2659655

Nom de l'organisation

S.I.I.T. srl

SRN

IT-MF-000022188

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW010

  4. Contraindications Do not take in case of: - intestinal obstruction; - intestinal stenosis; - intestinal perforation; - inflammatory bowel disease (as an example Crohn's disease, ulcerative colitis). There is no experience on the assumption during pregnancy and lactation therefore take BRAND NAME only where necessary on medical advice. In patients with renal impairment is not necessary to adjust the dosage. The duration of treatment with BRAND NAME should not exceed 2 weeks. In case of need can be repeated treatment. Prolonged use may be necessary in case of refractory and / or chronic constipation. Such constipation can be caused by drugs, painkillers (opioids) and for the treatment of Parkinson's (anticholinergics) or appear in the case of diseases such as multiple sclerosis or Parkinson's disease may cause refractory constipation

Marché principal en Italie ; disponible dans 2 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

D-060080867G

Basic UDI-DI

B-060080867G

Numéro de référence/catalogue

2659655

Entité d'attribution

EUDAMED

Catégorie de risque

Classe IIa

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Makrogol 3350 balance is a laxative medical device that, through osmotic action, regulates the bowels in a natural way. It is not absorbed nor ferments in the gut, does not irritate the mucosa and is eliminated in the faeces. Makrogol 3350 balance is particularly suitable in cases of occasional and chronic constipation. In fact, thanks to its affinity for water, Makrogol 3350 balance softens stools facilitating the evacuation without causing cramps or abdominal pain, or emergency conditions. Its effectiveness is not reduced over time. 1.1 Components Each sachet contains: functional ingredient: Macrogol 3350. 2. Package Makrogol 3350 balance comes in powder for oral solution. The box contains X disposable sachets. 3. Dosage and method for use Children > 2 to 11 year (from 12 kg to 20 kg): 1-2 sachets (10 g each) per day. Children over 11 years and adults (or above 20 kg): 1-3 sachets (10 g each) per day.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

Santé des certificats sur le portefeuille de ce fabricant.