MEDOPRED Tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Medopred 5 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains prednisolone 5 mg. <u>Excipient with known effect:</u> lactose monohydrate. Each Medopred tablet contains 105.0mg mg lactose monohydrate. For the full list of excipients, see section ...
3. Pharmaceutical form
Tablet. Tablets are white, round, flat, scored tablets, 7 mm diameter.
4.1. Therapeutic indications
<u>Allergy and anaphylaxis:</u> bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis. <u>Arteritis/collagenosis:</u> giant cell arteritis/polymyalgia rheumatica, ...
4.2. Posology and method of administration
Posology The initial dosage of prednisolone may vary from 5mg to 60mg daily depending on the disorder being treated. Divided daily dosage is usually used. The following therapeutic guidelines should be ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Systemic infections unless specific anti-infective therapy is employed. Ocular herpes simplex because of possible ...
4.4. Special warnings and precautions for use
Patients/and or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of ...
4.5. Interaction with other medicinal products and other forms of interaction
Vaccines Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished. Antacids The absorption of prednisolone may be ...
4.6. Pregnancy and lactation
Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however, 88% of prednisolone is inactivated as it crosses the placenta. Administration of corticosteroids ...
4.7. Effects on ability to drive and use machines
The effect of prednisolone on the ability to drive or use machinery has not been evaluated. There is no evidence to suggest that prednisolone may affect these abilities.
4.8. Undesirable effects
A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, ...
4.9. Overdose
Symptoms Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. High systemic doses of corticosteroids caused by chronic use have been associated with adverse effects ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Corticosteroids for systemic use <b>ATC code:</b> H02AB06 Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, ...
5.2. Pharmacokinetic properties
Prednisolone is rapidly and apparently almost completely absorbed after oral administration; it reaches peak plasma concentrations after 1-3 hours. There is however wide inter-subject variation suggesting ...
5.3. Preclinical safety data
Not applicable.
6.1. List of excipients
Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate Magnesium stearate
6.2. Incompatibilities
None stated.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C in the original package, in order to protect from light.
6.5. Nature and contents of container
Tablets are packed in blisters of polyvinylchloride film and aluminium foil. Packs containing 50, 100, 500 or 1000 tablets, with a patient information leaflet are available. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
11559
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 23/11/1987 Date of Renewal: 30/11/2010
10. Date of revision of the text
04/2021
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