BETNESOL Solution for injection (2021)
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Περιεχόμενα
1. Name of the medicinal product
Betnesol 4mg/ml Solution for injection. Betamethasone 4mg/ml Solution for injection.
2. Qualitative and quantitative composition
Each ampoule contains 5.3mg of betamethasone sodium phosphate equivalent to 4mg betamethasone in 1ml of sterile aqueous solution. <u>Excipients with known effect:</u> Sodium Metabisulphite contains 0.100% ...
3. Pharmaceutical form
Solution for injection. 1ml ampoules containing a clear colourless or pale yellow solution.
4.1. Therapeutic indications
Betamethasone is a glucocorticosteroid which is about eight to ten times as active as prednisolone on a weight-for-weight basis. It may be indicated in the following conditions: Status asthmaticus and ...
4.2. Posology and method of administration
Posology Systemic therapy in adults 4 to 20mg betamethasone (1 to 5ml) administered by slow intravenous injection over half to one minute. This dose can be repeated three or four times in 24 hours, or ...
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. Betnesol Injection/Betamethasone Injection ...
4.4. Special warnings and precautions for use
A patient information leaflet should be supplied with this product. Undesirable effects may be minimised by using the lowest effective dose for the minimum period and by administering the daily requirement ...
4.5. Interaction with other medicinal products and other forms of interaction
Steroids may reduce the effects of anticholinesterases in myasthenia gravis, cholecystographic X-ray media and non-steroidal anti-inflammatory agents. Rifampicin, rifabutin, carbamazepine, phenobarbitone, ...
4.6. Pregnancy and lactation
Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however, betamethasone readily crosses the placenta. Administration of corticosteroids to pregnant animals ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression, correlates with the relative potency of the drug, dosage, timing of administration and ...
4.9. Overdose
Management Should overdosage occur, the possibility of adrenal suppression should be minimised by a gradual reduction of dosage over a period of time. The patient may need support during any further trauma. ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Betamethasone sodium phosphate is an active corticosteroid with topical anti-inflammatory activity. ATC Code: H02AB01 Betamethasone is a glucocorticoid which is about eight to ...
5.2. Pharmacokinetic properties
Corticosteroids are bound to plasma proteins in varying degrees. Biotransformation Corticosteroids are metabolised primarily by the liver. Elimination Corticosteroids are excreted by the kidneys.
5.3. Preclinical safety data
None stated.
6.1. List of excipients
Disodium edetate Sodium metabisulphite Sodium chloride Sodium hydroxide Hydrochloric acid Water for injection
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
6.5. Nature and contents of container
1ml clear, one-point cut (OPC) colourless glass Type 1 Ph Eur ampoules packed in cartons of 5 ampoules.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden
8. Marketing authorization number(s)
PL 36301/0054
9. Date of first authorization / renewal of the authorization
22nd December 1992
10. Date of revision of the text
03/02/2021
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