REFLUXAID. anti-reflux syrup for Paediatric use MEDICAL DEVICE
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1 anti-reflux syrup for Paediatric use MEDICAL DEVICE
2 Innovative and safe anti-reflux oral syrup based on a proprietary high-viscosity magnesium alginate. Refluxaid Nipio is used for the treatment of reflux and regurgitation in infants and young children (range 0 3 years old). Refluxaid Nipio works as a long lasting physical barrier which actively protects the baby oesophagus from the reflux symptoms.
3 Refluxaid Nipio is designed for brestfed, bottlefed infants and young children, and it is indicated to limit the following symptoms: burning sensation (heartburn) regurgitation difficulty swallowing (dysphagia) painful swallowing (odynophagia) cough hoarseness
4 KEY POINTS High viscosity alginate low concentration Natural based formulation Patented manufacture technology Clinical studies in progress Antacid free Sodium free Sugar, lactose, gluten, OGM free Worldwide distribution
5 Refluxaid Nipio is a HI-TECH last generation product made of selected raw materials having unique performances compared to other alginate formulations. Viscosity (centipoise) REFLUXAID 500 Other alginates COMPOSITION Magnesium alginate Xanthan gum Sucralose Methyl p-hydroxybenzoate Propyl p-hydroxybenzoate Purified water
6 REFLUXAID NIPIO FOR PRESCRIPTIONERS Around 50% of all babies at any latitude will experience some reflux during their first three months of life. Silent reflux: some babies can also suffer from silent reflux, a condition where no outward symptoms appear which can make diagnosis difficult. Babies show signs of being in pain, especially when not upright, and may have an associated persistent cough. REFLUXAID Nipio in PAEDIATRY A safe and effective treatment based exclusively on a mechanical effect without any possible systemic toxicity AGE WEIGHT in kg POSOLOGY Newborns 5 1 ml about 5-10 minutes after brestfeeding. In case of regurgitation soon after brestfeeding, add 1 ml more. Up to ml always after meals and before years sleeping.
7 Gastroesophageal Reflux Disease in Children GERD is very common in children of all ages, but it is usually mild. Symptoms get better in most infants by age 12 months, and in nearly all children by 24 months. Children with the following conditions are at higher risk for severe GERD: Neurological impairments Food allergies Scoliosis Cyclic vomiting Cystic fibrosis Problems in the lungs, ear, nose, or throat Symptoms Frequent regurgitation, irritability, arching the back, choking or gagging, and resisting feedings. In particular, a severe GERD may have dramatic complications such as anemia, failure to gain weight, or respiratory problems. Symptoms of severe GERD in infants may include: Failure to thrive Chronic coughing Frequent infections Wheezing Gasping, or frequently stopping breathing while asleep ( sleep apnea ) Severe vomiting: if it is green colored (bilious), it could be a symptom of a severe obstruction Complications Feeding problems: children tend to refuse food, and may be late in eating solid foods. Associations with Asthma and infections in the upper airways, including ear infections and sinusitis. Rare Complications Failure to thrive Anemia resulting from feeding problems and severe vomiting The acid backup inhaled into the airways may cause pneumonia The infant's life may be in danger if acid reflux causes spasms in the larynx severe enough to block the airways. This chain of events may contribute to the Sudden Infant Death Syndrome (SIDS).
8 Refluxaid Nipio is highly indicated to lower the PPIs posology in order to give a concrete patient support. MANAGING THE BABY REFLUX PPIs in association with H2 BLOCKERS PPIs appear to be safe and effective even for children as young as 1 year old who fail less intensive therapies. However, children treated with PPIs in association to H2 Blockers (famotidine, cimetidine, ranitidine) may have risk of developing respiratory and intestinal infections. ANTACIDS A long-term use of antacids in paediatry is generally not recommended due to important side-effects such as diarrhea or constipation. DOMPERIDONE This molecule is certainly effective, but there are important safety warnings (in EU and Canada) due to adverse cardiac events including QT prolongation and arrhythmias (March 2013). FDA has never approved domperidone for any indication.
9 Refluxaid Nipio: 150 ml syrup - with no added colours / flavours Equipped with a 5 ml syringe for best dosing. Refluxaid Nipio is highly palatable.
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