Rozex

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Metronidazole 0.75%{relative}

可用日期:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN（国际名称）:

Metronidazole 0.75% w/w

剂量:

0.75% w/w

药物剂型:

Topical cream

组成:

Active: Metronidazole 0.75%{relative} Excipient: Benzyl alcohol Emulsifying wax Glycerol Isopropyl palmitate Lactic acid Purified water Sodium hydroxide Sorbitol

每包单位数:

Tube, aluminium, 5 g

类:

Prescription

处方类型:

Prescription

厂商:

Corden Pharma Bergamo SpA

產品總結:

Package - Contents - Shelf Life: Tube, aluminium, - 5 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 30 g - 36 months from date of manufacture stored at or below 25°C

授权日期:

1997-08-20

资料单张

ROZEX
®
CREAM
_METRONIDAZOLE 0.75%_
CONSUMER MEDICINE INFORMATION
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ROZEX CREAM. Please
read this leaflet
carefully before you start using the cream. It does not contain all
the information available on
this medicine. It does not take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of using ROZEX
CREAM against the benefits it might have for you. If you have concerns
about using this
medicine ask your doctor or pharmacist.
Keep this leaflet with your tube. You may wish to read it again later.
WHAT ROZEX CREAM IS USED FOR
ROZEX CREAM is used for the treatment of inflammatory papules and
pustules of rosacea.
Skin affected by rosacea has one or more of the following features: a
redness that looks like a
blush; pimples; small knobbly lumps on the nose and / or thin red
lines due to enlarged blood
vessels.
The active ingredient in ROZEX CREAM is metronidazole which belongs to
the class of
medicines known as antiprotozoals and antibacterials.
It is not clear how ROZEX CREAM works however it may have
antibacterial and anti-
inflammatory action.
Preparations which are applied to the skin such as ROZEX CREAM can be
used in
combination with other oral medications prescribed by your doctor.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ROZEX CREAM HAS
BEEN
PRESCRIBED FOR YOU. Your doctor may have prescribed it for another
reason.
BEFORE YOU USE ROZEX CREAM
_WHEN YOU MUST NOT USE IT _
_ _
Do not use ROZEX CREAM:
•
if you have an allergy to metronidazole or any of the inactive
ingredients in the cream
•
if you have or ever have had a blood disorder
•
to treat your child’s skin problem. ROZEX CREAM has not been studied
for use in
children.
•
if you are pregnant. There are no well controlled studies of therapy
with ROZEX
CREAM in pregnant women.
Symptoms of an allergic reaction may include:
•
swelling of the face, lips, tongue or other parts of the body
•

产品特点

NEW ZEALAND DATASHEET
1 PRODUCT NAME
ROZEX
®
CREAM
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole 7.5 mg/g
3 PHARMACEUTICAL FORM
Contains 0.75% w/w metronidazole as the active ingredient in an
oil-in-water cream base
containing
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
ROZEX CREAM is indicated for the treatment inflammatory papules and
pustules of rosacea.
4.2 Dosage and method of administration
ROZEX CREAM 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 CREAM. The dosage does not need to be adjusted
for elderly
patients. Safety and effectiveness in paediatric patients have not
been established. ROZEX
is not recommended for use in children.
The average period of treatment is three to four months. The
recommended duration of
treatment should not be exceeded.
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 upon the severity of the condition. Clinical
experience with ROZEX
CREAM over prolonged periods is limited at present. Patients should be
monitored to ensure
that clinical benefit continues and that no local or systemic events
occur. In the absence of a
clear clinical improvement therapy should be stopped.
ROZEX CREAM should not be used in or close to the eyes.
The use of a sunscreen is recommended when exposure to sunlight cannot
be avoided.
4.3 Contraindications
Contraindicated in individuals with a history of hypersensitivity to
metronidazole or other
ingredients of the formulation.
4.4 Special warnings and precautions for use
ROZEX CREAM has been reported to irritate the eyes (watering),
therefore contact with the
eyes should be avoided, as well as with mucous membranes. If a
reaction suggesting local
irritation
occurs,
patients
should
be
directed
to
use
the
medica