REDIPRED Oral solution (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Redipred oral solution 5 mg/mL.
2. Qualitative and quantitative composition
Redipred contains 6.72 mg/mL of the active ingredient, prednisolone sodium phosphate (equivalent to prednisolone 5 mg/mL). For the list of excipients, see section 6.1.
3. Pharmaceutical form
Redipred is a preserved, raspberry flavoured, clear, colourless to slightly yellow aqueous solution.
4.1. Therapeutic indications
Redipred is used wherever corticosteroid therapy is indicated.
4.2. Posology and method of administration
The severity, prognosis, expected duration of the disease, and the patients reaction to medication are primary factors in determining dosage. Children Acute asthma requiring oral steroids 2 mg/kg at once, ...
4.3. Contraindications
Uncontrolled infections. Known hypersensitivity to prednisolone or prednisone, or any of the excipients in the oral liquid. Live virus immunisation.
4.4. Special warnings and precautions for use
Adrenocorticol insufficiency During prolonged corticosteroid therapy, adrenal suppression and atrophy may occur and secretion of corticotrophin may be suppressed. Duration of treatment and dosage appear ...
4.5. Interaction with other medicinal products and other forms of interaction
The following drug interactions with corticosteroids have been selected on the basis of their potential clinical significance: antacids, antidiabetic agents (oral or insulin), digitalis glycosides, diuretics, ...
4.6. Fertility, pregnancy and lactation
Pregnancy Category A. In animal experiments, corticosteroids have been found to cause malformations of various kinds (cleft palate, skeletal malformation) and abortion. These findings do not seem to be ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. ...
4.9. Overdose
Treatment is symptomatic with the dosage being reduced or the drug withdrawn. For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
5.1. Pharmacodynamic properties
Actions Prednisolone is a synthetic glucocorticoid with the general properties of the corticosteroids. Prednisolone exceeds hydrocortisone in glucocorticoid and anti-inflammatory activity, being about ...
5.2. Pharmacokinetic properties
Prednisolone is rapidly and well absorbed from the gastrointestinal tract following oral administration. REDIPRED Oral Solution produces a 20% higher peak plasma level of prednisolone which occurs approximately ...
5.3. Preclinical safety data
Not relevant.
6.1. List of excipients
Sorbitol solution (70 per cent)(non-crystallising), disodium edetate, dibasic sodium phosphate, monobasic sodium phosphate, methyl hydroxybenzoate, propyl hydroxybenzoate, nature identical raspberry flavour ...
6.2. Incompatibilities
Not relevant.
6.3. Shelf life
18 months. Once opened, Redipred is stable for 4 weeks. Product should not be used beyond the expiry date printed on the bottle.
6.4. Special precautions for storage
Store at or below 30°C.
6.5. Nature and contents of container
30 mL & 100 mL PET bottles. 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
Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand, Telephone: (09) 918 5100, Email: aspen@aspenpharma.co.nz
10. Date of revision of the text
29 March 2021
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