DIPROGENTA Cream / Ointment (2021)

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Περιεχόμενα

1. Name of the medicinal product

Diprogenta Cream. Diprogenta Ointment.

2. 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 ...

3. Pharmaceutical form

Cream. Ointment.

4.1. Therapeutic indications

Diprogenta Cream is indicated for the relief of the inflammatory manifestations of corticosteroidresponsive dermatoses when complicated by secondary infections caused by organisms susceptible to gentamycin. ...

4.2. 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. ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients used in the preparation as well as to aminoglycoside antibiotics (cross allergy to gentamicin). Skin infections [of viral, bacterial ...

4.4. Special warnings and precautions for use

If irritation or sensitization develops with the use of Diprogenta Cream or Ointment, treatment should be discontinued and appropriate therapy instituted. When applied topically, systemic absorption of ...

4.6. Pregnancy and lactation

Pregnancy In animal studies, topical application of corticosteroids was shown to have a teratogenic effect. There are no data on its use in human pregnancies. Aminoglycosides cross the placental barrier ...

4.7. Effects on ability to drive and use machines

The effect on the ability to drive and operate machinery has not been studied.

4.8. Undesirable effects

Initiation of treatment Skin and subcutaneous tissue disorders Rare: irritations, burning sensations, pruritus, skin dryness, hypersensitivity reactions to one of the ingredients used in the product ...

4.9. Overdose

Symptoms Excessive or prolonged use of topical corticosteroids may lead to a suppression of the pituitary-adrenal function, and may cause secondary adrenal insufficiency and symptoms of adrenal cortex ...

5.1. Pharmacodynamic properties

ATC Code: D07CC01 Mechanism of action Diprogenta combines the antibacterial action of gentamicin (an aminoglycoside antibiotic) with the anti-inflammatory, antipruritic and vasoconstrictive properties ...

5.2. Pharmacokinetic properties

No penetration or absorption studies have been performed on this galenic formulation. Under normal circumstances, only a fraction of the locally applied amount of corticosteroid is systemically available. ...

5.3. Preclinical safety data

Betamethasone Corticosteroid studies using animal models have shown that bethamethasone is toxic to reproduction (cleft palate, skeletal malformations). In reproduction toxicity studies on rats, prolonged ...

6.1. List of 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, ...

6.3. Shelf life

The expiry date of the product is indicated on the packaging materials.

6.4. Special precautions for storage

Store up to 25°C. After first opening, can be used up to 3 months. Keep out of the reach and sight of children

6.5. Nature and contents of container

Diprogenta Cream is supplied in tubes of 15 g. Diprogenta Ointment is supplied in tubes of 15 g.

7. Marketing authorization holder

Merck Sharp & Dohme (Israel-1996) Company Ltd., P.O.Box 7121, Petah-Tikva 49170, Israel

10. Date of revision of the text

Revised in March 2021 according to MOHs guidelines.

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