THROFLAM-CO SOLUTION

Land: Suður-Afríka

Tungumál: enska

Heimild: South African Health Products Regulatory Authority (SAHPRA)

Fáanlegur frá:

Pharmacare Limited û Woodmead

Skammtar:

See ingredients

Lyfjaform:

SOLUTION

Samsetning:

EACH 15,0 ml SOLUTION CONTAINS BENZYDAMINE HYDROCHLORIDE 22,50 mg CHLORHEXIDINE GLUCONATE 18,0 mg

Leyfisstaða:

Registered

Leyfisdagur:

2009-06-04

Upplýsingar fylgiseðill

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_Page 1 of 6 _
1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S1
PROPRIETARY NAME AND DOSAGE FORM
THROFLAM-CO (solution)
COMPOSITION
Each 15 ml of THROFLAM-CO solution contains:
Benzydamine hydrochloride
22,5 mg
Chlorhexidine gluconate solution
18 mg
_ _
_Excipients: _
Dye red raspberry (C.I. 14720), ethanol, flavour cherry, levomenthol,
macrogolglycerol
hydroxystearate, purified water, sorbitol liquid, thymol
Contains alcohol: Ethanol 8,96 % _v/v _
Contains sugar: Sorbitol liquid 1,8 g
CATEGORY AND CLASS
A 16 Ear, nose and throat preparations
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Benzydamine hydrochloride has local analgesic and anti-inflammatory
properties.
_ZA_THROCOSOL_0804_02 _
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_Page 2 of 6 _
Benzydamine hydrochloride exerts this action by stabilising the cell
membrane and inhibiting
the synthesis of prostaglandins. Chlorhexidine gluconate is an
antiseptic and a disinfectant.
It is bactericidal or bacteriostatic against a wide range of
Gram-positive and Gram-negative
bacteria. The chlorhexidine gluconate is absorbed onto the cell walls
of micro-organisms,
and causes leakage of the intracellular components.
PHARMACOKINETIC PROPERTIES
Approximately 30 % chlorhexidine gluconate is retained in the oral
cavity following rinsing. It
is subsequently released slowly into the oral fluids. Chlorhexidine is
poorly absorbed from
both the gastrointestinal tract and skin.
INDICATIONS
THROFLAM-CO can be used for the relief of minor infections as well as
painful inflammatory
conditions of the mouth and throat. Chlorhexidine can be used for the
reduction of dental
plaque.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients in the formulation.
THROFLAM-CO should not be
used in children under 6 years of age. The safety in pregnancy and
lactation has not been
established (see HUMAN REPRODUCTION).
WARNINGS AND SPECIAL PRECAUTIONS
THROFLAM-CO should not be used uninterrupted for longer than 7 days
e

Vara einkenni

_ZA_THROCOSOL_0804_02 _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Page 1 of 6 _
1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S1
PROPRIETARY NAME AND DOSAGE FORM
THROFLAM-CO (solution)
COMPOSITION
Each 15 ml of THROFLAM-CO solution contains:
Benzydamine hydrochloride
22,5 mg
Chlorhexidine gluconate solution
18 mg
_ _
_Excipients: _
Dye red raspberry (C.I. 14720), ethanol, flavour cherry, levomenthol,
macrogolglycerol
hydroxystearate, purified water, sorbitol liquid, thymol
Contains alcohol: Ethanol 8,96 % _v/v _
Contains sugar: Sorbitol liquid 1,8 g
CATEGORY AND CLASS
A 16 Ear, nose and throat preparations
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Benzydamine hydrochloride has local analgesic and anti-inflammatory
properties.
_ZA_THROCOSOL_0804_02 _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Page 2 of 6 _
Benzydamine hydrochloride exerts this action by stabilising the cell
membrane and inhibiting
the synthesis of prostaglandins. Chlorhexidine gluconate is an
antiseptic and a disinfectant.
It is bactericidal or bacteriostatic against a wide range of
Gram-positive and Gram-negative
bacteria. The chlorhexidine gluconate is absorbed onto the cell walls
of micro-organisms,
and causes leakage of the intracellular components.
PHARMACOKINETIC PROPERTIES
Approximately 30 % chlorhexidine gluconate is retained in the oral
cavity following rinsing. It
is subsequently released slowly into the oral fluids. Chlorhexidine is
poorly absorbed from
both the gastrointestinal tract and skin.
INDICATIONS
THROFLAM-CO can be used for the relief of minor infections as well as
painful inflammatory
conditions of the mouth and throat. Chlorhexidine can be used for the
reduction of dental
plaque.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients in the formulation.
THROFLAM-CO should not be
used in children under 6 years of age. The safety in pregnancy and
lactation has not been
established (see HUMAN REPRODUCTION).
WARNINGS AND SPECIAL PRECAUTIONS
THROFLAM-CO should not be used uninterrupted for longer than 7 days
e