CONSTELLA Hard capsule (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Constella 290 micrograms hard capsules.
Qualitative and quantitative composition
Each capsule contains 290 micrograms of linaclotide. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule. White to off-white-orange opaque capsule (18 mm x 6.35 mm) marked 290 with grey ink.
Therapeutic indications
Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
Posology and method of administration
Posology The recommended dose is one capsule (290 micrograms) once daily. Physicians should periodically assess the need for continued treatment. The efficacy of linaclotide has been established in double-blind ...
Contraindications
Hypersensitivity to linaclotide or to any of the excipients listed in section 6.1. Patients with known or suspected mechanical gastrointestinal obstruction.
Special warnings and precautions for use
Constella should be used after organic diseases have been ruled out and a diagnosis of moderate to severe IBS-C (see section 5.1) is established. Patients should be aware of the possible occurrence of ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Linaclotide is rarely detectable in plasma following administration of the recommended clinical doses and in vitro studies have shown that linaclotide is neither ...
Fertility, pregnancy and lactation
Pregnancy There is limited amount of data from the use of linaclotide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section ...
Effects on ability to drive and use machines
Constella has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Linaclotide has been given orally to 1,166 patients with IBS-C in controlled clinical studies. Of these patients, 892 patients received linaclotide at the recommended dose ...
Overdose
An overdose may result in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal product, mainly diarrhoea. In a study in healthy volunteers receiving a single dose ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for constipation, other drugs for constipation ATC Code: A06AX04 Mechanism of action Linaclotide is a Guanylate Cyclase-C receptor agonist (GCCA) with visceral analgesic ...
Pharmacokinetic properties
Absorption In general, linaclotide is minimally detectable in plasma following therapeutic oral doses and therefore standard pharmacokinetic parameters cannot be calculated. Following single doses of up ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and ...
List of excipients
Capsule contents: Microcrystalline cellulose Hypromellose 4-6 mPas – substitution type 2910 Calcium chloride dihydrate Leucine Capsule shell: Titanium dioxide (E171) Gelatin Red iron oxide (E172) Yellow ...
Incompatibilities
Not applicable.
Shelf life
Shelf life Unopened bottle for 28, 90 and multipack containing 112 (4 packs of 28) capsules: 3 years. Unopened bottle for 10 capsules: 2 years. After first opening: 18 weeks.
Special precautions for storage
Do not store above 30°C. Keep the bottle tightly closed in order to protect from moisture. The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry. Keep the canisters ...
Nature and contents of container
White high density polyethylene (HDPE) bottle with a tamper evident seal and a child-resistant closure, together with one or more desiccant canisters containing silica gel. Pack sizes: 10, 28 or 90 capsules ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology Park Dublin 17, D17 E400, Ireland
Marketing authorization number(s)
EU/1/12/801/001 EU/1/12/801/002 EU/1/12/801/004 EU/1/12/801/005
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 November 2012 Date of latest renewal: 28 August 2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
