YOVIS OS GRAT 10BUST 1G

YOVIS

active ingredients

Yovis 1 g Oral Suspension Granulate A sachet contains: Active ingredients: Live lyophilized lactic fermentations 1.0 g Lactic ferments have the following composition: Streptococcus salivarius subsp. thermophilus minimum 204 billion UFC Bifidobacteria (Bifidobacterium brevis), Bifidobacterium animalis lactis) minimum 93 billion UFC Lactobacillus acidophilus minimum 2 billion UFC Lactobacillus plantarum minimum 220 million UFC Lactobacillus paracasei minimum 220 million UFC Lactobacillus delbrueckii subsp. Bulgarian minimum 300 million UFC Enterococcus faecium minimum 30 million UFC Excipients with known effects: lactose and sucrose. A bag contains: lactose 2.0 g sucrose 63 mg Yovis 250 mg Oral Suspension Granulate A bag contains: Active ingredients: Live lactic fermentations 250 mg Lactic fermentations have the following composition: Streptococcus salivarius subsp. thermophilus minimum 48 billion UFC Bifidobacteria (Bifidobacterium brevis), Bifidobacterium animalis lactis) minimum 22 billion UFC Lactobacillus acidophilus minimum 460 million UFC Lactobacillus plantarum minimum 50 million UFC Lactobacillus paracasei minimum 50 million UFC Lactobacillus delbrueckii subsp. Bulgarian minimum 70 million UFC Enterococcus faecium minimum 7 million UFC Excipients with known effects: lactose and sucrose A bag contains: lactose 59 mg sucrose 21 mg Yovis 250 mg Hard capsules One capsule contains: Active ingredients: Live lactic fermentations 250 mg Lactic fermentations have the following composition: Streptococcus salivarius subsp. thermophilus minimum 48 billion UFC Bifidobacteria (Bifidobacterium brevis, Bifidobacterium animalis lactis) minimum 22 billion UFC Lactobacillus acidophilus minimum 460 million UFC Lactobacillus plantarum minimum 50 million UFC Lactobacillus paracasei minimum 50 million UFC Lactobacillus delbrueckii subsp. Bulgarian minimum 70 million UFC Enterococcus faecium minimum 7 million UFC Excipients with known effects: lactose and sucrose One capsule contains: lactose 23,6 mg sucrose 8,4 mg For full list of excipients, see paragraph 6.1.

Excellent

Yovis 1 g Oral suspension granulate: Lactose, cryoprotectives (powdered milk, lactose, sucrose, yeast extract, water, sick sodium, glutamate sodium, tween 80, ascorbic acid, silica). Yovis 250 mg Oral Suspension Granulate: Colloidal silica, magnesium stearate, corn starch, cryoprotective (scrammed milk powder, lactose, sucrose, yeast extract, water, sick sodium, glutamate sodium, tween 80, ascorbic acid, silica). Yovis 250 mg Hard capsules: colloidal silica, magnesium stearate, maize starch, gelatin, titanium dioxide, carmine indigo, yellow chinolina, cryoprotective (scrammed milk powder, lactose, sucrose, yeast extract, water, sick sodium, glutamate sodium, tween 80, ascorbic acid, silica).

Therapeutic indications

Intestinal dysmicrobial syndromes: diarrhoic syndromes and dispeptics from altered bacterial flora (diarrhea, aspecific enteritis, colitis); intestinal dysmicrobism from antibiotics.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Yovis 1 g granulate for oral suspension contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose–galactose mal absorption, should not take this medicine.

Population

Population Yovis 1 g Oral suspension granulate Adults: 1–3 sachets per day Yovis 250 mg Oral Suspension Granulate Adults: 4 sachets 1–3 times a day, preferably before meals Yovis 250 mg Hard capsules Adults: 4 capsules 1–3 times daily Pediatric population Yovis 1 g Oral suspension granulate Children 6–12 years: 1 sachet per day Yovis 250 mg Oral Suspension Granulate Children0–6 months: 1 sachet per day 6–12 months: 1–2 sachets per day 1–3 years: 2 sachets per day 3–6 years: 2–3 sachets per day 6–12 years: 4 sachets per day Yovis 250 mg Hard capsules Children0–6 months: 1 capsule per day 6–12 months: 1–2 capsules per day 1–3 years: 2 capsules per day 3–6 years: 2–3 capsules per day 6–12 years: 4 capsules per day Method of administration The contents of the envelopes can be dissolved in water or milk or other non-hot drink. The capsules are openable; the contents of the capsule can be dissolved in water or milk or other non-hot drink. The average duration of treatment is 1–2 weeks, according to medical advice.

Conservation

Store in the refrigerator (2°C – 8°C).

Warnings

Yovis 250 mg rigid capsules and Yovis 250 mg and 1 g granulate for oral suspension also contain sucrose. Patients suffering from rare hereditary problems of fructose intolerance, glucose–galactose mal absorption or isomaltase sucrasis failure, should not take this medicine. Yovis 1 g Oral Suspension Granulate contains 2 g lactose (1 g glucose and 1 g galactose) per dose; the recommended daily dosage (1–3 sachets) therefore provides 2–6 g lactose. To consider in people with diabetes mellitus. Patients with liver failure Data on the use of Yovis in patients with liver failure are not available. Patients with kidney failure Data on the use of Yovis in patients with kidney failure are not available. Other special populations Since rare cases of infectious complications occurred with the use of probiotics in patients at risk of severe acute pancreatis, caution is recommended in this population.

Interactions

Don't report.

Effects

Reactions tovverse have been identified by the clinical studies, literature and post-marketing of Yovis/Eptavis. The information is provided according to MedDRA system organ classification (SOC). Adverse events are classified according to the frequency: Very common (≥1/10), common (≥1/100, Classification for Systems and Organs according to MedDRA (SOC) Adverse reactions (Termine MedDRA Preferred [PT]) Frequency Gastrointestinal diseases constipation* abdominal pain Not common Pathologies of skin and subcutaneous tissue itching hives Notable *extended treatment Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.aifa.gov.it/content/segnalazioni–reactions–adverse.

Overdosing

No overdose reactions have been reported. Pediatric population No overdose reactions have been reported in the pediatric population.

Pregnancy Yovis can be used during pregnancy only under the direct control of the doctor. Food Yovis can be used during breastfeeding only under the direct control of the doctor. Fertility No fertility studies have been conducted.

Source: Farmadati