DAKTARIN ORAL GEL 2%

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

MICONAZOLE NITRATE

Disponibil de la:

JNTL (MALAYSIA) SDN. BHD.

INN (nume internaţional):

MICONAZOLE NITRATE

Unități în pachet:

15gm mcg/mL; 30 gm mcg/mL

Produs de:

JANSSEN PHARMACEUTICA N.V.

Prospect

DAKTARIN
® ORAL GEL
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Miconazole Nitrate (20mg)
WHAT IS IN THIS LEAFLET
1.
What DAKTARIN
®
Oral Gel is
used for
2.
How DAKTARIN
®
Oral Gel works
3.
Before you use DAKTARIN
®
Oral
Gel
4.
How to use DAKTARIN
®
Oral Gel
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DAKTARIN
®
Oral Gel
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DAKTARIN
® ORAL GEL IS USED
FOR
DAKTARIN
®
Oral Gel is used to treat
fungal infections of the mouth, throat,
stomach or intestines in adults and
children 4 months and older. For a child
between 4 and 6 months of age, be sure
they do not have any swallowing
problems before treating them with the
oral gel.
HOW DAKTARIN
® ORAL GEL WORKS
Miconazole nitrate - an antifungal which
works by destroying both the fungus that
causes the infection and some of the
associated bacteria which may also be
present.
BEFORE YOU USE DAKTARIN
® ORAL GEL
-
_When you must not use it _
•
Infants less than 4 months of age or
infants less than 5-6 months of age if
the infant is pre-term or has problems
swallowing due to risk of choking;
•
If you have any kind of liver disease;
•
If you are allergic to miconazole or to
any of the other ingredients it contains;
•
If you are taking certain medicine(s)
such as:
o
Allergy, namely terfenadine,
astemizole and mizolastine;
o
Cisapride, a medicine used for
certain digestive problems;
o
Certain medicines that lower your
cholesterol, for example
simvastatin and lovastatin;
o
Midazolam (by mouth) and
triazolam, medicines that are taken
for anxiety or to help you sleep
(tranquilizers);
o
Pimozide and sertindole, medicines
for certain psychiatric disorders;
o
Halofantrine, an antimalaria
medicine;
o
Certain medicines used in the
treatment of migraine, such as ergot
alkaloids (Cafergot
®
);
o
Certain medicines used to treat
irregular heartbeat, namely bepridil,
quinidine, and dofetilide.
Do not use DAKTARIN
®
Oral Gel if you
are on warfarin t

Caracteristicilor produsului

PRODUCT NAME
DAKTARIN ® ORAL GEL
DOSAGE FORM AND STRE NGTHS
W hite, homogeneous gel for oral use. Each gram contains 20 mg of miconazole.
For excipients, see List of Excipients.
CLINICAL INFORMATION
Indications
Treatment of candidosis of the oropharynge al cavity and the gastrointestinal tract
in adults and pediatric patients 6 months and older (see Contraindications and
Warnings and Precautions ).
Dosage and Administration
Oropharyngeal candidosis
Infants: 6 -24 months: 1.25 mL (1/4 teaspoon ) of gel, appl ied four times a day after
meals . Each dose is to be divided into smaller portions and the gel applied to the
affected area(s) with a clean finger . The gel is not to 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 teaspoon ) of gel,
applied four times a day after meals . The gel is not to be swallowed immediately,
but kept in the mouth as long as possible.
Continue t he treatment for at least a week after the symptoms have disappe ared.
For oral candidosis, dental prostheses are to 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 difficulty swallowing tablets. The dosa ge is 20 mg per kg body weight per
day, administered in 4 divided doses. The daily dose should not exceed 250 mg
(10 mL Oral Gel) four times a day.
Continue t he treatment for at least a week after the symptoms have disappeared.
Contraindications
DAKTARIN ® Oral Gel is contraindicated in the following situations:
• In patients with hypersensitivity to miconazole , another ingredient of the
formulation, or other imidazole derivatives.
• In infants less than 6 months of age or in those whose swallowing reflex is not
yet sufficiently developed .
• In patients with liver dysfunction .
• Use in combination with the following drugs that are subject to metabolism by
CYP3A4: (See Interactions )
o Substrates known to prolong the QT -interval for exam