CATHEJELL WITH LIDOCAINE

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CHLORHEXIDINE DIHYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE

متاح من:

A.LAPIDOT PHARMACEUTICALS LTD, ISRAEL

ATC رمز:

D04AB01

الشكل الصيدلاني:

GEL

تركيب:

LIDOCAINE HYDROCHLORIDE 2 %W/W; CHLORHEXIDINE DIHYDROCHLORIDE 0.05 %W/W

طريقة التعاطي:

URETHRAL

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

PHARMAZEUTISCHE FABRIK MONTAVIT GMBH, AUSTRIA

المجموعة العلاجية:

LIDOCAINE

المجال العلاجي:

LIDOCAINE

الخصائص العلاجية:

Instillation into the urethra prior to the instillation of catheters or other instruments and manipulations which require the use of a local anesthetic.

تاريخ الترخيص:

2021-05-31

نشرة المعلومات

Page 1 of 6
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS)
- 1986
The medicine is dispensed with a doctor’s prescription only
CATHEJELL WITH LIDOCAINE
Gel for Urethral Instillation
COMPOSITION:
ACTIVE INGREDIENTS AND THEIR CONCENTRATIONS:
Lidocaine hydrochloride 2%
Chlorhexidine dihydrochloride 0.05%
For the list of inactive ingredients, refer to section 6 at the end of
this leaflet.
Read all of this leaflet carefully to the end before you start using
this medicine. This leaflet contains
concise information about the medicine.
If you have any further questions, refer to the doctor or pharmacist
or nurse.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their illness is similar.
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
1.
WHAT IS THE MEDICINE USED FOR?
This medicine is intended for instillation into the urethra prior to
the insertion of a catheter or other
medical device, endoscopy, cystoscopy.
Therapeutic group: Lidocaine - local anesthetic agent; chlorhexidine -
local antiseptic agent.
MECHANISM OF ACTION OF THE DRUG:
Cathejell with Lidocaine is a sterile, anaesthetising gel.
Besides its lubricant action, it has a local anaesthetic and
germ-killing effect to relieve pain during
medical procedures and prevent infections to a large extent. The
effect sets in as early as 5 to
10 minutes after application and lasts for 20 to 30 minutes.
As a local numbing agent (local anaesthetic), it contains lidocaine.
In topical anaesthesia, it generally
takes effect after about 3 to 5 minutes. In inflamed tissue, the
effect is reduced.
To avoid infections at the application site, Cathejell with Lidocaine
contains chlorhexidine. This agent
disinfects and acts against many bacteria, some fungi and viruses.
2.
BEFORE USING THE MEDICINE
DO NOT USE CATHEJELL WITH LIDOCAINE:
-
if you are sensitive (allergic) to

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cathejell with Lidocaine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains:
20 mg Lidocaine hydrochloride (2% w/w)
0.5 mg Chlorhexidine dihydrochloride (0.05% w/w)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Water-soluble and clear, colourless anaesthetising gel.
Sterile single-use form.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Instillation into the urethra prior to the instillation of a catheter
or other instruments
(catheterization, cystoscopy) and manipulations which require the use
of a local
anesthetic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cathejell with Lidocaine is instilled into the urethra prior to the
insertion of
instruments and/or applicated onto the instrument.
The content of one syringe is sufficient to fill the urethra.
Never instill more than one syringe.
The tubes contain 12,5 g, of which 10 g are instilled into the
urethra.
Slow instillation of the gel into the urethra prior to the insertion
of instruments (by a
physician or trained medical qualified personnel).
Handling:
_ _
1. Clean and disinfect the external orifice of the urethra.
2. Peel off the paper from the blister back cover (possibly up to the
waist of the
transparent blister material).
3. Break off the applicator tip (in the blister pack if required).
Take care to remove the tip completely to prevent insertion into the
urethra.
4. Release one drop of gel for easier insertion of the applicator.
5. Complete extrusion by applying slight steady pressure to the
accordion
The duration of application is not limited.
4.3 CONTRAINDICATIONS
-
Hypersensitivity to the active substances or to any of the excipients
listed in
section 6.1.
-
Hypersensitivity to other local anaesthetics of the amide type.
-
Infants under 2 years of age.
-
Bulbocavernosus (urethrocavernous) reflux, an injury to the thin
urethral mucosa
which may lead to intrusion of the lubricant into erectile tissue,
where absorption
might occur.
-
Severe hear