Ultraproct suppositories 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:

0,612mg+ 0,63mg+ 1mg

forme pharmaceutique:

suppositories rectal

Unités en paquet:

(10/2x5/)

Type d'ordonnance:

Prescription

Statut de autorisation:

Registered

Date de l'autorisation:

2019-07-02

Résumé des caractéristiques du produit

Page 1 of 4
Summary of Product Characteristics
Ultraproct, suppository
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ULTRAPROCT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One suppository contains:
fluocortolone pivalate
0.612 mg
fluocortolone caproate
0.630 mg
cinchocaine hydrochloride
1.0 mg
3.
PHARMACEUTICAL FORM
Suppository
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. In general, one suppository daily is
inserted high into
the rectum.
After the symptoms have completely disappeared, treatment should be
continued for a
further week, using 1 suppository every 2 days
However, duration of treatment should,
as far as possible, not exceed 4 weeks.
The consistency of suppositories that have become soft due to warmth
should be
restored by placing them in cold water before the covering is removed.
_Pediatric population:_ not recommended due to lack of clinical data.
The product
must only be administered to infants in case of effective necessity
and under direct
medical supervision.
_4.3 _
_CONTRAINDICATIONS _
Hypersensitivity to the active substances, especially cinchocaine, or
to any of the
excipients.
Tubercular and syphilitic processes in the region to be treated,
smallpox, chicken
pox, vaccination pustules.
_4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
If fungi are present in the zone to be treated, topical antimycotics
should be used.
The
use
of
topical
products,
especially
for
prolonged
periods,
can
cause
sensitization phenomena.
In this case treatment must be interrupted and suitable treatment
started.
If topical products are applied to large surface areas, to damaged
skin, or in the
presence of occlusive bandages, corticosteroids can be absorbed in
quantities that
can cause unwanted systemic effects.
Avoid contact with the eyes. Wash your hands thoroughly after a