DIPROGENTA CREAM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BETAMETHASONE AS DIPROPIONATE; GENTAMICIN (AS SULFATE)

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

D07CC

Pharmaceutical form:

CREAM

Composition:

GENTAMICIN (AS SULFATE) 1 MG/G; BETAMETHASONE AS DIPROPIONATE 0.5 MG/G

Administration route:

TOPICAL

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

CORTICOSTEROIDS, POTENT, COMBINATIONS WITH ANTIBIOTICS

Therapeutic indications:

For the relief of the inflammatory manifestations of corticosteroid-responsive dermatoses when complicated by secondary infections caused by organisms susceptible to gentamycin.

Authorization date:

2017-01-31

Patient Information leaflet

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

Summary of Product characteristics

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