Uront 12.5 g. 5 pieces

WHAT IS URONT URTral EMULSION AND WHAT IT IS USED
Uront Urethral Emulsion is used after urethral instrumental surgery (such as catheterization, endoscopy). The emulsion has anti-inflammatory, locally analgesic (anesthetic) and antimicrobial (antiseptic) action, which relieves inflammation and pain after instrumental intervention and prevents large wall infections.
Uroth Urethral Emulsion contains dexamethasone (a synthetic glucocorticoid). It has anti-inflammatory action, which prevents the formation of hypertrophic scars and thus prevents the urethra from narrowing.
Uroth Urethral Emulsion also contains lidocaine, a local anesthetic, which relieves pain during manipulation.
Uront Urethral Emulsion also contains chlorhexidine disinfectant because local corticosteroid therapy requires the presence of an antiseptic agent.
Methyl parahydroxybenzoate is a preservative that is characterized by a wide spectrum of its antimicrobial activity.
The fat-water consistency allows the emulsion to be placed in the urethra with moderate pressure without the risk of subsequent reflux. The components of the emulsion are selected because of their mucosal tolerance and open wounds.

Therapeutic indications:
Prophylaxis of stricture (narrowing of the urethra due to the formation of hypertrophic scars), formed after instrumental transurethral interventions.

2. BEFORE USING URONT URTRAAL EMULSION
Do not use Uront Urethral Emulsion:

if you are allergic (hypersensitive) to dexamethasone, lidocaine or any of the other ingredients of Uront Urethral Emulsion;
in children and adolescents up to 18 years of age;
during the first trimester of pregnancy (see Pregnancy and breast-feeding);
if you have a proven functional impairment of the urinary system (eg bulbocorticoid reflux);
if you suffer from cerebral malaria (a form of malaria affecting the brain);
if you are allergic (hypersensitive) to other local pain relievers (eg amide type);
if you have a serious heart disease, a significant delay in heart rhythm, impaired heart rate (AV block), shock due to a heart attack and a decrease in blood volume;
if you have disorders in the area of application (syphilis, tuberculosis); in bacterial or fungal inflammation, Urout urethral emulsion should be administered after the infection has resolved.
Please tell your doctor if any of these conditions affect you or affect you.

Take special care with Urout Urethral Emulsion:

if you have severely impaired renal or hepatic function;
if you have a heart or respiratory disorder;
if you have an infected, injured or ulcerative lining of the urethra;
if you are an adult, in a failing state, you have acute illness or serious convulsions;
if you have a specific muscular disease (myasthenia gravis).
If more than one tube is administered, or a significant amount of bladder emulsion is injected or in patients with an ulcer or ulcerative urethra, an increase in the absorption of lidocaine with subsequent CNS or cardiovascular overdose may occur, especially in adult patients ( see How to Use Urethral Urethral Emulsion).
Like all corticosteroids, prolonged use of dexamethasone may reduce immune protection and increase the risk of infections.
Urethral Urethral Emulsion should not have eye contact.

Doping warning:
The use of Uront Urethral Emulsion may result in a positive doping test.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Urea urethral emulsion should not be administered concomitantly with other products containing lidocaine or other local amide-type anesthetics because the effect may potentiate in an unpredictable manner. Lidocaine is also used to treat heart rhythm disturbances.
Due to the increase in the effect on the heart, lidocaine should be used with caution in patients taking antiarrhythmic and blood pressure lowering drugs (beta-blockers and calcium antagonists).
Because of the low exposure and short-term use of Uroth urethral emulsion, other significant interactions are not observed.

Uses Uront  Urethral Emulsion with Food and Drinks
No interactions were observed.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Ear Urethral Emulsion should not be given during the first three months of pregnancy. In a later pregnancy and during breastfeeding Uroth urethral emulsion should be administered after careful consideration of the benefit / risk ratio by the physician and after careful individual dose determination. Re-administration during pregnancy and lactation is not recommended.
Please observe an interval of 12 hours between use
If you use more Urout  Urethral Emulsion than you should
Urout  Urethral Emulsion is administered by a physician and overdose is not expected.
If, however, an overdose occurs, e.g. if the amount of emulsion is not optimally adapted to the patient's needs, or if a large amount of gel enters the bladder or if the urethra is inflamed, ulcerated or injured, this may lead to increased absorption of lidocaine and dexamethasone and subsequent overdose with central and cardiovascular system. This is particularly true when other local analgesic drugs are administered simultaneously.
Overdose is expressed in overexposure / suppression of the central nervous system, which is expressed, for example, in nervousness, dizziness, drowsiness and tremor. The first symptoms of overdose are stiffness of the tongue, involuntary eye movements, dizziness and fatigue. Cardiovascular disorders such as slowing of heart rhythm, cardiac disorders or low blood pressure are only seen at high plasma concentrations of lidocaine. In case of massive overdose with lidocaine, a respiratory or cardiovascular collapse may occur.
If you notice any symptoms of overdosage, tell your doctor immediately.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Urout urethral emulsion can cause side effects, although not everyone gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The following frequencies were used to evaluate the adverse drug reactions:

rare (> 1 / 10,000 to <1 / 1,000);
very rare (<1 / 10,000);
not known (can not be estimated from the available data).
Side effects with Uroth urethral emulsion are very rare if the product is administered according to the recommendations for dosing and use and with due care. Because of the route and duration of URN administration, low plasma concentrations of lidocaine and dexamethasone are expected. Other systemic side effects following intraureural administration of Uroth urethral emulsion are likely.

Cardiovascular disorders
Cardiovascular responses due to lidocaine absorbed through the mucous membrane, in particular cardiac arrhythmia and impaired conduction (including AV block), are rare. There have been rare reports of dexamethasone-induced increases in blood pressure after prolonged use and high doses.

Nervous system disorders
The effects of lidocaine on CNS are manifested by nausea, vomiting, agitation, tremor, fear, involuntary eye movements, and so on.

Eye disorders
There have been rare reports of dexamethasone-induced glaucoma after prolonged administration and high doses.

Gastrointestinal disorders
Systemic adverse reactions of dexamethasone such as ulcer and decreased glucose tolerance occur after prolonged intake and high doses. These effects are rare.

Eating disorders and metabolism
Dexamethasone increases the level of blood sugar in diabetics. The frequency is unknown.

General disorders and site disorders
Local and / or systemic hypersensitivity reactions may occasionally occur and severe reactions can not be totally excluded. Systemic reactions of dexamethasone and lidocaine are possible after use on injured or inflamed mucosa.
Very rarely, allergic reactions to dexamethasone occur.

In clinical studies, neither local nor systemic adverse reactions were observed. However, they can not be completely excluded, especially after high doses and prolonged use.

Immune system disorders
Prolonged use of dexamethasone weakens the immune response and reduces resistance to infections. In addition, changes in the urethral lining and expansion of the capillary vessels may occur.

Methyl parahydroxybenzoate may provoke a hypersensitivity reaction including late reactions. The frequency is unknown.

5. HOW TO STORE URONT URTRAAL EMULSION
Store below 25 ° C.
Keep the insert in the outer carton in order to protect from light.
Keep out of the reach and sight of children.
Do not use Uron Urethral Emulsion after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Ear urethral emulsion in a tube is for single use only. The remainder of the emulsion is discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
What Uront contains Urethral Emulsion
The active substances are dexamethasone and lidocaine hydrochloride.
Other ingredients are: chlorhexidine dihydrochloride, methyl parahydroxybenzoate, xalifine, purified water.

What Uront Urethral Emulsion looks like and contents of the pack
White emulsion filled in polypropylene tube "harmonica" with applicator tip.
The individual tubes are packaged in inserts. The material of the inserts is a polypropylene thermo foil with a layer of medical paper packed in cardboard boxes of 1, 5 or 10 inserts.

 

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