FUNGILIN amphotericin B (amphotericin) 10 mg lozenge bottle

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

amphotericin B, Quantity: 10 mg

Pieejams no:

Aspen Pharma Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

amphotericin B (amphotericin)

Zāļu forma:

Lozenge

Kompozīcija:

Excipient Ingredients: Acacia; mannitol; polyvinyl alcohol; saccharin sodium; sodium cyclamate; purified talc; stearic acid; Flavour

Ievadīšanas:

Buccal

Vienības iepakojumā:

20 Lozenges

Klase:

Medicine Registered

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Treatment of candidal infections of the oral and perioral areas including oral thrush, angular cheilitis, denture stomatitis and in other conditions of the mouth, throat and tongue complicated by the overgrowth of Candida albicans.

Produktu pārskats:

Visual Identification: Yellow, flat-faced, bevel-edged, disc-shaped lozenge. Odour of orange; Container Type: Bottle; Container Material: Glass; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Autorizācija statuss:

Registered

Autorizācija datums:

1991-09-30

Lietošanas instrukcija

FUNGILIN- Consumer Medicine Information
Page 1 of 3
FUNGILIN LOZENGES
_ _
_Amphotericin B (amphotericin) _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking Fungilin Lozenges. This
leaflet answers some common
questions about Fungilin.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Fungilin against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
ALWAYS FOLLOW THE INSTRUCTIONS
THAT YOUR DOCTOR OR PHARMACIST
GIVES YOU ABOUT FUNGILIN
LOZENGES.
Keep this leaflet with the
medicine. You may need to read
it again.
WHAT FUNGILIN IS USED
FOR
Fungilin is a trade name for the
antifungal medicine, Amphotericin
B. Fungilin Lozenges are used
to treat infections in or around the
mouth, throat or tongue caused
by yeast-like fungi called
_Candida_. This condition is
known as oral candidiasis or
thrush. _Candida albicans _is the
most common cause of thrush.
_C. albicans_ is present in the gut
of both men and women, and
often in women’s vaginas without
causing problems. When
conditions are suitable for its
growth, _C. albicans_ will multiply
and cause infection.
A number of different conditions
provide favourable growth
conditions for Candida, such as
Acquired Immune Deficiency
Syndrome (AIDS), diabetes,
treatment with some antibiotic or
cortisone medicines, or treatment
for cancer.
Fungilin is not expected to affect
your ability to drive a car or
operate machinery. Fungilin
Lozenges are tolerated well by all
age groups.
Your doctor may have prescribed
Fungilin for another reason. Ask
your doctor if you have any
questions about why Fungilin has
been prescribed for you.
BEFORE YOU TAKE
FUNGILIN
It is important that you check the
information below before you take
Fungilin Lozenges.
_ _
_ _
_WHEN YOU MUST NOT TAKE _
_THEM _
Do not take Fungi

Produkta apraksts

Fungilin- Product Information
Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION
FUNGILIN AMPHOTERICIN B (AMPHOTERICIN) LOZENGE
1
NAME OF THE MEDICINE
Amphotericin B (amphotericin)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FUNGILIN Oral lozenges contains 10 milligrams of amphotericin B
(amphotericin).
Amphotericin is a mixture of macrolide – antifungal polyenes
produced by the growth
of certain strains of Streptomyces nodosus. It consists largely of
amphotericin B
(amphotericin).
For the full list of excipients, see 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FUNGILIN
10
mg
Oral
lozenges
are
yellow,
flat-faced,
bevel-edged,
disc-shaped
lozenge.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of candidal infections of the oral and perioral areas
including oral thrush,
angular cheilitis, denture stomatitis and in other conditions of the
mouth, throat and
tongue complicated by the overgrowth of Candida albicans.
4.2
DOSE AND METHOD OF ADMINISTRATION
One (1) lozenge should be sucked and allowed to dissolve slowly in the
mouth four
times a day for a duration of 7 to 14 days. The lozenges should be
taken after meals and
at bedtime. Patients wearing dentures should be especially careful to
cleanse them
thoroughly and to remove them while sucking the lozenge to allow the
active material
to reach all tissues.
Fungilin- Product Information
Page 2 of 7
4.3
CONTRAINDICATIONS
FUNGILIN is contra-indicated in patients with a history of
hypersensitivity to
amphotericin
B
(amphotericin)
or
any
other
component
of
the
FUNGILIN
formulation.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Orally administered amphotericin B (amphotericin) is not to be used
for the treatment
of systemic fungal infections.
HYPERSENSITIVITY
Hypersentivity reactions to the FUNGILIN amphotericin B
(amphotericin)) lozenge are
rare, but should sensitivity develop, treatment should be
discontinued. Treatment
with Fungilin lozenges should not be attempted in those individuals
who have shown
hypersensitivity to any of its components.
USE IN THE ELDERLY
N