Travocort cream for external use

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

isoconazole (isoconazole nitrate), diflucortolone (diflucortolone valerate)

Prieinama:

Bayer Healthcare Manufacturing S.r.l.

ATC kodas:

առկա չէ (D07XC)

INN (Tarptautinis Pavadinimas):

isoconazole (isoconazole nitrate), diflucortolone (diflucortolone valerate)

Dozė:

10mg/g+ 1mg/g

Vaisto forma:

cream for external use

Vienetai pakuotėje:

15g aluminium tube

Recepto tipas:

Prescription

Autorizacija statusas:

Registered

Leidimo data:

2019-01-31

Prekės savybės

Page 1 of 5
Summary of Product Characteristics
Travocort 0.1% + 1% cream
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Travocort
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of Travocort cream contains:
Isoconazole nitrate
10 mg (1%)
Diflucortolone valerate
1 mg (0.1%)
3.
PHARMACEUTICAL FORM
Cream
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Superficial
fungal
infections
of
the
skin
which
are
accompanied
by
highly
inflammatory or eczematous skin conditions:
- ringworm of the body including interdigital spaces and genital
regions localization,
- skin candidamycosis
- pityriasis versicolor.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Unless otherwise prescribed by your physician, Travocort should be
applied twice a
day. Maximum length of treatment is 2 weeks.
After regression of the inflammatory skin condition, the therapy
followed up with the
corticoid-free preparation.
_Paediatric population _
Only limited data is available on the safety and efficacy of Travocort
in children under
12 years of age. The safety and efficacy in children under 2 years of
age have not yet
been established.
_4.3 _
_CONTRAINDICATIONS _
Hypersensitivity to the active substance or to any of the excipients.
Presence of tubercular, syphilitic or viral lesions (chicken pox,
shingles), rosacea,
perioral dermatitis and skin reactions to vaccinations in the area to
be treated.
_4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
It is advisable to associate a specific additional treatment when
treating mixed
infections caused by gram-negative bacteria.
When applying the preparation to the face, it should not come into
contact with the
eyes.
Page 2 of 5
Summary of Product Characteristics
Travocort 0.1% + 1% cream
The use of topical glucocorticoids on large areas of the body, or for
prolonged
periods of time, particularly under occlusive bandages, can increase
the risk of
systemic unwanted effects.
As is known for systemic glucocorticoids, glaucoma can appear with the
use of
topical
glucocorticoids
(for
exam