AGISTEN LOZENGES

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

CLOTRIMAZOLE

Tilgjengelig fra:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC-kode:

A01AB18

Legemiddelform:

LOZENGES

Sammensetning:

CLOTRIMAZOLE 10 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

PADDOCK LABORATORIES, LCC (PERRIGO MINNESOTA), USA

Terapeutisk område:

CLOTRIMAZOLE

Indikasjoner:

For local treatment of oropharyngeal candidiasis.Prophylactic treatment to reduce incidence of oropharyngeal candidiasis in patientsimmunocompromised by:- chemotherapy,- radiotherapy,- steroid therapy in Leukemia,- solid tumors,- renal transplantation.

Autorisasjon dato:

2022-07-31

Informasjon til brukeren

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s
prescription only.
AGISTEN
®
LOZENGES
ACTIVE INGREDIENT AND ITS QUANTITY:
Each lozenge contains Clotrimazole 10 mg
Inactive and allergenic ingredients in the preparation –
see section 6 in the leaflet and section 2
"
Important
information about some of the ingredients of the
medicine
"
. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet contains
concise information about the medicine. If you have
further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if it
seems to you that their medical condition is similar.
THE MEDICINE IS NOT INTENDED FOR CHILDREN UNDER
THE AGE OF 3. You must use the product according to
the instructions in the dosage section in this leaflet.
Consult the pharmacist if you need further information.
Refer to the doctor if signs of the illness (symptoms)
worsen or do not improve after 7 days.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
·
You
are
sensitive
(allergic)
to
the
active
ingredient clotrimazole or to any of the additional
ingredients contained in the medicine.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
·
Agisten
®
lozenges
are
not
intended
for
the
treatment of systemic fungal infection.
·
Do not use this medicine for a prolonged period
without consulting a doctor.
·
The
medicine
may
affect
the
results
of
liver
function tests.
BEFORE TREATMENT WITH AGISTEN
® LOZENGES, TELL THE
DOCTOR IF
·
you are sensitive to any food or medicine.
·
you are pregnant or breastfeeding.
TESTS AND FOLLOW-UP
It is recommended to perform periodic liver function
tests,
particularly
in
patients
with
existing
liver
disease.
DRUG INTERACTIONS:
IF
YOU
ARE
TAKING,
OR
HAVE
RECENTLY
TAKEN,
OTHER
MEDICINES
INCLUDING
NON-PRESCRIPTION
MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL THE
DOCTOR OR PHARMACIST.
PREGNANCY AND BREASTFEEDING
I

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Agisten Lozenges
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
Agisten
Lozenge
contains
10
mg
clotrimazole
[1-(o-chloro-
α
,
α
-diphenylbenzyl)
imidazole], a synthetic antifungal agent, for topical use in the
mouth.
For the full list of excipients, see section 6.1.
Structural Formula:
Chemical Formula: C
22
H
17
ClN
2
3.
PHARMACEUTICAL FORM
For topical oral administration.
The lozenge dosage form is a large, slowly dissolving tablet (troche),
round, flat, bevel-edged
white to off-white compressed lozenge, debossed with PAD 0107.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Agisten Lozenges are indicated for the local
treatment of oropharyngeal candidiasis. The
diagnosis should be confirmed by a KOH smear and/or culture prior to
treatment.
Agisten Lozenges are also indicated prophylactically to reduce the
incidence of oropharyngeal
candidiasis
in
patients
immunocompromised
by
conditions
that
include
chemotherapy,
radiotherapy, or steroid therapy utilized in the treatment of
leukemia, solid tumors, or renal
transplantation.
2
There are no data from adequate and well-controlled trials to
establish the safety and efficacy of this
product for prophylactic use in patients immunocompromised by
etiologies other than those listed
in the previous sentence. (See DOSAGE AND ADMINISTRATION).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Agisten Lozenge must be slowly dissolved in the mouth. The recommended
dose is one lozenge
five times a day for fourteen consecutive days. Only limited data are
available on the safety and
effectiveness of the Agisten Lozenge after prolonged administration;
therefore, therapy should be
limited to short term use, if possible.
For
prophylaxis,
to
reduce
the
incidence
of
oropharyngeal
candidiasis
in
patients
immunocompromised by conditions that include chemotherapy,
radiotherapy, or steroid therapy
utilized in the treatment of leukemia, solid tumors, or renal
transplantation, the recommended dose
is one troche three times d