DAKTARIN ORAL GEL

Country: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

MICONAZOLE

Доступно од:

J-C HEALTH CARE LTD

АТЦ код:

A01AB09

Фармацеутски облик:

GEL

Састав:

MICONAZOLE 20 MG/G

Пут администрације:

LOCAL ORAL

Тип рецептора:

Not required

Произведен од:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Терапеутска група:

MICONAZOLE

Терапеутска област:

MICONAZOLE

Терапеутске индикације:

Oral mycosis (thrush) and fungal infections of the upper gastrointestinal tract. Daktarin oral gel can be used for the prevention of oral thrush in patient receiving long-term treatment with antibiotics, steroids, cytotoxic and radiation therapy.

Датум одобрења:

2017-06-30

Информативни летак

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed
without a doctor’s prescription
PRODUCT NAME AND ITS FORM
DAKTARIN® ORAL GEL
Active ingredient and its concentration:
Miconazole 20 mg/g
Inactive ingredients and allergens in the product -
see section 6 “Further
Information”.
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.
The medicine is not intended for infants below the age of 6 months or
for infants whose
swallowing reflex is not sufficiently developed, due to the risk of
choking.
Use it properly. Consult a pharmacist if you need further information.
Refer to the doctor if the
signs of the disease (symptoms) worsen or do not improve.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For the treatment and prevention of oral mycosis and fungal infections
of the upper
gastrointestinal tract (throat, esophagus, stomach, intestines).
THERAPEUTIC GROUP: Antifungal, of the imidazole derivatives.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
- you are sensitive (allergic) to miconazole, to similar antifungals
or to any of the additional
ingredients contained in the medicine. For the list of additional
ingredients, see section 6
“Further
Information”.
- you are suffering from any liver disease.
- in infants below the age of 6 months or in infants whose swallowing
reflex is not sufficiently
developed, due to the risk of choking.
- you are taking any of the following medicines:
- terfenadine, astemizole and mizolastine (medicines for hay fever or
allergy).
- cisapride (a medicine used to treat certain digestive problems).
- cholesterol-lowering medicines, such as simvastatin and lovastatin.
- midazolam (taken by mouth) and triazolam (medicines used to treat
anxiety and sleep
disorders).
- pimozide and sertindole (medicines used to treat psychotic
disorders).
- quinidine and dofetilide (medic

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DAKTARIN ORAL GEL
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Daktarin Oral Gel contains 20 mg of miconazole.
Excipients with known effect:
Alcohol 7.85 mg per g, orange flavour (containing: citral,
citronellol, d-limonene,
geraniol, linalool) and cocoa flavour (containing: 0.00000000138 mg
benzyl benzoate
and 0.0000000023 mg of benzyl alcohol in each gram).
For full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Oral gel.
White gel with orange taste.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral mycosis (thrush) and fungal infections of the upper
gastrointestinal tract.
Daktarin Oral Gel can be used for the prevention of oral thrush in
patients receiving long-term
treatment with antibiotics, steroids, cytotoxic and radiation therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
1 measuring spoon (provided) is equivalent to 124 mg miconazole per 5
mL gel.
_Oropharyngeal candidosis _
Infants: 6-24 months: 1.25 mL (1/4 measuring spoon) of gel, applied
four times a day after meals.
Each dose should be divided into smaller portions and the gel should
be applied to the affected
area(s) with a clean finger. The gel should NOT be applied to the back
of the throat due to possible
choking. The gel should not be swallowed immediately, but kept in the
mouth as long as possible.
Adults and children 2 years of age and older: 2.5 mL (1/2 measuring
spoon) of gel, applied four
times a day after meals. The gel should not be swallowed immediately,
but kept in the mouth as
long as possible.
The treatment should be continued for at least a week after the
symptoms have disappeared.
For oral candidosis, dental prostheses should be removed at night and
brushed with the gel.
_Gastrointestinal tract candidosis _
The gel may be used for infants (≥ 6 months of age), children, and
adults who have difficult
y
swallowing tablets.
The dosage is 20 mg per kg body weight per day, administered in 4
divided doses. The daily
dose sho