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ACTION AND MECHANISM Antidiarrheal. Bacterial microorganism. It works by replacing the pathogenic flora of the intestine with one similar to the physiological flora. SPECIAL WARNINGS - Evaluate the patient if diarrhea persists for more than 2 days or if blood appears in the stool or fever develops, reconsidering the treatment and the need to introduce oral or parenteral rehydration. Cases of fungemia have been reported in patients treated with Saccharomyces boulardii, including some fatal cases in critically ill patients. Therefore, its use is contraindicated in critically ill patients, immunocompromised patients, and patients with central venous catheters. Furthermore, patients in close proximity to those being treated with S. boulardii may also be exposed to the risk of contamination by the microorganisms in the product. Consequently, special care should be taken when handling the product in the presence of critically ill or immunocompromised patients, or patients with central or peripheral venous catheters who are not receiving this product. To prevent contamination via hands or airborne transmission of microorganisms, sachets or capsules should not be opened in patient rooms. Healthcare professionals should wear gloves when handling the probiotics and then dispose of them promptly and wash their hands thoroughly. PATIENT ADVICE - Notify your doctor and/or pharmacist if diarrhea persists for more than 2 days or if blood appears in the stool or fever develops. CONTRAINDICATIONS - Hypersensitivity to the active ingredient, to yeasts (especially Saccharomyces boulardii) or to any of the excipients. - Patients with a central venous catheter. - Seriously ill patients or those with [IMMUNODEFICIENCY] due to a risk of fungemia (see Precautions). PREGNANCY There are no data in pregnant women. Therefore, as a precaution, the benefit/risk ratio should be assessed before taking this medication during pregnancy. INDICATIONS - Symptomatic treatment of acute nonspecific [DIARRHEA] and in the prevention and symptomatic treatment of diarrheal processes caused by the administration of antibiotics. INTERACTIONS - Oral or systemic antifungal treatments, due to the fungal nature of the yeast Saccharomyces boulardii. Avoid concurrent administration. - Very hot drinks or foods (above 50ºC), ice cream, or foods containing alcohol should be avoided, as Saccharomyces boulardii contains live cells. Avoid administering Saccharomyces boulardii with these types of drinks or foods. LACTATION There are no data regarding its use in breastfeeding women. Although Saccharomyces boulardii is not absorbed, it is preferable to assess the benefit/risk ratio before using it during breastfeeding. GUIDELINES FOR PROPER ADMINISTRATION - Sachets: Dissolve the contents of the sachets in a glass of water. Drink immediately afterwards. POSOLOGY Granule dosage for oral suspension - Adults and adolescents > 18 years: 250-500 mg/24 h, divided into 2 doses in the morning and at night. - Children < 12 years: 250 mg/24 h. Use under medical supervision in children < 2 years. - Elderly: no specific dosage recommendations have been established. PRECAUTIONS - Infection. Very rare cases of fungemia with fever (and positive blood cultures for Saccharomyces strains) have occurred, mainly in patients with central venous catheters who are critically ill or immunocompromised. In most cases, the patient recovered upon discontinuation of treatment, administration of antifungals, and removal of the catheter when necessary. However, fatal cases have been reported (see Contraindications). Pay special attention to handling the medication in the presence of patients, mainly those with a central venous catheter, but also those with a peripheral catheter, even if they are not receiving treatment with Saccharomyces boulardii, to avoid any contamination through the hands or the spread of microorganisms through the air. PRECAUTIONS RELATING TO EXCIPIENTS This medicine contains lactose. Patients with hereditary lactose or galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. ADVERSE REACTIONS Adverse reactions are described according to each frequency interval, being considered very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data). - Digestive: rare [FLATULENCE]. - Infectious: very rare fungemia in patients with a central venous catheter and in critically ill or immunocompromised patients (see Precautions and Contraindications). - Allergic: very rare [HYPERSENSITIVITY REACTIONS], with [PRURITUS], [URTICARIA], [EXANTHEMATOUS ERUPTIONS], [ANGIOEDEMA] or [ANAPHYLAXIS].
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