GERMOLENE ANTISEPTIC LIQUID*

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmacare Limited û Woodmead

Dosage:

See ingredients

Pharmaceutical form:

LIQUID

Composition:

EACH 1 ml LIQUID CONTAINS CETRIMIDE 30 mg CHLORHEXIDINE GLUCONATE 3 mg

Authorization status:

Registered

Authorization date:

1991-10-10

Patient Information leaflet

ANNEXURE 1
GERMOLENE ANTISEPTIC LIQUID
1.1
ANNEXURE 1
NAME OF APPLICANT:
PHARMACARE LIMITED
NAME OF MEDICINE:
GERMOLENE ANTISEPTIC LIQUID
DOSAGE FORM:
LIQUID
A.
THE UNDERMENTIONED INFORMATION WITH REGARD TO THIS MEDICINE SHALL
APPEAR ON THE PACKAGE INSERT. THE
INFORMATION SHALL BE PRESENTED IN THE FORMAT STIPULATED: PROVIDED THAT
THE COUNCIL MAY AUTHORISE ANY DEVIATION
FROM SUCH INFORMATION OR SUCH FORMAT.
B.
THE FOLLOWING IS A FACSIMILE OR SPECIMEN OF THE LABEL
INDEX
PACKAGE INSERT
PAGE
Information format
1.2
English Package Insert Text
1.3 – 1.4
Afrikaans Package Insert Text
1.5 – 1.6
Approved Abbreviated Package Insert text (English and Afrikaans)
1.7 – 1.9
Labelling text
Label text
1.9
ANNEXURE 1
GERMOLENE ANTISEPTIC LIQUID
1.2
FORMAT OF INFORMATION REQUIRED
Scheduling status
Proprietary name (and dosage form)
Composition
Pharmacological classification
Pharmacological action
Indications
Contra-indications
Warnings
Dosage and directions for use.
Side-effects and special precautions
Known symptoms of overdosage and particulars of its treatment
Identification
Presentation
Storage instructions
Registration number
Applicant
Date of publication
ANNEXURE 1
GERMOLENE ANTISEPTIC LIQUID
1.3
ANNEXURE 1
GERMOLENE ANTISEPTIC LIQUID
1.4

Summary of Product characteristics

ANNEXURE 1
GERMOLENE ANTISEPTIC LIQUID
1.1
ANNEXURE 1
NAME OF APPLICANT:
PHARMACARE LIMITED
NAME OF MEDICINE:
GERMOLENE ANTISEPTIC LIQUID
DOSAGE FORM:
LIQUID
A.
THE UNDERMENTIONED INFORMATION WITH REGARD TO THIS MEDICINE SHALL
APPEAR ON THE PACKAGE INSERT. THE
INFORMATION SHALL BE PRESENTED IN THE FORMAT STIPULATED: PROVIDED THAT
THE COUNCIL MAY AUTHORISE ANY DEVIATION
FROM SUCH INFORMATION OR SUCH FORMAT.
B.
THE FOLLOWING IS A FACSIMILE OR SPECIMEN OF THE LABEL
INDEX
PACKAGE INSERT
PAGE
Information format
1.2
English Package Insert Text
1.3 – 1.4
Afrikaans Package Insert Text
1.5 – 1.6
Approved Abbreviated Package Insert text (English and Afrikaans)
1.7 – 1.9
Labelling text
Label text
1.9
ANNEXURE 1
GERMOLENE ANTISEPTIC LIQUID
1.2
FORMAT OF INFORMATION REQUIRED
Scheduling status
Proprietary name (and dosage form)
Composition
Pharmacological classification
Pharmacological action
Indications
Contra-indications
Warnings
Dosage and directions for use.
Side-effects and special precautions
Known symptoms of overdosage and particulars of its treatment
Identification
Presentation
Storage instructions
Registration number
Applicant
Date of publication
ANNEXURE 1
GERMOLENE ANTISEPTIC LIQUID
1.3
ANNEXURE 1
GERMOLENE ANTISEPTIC LIQUID
1.4