ULTRAPROCT N

Država: Indonezija

Jezik: indonezijščina

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

Prenos Lastnosti izdelka (SPC)
04-03-2022

Aktivna sestavina:

FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE

Dostopno od:

TUNGGAL IDAMAN ABDI - Indonesia

INN (mednarodno ime):

FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE

Odmerek:

1 MG /20 MG

Farmacevtska oblika:

KRIM

Enote v paketu:

DUS, 1 TUBE @ 10 GRAM

Izdeluje:

LEO PHARMA MANUFACTURING ITALY S.R.L - Italy

Datum dovoljenje:

2020-12-23

Lastnosti izdelka

                                Important information, please read carefully!
COMPOSITION
1 g cream contains 1 mg fluocortolone pivalate and
20 mg Lidocaine hydrochloride.
PHARMACODYNAMIC PROPERTIES
Ultraproct® 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 haemorr-
hoids. The preparation is, however, suitable for
treatment in preparation for haemorrhoidectomy or
haemorrhoidolysis and for post operative treatment.
Combined treatment with Ultraproct® N is recom-
mended 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, the cream should be applied twice a day,
morning and evening, or even 3 times a day for the
first few days of treatment. One application a day is
often sufficient once the condition has improved.
Smear a little cream (about the size of a pea) around
the anus and in the anal ring with a finger, using the
fingertip to overcome the resistance of the sphincter.
If the cream is to be used within the rectum, the
enclosed applicator should be screwed onto the
tube and inserted through the anus. A small amount
of cream can then be applied in the rectum by
squeezing the tube lightly.
However, for very inflamed and hence painful lesions,
it is advisable initially to apply the cream internally
with the finger. Protruding lumps should be smeared
thickly and pressed carefully back with the finger.
_OVERDOSE_
According to results from acute toxicity studies with
the ac
                                
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