Ultraproct ointment rectal

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

fluocortolone pivalate, fluocortolone hexanoate, cinchocaine (cinchocaine hydrochloride)

Disponible depuis:

Bayer Healthcare Manufacturing S.r.l.

Code ATC:

C05AX03

DCI (Dénomination commune internationale):

fluocortolone pivalate, fluocortolone hexanoate, cinchocaine (cinchocaine hydrochloride)

Dosage:

0.918mg/g+ 0,945mg/g+ 5mg/g

forme pharmaceutique:

ointment rectal

Unités en paquet:

30g aluminium tube

Type d'ordonnance:

OTC

Statut de autorisation:

Registered

Date de l'autorisation:

2018-07-31

Résumé des caractéristiques du produit

Page 1 of 4
Summary of Product Characteristics
Ultraproct, ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ULTRAPROCT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains:
fluocortolone pivalate
0.918 mg
fluocortolone caproate
0.945 mg
cinchocaine hydrochloride
5.0 mg
3.
PHARMACEUTICAL FORM
Ointment
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
■
Hemorrhoids, superficial anal fissures, proctitis.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
The anal region should be cleaned thoroughly before using Ultraproct,
which is
best applied after defecation. There is usually a rapid improvement,
but this should
not mislead one into stopping treatment too soon. To avoid relapses,
Ultraproct
should be continued for at least one week, though less frequently
(once a day),
even when the symptoms have completely disappeared. However, duration
of
treatment should, as far as possible, not exceed 4 weeks.
Generally, Ultraproct ointment is applied twice daily, on the first
day for faster
symptomatic relief, up to four times. A little ointment (about the
size of a pea) is
smeared around the anus and in the anal ring with a finger, using the
fingertip to
overcome the resistance of the sphincter. Before applying within the
rectum, the
enclosed nozzle should be screwed on to the tube. However, for very
inflamed and
hence painful lesions, it is advisable initially to apply the ointment
internally with
the finger. Protruding lumps should be smeared thickly and pressed
carefully back
with the finger.
Pediatric population: not recommended due to lack of clinical data.
_4.3 _
_CONTRAINDICATIONS _
Tuberculous or syphilitic processes in the area to be treated; virus
diseases (e.g.
vaccinia, chickenpox); hypersensitivity to any of components.
_4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
Additional specific therapy is required in fungal infections.
Inadvertent contact of the preparation with the eyes should be
avoided. Careful
handwashing after use is recommended.
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