País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
COAL TAR SOLUTION SALICYLIC ACID
Foran Chemicals Ltd
Ointment
1991-01-29
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tar Pomade 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Coal tar solution 6.0% w/w Salicylic Acid 2.0% w/w 3 PHARMACEUTICAL FORM Light brown coloured ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS It is recommended for use in the treatment of eczema, psoriasis and related skin affections. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION _Dosage_ Apply to the affected area as directed by the pharmacist and/or the physician. _Administration_ Cutaneous (topical) use. 4.3 CONTRAINDICATIONS Use in persons hypersensitive to any of the ingredients. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE If the condition does not improve, or is aggravated consult the doctor. Exposure of the treated areas to direct sunlight should be avoided after application. Avoid contact with eyes. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interactions known. 4.6 PREGNANCY AND LACTATION Use in pregnancy and lactation has not been established for this product, however, due to the established nature of the ingredients, no adverse effects are anticipated. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 15/11/2005_ _CRN 2016847_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. 4.8 UNDESIRABLE EFFECTS None. 4.9 OVERDOSE Not applicable. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Tar pomade has antipruritic, keratolytic and antiseptic properties. 5.2 PHARMACOKINETIC PROPERTIES Not relevant. 5.3 PRECLINICAL SAFETY DATA Coal Tar Skin and eye irritation: Skin (human): 15 µg/3D-1 Mild Skin (rabbit): 5%/3H Mild Salicylic Acid Skin and eye irritation: Skin (rabbit) 500 mg/24H Mild Eye (rabbit) 100 mg Severe Skin (man): TDLo: 57 mg/kg Sense organs Leer el documento completo