Calmurid 10%/ 5% w/w Cream

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Lactic acid; Urea

থেকে পাওয়া:

Galderma International S.A.S.

এটিসি কোড:

D02AE; D02AE01

INN (আন্তর্জাতিক নাম):

Lactic acid; Urea

ডোজ:

10%w/w +5 percent weight/weight

ফার্মাসিউটিকাল ফর্ম:

Cream

থেরাপিউটিক এলাকা:

Carbamide products; carbamide

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1978-07-28

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
22 May 2019
CRN008Y1X
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calmurid 10%/ 5% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 100 mg of Urea (10% w/w) and 50 mg of
Lactic acid (5% w/w).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A homogenous, white, oil-in-water cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of dermatoses characterised by hyperkeratosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For external use only.
Adults, paediatric population and older people
Application: twice daily or as directed by the physician, ideally
after washing.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Calmurid is acidic and hypertonic and can cause smarting if applied to
raw areas, fissures or mucous membranes. Where this is
a barrier to therapy the use of Calmurid diluted 50% with aqueous
cream B.P. for one week should result in freedom from
smarting upon use of Calmurid.
Avoid contact with the eyes and surrounding area and do not apply
Calmurid on inflamed skin or open wounds.
Because of potential transcutaneous penetration of urea, the product
should not be used extensively in subjects with severe
renal impairment without medical supervision.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Low pH of the cream might affect stability of other drugs.
Urea may enhance the penetration of other active substances into the
skin. This is particularly well-known for corticosteroids,
dithranol and 5-fluoruracil.
Health Products Regulatory Authority
22 May 2019
CRN008Y1X
Page 2 of 3
4.6 FERTILITY, PREGNANCY AND LACTATION
There is no specific data available regarding the use in pregnant
women and during lactation.
In breast-feeding women Calmurid should be removed from the breast
area before breast feeding.
4.7 EFFECTS ON AB