Organic Nature Royal Jelly 2% 1000

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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下载 资料单张 (PIL)
24-08-2020
下载 产品特点 (SPC)
24-08-2020
下载 公众评估报告 (PAR)
25-05-2019
下载 公众评估报告 (PAR)
22-11-2017

有效成分:

Royal jelly

可用日期:

H C L Manufacturers Pty Ltd

INN(国际名称):

Royal jelly

类:

Medicine Listed

授权状态:

Listed

资料单张

                                GRISOVIN- Consumer Medicine Information
Page 1 of 4
GRISOVIN
_ _
_griseofulvin _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
GRISOVIN.
It does not contain all the
available information.
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 treating you
with GRISOVIN against the
benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read
it again.
WHAT IS GRISOVIN
The name of your medicine is
GRISOVIN.
GRISOVIN contains the
antifungal griseofulvin.
_ _
This medicine is available in two
strengths: Grisovin
_ _
125 mg
uncoated tablets and Grisovin 500
mg uncoated tablets.
WHAT IS IT USED FOR
GRISOVIN is used to treat tinea,
a fungal infection.
It is only used when other
antifungal treatments, such as
tinea creams or powders, have not
worked.
GRISOVIN will not work for
bacterial or viral infections.
Tinea may occur in the skin of the
body, scalp, hair or nails.
GRISOVIN works by helping
newly formed skin, hair and nails
to resist attack by fungi. As the
new tissue (keratin) grows, the
old infected keratin is cast off.
That is why it is important to
continue treatment until all the
old infected tissue is gone.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY QUESTIONS ABOUT
WHY GRISOVIN HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE IT
_ _
Before taking GRISOVIN, you
must tell your doctor if you:
•
have ever had an allergic
reaction to any of the
ingredients listed at the end of
this leaflet
•
are or may become pregnant
•
are breast-feeding
•
planning to father a child
•
are on a low fat diet
•
have any other health
problems, especially liver
disease, lupus (systemic lupus
erythematosis) or porphyria (a
blood disease)
GRISOVIN may reduce the
effectiveness of oral
contraceptives. Ex
                                
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                                GRISOVIN- Product Information
Page 1 of 8
AUSTRALIAN PRODUCT INFORMATION GRISOVIN
(GRISEOFULVIN)
1. NAME OF THE MEDICINE
Griseofulvin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
GRISOVIN “500” TABLETS contain 500 mg of griseofulvin B.P (fine
particle). Grisovin “500”
tablets also contain microcrystalline cellulose, potato starch,
povidone, sodium lauryl sulfate,
maize starch, magnesium stearate
GRISOVIN UNCOATED TABLETS contain 125 mg of griseofulvin B.P. (fine
particle). Grisovin
uncoated tablets contain potato starch, povidone, sodium lauryl
sulfate, maize starch and
magnesium stearate.
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Grisovin “500”: round, white to off white, biconvex, uncoated
tablets engraved with “G500”
on one side and on the other.
Grisovin “125: Tablets: round, white to off white, bevel edged
tablets engraved with a
breakline on one side and “G125” on the other.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Griseofulvin is indicated in the treatment of fungal infections of the
skin, scalp, hair or nails,
where topical therapy is considered inappropriate or has failed.
When griseofulvin is given orally for systemic treatment of fungal
infections, it enables newly
formed keratin of the skin, hair and nails to resist attack by the
fungi. As the new keratin
extends, the old infected keratin is shed.
4.2. DOSE AND METHOD OF ADMINISTRATION
_Adults_: The usual recommended dosage is 500 mg per day. However, in
certain infections
higher doses are necessary. For nail infections some patients may
require up to 1000 mg daily
until a response is apparent, at which time the dose may be reduced to
500 mg per day.
_Children_: The usual dose for children is 10 mg/kg body weight daily,
in divided doses.
ATTACHMENT 2B.
GRISOVIN- Product Information
Page 2 of 8
Doses should be taken after meals otherwise absorption is likely to be
inadequate. Absorption
is increased when Grisovin is taken with a high-fat meal.
_ _
_Duration of Treatment _
                                
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