ELMIRON 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
elmiron 100 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains 100 mg of pentosan polysulfate sodium. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule. White opaque capsules size 2.
Therapeutic indications
elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunners lesions in adults with moderate to severe pain, urgency and frequency of micturition (see ...
Posology and method of administration
Posology Adults The recommended dose of pentosan polysulfate sodium is 300 mg/day taken as one 100 mg capsule orally three times daily. Response to treatment with pentosan polysulfate sodium should be ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Due to the weak anticoagulant effect of pentosan polysulfate sodium, elmiron must not be used in patients who ...
Special warnings and precautions for use
Bladder pain syndrome is a diagnosis of exclusion and other urologic disorders should be eliminated by the prescriber, such as urinary tract infection or bladder cancer. Pentosan polysulfate sodium is ...
Interaction with other medicinal products and other forms of interaction
A study in healthy subjects revealed no pharmacokinetic or pharmacodynamic interactions between therapeutic doses of warfarin and pentosan polysulfate sodium. No further interaction studies have been performed. ...
Pregnancy and lactation
Pregnancy There are no data from the use of pentosan polysulfate sodium in pregnant women. Animal studies with respect to reproductive toxicity were not conducted. elmiron is not recommended during pregnancy. ...
Effects on ability to drive and use machines
Pentosan polysulfate sodium has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The following section lists adverse events reported in the literature from clinical studies with pentosan polysulfate sodium. The potential relatedness between these adverse ...
Overdose
In the case of an accidental overdose, patients should be evaluated for potential adverse effects of pentosan polysulfate sodium like gastrointestinal symptoms or bleeding. In case of adverse reactions, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Urologicals, other urologicals ATC code: G04BX15 Mechanism of action The hypothetic mechanism of action of pentosan polysulfate sodium includes a local effect in the bladder ...
Pharmacokinetic properties
Absorption Less than 10% of orally administered pentosan polysulfate sodium are slowly absorbed from the gastrointestinal tract and are available in systemic circulation in the form of unchanged pentosan ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional repeated dose toxicity, genotoxicity and long-term carcinogenicity studies. The effect of pentosan polysulfate sodium on reproductive ...
List of excipients
Capsule content: Microcrystalline cellulose Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171)
Incompatibilities
Not applicable.
Shelf life
<u>Bottle:</u> 3 years. After first opening: use within 45 days. <u>Blister:</u> 21 months.
Special precautions for storage
Bottle: Keep the bottle tightly closed in order to protect from moisture. For storage conditions after first opening of the bottle, see section 6.3. Blister: Do not store above 30°C.
Nature and contents of container
HDPE bottle with a tamper-evident child resistant closure of PP with 90 capsules. HDPE bottle with a tamper-evident child resistant closure of PP with 100 capsules. PVC/Aclar-Aluminium blister with 90 ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
bene-Arzneimittel GmbH, Herterichstrasse 1-3, D-81479 Munich, tel: ++49 (0) 89/7 49 87-0, fax: ++49 (0) 89/7 49 87-142, e-mail: contact@bene-arzneimittel.de
Marketing authorization number(s)
EU/1/17/1189/001 EU/1/17/1189/002 EU/1/17/1189/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 2 June 2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
