ACTI-FLORA POWDER

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

ACTI-FLORA POWDER

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

ACTI-FLORA POWDER

COMPOSITION:
Each gram of powder contains not less than 10 million viable Lactobacillus acidophilus cells. Contains at least 100 000 antibiotic resistant cells.

PHARMACOLOGICAL CLASSIFICATION:
A 11.9.2 Antidiarrhoeals. Other

PHARMACOLOGICAL ACTION:
ACTI-FLORA powder contains the freeze-dried cells of different strains of Lactobacillus acidophilus, an inhabitant of the human intestine, which were specially cultivated to be resistant to penicillin, streptomycin, tetracycline, neomycin, erythromycin and chloramphenicol.
ACTI-FLORA is administered to replace the normal intestinal lactobacilli destroyed by broad spectrum antibiotics, therefore limiting the overgrowth of non-susceptible organisms such as resistant staphylococci or fungi. At the same time an appearance or increase of Gram-positive bacilli is noted in many cases.
The overgrowth of fungi is not inhibited in some cases even though 50 - 80% of the flora may be Gram-positive bacilli.

INDICATIONS:
ACTI-FLORA powder is indicated for the replacement of the intestinal flora during antibiotic therapy and diarrhoea due to a distrubed GI.

CONTRA-INDICATIONS:
There are no known contra-indications.

DOSAGE AND DIRECTIONS FOR USE:
Adults: Half a sachet in cold or warm milk or water three times a day at intervals between administration of the antibiotic therapy and continued for 2 to 3 days thereafter.
Children: Half a sachet twice a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The only side-effects reported after very large doses were taken was loose stools.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The symptoms of overdosage may be loose stools, whereupon the administration of ACTI-FLORA powder must be discontinued.

IDENTIFICATION:
A white to creamy powder.

PRESENTATION:
Sachet containing 1,5 g of the powder.

STORAGE DIRECTIONS:
Store in a cool dry place below 25°C.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
M/11.9.2/74

NAME OF APPLICANT:
Brovar S & P (Pty) Ltd
24 Dogar Street
Delville Ext 1
Germiston

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

Code: AFP PI/0
Britepak