DEPO-MEDRONE Suspension for injection (2021)
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Περιεχόμενα
1. Name of the medicinal product
Depo-Medrone 40 mg/ml.
2. Qualitative and quantitative composition
Methylprednisolone acetate 40 mg/ml. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for Injection. White, sterile, white aqueous suspension.
4.1. Therapeutic indications
Depo-Medrone may be used locally or systemically, particularly where oral therapy is not feasible. Depo-Medrone may be used by any of the following routes: intramuscular, intra-articular, periarticular, ...
4.2. Posology and method of administration
Depo-Medrone should not be mixed with any other suspending agent or solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever ...
4.3. Contraindications
Depo-Medrone is contraindicated: in patients with known hypersensitivity to the active substance or to any of the excipients listed in section 6.1 in patients who have systemic infection unless specific ...
4.4. Special warnings and precautions for use
Warnings and Precautions Undesirable effects may be minimised by using the lowest effective dose for the minimum period. Frequent patient review is required to appropriately titrate the dose against disease ...
4.5. Interaction with other medicinal products and other forms of interaction
Methylprednisolone is a cytochrome P450 enzyme (CYP) substrate and is mainly metabolized by the CYP3A enzyme. CYP3A4 is the dominant enzyme of the most abundant CYP subfamily in the liver of adult humans. ...
4.6. Fertility, pregnancy and lactation
Fertility Corticosteroids have been shown to impair fertility in animal studies (see section 5.3). Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however, ...
4.7. 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 ...
4.8. Undesirable effects
The incidence of predictable undesirable side effects associated with the use of corticosteroids, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, ...
4.9. Overdose
Following overdosage the possibility of adrenal suppression should be guarded against by gradual diminution of dose levels over a period of time. In such event the patient may require to be supported during ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Glucocorticoids <b>ATC code:</b> H02AB04 Methylprednisolone acetate is a synthetic glucocorticoid. It has greater anti-inflammatory potency than prednisolone and less ...
5.2. Pharmacokinetic properties
Absorption One in-house study of eight volunteers determined the pharmacokinetics of a single 40 mg intramuscular dose of Depo-Medrone. The average of the individual peak plasma concentrations was 14.8 ...
5.3. 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 ...
6.1. List of excipients
Polyethylene glycol Sodium chloride Myristyl-gamma-picolinium chloride Water for injections
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Do not store above 25°C. Do not freeze.
6.5. Nature and contents of container
Type I flint glass vial with a butyl rubber plug and metal seal. Each vial contains 1 ml, 2 ml, or 3 ml of Depo-Medrone 40 mg/ml.
6.6. Special precautions for disposal and other handling
Depo-Medrone should not be mixed with any other fluid. Discard any remaining suspension after use.
7. Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
8. Marketing authorization number(s)
PL 00057/0963
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 7 March 1989 Date of latest renewal: 5 September 1996
10. Date of revision of the text
04/2021
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