Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC: NEOFORDEX Tablets (2018)

Αναφορές

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

Περιεχόμενα

Name of the medicinal product

Neofordex 40 mg tablets.

Qualitative and quantitative composition

Each tablet contains dexamethasone acetate, equivalent to 40 mg dexamethasone. Excipient with known effect: Each tablet contains 98.1 mg lactose (as monohydrate). For the full list of excipients, see section ...

Pharmaceutical form

Tablet. White, oblong (11 mm × 5.5 mm) tablet with a score-line on one face. The tablet can be divided for administration of a 20 mg dose (see section 4.2).

Therapeutic indications

Neofordex is indicated in adults for the treatment of symptomatic multiple myeloma in combination with other medicinal products.

Posology and method of administration

Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma. Posology The dose and administration frequency varies with the therapeutic ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active viral disease (especially viral hepatitis, herpes, varicella, shingles). Uncontrolled psychoses. When ...

Special warnings and precautions for use

Neofordex is a high-dose glucocorticoid. This should be taken into consideration in the surveillance of the patient. The benefit from dexamethasone treatment should be carefully and continuously weighed ...

Interaction with other medicinal products and other forms of interaction

Prior to the use of Neofordex in combination with any other medicinal product, reference should be made to the Summary of Product Characteristics of that product. Pharmacodynamic interactions The following ...

Fertility, pregnancy and lactation

Women of childbearing potential Women should avoid pregnancy during Neofordex treatment. Dexamethasone may cause congenital malformations (see section 5.3). Dexamethasone may be used with known teratogens ...

Effects on ability to drive and use machines

Neofordex has moderate influence on the ability to drive and use machines. Dexamethasone may cause confusional state, hallucinations, dizziness, somnolence, fatigue, syncope and blurred vision (see section ...

Undesirable effects

Summary of the safety profile Adverse reactions to Neofordex correspond to the predictable safety profile of glucocorticoids. Hyperglycaemia, insomnia, muscle pain and weakness, asthenia, fatigue, oedema ...

Overdose

Acute toxicity of dexamethasone is weak and toxic effects have rarely been observed after an acute overdose. No antidote exists and treatment is symptomatic.

Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids ATC code: H02AB02 Mechanism of action Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects ...

Pharmacokinetic properties

Absorption After oral administration of Neofordex, dexamethasone peak plasma levels are reached at a median of three hours. Bioavailability of dexamethasone is approximately 80%. There is a linear relationship ...

Preclinical safety data

Glucocorticoids have only weak acute toxicity. No chronic toxicity and carcinogenicity data are available. Genotoxicity findings have been shown to be artefactual. In reproductive toxicity studies in mice, ...

List of excipients

Lactose monohydrate Microcrystalline cellulose Magnesium stearate Colloidal anhydrous silica

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions. Tablets should be kept in the blister package until administration. Individual tablets in intact packaging should be separated from ...

Nature and contents of container

10 1 tablets in OPA/Aluminium/PVC-Aluminium perforated unit dose blister. Pack size of 10 tablets.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Advise patients to not dispose of unused tablets through household waste or wastewater.

Marketing authorization holder

Laboratoires CTRS, 63, rue de l’Est, 92100 Boulogne-Billancourt, France, Email: ctrs@ctrs.fr

Marketing authorization number(s)

EU/1/15/1053/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 March 2016

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: