Instillagel 6 ml Urethral, vaginal, rectal and oropharyngeal gel

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Lidocaine Hydrochloride, anhydrous; Chlorhexidine digluconate (as chlorhexidine digluconate solution (20% w/v) ph.eur.; Methyl parahydroxybenzoate; Propyl parahydroxybenzoate

Disponibbli minn:

Farco-Pharma GmbH

Kodiċi ATC:

N01BB; N01BB52

INN (Isem Internazzjonali):

Lidocaine Hydrochloride, anhydrous; Chlorhexidine digluconate (as chlorhexidine digluconate solution (20% w/v) ph.eur.; Methyl parahydroxybenzoate; Propyl parahydroxybenzoate

Dożaġġ:

6 millilitre(s)

Għamla farmaċewtika:

Gel

Tip ta 'preskrizzjoni:

Product subject to prescription which may not be renewed (A)

Żona terapewtika:

Amides; lidocaine, combinations

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

1981-12-21

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
INSTILLAGEL 6 ML/ 11ML
URETHRAL, VAGINAL, RECTAL AND OROPHARYNGEAL GEL
_ _
LIDOCAINE HYDROCHLORIDE, CHLORHEXIDINE DIGLUCONATE, METHYL
PARAHYDROXYBENZOATE, PROPYL
PARAHYDROXYBENZOATE.
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
sterile
_ _
_ _
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.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor.
WHAT IS IN THIS LEAFLET
1.
What INSTILLAGEL is and what it is used for
2.
What you need to know before INSTILLAGEL is used
3.
How to use INSTILLAGEL
4.
Possible side effects
5.
How to store INSTILLAGEL
6.
Contents of the pack and other information
1.
WHAT INSTILLAGEL IS AND WHAT IT IS USED FOR
INSTILLAGEL is a gel that is used to numb the parts of the body it is
applied to (local anaesthetic).
It is used when examining or putting an instrument into a body cavity,
such as the mouth,
bladder or vagina. It provides lubrication to ease this process.
The gel contains substances (antiseptics) to reduce the risk of
infection.
INSTILLAGEL may be used before you have a catheter inserted or
replaced. It may also be used in
your throat, bladder,vagina, rectum or colon. This makes it easier for
your doctor to look inside
these parts of your body without causing you discomfort.
2.
WHAT YOU NEED TO KNOW BEFORE INSTILLAGEL IS USED
DO NOT USE INSTILLAGEL

if you are allergic (hypersensitive) to lidocaine, chlorhexidine,
methyl
parahydroxybenzoate, propyl parahydroxybenzoate, parabens or any of
the other
ingredients of INSTILLAGEL (see section 6 for details)

if you ever had a reaction to a local anaesthetic

INSTILLAGEL must not be used in childr

Karatteristiċi tal-prodott

Health Products Regulatory Authority
08 October 2020
CRN009RPH
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Instillagel 6 ml Urethral, vaginal, rectal and oropharyngeal gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
6 ml gel contains:
Active substances
Lidocaine Hydrochloride
125.40 mg
Chlorhexidine Digluconate
3.14 mg
Methyl Parahydroxybenzoate (E218)
3.76 mg
Propyl Parahydroxybenzoate (E216)
1.57 mg
Excipients with known effect
Propylene Glycol (E1520)(Ph. Eur.) 3140.00 mg
For full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Urethral, vaginal, rectal and oropharyngeal gel
Instillagel 6 ml is a clear, practically colourless, slightly
opalescent, viscous gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a lubricant gel, disinfectant, and local anaesthetic e.g. in
catheterizations and internal examinations, also intraoperatively; all
forms of endoscopy, changes of fistula catheters, intubations, also in
artificial respiration, for the prevention of iatrogenic
injuries to the rectum and colon, and in paediatrics.
Instillagel must not be used in children under 2 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Unless otherwise prescribed:
a) For urethral probe examination and catheterization:
Instil 6 or 11 ml. After the normal cleaning of the glans and the
external urethral orifice, instil Instillagel slowly into the urethra,
keeping the glans compressed, until the local anaesthetic and
disinfectant action has set in.
b) For cystoscopy:
Instil 11 ml, and possibly an additional 6 or 11 ml. The entire
urethral including the external sphincter must be covered with the
lubricating film and anaesthetized for germ-free and painless
introduction of instruments. A penis clamp is attached in the
region of the sulcus coronarius.
In women, children (2-12 years) and adolescents (under 18 years) the
effect of Instillagel with lidocaine is not so well
demonstrated and therefore the need to use it should be assessed by
the doctor. Specific dosage recommendations cannot be
g