ULTRAPROCT N

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

active_ingredient:

FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE

MAH:

TUNGGAL IDAMAN ABDI - Indonesia

INN:

FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE

dosage:

1 MG /40 MG

pharmaceutical_form:

SUPPOSITORIA

units_in_package:

DUS,1 STRIP @ 6 SUPPOSITORIA

manufactured_by:

LEO PHARMA MANUFACTURING ITALY S.R.L - Italy

authorization_date:

2020-12-23

SPC

ULTRAPROCT
®
N
Suppository
Fluocortolone Pivalate + Lidocaine Hydrochloride
FOR THE TREATMENT OF INFLAMMATORY ANAL AFFECTIONS
Important information, please read carefully!
COMPOSITION
1 suppository contains 1 mg fluocortolone pivalate,
40 mg Lidocaine hydrochloride.
PHARMACODYNAMIC PROPERTIES
Ultrproct N is intended for the local treatment of
inflammatory processes in the lower part of the rectum
and around the anus caused primarily by haemorrhoids.
The cream is also suitable for the treatment of anal eczemas.
Ultraproct® N alleviates the pain and itching and leads to
the regression of inflammatory symptoms in the region
being treated.
Ultraproct® N cannot eliminate the cause of haemorrhoids.
The preparation is, however, suitable for treatment in
preparation for haemorrhoidectomy or haemorrhoidolysis
and for post operative treatment.
Combined treatment with Ultraproct® N is recommended
in cases in which haemorrhoidal complaints are
accompanied by inflammation and eczema.
INDICATIONS
Haemorrhoids, proctitis, superficial anal fissures, anal
eczema, pre-and post operative treatment.
DOSAGE AND ADMINISTRATION
The anal region should be cleaned thoroughly before using
Ultraproct® N, which is best applied after defecation.
Duration of treatment should not exceed 4 weeks.
In general, one suppository should be inserted deep into
the anus twice daily, morning and evening, but 3 times
daily in the first three days if the complaints are severe.
With increasing improvement, just one suppository per
day or every second day is sufficient in many cases.
OVERDOSE
According to results from acute toxicity studies with the
active substances contained in Ultraproct® N no acute risk
of intoxication is to be expected following a single rectal
or perianal administration of Ultraproct® N even in the case
of inadvertent overdose. If the preparation is accidentally
taken in orally (e.g. a few grams of cream or more than one
suppository is swallowed), the main effects to be expected
are systemic effects of the lidocaine hydrochloride