MFSONE Cream 0.1

Страна: Танзания

Язык: английский

Источник: Tanzania Medicinces & Medical Devices Authority

Активный ингредиент:

Mometasone Furoate

Доступна с:

KLM LABORATORIES PVT LTD, INDIA

код АТС:

Corticosteroids, dermatological preparations, cort

ИНН (Международная Имя):

Mometasone Furoate

дозировка:

0.1

Фармацевтическая форма:

Cream

Производитель:

East African (India) Overseas, INDIA

Обзор продуктов:

Physical description: White homogenous semi-solid mass filled in printed lami tubes; Local technical representative: Planet Pharmaceutical Limited (6099)

Статус Авторизация:

Registered/Compliant

Дата Авторизация:

2022-01-10

Характеристики продукта

PRESCRIBING INFORMATION (SUMMARY OF PRODUCT CHARACTERISTICS)
1.
NAME OF THE MEDICINAL PRODUCT
Trade name
:
MFSONE CREAM
Generic name
:
Mometasone Furoate Cream USP 0.1% w/w
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION
Mometasone Furoate
USP
0.1 % w/w
........
In a cream base
q.s.
.......................................................
For external use only
QUANTITATIVE COMPOSITION
Excipients with known effect
40 mg of Propylene Glycol (Cosolvent), 1.8 mg of Methyl Paraben
(Antimicrobial agent), 0.2 mg
of Propyl Paraben (Antimicrobial agent), 80 mg of Light Liquid
Paraffin (Emollient; oleaginous
vehicle) / 1 gm.
_For full list of excipients see section 6.1 _
3.
PHARMACEUTICAL FORM
Prescription Only Medicine
Semi solid dosage form (cream)
White homogenous semi-solid mass filled in printed lami tubes
4.
CLINICAL PARTICULARS
1.
THERAPEUTIC INDICATIONS
Mometasone Furoate 1mg/g Cream is indicated for the treatment of
inflammatory and pruritic
manifestations of psoriasis (excluding widespread plaque psoriasis)
and atopic dermatitis. This
medicinal product is indicated in adults and children above 6 years of
age.
2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults, including elderly patients, adolescents and children aged 6
years and over:
A thin film of Mometasone Furoate 1mg/g Cream should be applied to the
affected areas of
skin once daily. One fingertip unit (a line from the tip of an adult
index finger to the first crease)
is enough to cover an area twice the size of an adult hand. Use of a
weaker corticosteroid is
often advisable when there is a clinical improvement.
PAEDIATRIC POPULATION
Mometasone Furoate 1mg/g Cream should not be used for long periods
(over 3 weeks) or on
large areas (over 20% of body surface area). In children a maximum of
10% of body surface
area should be treated.
Use of topical corticosteroids in children aged 6 years and over, or
on the face should be
limited to the least amount compatible with an effective therapeutic
regimen and duration of
treatment should be