Daktarin

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Miconazole 20 mg/g;  

Tillgänglig från:

JNTL Consumer Health (New Zealand) Limited

INN (International namn):

Miconazole 20 mg/g

Dos:

2% w/w

Läkemedelsform:

Oral gel

Sammansättning:

Active: Miconazole 20 mg/g   Excipient: Ethanol Cocoa Glycerol Orange flavour Polysorbate 20 Potato starch Purified water Saccharin sodium

Enheter i paketet:

Tube, aluminium, 15g, 15 g

Klass:

Restricted

Receptbelagda typ:

Restricted

Tillverkad av:

Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)

Terapeutiska indikationer:

DAKTARIN oral gel is indicated for the treatment of clinically significant oral and gastrointestinal candidiasis.

Produktsammanfattning:

Package - Contents - Shelf Life: Tube, aluminium, - 15 g - 36 months from date of manufacture stored at or below 30°C - Tube, aluminium, - 30 g - 36 months from date of manufacture stored at or below 30°C - Tube, aluminium, - 40 g - 36 months from date of manufacture stored at or below 30°C

Tillstånd datum:

1980-11-27

Bipacksedel

CONSUMER MEDICINE INFORMATION 
DAKTARIN
®  
MICONAZOLE 
20 mg/g Oral Gel 

WHAT IS IN THIS LEAFLET 
This leaflet answers some of the common questions about DAKTARIN
Oral Gel. It does not 
contain all of the available information. It does not take the
place of talking to your doctor or 
pharmacist. 
If you have any concerns about using DAKTARIN Oral Gel, ask your
doctor or pharmacist.  
Your doctor and pharmacist have more information. 
Keep this leaflet with your DAKTARIN Oral Gel. You may need to read
it again. 
WHAT DAKTARIN ORAL GEL IS USED FOR 
DAKTARIN Oral Gel is used to treat infections of the mouth and
throat (e.g. thrush). 
DAKTARIN Oral Gel is an antifungal.  These medicines work by
treating infections caused by 
fungi, including yeast. 
Your doctor may have prescribed DAKTARIN Oral Gel for another
reason.  Ask your doctor if 
you have any questions about why this medicine has been prescribed
for you. 
BEFORE YOU USE DAKTARIN ORAL GEL 
_WHEN YOU MUST NOT USE IT _
Do not use DAKTARIN Oral Gel if you know you are allergic to any of
the ingredients. (See 
the last section of this leaflet for a list of ingredients). Signs of
allergy include a skin rash, 
itching, shortness of breath and/or a swollen face, lips, tongue
or other parts of the body. 
Do not use DAKTARIN Oral Gel if you have liver disease.  DAKTARIN
Oral Gel could make 
the symptoms of your liver disease worse. 
Do not give DAKTARIN Oral Gel to an infant below the age of 6 months.
 The safety of this 
medicine in infants under 6 months of age has not been established. 
Do not use DAKTARIN Oral Gel if the packaging is torn or shows signs
of tampering.  Do not 
use DAKTARIN Oral Gel beyond the expiry date (month and year)
printed on the pack. 
Do not use DAKTARIN Oral Gel if you are taking any of the
following medicines because it 
may affect the way these medicines work: 
•  cisapride (used for digestive problems) 
•  simvastatin or lovastatin (used to low

Produktens egenskaper

DATA SHEET
1. PRODUCT NAME
DAKTARIN® Oral Gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 20 mg of miconazole. The other ingredients are
glycerol, purified water,
pregelatinised potato starch, ethanol, polysorbate 20, sodium
saccharin, orange flavour, and cocoa
flavour. For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
A white, homogenous, orange-flavoured oral gel.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DAKTARIN® oral gel is indicated for the treatment of clinically
significant oral and gastrointestinal
candidiasis.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose:
Infants: For infants 6-24 months, one quarter (
1
/
4
)
of a measuring spoon* of gel four times daily, or
20 mg/kg/day is recommended.
Children (2 years of age and older) and Adults: Half (
1
/
2
)
a measuring spoon* of gel four times
daily.
*
A measuring spoon (5 mL) is provided with the gel. One spoonful
contains approximately
124 mg of miconazole. All spoonful dose volumes should be administered
with this spoon.
Method of administration:
DAKTARIN® oral gel should be placed on the tongue and kept in mouth
for as long as possible
before swallowing. When treating infants and younger children it is
recommended that the
measured dose of gel be given in several portions in the front of the
mouth. Avoid dosing to the
back of the throat to prevent obstruction. With oral thrush in elderly
patients where a contributing
cause is the dental prosthesis it is recommended that DAKTARIN® oral
gel be applied directly to
the dentures in the evening and left on overnight. The treatment
should be continued for at least
one week after the symptoms have disappeared and generally until all
clinical and mycological
laboratory tests no longer indicate that active fungal infection is
present.
4.3 CONTRAINDICATIONS
DAKTARIN® Oral Gel is contraindicated in the following situations:
•
In patients with a known hypersensitivity to miconazole or to any of
the other ingredients of
the gel or other imidazole derivatives.
•
In in