Country: Israel
Language: English
Source: Ministry of Health
BETAMETHASONE AS DIPROPIONATE; GENTAMICIN AS SULFATE
ORGANON PHARMA ISRAEL LTD., ISRAEL
N/A
OINTMENT
BETAMETHASONE AS DIPROPIONATE 0.5 MG / 1 G; GENTAMICIN AS SULFATE 1 MG / 1 G
TOPICAL
Required
ORGANON LLC, USA
Topical treatment of dermatosis complicated by secondary infection caused by organisms sensitive to Gentamicin
2017-03-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine can be sold under doctor’s prescription only DIPROGENTA ® CREAM DIPROGENTA ® OINTMENT Each gram of cream contains: Betamethasone dipropionate 0.64 mg* * Equivalent to 0.5 mg Betamethasone Gentamicin (as sulfate) 1 mg Each gram of ointment contains: Betamethasone dipropionate 0.64 mg* * Equivalent to 0.5 mg Betamethasone Gentamicin (as sulfate) 1 mg For a list of the inactive ingredients see section 6 ‘‘FURTHER INFORMATION’’. See also section 2.5 “Important information about some of the ingredients of DIPROGENTA” . READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE. • This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. 1. WHAT DIPROGENTA IS USED FOR? DIPROGENTA is used for the local treatment of inflammatory skin diseases with secondary infections caused by microorganisms sensitive to gentamicin. The ointment can be used for lesions on dry skin, the cream on oily skin and for weeping conditions. THERAPEUTIC GROUP: DIPROGENTA is a combination product containing two active substances: betamethasone dipropionate and gentamicin. Betamethasone dipropionate is part of a drug group named topical corticosteroids (for local use). It is classified as a ”potent corticosteroid” (powerful). Gentamicin is an antibiotic that belongs to the aminoglycoside group. 2. BEFORE USING THE MEDICINE 2.1 DO NOT USE THE MEDICINE: − if you are sensitive (allergic) to betamethasone dipropionate, gentamicin sulfate or any other components of this medicine (for a list of inactive ingredients, see section 6). − in case of skin infections [of viral, bacterial (including tuberculous) and fungal aetiology] or skin diseases related to syphilis, herpes infections (e.g. fever Read the complete document
DIPROGENTA ® CREAM, DIPROGENTA ® OINTMENT _ _ QUALITATIVE AND QUANTITATIVE COMPOSITION _Active substances: _ Betamethasone dipropionate 0.64 mg/g Gentamicin (as sulfate) 1 mg/g _ _ 1 g of cream contains: Betamethasone dipropionate 0.64 mg Equivalent to 0.5 mg Betamethasone, Gentamicin (as sulfate) 1 mg. 1 g of ointment contains: Betamethasone dipropionate 0.64 mg Equivalent to 0.5 mg Betamethasone, Gentamicin (as sulfate) 1 mg. _ _ _Excipients: _ _Diprogenta Cream:_ white petrolatum, 72mg/g cetostearyl alcohol, mineral oil, polyethylene glycol 1000 monocetyl ether, sodium phosphate monobasic, chlorocresol 1mg/g, phosphoric acid, purified water, sodium hydroxide or phosphoric acid for PH adjustment _Diprogenta Ointment:_ White petrolatum, mineral oil. PHARMACEUTICAL FORM Cream or Ointment THERAPEUTIC INDICATIONS Diprogenta Cream is indicated for the relief of the inflammatory manifestations of corticosteroid- responsive dermatoses when complicated by secondary infections caused by organisms susceptible to gentamicin. Diprogenta Ointment is indicated for topical treatment of dermatosis complicated by secondary infection caused by organisms sensitive to gentamicin. _ _ POSOLOGY AND METHOD OF ADMINISTRATION _Adolescents and Adults _ Apply a thin film to the affected skin areas twice daily and carefully rub in. Frequency of application should be determined by the physician according to the severity of the condition. For some patients, adequate maintenance therapy may be achieved with less frequent application. Duration of therapy varies depending upon the extent and location of disease and patient response. However, if clinical improvement is not achieved by two to three weeks, diagnosis should be reviewed. _Children 2 to 12 years old _ Apply a thin film to only the affected skin and carefully rub in. Apply a sufficient amount no more frequently than twice daily with at least 6-12 hours between applications. Application to face, neck, scalp, genitalia, rectal area, and skin flexures should be applied under medical s Read the complete document