SOLU-MEDRONE Powder for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Solu-Medrone 125 mg or methylprednisolone sodium succinate for injection.
Qualitative and quantitative composition
<u>Solu-Medrone 125 mg:</u> Methylprednisolone sodium succinate 165.8 mg equivalent to 125 mg of methylprednisolone. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for injection.
Therapeutic indications
Solu-Medrone is indicated to treat any condition in which rapid and intense corticosteroid effect is required such as: Dermatological diseaseSevere erythema multiforme (Stevens-Johnson syndrome) Allergic ...
Posology and method of administration
Solu-Medrone may be administered intravenously or intramuscularly, the preferred method for emergency use being intravenous injection given over a suitable time interval. When administering Solu-Medrone ...
Contraindications
Solu-Medrone is contraindicated: In patients who have systemic fungal infections unless specific anti-infective therapy is employed and in cerebral oedema in malaria. In patients with known hypersensitivity ...
Special warnings and precautions for use
Immunosuppressant Effects/Increased Susceptibility to Infections Corticosteroids may increase susceptibility to infection, may mask some signs of infection, and new infections may appear during their use. ...
Interaction with other medicinal products and other forms of interaction
Methylprednisolone is a cytochrome P450 enzyme (CYP) substrate and is mainly metabolized by the CYP3A4 enzyme. CYP3A4 is the dominant enzyme of the most abundant CYP subfamily in the liver of adult humans. ...
Fertility, pregnancy and lactation
Fertility Corticosteroids have been shown to impair fertility in animal studies (see section 5.3). In women treatment with corticosteroids can lead to menstrual irregularities. Pregnancy The ability of ...
Effects on ability to drive and use machines
The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Undesirable effects, such as dizziness, vertigo, visual disturbances, and fatigue are possible ...
Undesirable effects
The following adverse reactions have been reported with the following routes of administration: Intrathecal/Epidural: Arachnoiditis, functional gastrointestinal disorder/bladder dysfunction, headache, ...
Overdose
There is no clinical syndrome of acute overdosage with corticosteroids. Reports of acute toxicity and/or death following overdosage of corticosteroids are rare. In the event of overdosage, no specific ...
Pharmacodynamic properties
Pharmacotherapeutic group: Glucocorticoids ATC code: H02AB04 Methylprednisolone is a corticosteroid with an anti-inflammatory activity at least five times that of hydrocortisone. An enhanced separation ...
Pharmacokinetic properties
Methylprednisolone pharmacokinetics is linear, independent of route of administration. Distribution Methylprednisolone is widely distributed into the tissues, crosses the blood-brain barrier, and is secreted ...
Preclinical safety data
Based on conventional studies of safety pharmacology and repeated dose toxicity, no unexpected hazards were identified. The toxicities seen in the repeated-dose studies were those expected to occur with ...
List of excipients
Sodium biphosphate Sodium phosphate
Incompatibilities
Not applicable.
Shelf life
Shelf-life of the medicinal product as packaged for sale: 5 years. After reconstitution with Sterile Water for Injections, use immediately, discard any remainder.
Special precautions for storage
This medicinal product does not require any special storage conditions. Refer to section 4.2. No diluents other than those referred to are recommended. Parenteral drug products should be inspected visually ...
Nature and contents of container
Type I clear glass vial with butyl rubber plug and flip top seal. Each vial of Solu-Medrone 125 mg contains the equivalent of 125 mg of methylprednisolone as the sodium succinate for reconstitution with ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/1046
Date of first authorization / renewal of the authorization
2<sup>nd</sup> February 2005
Date of revision of the text
12/2018
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