CATHEJELL GEL 8.5 gr
Designed for use on mucous membranes. As a consequence of the effect of lubricant locally anesthetized and antibacterial activity, it is intended for analgesia in the above procedures and to prevent many infections.
CATHEJELL GEL 8.5 gr
WHAT CATHEJELL lidocaine AND WHAT IT IS USED
CATHEJELL with Lidocaine is a sterile gel is used as a lubricant with a local anesthetic and antiseptic before use of catheters, endoscopes and other medical instruments .
Designed for use on mucous membranes . As a consequence of the effect of lubricant locally anesthetized and antibacterial activity, it is intended for analgesia in the above procedures and to prevent many infections. Its effect is felt at least 5-10 minutes after administration and lasts 20-30 minutes.
As a local anesthetic substance it contains Lidocaine . For surface anesthesia , its effect lasts for 3-5 minutes. In inflamed tissue its effect is reduced.
To prevent infection at the injection site , Katezhel lidocaine containing Chlorhexidine . This disinfectant active against many bacteria , some fungi and viruses .
2 . BEFORE YOU USE CATHEJELL with Lidocaine
Do not use Katezhel with Lidocaine :
if you are allergic (hypersensitive ) to the active substances or to any of the ingredients of Katezhel with Lidocaine ;
if you are allergic ( hypersensitive) to any other local anesthetics ( amide type of ) ;
in children under 2 years of age;
bulbokavernozen at reflux ( urethral injury thin tissue, which can cause the lubricant to penetrate into the erectile tissue , which can be accomplished resorption ) ;
in severe heart failure, severe bradycardia , impaired cardiac function (AV - block) , shock due to heart failure or decreased blood volume.
Please talk to your doctor if one or more of these conditions happen to you or ever happened to you in the past.
Take special care with Katezhel with Lidocaine
If you use high doses can be some serious side effects . Greater absorption of lidocaine , it is possible for use in the bronchial region , leading to a partially increased risk of overdose ;
If you have any wounds , injuries or mucosal ulcers / sores in or around the recommended site of application ;
if you have severe impairment of hepatic or renal function ;
with heart or respiratory malfunctions ;
in adults debilni patients suffering from acute or diseases;
If you are prone to convulsions ;
if you have some muscle disease (myasthenia gravis);
if you are taking certain medicines for the treatment of heart rhythm disturbances known as class III antiarrhythmics ( eg, amiodarone) cardiac effects may be intensified ;
If you suffer from porphyria (a disorder of the formation of blood).
Violation swallowing can be observed when using Katezhel lidocaine in the mouth and throat. There is a risk of inhalation ( aspiration of the gel ) . Numbness of the tongue or in the mouth can lead to a risk of bites.
If the content of more than one container is placed in the ureter , if a large amount of gel entered the bladder or urethra is ulcerative / inflammation that may lead to increased absorption of lidocaine transmucosal, mainly in children and adults as a result of which receive strong reactions ( see also section 3 " If you use more than the amount Katezhel lidocaine than is necessary " ) .
Katezhel lidocaine gel should not come in contact with eyes.
Under general anesthesia should not be used without lubricant Lidocaine .
Use with other drugs
Please tell your doctor or pharmacist if you are taking / using or often you have taken / used any other medicines, including medicines obtained without a prescription .
Katezhel with Lidocaine should not be used concomitantly with other medicinal products containing lidocaine or other local anesthetics ( amide type of ) because it can enhance their impact in an unpredictable way.
As can influence increased heart Lidocaine should be used with caution in patients taking anti-arrhythmic drugs (antiarrhythmics, eg . Mexileletine, tocainide), on medication for high blood pressure ( beta-blockers, such as propranolol) or calcium channel blockers (eg, diltiazem, verapamil).
No studies on the specific interaction between lidocaine and class III antiarrhythmic agents , however, caution should be exercised (see also " exercised to the use of lidocaine Katezhel " ), since cardiac effects may be intensified .
If you are taking cimetidine ( which blocks the release of stomach acid), talk to your doctor before applying lidocaine Katezhel . The use of these drugs at the same time can increase the risk of side effects .
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine .
During pregnancy and lactation Katezhel lidocaine should be used only after your doctor has carefully assess the benefits and risks of the application and has determined adequate individual dose .
Re-use during pregnancy and lactation is not recommended.
Please note that the application of Katezhel between lidocaine and breastfeeding should be a space of at least 12 hours.
Women who are planning a pregnancy , or to suggest that they are pregnant should notify their physician .
Driving and using machines
Effects on ability to drive and use machines is unlikely but can not be ruled out, because of possible increased individual hypersensitivity.
3 . HOW TO USE CATHEJELL with Lidocaine
This medicine should only be administered by a doctor or qualified and trained medical personnel. The appropriate dosage for each patient must be determined individually .
The following information is only for dosing recommendation: patient information , doctor's experience and knowledge of the physical condition of the patient is very important to determine the appropriate dose.
The extent of absorption is particularly high in the bronchial tree .
Using prior to insertion into the urethra of a catheter, endoscope or other medical instrument
Folding syringes ( accordion ) ( hereinafter referred to as " syringes " ) contain 12.5 g or 8.5 g gel, which is instilled into the urethra respectively 10 g and 6 g.
Dosage recommendations :
Older men : one man one syringe of 12.5 g is sufficient to fill the urethra. The contents of one syringe , should not be more than one instillation syringe. Anesthetic effect occurs after 5-10 minutes and lasts for 20-30 minutes.
Women, children ( 2-12 years) and adolescents (under 18 years): from insufficient data, no specific recommendations can be given for this patient group.
Method of administration :
1. Clean and disinfect the external opening of the urethra.
2 . Paper is peeled off from the transparent top surface of the blister to the constriction of the transparent material of the blister.
3 . Is broken off the applicator tip , where possible, while still in the blister.
4 . Complete removed tip to prevent insertion into the urethra.
5 . One drop squeezed out from the gel , for ease of insertion of the applicator .
6 . Gela is introduced slowly with a slight push of the syringe.
Syringes CatHejell lidocaine gel intended for single use. The gel left in the syringe after use should be discarded .
Use of general anesthesia and tracheal intubation
Adults and adolescents 15 years and older:
Place about 5 ml on the lower third of the tube ( cannula ) . To prevent contamination , the gel must be applied to the instrument prior to use. The gel should be within the opening of the tube before the intervention . For adults with normal body weight , the maximum dose is 16 g Katezhel with Lidocaine - anesthetic gel.
Dose recommendations for children and adolescents over 15 years:
In children under 15 years, the dose should not exceed 6 mg Lidocaine (= 0,3 ml gel) per kilogram of body weight. No more than four doses may be administered within 24 hours.
In children under 2 years Katezhel lidocaine should not be administered (see section 2) .
Dosing recommendations in patients at risk :
In elderly patients who are debilni or in patients with severe disease , the dose should be carefully considered . This also applies to patients with severe hepatic or renal impairment . The maximum dosage should be calculated in mg lidocaine hydrochloride per kilogram of body weight (2.9 mg lidocaine hydrochloride per kilogram of body weight ) .
If you use more than the amount Katezhel with Lidocaine
If this medicine is administered by a doctor or qualified and trained medical personnel , overdose is unlikely.
But if you overdose , eg . if the amount of gel is not optimally calculated according to your needs , if a large amount of gel entered the bladder or mucosa is irritated , or ulcerative damaged , this may lead to increased absorption of lidocaine , which causes distortion of the activity of the central nervous system or of cardiovascular system . Especially this occurs in the concomitant use of other local anesthetics .
In overdose may occur excitation / central nervous system , which may be manifested by symptoms of nervousness , dizziness , somnolence , and tremor . The first signs of overdose may have tongue numbness , twitching eyes, dizziness or fatigue.
At very high blood concentrations of lidocaine can usually be observed side effects from the cardiovascular system as a slow heart rate , weak heart function or decrease in blood pressure.
In a large overdose of Lidocaine may monitor respiratory paralysis and cardiovascular failure.
If signs of overdose , consult a physician immediately .
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
You can find further information for healthcare professionals at the end of this leaflet: information for the patient.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, Cathejell with Lidocaine can cause side effects, although not everybody gets them .
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
Side effects may include:
Very rare: affects less than 1 in 10,000 patients treated ;
Not known: frequency can not be estimated from available data.
Side effects are rarely seen after the use of lidocaine Katezhel , provided that the medicinal product is used as directed in the dosage recommendations / recommendations for use and taken the necessary precautions ( see Section 2).
Disorders of the immune system
Rarely noticed local hypersensitivity reactions such as redness , tingling or itching and / or systemic hypersensitivity reactions to lidocaine and / or Chlorhexidine they can not be completely excluded and severe reactions (often accompanied by a drop in blood pressure dizziness , vomiting and possible shortness of breath ), including anaphylactic shock .
Effects on the central nervous system and cardiovascular system : They are mainly due to rapid absorption overdose or hypersensitivity. May notice the following symptoms:
Nervousness, dizziness , blurred vision or tremors , drowsiness, unconsciousness and respiratory failure , low blood pressure , slow heart rate, cardiac arrest . For treatment of adverse reactions see " If you use more than the amount Katezhel lidocaine ."
As a local reaction , can be observed roughness when used as a lubricant for the endotracheal tube ( the respiratory tract ) .
When consumed in urology because of the low concentration of lidocaine in the blood, do not expect other systemic side effects after instillation of lidocaine in Cathejell urethra.
5 . HOW TO STORE CATHEJELL with Lidocaine
Keep the blister in the outer carton to protect from light.
Do not store above 25 ° C.
Keep out of reach of children.
Do not use Katezhel lidocaine after the expiry date stated on the carton after < EXP > . The expiry date refers to the last day of that month.
Syringes Katezhel lidocaine are designed for single use. The amount of gel remaining in the partly emptied syringes should be used .
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . ADDITIONAL INFORMATION
What does CatHejell with Lidocaine
The active substances are : lidocaine hydrochloride, and chlorhexidine dihydrochloride .
1 g of gel contains 20 mg of lidocaine hydrochloride, and chlorhexidine dihydrochloride 0,5 mg .
Other ingredients are: hydroxyethylcellulose, glycerol, sodium lactate solution , water for injections, hydrochloric acid and sodium hydroxide for pH adjustment .
Looks like Cathejell lidocaine and contents of container
Sterile disposable syringe . A clear, water soluble gel in folding ( accordion ) syringes containing 8,5 g 12,5 g or gel . Syringes are individually packaged in blister packs and are sterilized with steam. Blister strips are packaged in cartons of 1, 5 or 25 syringes.
1, 5 and 25 folding ( accordion ) syringes with 12,5 g gel per carton.
5 and 25 folding ( accordion ) syringes with 8,5 g gel per carton.