Caldesene 10% w/w Medicated Powder

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Calcium undecylenate

זמין מ:

Clonmel Healthcare Ltd

קוד ATC:

D01AE; D01AE54

INN (שם בינלאומי):

Calcium undecylenate

כמות:

10 percent weight/weight

טופס פרצבטיות:

Cutaneous powder

סוג מרשם:

Product not subject to medical prescription

איזור תרפויטי:

Other antifungals for topical use; undecylenic acid, combinations

מצב אישור:

Marketed

תאריך אישור:

1977-04-03

מאפייני מוצר

Health Products Regulatory Authority
14 May 2019
CRN008WXW
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caldesene 10% w/w Medicated Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Undecylenate 10 % w/w
Excipients with known effect
Benzyl benzoate <0.25% w/w.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous powder.
A white perfumed free-flowing cutaneous powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention and treatment of local rashes of buttocks due to
friction and irritation particularly those at risk of infection
such as nappy rash.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Nappy rash: Cleanse and dry the affected area, sprinkle on Caldesene
after each nappy change or as directed by a doctor.
Prevention: Apply to affected area as required or as directed by a
doctor.
Treatment: Cleanse and dry the affected area, apply powder as required
or as directed by a doctor.
There is no recommended dosing schedule.
Method of administration:
For Cutaneous use.
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
This product contains benzyl benzoate which may be a mild irritant to
the skin, eyes and mucous membranes.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Not applicable.
4.6 FERTILITY, PREGNANCY AND LACTATION
As this product is applied topically, its use is not contra-indicated
during pregnancy or lactation.
Health Products Regulatory Authority
14 May 2019
CRN008WXW
Page 2 of 3
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8 UNDESIRABLE EFFECTS
Skin irritation can occur occasionally to some of the ingredients. If
this occurs, use of the product should be discontinued.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the m