THD LEVORAG Instruction Manual

TECNICAL SHEET
Intended use
The medical device LEVORAG – EmulGel is used as coadjuvant for the symptomatic and asymptomatic
treatment of anal fissures.
Description
The medical device LEVORAG – EmulGel consists of a gel cream in 3.5ml single-dose tubes with built-in
applicator, each carton contains 20 single-doses.
The device possesses emollient, lubricating, film-forming, soothing and protective properties.
The device creates a film over the anal fissures making it possible to maintain a microenvironment protected
from external microorganisms.
The oily part of the formulation helps to lubricate the area being treated by facilitating the expulsion of faeces
and thus preventing the formation of further microlesions.
The device helps relieve pain upon defecation, prevent the formation of further fissures, and protect the
treated area by creating an environment that is conducive to healing of fissures and non-conductive to
bacterial attachment.
The natural ingredients it contains contribute to a rapid well-being and recovery of optimal physiological
conditions.
It contains no cortisone, anesthetics, fragrance, dyes, or nickel

Instructions for use and dosage
Thoroughly clean the area to be treated; the use of Deliclin disinfecting wipes is recommended.
1Remove the cap on the end of
the applicator ,
1 2
3
2Grip the tube as shown
3 Insert the applicator gently into
the anal orifice, take care not to
fully insert the cannula, and press
the container thoroughly to
dispense the entire contents of the
tube.
A single-dose container is for one application. Apply twice a day, for at least 20 consecutive days, unless otherwise advised by your
doctor, preferably morning and evening, if possible after bowel movements.
Warnings and precautions for use
In the event of adverse reactions, stop treatment and consult your doctor.
Avoid the use of disinfectants because they have a negative effect on the wound healing process.
Currently there is no evidence of any contraindications for the use of any of the components of LEVORAG during pregnancy or
breast-feeding. However, for caution's sake, it is recommended for use under direct supervision of your physician.
Avoid contact with eyes.
Keep out of the reach of children.
If symptoms persist after treatment, please consult your doctor.
Do not use if the original packaging is opened or damaged.
Contraindications
Do not use in the case of known hypersensitivity to any component of the product.
If you experience unexpected reactions stop treatment and consult a doctor.
Do not apply the device to areas treated simultaneously with other ointments or disinfectants. Improper use of the device may result
in delayed tissue repair by preventing the physiological healing process.
It is not recommended for use in patients with:
-Expulsive constipation requiring prolonged straining or manual manoeuvring during evacuation.
- Presence of faecal incontinence.
Storage and expiry date
Store in a cool, dry place, away from heat sources.
The expiry date is stated on the box and on each individual single-dose, do not use the product after the indicated date.
Ingredients
Aqua, dimethicone, glycerin, prunus amygdalus dulcis oil, phenyl trimethicone, borago officinalis seed oil, malva sylvestris extract,
panthenol, dextrin, hydrolyzed hibiscus esculentus extract, phenoxyethanol, glyceryl stearate, cetyl alcohol, PEG-75 stearate,
acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, tocopherol, caprylyl glicol, 1,2-hexanediol, calendula officinalis
extract, maltodextrin, glycyrrhiza glabra extract, ceteth-20, steareth-20, ethylhexylglycerin, sodium carboxymethyl beta-glucan,
trisodium ethylenediamine disuccinate, tropolone, aspartic acid, sodium chloride, sodium bromide
REF. 830011 Pack 20 single dose tubes with integral
applicator MEDICAL DEVICE
THD S.p.A –Via Industria,1 -42015 Correggio (RE) – Italy
Tel. [phone] Fax [phone]
email: [e-mail]
360174 Rev.01-02-2012
www.thdlab.com
Local contact