NIZSHAMPOO

国: 南アフリカ

言語: 英語

ソース: South African Health Products Regulatory Authority (SAHPRA)

から入手可能:

Johnson & Johnson (Pty) Ltd û East London

投薬量:

See ingredients

医薬品形態:

SHAMPOO

構図:

EACH 1,0 g SHAMPOO CONTAINS KETOCONAZOLE 20,0 mg

認証ステータス:

Registered

承認日:

1988-03-11

情報リーフレット

Johnson & Johnson (Pty) Ltd
NIZSHAMPOO® Solution
20 mg/g ketoconazole
DATE OF APPROVAL: 20.10.2021
THIS AMENDMENT: Clinical Variation Resubmission.
DATE OF ORIGINAL SUBMISSION: 03 November 2014
Sign: ______
Page 1 of 7
PROPOSED PATIENT INFORMATION LEAFLET FOR NIZSHAMPOO
®
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S1
NIZSHAMPOO
®
KETOCONAZOLE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
NizShampoo
®
is available without a doctor’s prescription, for you to treat a
mild illness.
Nevertheless, you still need to take NizShampoo
®
carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask you pharmacist if you need more information or advice.

You must see a doctor if your symptoms worsen or do not improve.
WHAT IS IN THIS LEAFLET
1.
What NizShampoo
®
is and what it is used for.
2.
What you need to know before you use NizShampoo
®
.
3.
How to use NizShampoo
®
.
4.
Possible side effects.
5.
How to store NizShampoo
®
.
6.
Contents of the pack and other information.
Johnson & Johnson (Pty) Ltd
NIZSHAMPOO® Solution
20 mg/g ketoconazole
DATE OF APPROVAL: 20.10.2021
THIS AMENDMENT: Clinical Variation Resubmission.
DATE OF ORIGINAL SUBMISSION: 03 November 2014
Sign: ______
Page 2 of 7
1.
WHAT NIZSHAMPOO
® IS AND WHAT IT IS USED FOR
NizShampoo
®
belongs to a group of medicines called antifungals and is used to
treat fungal
infections on your scalp and body, such as:

Dandruff;

dry or greasy scaling of your scalp and body called seborrheic
dermatitis;

white or brown patches on your body that appear after being in the
sun, called pityriasis
versicolor.
These conditions can be itchy and are caused by a fungus called
_Malassezia_. This fungus is
found on everyone’s skin, but sometimes it can overgrow and cause
problems. NizShampoo
®
works by killing the fungus and stopping it from coming back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NIZSHAMPOO
®
DO NOT USE NIZSHAMPOO
®
:
If you are hypersensitive (allergic) t

製品の特徴

Johnson & Johnson (Pty) Ltd
NIZSHAMPOO® Solution
20 mg/g ketoconazole
DATE OF APPROVAL: 20.10.2021
THIS AMENDMENT: Clinical Variation Resubmission.
DATE OF ORIGINAL SUBMISSION: 03 November 2014
Sign: ______
Page 1 of 7
PROPOSED PROFESSIONAL INFORMATION FOR NIZSHAMPOO®
SCHEDULING STATUS
S1
1.
NAME OF THE MEDICINE
NizShampoo
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 gram of shampoo contains 20 mg ketoconazole.
_Excipients with known effect: _
Preservative: Imidurea 0,2 % _m/m_.
For the full list of excipients, see section 6 .1.
3.
PHARMACEUTICAL FORM
Solution.
Pink viscous liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of infections in which the yeast _Malassezia _is involved,
such as pityriasis versicolor,
seborrhoeic dermatitis and pityriasis capitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
FOR EXTERNAL USE ONLY.
The affected areas of the skin or the hair should be washed with
NizShampoo
®
which should be
Johnson & Johnson (Pty) Ltd
NIZSHAMPOO® Solution
20 mg/g ketoconazole
DATE OF APPROVAL: 20.10.2021
THIS AMENDMENT: Clinical Variation Resubmission.
DATE OF ORIGINAL SUBMISSION: 03 November 2014
Sign: ______
Page 2 of 7
left for 3 to 5 minutes before rinsing.
TREATMENT
-
Pityriasis versicolor: once daily for maximum 5 days.
-
Seborrhoeic dermatitis and pityriasis capitis (dandruff): twice weekly
for 2 to 4 weeks.
4.3
CONTRAINDICATIONS
Hypersensitivity to ketoconazole or any of the other excipients (see
section 6.1).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Irritation may occur when NizShampoo
®
is used immediately after prolonged treatment with
topical corticosteroids. Therefore, to prevent a rebound effect after
stopping a prolonged
treatment with topical corticosteroids, it is recommended to continue
applying a mild topical
corticosteroid in the morning and to apply NizShampoo
®
in the evening, and to subsequently and
gradually withdraw the steroid therapy over a period of 2-3 weeks.
Avoid contact in the eyes. If the NizShampoo
®
should get into the eyes, they sho