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LAKCID®capsules

Lakcid ® capsules                      



Lakcid hard capsules, oral

Lactobacillus rhamnosus

Minimum 2 billion CFU Lactobacillus rhamnosus





2 QUANTITY



Minimum 2 billion CFU Lactobacillus rhamnosus:

Strain Lactobacillus rhamnosus Pen - 40%

Lactobacillus rhamnosus E / N - 40%

Lactobacillus rhamnosus Oxy - 20%

Chopsticks resistant: amoxicillin, ampicillin, azlocylinę, cefepime, cefotaxime, cefradine, ceftazidime, cefuroxime, doxycycline, erythromycin, gentamicin, imipenem, clindamycin, cloxacillin, colistin, cotrimoxazole, nalidixic acid, meropenem, metronidazole, neomycin, netilmicin, penicillin, piperacillin , streptomycin, teicoplanin, tobramycin, vancomycin.



CFU - colony forming unit (called colony forming unit).



The full list of excipients, see section 6.1.





3 PHARMACEUTICAL FORM



Hard capsules, cellulose, consisting of two cylindrical parts.



Before reconstitution of the powder in the capsule is in the form of loose, finely divided particles of color from light to dark beige.

After reconstitution, formed a homogeneous suspension, no visible impurities.





4 CLINICAL PARTICULARS



4.1 Indications for use



- Inflammatory bowel disease caused by antibiotic treatment with particular reference to supportive treatment of pseudomembranous colitis, a treatment mainly by recurrent pseudomembranous colitis,

- Prevention of travelers diarrhea,

- Supportive care during and after antibiotic treatment.



4.2 Dosage and method of administration



Dosage



Children and young people

Amounts, unless your doctor tells you otherwise, 3 - 4 times a day, one dose (the entire contents of the capsule or capsule).



Adults



Amounts, unless your doctor tells you otherwise, 3 - 4 times a day, one dose (the entire contents of the capsule or capsule).



Method of administration



The product is administered orally

Capsule contents (powder) should be dissolved in about 1/8 cup of boiled and cooled to room temperature water or milk and mix thoroughly. This method of administration is particularly recommended for infants and children.

The capsule can also be swallowed whole with the boiled and the cooled to room temperature with water or milk.



4.3 Contraindications



Hypersensitivity to the active substance or to any of the excipients (including cow's milk protein) listed in section 6.1.



4.4 Special warnings and precautions for use



Do not occur.



4.5 Interaction with other medicinal products and other forms of interaction



Do not occur.



4.6 Fertility, pregnancy and lactation



Pregnancy

Lakcid product can be used during pregnancy.



Breastfeeding Lakcid product can be used during breastfeeding.



4.7 Effects on ability to drive and use machines



Lakcid does not affect the ability to drive and use machines.



4.8 Undesirable effects



Not found.



4.9 Overdose



No case of overdose.





5 Pharmacological Properties



5.1 Pharmacodynamic properties



Pharmacotherapeutic group: antidiarrheal microorganisms, ATC code: A07FA


Lactobacillus rhamnosus strains present in the formulation, as well as other lactic acid bacteria colonize the intestinal mucosa and normalize the intestinal microflora particularly after sterilization by the use of antibiotics. Our results confirmed that these strains survive in the gastric environment, and are resistant to bile salts, which allows them to adapt and survival in the gastrointestinal tract.

Competing for space colonization of the substrates and the intestinal mucosa and produce lactic acid as a result of anaerobic decomposition of sugars produce unfavorable conditions for the development of most pathogenic microorganisms.

These strains have a natural resistance to broad-spectrum antibiotics used clinically.



5.2 Pharmacokinetic properties



Not applicable.



5.3 Preclinical safety data



Studies in laboratory animals (guinea pigs and white mice) found that Lakcid is non-toxic.





6 PHARMACEUTICAL



6.1 List of excipients



Capsule content:

Skim milk,

Sucrose,

Colloidal anhydrous silica,

Magnesium stearate



Capsule shell:

titanium dioxide (E 171),

hydroxypropylmethylcellulose,

Chlorophyll copper complex (E 141),

iron oxide yellow (E172)



6.2 Incompatibilities



Not applicable.



6.3 Shelf life



18 months.



6.4 Special precautions for storage



Store in a refrigerator (2 ° C - 8 ° C).

In the current period of validity of the product can be stored for one month at 15 ° C - 25 ° C.

Keep out of the reach and sight of children.



6.5 Nature and contents of container



Pack sizes:

() 1 blister after 10 () capsules with powder 1 dose,

2 blisters of 10 capsules of powder after one dose

5 blisters of 10 capsules of powder after one dose.



Blister PVC / PVDC / aluminum or PVC / PE / PVDC / aluminum in a cardboard box.

Not all pack sizes may be marketed.





6.6 Special precautions for disposal of a medicinal product for use



Any unused product or waste material should be disposed of in accordance with local regulations.





7 MARKETING


"BIOMED-Lublin" Sera and Vaccines Manufacturing Joint Stock Company

20-029 Lublin, ul. University 10

tel 81 533 82 21

Fax 81 533 80 60

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