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LAKCID® forte


NAME OF THE MEDICINAL PRODUCT

Lakcid® forte
(Lactobacillus rhamnosus)

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES

10 bn CFU of Lactobacillus rhamnosus bacilli:
Lactobacillus rhamnosus strain penicillin-resistant - 40 %
Lactobacillus rhamnosus strain erythromycin- and neomycin-resistant - 40 %
Lactobacillus rhamnosus strain oxytetracycline-resistant - 20 %
Bacilli resistant to: amoxicillin, ampicillin, azlocilin, cephradin, cephtazidim, cephuroxim,
doxycycline, erythromycin, gentamycin, imipenem, clindamicin, cloxacilin, colistin, nalidixic acid, neomycin, netilmycin, penicillin, piperacilin, streptomycin, tobramicin, vankomycin.
CFU - colony formation unit.
For excipients see the list of excipients.

PHARMACEUTICAL FORM

Powder for the preparation of oral suspension.

CLINICAL PARTICULARS

Indications to use

Post-antibiotic enteritis with particular reference to auxiliary treatment in pseudomembranous colitis; for the treatment of most of types of recurring pseudomembranous colitis, the prevention of diarrhoea in travellers, and auxiliary treatment during and after treatment with antibiotics.

Dosage and method of administration

The product is to be administered orally. The dosage, if not otherwise recommend by a physician is one vial, 2 times daily.

Contraindications

Hypersensitivity to the protein of cow's milk.

Special warnings and precautions for use

None.

Interactions with other medicinal products and other forms of interactions

None.

Pregnancy and lactation

The product can be used in pregnant and breast feeding women.

Effects on ability to drive and use machines

No effect on the ability to drive or use machines after Lakcid forte administration have been observed.

Undesirable effects

Have not been observed.

Overdose

The consequences of an overdose have not been reported.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: antidiarrheal microorganisms: ATC code A07FA

Lactobacillus rhamnosus strains present in the medicinal product, as with other bacteria
of lactic acid colonize the mucous membrane of the intestines and normalize the composition of the microflora of the alimentary tract, especially after its impoverishment resulting from treatment with antibiotics. The results of research have confirmed that such strains survive in the habitat of gastric juice and are resistant to the activity of bile acids salts, which facilitates their adaptation and survival rate in the alimentary tract. Competing for substrata and a place for colonization in the intestinal mucous membrane, and producing lactic acid as a result of the anaerobic decomposition of sugars, produce unfavourable conditions for the development of most pathogenic microorganisms.

These strains possess a natural resistance to a wide spectrum of antibiotics used clinically.

Pharmacokinetic properties

Does not apply.

Preclinical safety data

In research on laboratory animals (guinea pigs and mice) no toxicity of Lakcid forte has been observed.

PHARMACEUTICAL PARTICULARS

List of excipients

Skim-milk, saccharose

Pharmaceutical incompatibilities

Does not apply.

Shelf life

1 year

Special precautions for storage

Store at 2°C - 8°C (refrigerated). Keep away from children.

Nature and contents of package

5 vials with powder, 1 dose each
10 vials with powder, 1 dose each
Ampoules made of neutral glass, volume of 3 ml, closed with a rubber stopper and aluminium cap, in a cardboard box.

Instructions for use and handling and disposal of medicinal product

Open the vial directly before use by removing the cap and rubber stopper. Add to the vial a small amount of water or milk which has been previously boiled and cooled to room temperature, and mix thoroughly. Pour the contents of the vial onto a spoon. Use orally.