Surolan Topical Suspension

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

MICONAZOLE NITRATE; PREDNISOLONE ACETATE; POLYMYXIN B SULPHATE

Available from:

ELANCO MALAYSIA SDN BHD

INN (International Name):

MICONAZOLE NITRATE; PREDNISOLONE ACETATE; POLYMYXIN B SULPHATE

Units in package:

15 ml

Manufactured by:

Lusomedicamenta Sociedade Tecnica Farmaceutica, S.A.

Summary of Product characteristics

Mat ID code Read Direction
Front
170mm
260mm
MAT ID CODE READ DIRECTION
TOPICAL SUSPENSION
1608508D
CA0813
NAME OF THE VETERINARY MEDICINAL PRODUCT
Surolan Topical Suspension
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml of ear drops and cutaneous suspension contains miconazole
nitrate 23 mg,
prednisolone acetate 5 mg and polymyxin B sulfate 0.5293 mg.
PRODUCT DESCRIPTION
A white colour suspension for topical use.
PROPERTIES
Miconazole is a synthetic imidazole derivative with a pronounced
antifungal effect and a potent activity against
Gram-positive bacteria. Polymyxin B is an antibiotic with a
bactericidal effect against Gram-negative bacteria.
To these two substances, prednisolone has been added to provide
anti-inflammatory and antipruritic activities.
TARGET SPECIES
Cats and dogs
PHARMACODYNAMIC PROPERTIES
Miconazole nitrate is a synthetic imidazole derivative with a
pronounced antifungal activity and a potent activity
against Gram-positive bacteria. Miconazole selectively inhibits the
synthesis of ergosterol, which is an essential
component of the membrane of yeasts and fungi.
Polymyxin B sulfate is a polypeptide antibiotic with bactericidal
activity against Gram-negative bacteria. It binds to
phospholipids in the cytoplasmic membrane, whereby the membrane
permeability is disturbed. This results in lysis
of the bacteria.
Prednisolone acetate is a glucocorticoid with strong anti-inflammatory
activity which results from its reduction of
the permeability of capillaries and vascular proliferation and from
the inhibition of fibroblast action.
PHARMACOKINETIC PROPERTIES
After topical application of miconazole nitrate, virtually no systemic
absorption takes place through the skin or
mucus membranes.
Systemic absorption of prednisolone on normal or abraded skin is
minimal. Absorption of polymyxin B via the skin is
also negligible. Excretion is almost completely via the kidneys.
INDICATION
For the topical treatment of otitis externa and skin infections caused
by Gram-positive bacteria
e.g. _Stap