Comagis cream инструкция по применению

комагиз крем

$21,25

Количество комагиз крем

Описание

Препарат широкого спектра действия для снятия воспалительных состояний сопровождающихся грибковыми инфекциями которые отвечают на терапию кортикоидами.

Детали

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Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BIFONAZOLE; FLUOCINONIDE

Available from:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC code:

D01AC10

Pharmaceutical form:

CREAM

Composition:

FLUOCINONIDE 0.05 W/W; BIFONAZOLE 1.00 W/W

Administration route:

DERMAL

Prescription type:

Required

Manufactured by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapeutic group:

BIFONAZOLE

Therapeutic area:

BIFONAZOLE

Therapeutic indications:

Broad-spectrum drug for relief of inflammatory conditions accompanied by fungal infection, which respond to corticoid therapy.

Authorization date:

2014-02-28

Patient Information leaflet

                                PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( - 1986
This medicine can be sold with a
physician’s prescription only
COMAGIS CREAM
EACH 100 GRAMS OF COMAGIS CREAM CONTAINS:
1 GRAM BIFONAZOLE
0.05 GRAMS FLUOCINONIDE
Inactive ingredients and allergens in the medicine
- see in section 6
"
Additional information
"
and
in section 2
"
Important information about some
of the ingredients of this medicine
"
.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE
USING THIS MEDICINE. This leaflet contains
concise information about the medicine. If you
have any further questions, ask the physician
or pharmacist.
This medicine has been prescribed for your
treatment. Do not pass it on to others. It may
harm them, even if you think that their medical
condition is the same as yours.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Comagis
Cream
relieves
conditions
of
inflammation accompanied by fungal infection
that respond to corticoid therapy.
THERAPEUTIC
GROUP:
Anti-inflammatory
+
antifungal.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
• If you are hypersensitive )allergic( to the active
ingredients or to any of the other ingredients
this medicine contains )see section 6(.
• To treat nappy rash. If your infant has nappy
rash, refer to the physician to receive a
suitable treatment.
• To treat nail or scalp infections.
• To treat vaginal infections.
• On large areas of the body or for a long time.
SPECIAL WARNINGS REGARDING THE USE OF
THE MEDICINE
• Do not let the medicine come in contact with
the eyes.
• Do not bandage, cover or wrap the treated
area so that an occlusive dressing is formed
unless directed by the physician.
BEFORE
THE
TREATMENT
WITH
COMAGIS
CREAM TELL THE PHYSICIAN IF
• you
have
ever
experienced
an
allergic
reaction to any antifungal substance.
DRUG INTERACTIONS
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN
OTHER MEDICINES INCLUDING NON-PRESCRIPTION
MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL
THE PHYSICIAN OR PHARMACIST. Especially
inform the physician or pharmacist if 
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Comagis Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients: For 100gram cream: Fluocinonide 0.05g
and Bifonazole 1.00g
Excipient with known effect: Cetostearyl Alcohol and Benzyl Alcohol.
For excipients see section 6.1.
3
PHARMACEUTICAL FORM
Cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Broad-spectrum drug for relief of inflammatory conditions accompanied
by fungal
infection, which respond to corticoid therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
A small amount of the cream should be applied to the affected skin
area once daily
(preferably before retiring), using a gentle, but thorough massage.
Children
Administration of topical corticosteroids to pediatric patients should
be limited to the
least amount compatible with an effective therapeutic regimen. Chronic
corticosteroid therapy may interfere with the growth and development
of pediatric
patients.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1
•
Treatment of infants with nappy rash.
•
Treatment of nail and scalp infections.
•
Treatment of vaginal infections.
•
Application to large areas of the body or for prolonged periods must
be
avoided.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product contains cetostearyl alcohol which may cause local skin
reactions (e.g.
contact dermatitis).
This product contains Benzyl alcohol which may cause allergic
reactions and mild
local irritation.
Patients with a history of hypersensitivity reactions to other
imidazole antifungal
agents (e.g. econazole, clotrimazole, miconazole) must take bifonazole
containing
products with caution.
– –
2
Systemic absorption of topical corticosteroids has produced reversible
hypothalamic-
pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's
syndrome,
hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application
of the more
poten
                                
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