Rozex

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

METRONIDAZOLE

から入手可能:

Galderma International Tour Europlaza - 20 Avenue Andre Prothin, La Defense 4, 92 927 Paris La Defense Cedex, France

ATCコード:

D06BX01

INN（国際名）:

METRONIDAZOLE 0.75 % (W/W)

医薬品形態:

GEL

構図:

METRONIDAZOLE 0.75 % (W/W)

処方タイプ:

POM

治療領域:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

認証ステータス:

Authorised

承認日:

2007-08-31

情報リーフレット

_REVIEWED, NO CHANGES_
_BY MAJIB REHMAN (15 JUN 2020, 4:45 PM)_

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICAL PRODUCT
Rozex 0.75% w/w Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole 0.75% w/w
Excipients with known effect:
Propylene glycol 30 mg/g
Propyl parahydroxybenzoate (E216) 0.2 mg/g
Methyl parahydroxybenzoate (E218) 0.8 mg/g
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel
Colourless to pale yellow homogeneous gel, which may turn to slightly
brown colour over time.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rozex Gel is indicated in the treatment of inflammatory papules,
pustules and erythema of rosacea
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For topical administration only.
The average period of treatment is three to four months. The
recommended duration of
treatment
should not be exceeded. However, if a clear benefit has been
demonstrated, continued
therapy for a
further three to four months period may be considered by the
prescribing physician
depending on the
severity of the condition. In clinical studies, topical metronidazole
therapy for
rosacea has been
continued for up to 2 years. In the absence of a clear clinical
improvement,
therapy should be stopped.
_Older people_
: The dosage recommended in the elderly is the same as that
recommended in adults.
_Paediatric population_
: Not recommended. Safety and efficacy have not been established.
Method of administration
Rozex Gel should be applied in a thin layer to the affected areas of
the skin twice daily,
morning and
evening. Areas to be treated should be washed with a mild cleanser
before
application. Patients may
use non-comedogenic and non-astringent cosmetics after application
of Rozex Gel.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contact with mucous membranes should be avoided.
Rozex Gel has been reported to cause lacrimation of the eyes,
therefore, contact with the eyes
should
be avoided. If a reaction suggesting local i