NEOFORDEX Tablet (2018)
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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
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
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