DAXAS Tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Daxas 250 micrograms tablets.
Qualitative and quantitative composition
Each tablet contains 250 micrograms of roflumilast. Excipient with known effect: Each tablet contains 49.7 mg lactose (as monohydrate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to off-white, round tablet, 5 mm in diameter, embossed with D on one side and 250 on the other side.
Therapeutic indications
Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV<sub>1</sub> post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult ...
Posology and method of administration
Posology Starting dose The recommended starting dose is one tablet of 250 micrograms roflumilast to be taken once daily, for 28 days. This starting dose is intended to reduce adverse events and patient ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Moderate or severe hepatic impairment (Child-Pugh B or C).
Special warnings and precautions for use
All patients should be informed about the risks of Daxas and the precautions for safe use and should be given a patient card before starting Daxas. Rescue medicinal products Daxas is not indicated as rescue ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. A major step in roflumilast metabolism is the N-oxidation of roflumilast to roflumilast N-oxide by CYP3A4 and CYP1A2. Both roflumilast and roflumilast ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing age should be advised to use an effective method of contraception during treatment. Roflumilast is not recommended in women of childbearing potential ...
Effects on ability to drive and use machines
Daxas has no influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions are diarrhoea (5.9%), weight decreased (3.4%), nausea (2.9%), abdominal pain (1.9%) and headache (1.7%). These adverse reactions ...
Overdose
Symptoms In Phase I studies, the following symptoms were observed at an increased rate after single oral doses of 2,500 micrograms and one single dose of 5,000 micrograms (ten times the recommended dose): ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases <b>ATC code:</b> R03DX07 Mechanism of action Roflumilast is a PDE4 inhibitor, ...
Pharmacokinetic properties
Roflumilast is extensively metabolised in humans, with the formation of a major pharmacodynamically active metabolite, roflumilast N-oxide. Since both roflumilast and roflumilast N-oxide contribute to ...
Preclinical safety data
There is no evidence for an immunotoxic, skin sensitising or phototoxic potential. A slight reduction in male fertility was seen in conjunction with epididymal toxicity in rats. No epididymal toxicity ...
List of excipients
Lactose monohydrate Maize starch Povidone Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PVDC aluminium blisters in packs of 28 tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
AstraZeneca AB, SE-151 85 Södertälje, Sweden
Marketing authorization number(s)
EU/1/10/636/008 28 tablets
Date of first authorization / renewal of the authorization
Date of first authorisation: 05 July 2010 Date of latest renewal: 20 May 2020
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