin solution, and thereafter the saline solution, is injected into

the bladder via the catheter while it is still in place. Thereafter the catheter is removed. Emptying of

the bladder should occur every 4 hours, via CIC.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Myasthenia gravis

Narrow-angle glaucoma or shallow posterior eye chamber

Gastrointestinal obstruction, paralytic ileus or intestinal atonia

Patients with ileostomy, colostomy, toxic megacolon, severe ulcerative colitis

Patients with urinary obstruction where urinary retention may occur

Frequent urination at night caused by heart or kidney disease

4.4

Special warnings and precautions for use

Oxybutynin should be used with caution in elderly patients and children, who may be

more sensitive to the effects of the medicinal product.

The product shall be used with caution in patients with autonomic neuropathy (e.g. Parkinson’s

disease) and in patients with liver or kidney diseases.

Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with

caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention,

and in conditions such as ulcerative colitis and intestinal atony. Anticholinergic medicinal products

should be used with caution in patients with hiatus hernia/gastroesophageal reflux and/or who

are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate

esophagitis.

The use of oxybutynin may aggravate the symptoms of hyperthyroidism, cardiac insufficiency, cardiac

arrhythmias, coronary artery disease, tachycardia, hypertension, and prostatic hypertrophy.

Oxybutynin decreases perspiration, which can lead to heat exhaustion in patients, if the medicinal

product is used in high temperature environments.

Since oxybutynin may trigger narrow-angle glaucoma the patient should be instructed to immediately

contact a doctor if the visual acuity suddenly disappears. Visual acuity and intraocular pressure

should be followed during treatment.

Proper dental care is important since treatment with oxybutynin increases the risk of caries due to

dryness of the mouth.

Anticholinergic medicinal products such as oxybutynin may decrease the cognitive ability and cause

CNS effects such as agitation and sleep disorders. Serious atropine symptoms may occur, particularly

in children, that may require dose adjustment or termination of treatment.

The risk for anticholinergic adverse events is clearly lower with intravesical use compared to oral

administration. This is probably due to oxybutynin being absorbed over a longer period with a delayed

peak serum level and a lower degree of metabolism to the active metabolite N-desethyloxybutynin

which is the main cause of these side effects.

During long term treatment with intravesical oxybutynin an increased frequency of asymptomatic

bacteriuria and lower urinary tract infections have been observed.

At urinary tract infections during

oxybutynin treatment appropriate antibacterial treatment should be initiated.

Paediatric population

In children on long term treatment with intravesical oxybutynin an increased frequency of

asymptomatic bacteriuria and lower urinary tract infections have been observed. At urinary tract

infections during oxybutynin treatment appropriate antibacterial treatment shall be initiated.

4.5

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions:

The anticholinergic activity of oxybutynin is increased by concomitant use of other anticholinergics or

medicinal products with anticholinergic activity such as amantadine and other anticholinergic

antiparkinsonian medicinal products (e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g.

phenothiazines, butyrophenones, clozapine), quinine, tricyclic antidepressants, atropine and related

compounds like atropinic antispasmodics, dipyridamole.

Alcohol may increase the drowsiness caused by anticholinergic drugs such as oxybutynin (see section

4.7).

Oxybutynin may antagonize prokinetic therapies.

Oxybutynin can potentially modify the absorption of certain concomitantly administered medicinal

products because of the anticholinergic effect on gastrointestinal motility.

Sublingual nitrates may dissolve to a lesser extent under the tongue due to mouth dryness, which can

lead to decreased therapeutic effect of the nitrates. Patients should be instructed to moisten the mouth

before taking a tablet.

The concomitant use of cholinesterase inhibitors can decrease the cholinesterase inhibiting effect.

Pharmacokinetic interactions:

Oxybutynin is metabolised via cytochrome P450 isoenzyme CYP 3A4.

Concomitant administration of inhibitors of CYP3A4 (e.g. itraconazole, erythromycine, grapefruit

juice) could inhibit the metabolism of oxybutynin resulting in an increased systemic exposure.

4.6

Fertility, pregnancy and lactation

Pregnancy: Clinical experience from pregnant women is limited. Studies in animals have shown

reproductive toxicity (see section 5.3). Until further experience is gained it is not recommended that

Oxybutinin Unimedic is used during pregnancy.

Breastfeeding: Small amounts are excreted in the mother’s milk and there may be a risk that the child

will be affected even at therapeutic doses. Use of oxybutynin while breast-feeding is therefore not

recommended.

Fertility: There are no data available on the effect on human fertility. Animal studies have shown

decreased fertility in female animals (see section 5.3).

4.7

Effects on ability to drive and use machines

Treatment with oxybutynin may cause dizziness, drowsiness and blurred vision, which affects the

ability to drive or use machines.

4.8

Undesirable effects

The systematic undesirable effects are less pronounced at intravesical compared to oral administration.

Exact frequency of undesirable events at intravesical administration is not known.

Dose dependent anticholinergic undesirable events may occur at oxybutynin treatment. The following

adverse events might occur with the frequency not known (cannot be estimated from the available

data):

System organ class

Frequency not known (cannot be estimated from the

available data)

Infections and infestations

Urinary tract infections

Psychiatric disorders

Anxiety, confusion, restlessness, disorientation, agitation

Nervous system disorders

Headache, dizziness, somnolence, drowsiness

Eye disorders

Dry eyes, blurred vision, narrow-angle glaucoma, light

hypersensitivity

Cardiac disorders

Tachycardia

Vascular disorders

Facial flushing

Gastrointestinal disorders

Mouth dryness, constipation, abdominal discomfort, diarrhoea

Skin and subcutaneous tissue

disorders

Dry skin

Renal and urinary disorders

Urinary retention

Injury, poisoning and procedural

complications

Heat exhaustion

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the national reporting system

listed in Appendix V.

4.9

Overdose

Experience from overdose of oxybutynin is limited, but has been associated with anticholinergic

effects.

Symtoms:

Anxiety, agitation, confusion, hallucinations, CNS depression, CNS exitation.

Tachycardia, ventricular extra systoles. Gastrointenstinal problems including vomiting.

Seizures, mydriasis, urinary retention, fever, dehydration.

Treatment:

Empty the urinary bladder. At anxiety, agitation or seizures diazepam is administered. At central

anticholinergic symptoms and no other cardic effect than tachycardia, possible treatment with

physostigmine. Symptomatic treatment.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for urinary frequency and incontinence. ATC code: G04B D04

Mechanism of action: Oxybutynin is an antimuscarinic anticholinergic i.e. a competitive antagonist of

acetylcholine at the muscarinic receptors. Intravesicular administration also provides a direct

spasmolytic effect on bladder smooth muscle (calcium antagonistic and local anesthetic effect).

Pharmacodynamic effects:

In therapeutic doses oxybutynin decreases the detrusor muscle contraction capacity, resulting in an

increased volume of the urinary bladder to first detrusor contraction and a prolonged time interval

between micturitions. Oxybutynin thus decreases the frequency of urinary urgency and consequently

also the incontinence episodes and voluntary urination.

Intravesically administered oxybutynin has less pronounced central effects and also less effect on the

coronary heart system compared to oral exposure.

Oxybutynin is a racemic (50:50) mixture of R- and S-isomers. Antimuscarinic activity resides

predominantly in the R-isomer, showing greater selectivity for the M1 and M3 muscarinic subtypes

(predominant in cerebral cortex and parotid gland, and in the bladder detrusor muscle and ileum

respectively) compared to the M2 subtype (predominant in cardiac tissue). The active metabolite, N-

desethyloxybutynin, has pharmacological activity on the human detrusor muscle that is similar to that

of oxybutynin

in vitro

studies, but has a greater binding affinity for parotid tissue than oxybutynin.

The free base form of oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride.

5.2

Pharmacokinetic properties

Absorption

Intravesical oxybutynin is well absorbed through the bladder wall into systemic circulation.

Measurements of oxybutynin plasma concentrations after intravesical administration revealed

extensive inter-individual variability, but there was a substantial absorption of the drug also after

intravesical application with maximum concentrations in plasma achieved after about one hour.

The pharmacokinetics of intravesical oxybutynin hydrochloride has been investigated in healthy

volunteers. Systemic exposure (AUC) to racemic oxybutynin was significantly greater after instillation

(294 %) compared to oral administration. In contrast, systemic exposure of the metabolite N-desethyl-

oxybutynin was significantly lower after instillation (21 % of exposure after oral administration). As a

consequence, the metabolite-to-parent ratio was 14-fold lower in case of intravesical application.

These observations clearly indicate that the mode of administration strongly influences absorption and,

in particular, first-pass metabolism of oxybutynin.

Obviously, the first-pass effect is significantly reduced in case of intravesical application. Considering

the reported oxybutynin bioavailability of about 6 % after oral administration, an absolute

bioavailability of about 20 % might be estimated for the parent compound after intravesical

instillation.

Distribution

Oxybutynin is to a large extent distributed to body tissue after systemic absorption.

The distribution volume is estimated to 193 liters after intravenous administration of 5 mg

oxybutynin hydrochloride. Approximately 85% of oxybutynin in blood is bound to serum albumin.

Metabolism:

Oxybutynin administered orally is metabolised primarily by the cytochrome P450 system, mainly

CYP3A4, found mostly in the liver and gut wall. Metabolites include mainly N-desethyloxybutynin,

which is pharmacologically active, and phenylcyclohexylglycolic acid, which is pharmacologically

inactive. Intravesical administration of oxybutynin bypasses the first-pass gastrointestinal and hepatic

metabolism, clearly reducing the formation of the N-desethyl metabolite, which can increase the

tolerability for the substance. N-desethyl oxybutynin is believed to be the cause of many

anticholinergic adverse events. C

for oxybutynin is lower and AUC flatter at intravesical compared

to oral administration, which is also considered to contribute to the lower frequency of anticholinergic

adverse events.

The influence of age, weight, race and tobacco use on the pharmacokinetics of oxybutynin is

unknown.

Elimination

The half life of oxybutynin is approximately 2 hours regardless of whether the substance is

administered orally or intravenously. The half life after intravesical administration is longer.

Oxybutynin is largely metabolised by the liver (see above) and less than 0.1% of the administered

dose is excreted unchanged in the urine. Less than 0.1% of the administered dose is excreted as the

metabolite N-desethyloxybutynin.

5.3

Preclinical safety data

Pre-clinical data reveal no special hazard for humans based on studies for acute toxicology, repeat

dose toxicity, genotoxicity, carcinogenic potential, and local toxicity. At a concentration of 0.4

mg/kg/day oxybutynin administered subcutaneously, the occurrence of organ anomalies is

significantly increased, but is observed only in the presence of maternal toxicity. However, in the

absence of understanding the association between maternal toxicity and developmental effect, the

relevance to human safety cannot be addressed. In the subcutaneous fertility study in rats, while no

effects were reported in males, in females, fertility was impaired. A NOAEL (no observed adverse

effect level) of 5 mg/kg was identified.

Environmental Risk Assessment (ERA)

The active substance oxybutynin is persistent in the environment.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Sodium chloride

Hydrochloric acid (for pH adjustment)

Water for injections

6.2

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal

products.

6.3

Shelf life

2 years.

Opened package: From a microbiological point of view the medicinal product should be used

immediately. If not used immediately the storage time and storage conditions before administration are

the responsibility of the user.

6.4

Special precautions for storage

Do not store above 25

For storage conditions after opening of the medicinal product, see section 6.3.

6.5

Nature and contents of container

Glass vial with a bromobutyl stopper and an aluminum cap: 10x20 ml.

6.6

Special precautions for disposal and other handling

For instillation in the urinary bladder via catheter.

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

requirements.

7.

MARKETING AUTHORISATION HOLDER

[To be completed nationally]

8.

MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

[To be completed nationally]

10.

DATE OF REVISION OF THE TEXT

2020-12-20

Detailed information on this medicinal product is available on the website of {name of MS/Agency}

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