HYDROAGISTEN CREAM

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CLOTRIMAZOLE; HYDROCORTISONE ACETATE

متاح من:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC رمز:

D07AA02

الشكل الصيدلاني:

CREAM

تركيب:

CLOTRIMAZOLE 1 %; HYDROCORTISONE ACETATE 1 %

طريقة التعاطي:

DERMAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

المجموعة العلاجية:

HYDROCORTISONE

المجال العلاجي:

HYDROCORTISONE

الخصائص العلاجية:

Skin inflammation involving fungal infection

تاريخ الترخيص:

2014-08-31

نشرة المعلومات

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hydroagisten
®
cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1% w/w and hydrocortisone Acetate 1% w/w
Excipient with known effect: cetostearyl alcohol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cream.
Off white cream
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Skin inflammation involving fungal infection.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Hydroagisten cream should be thinly and evenly applied to the affected
area twice daily and
rubbed in gently. Treatment should be for a maximum of 7 days.
A total daily dose of 10 mg cream per kg body weight should not be
exceeded. For an
adult weighing 50 kg the maximum daily dose is 500 mg cream which
equals
approximately 2 cm of cream to be divided into 2 applications per day.
There is no separate dosage schedule for the elderly or the young.
However, long-term
therapy to extensive areas of skin should be avoided particularly in
infants and
children.
Treatment duration:
If the acute symptoms have subsided after about 7 days but treatment
is still required,
this may be carried out with the corticoid-free preparation intended
for this purpose.
4.3.
CONTRAINDICATIONS
- Hypersensitivity to the active substances or to any of the
excipients listed in section
6.1.
- Use on broken skin.
- Diseases affecting the skin (e.g. acne, rosacea, perioral
dermatitis, lues,
tuberculosis, etc.).
- Any untreated bacterial skin diseases.
- Viral skin diseases (e.g. herpes simplex, chicken pox, shingles
etc.).
- Dermal vaccination reactions.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Because of its corticosteroid content, Hydroagisten cream should not
be applied:
• To large areas (more than 5 - 10% of the body surface).
• In long term continuous therapy.
• Under occlusive dressings (such as nappies and bandages).
These restrictions apply particularly in:
• Infants, where the nappy can act as an occlusive dressing and
increase
systemic absorption.

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hydroagisten cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1% w/w and hydrocortisone Acetate 1% w/w
Excipient with known effect: cetostearyl alcohol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cream.
Off white cream
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Skin inflammation involving fungal infection.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Hydroagisten cream should be thinly and evenly applied to the affected
area twice daily and
rubbed in gently. Treatment should be for a maximum of 7 days.
A total daily dose of 10 mg cream per kg body weight should not be
exceeded. For an
adult weighing 50 kg the maximum daily dose is 500 mg cream which
equals
approximately 2 cm of cream to be divided into 2 applications per day.
There is no separate dosage schedule for the elderly or the young.
However, long-term
therapy to extensive areas of skin should be avoided particularly in
infants and
children.
Treatment duration:
If the acute symptoms have subsided after about 7 days but treatment
is still required,
this may be carried out with the corticoid-free preparation intended
for this purpose.
4.3.
CONTRAINDICATIONS
- Hypersensitivity to the active substances or to any of the
excipients listed in section
6.1.
- Use on broken skin.
- Diseases affecting the skin (e.g. acne, rosacea, perioral
dermatitis, lues,
tuberculosis, etc.).
- Any untreated bacterial skin diseases.
- Viral skin diseases (e.g. herpes simplex, chicken pox, shingles
etc.).
- Dermal vaccination reactions.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Because of its corticosteroid content, Hydroagisten cream should not
be applied:
• To large areas (more than 5 - 10% of the body surface).
• In long term continuous therapy.
• Under occlusive dressings (such as nappies and bandages).
These restrictions apply particularly in:
• Infants, where the nappy can act as an occlusive dressing and
increase
systemic absorption.
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