Fungilin

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Amphotericin B 10mg (Overage of 20% (12mg))

Dostupné z:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Medzinárodný Name):

Amphotericin B 10 mg (Overage of 20% (12mg))

Dávkovanie:

10 mg

Forma lieku:

Lozenge

Zloženie:

Active: Amphotericin B 10mg (Overage of 20% (12mg)) Excipient: Acacia Curacao flavour 50397 AP0500 Mannitol Orange flavour Orange flavour 051226T Polyvinyl alcohol Purified talc Saccharin sodium Sodium cyclamate Stearic acid

Počet v balení:

Bottle, glass, Amber, 20 lozenges

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

ACS Dobfar SpA

Terapeutické indikácie:

For the treatment of candidal lesions (thrush) of the oral and perioral areas.

Prehľad produktov:

Package - Contents - Shelf Life: Bottle, glass, Amber - 20 lozenges - 18 months from date of manufacture stored at or below 25°C

Dátum Autorizácia:

1969-02-18

Príbalový leták

NEW ZEALAND CONSUMER MEDICINE INFORMATION  

FUNGILIN
®
 LOZENGES 
_Amphotericin B, 10 mg/Lozenge _ 
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.  Some  of  the  information  contained  in  this  leaflet  may  not 
apply to you.  
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  (manufacturer=s  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  Defic

Súhrn charakteristických

NEW ZEALAND DATA SHEET
1.
FUNGILIN (AMPHOTERICIN B) 10MG LOZENGES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION Fungilin (amphotericin B lozenge) contains 10mg of amphotericin.
Fungilin (Amphotericin B lozenges) is an antifungal polyene macrolide
antibiotic obtained from Streptomyces nodosus.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenge: 10mg; round, pale, yellow.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTICAL INDICATIONS
Lozenge:
For the treatment of candidal lesions (thrush) of the oral and
perioral areas.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULT DOSAGE:
LOZENGES:
Dissolve 1 slowly in the mouth four times a day. Depending on the
severity of
infection, the dose may be increased to 8 lozenges daily.
To clear the condition fully may require 10-15 days' treatment.
Administration of Fungilin for oral and intestinal candidosis should
be
continued for 48 hours after clinical cure to prevent relapse.
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.
ELDERLY:
No specific dosage recommendations or precautions.
4.3 CONTRAINDICATIONS
FUNGILIN is contraindicated in patients with a history of
hypersensitivity to
amphotericin B or any other component of the FUNGILIN formulation.
Orally
administered amphotericin B is not to be used for the treatment of
systemic
fungal infections.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
No data available.
4.5 INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION
No data available.
4.6 FERTILITY, PREGNANCY AND LACTATION
FERTILITY:
No data available
PREGNANCY:
Category B3
There are no adequate and well-controlled studies in pregnant women.
Oral
forms of amphotericin B should be used during pregnancy only if the
potential
benefit justifies the potential risk to the foetus.
LACTATION:
It is not known whether amphotericin B is excreted in human milk.
Though
gastrointestin