DEPO-MEDRONE WITH LIDOCAINE Suspension for injection (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Depo-Medrone 40mg/ml with Lidocaine 10mg/ml Suspension for Injection, 1ml vial.
2. Qualitative and quantitative composition
Each ml contains methylprednisolone acetate 40 mg and lidocaine hydrochloride 10 mg. Each vial contains 40 mg methylprednisolone acetate and 10 mg lidocaine hydrochloride. <u>Excipient with known effect: ...
3. Pharmaceutical form
Suspension for Injection. Sterile white aqueous suspension.
4.1. Therapeutic indications
Depo-Medrone with Lidocaine is indicated in conditions requiring a glucocorticoid effect: e.g. anti-inflammatory or anti-rheumatic. It is recommended for local use where the added anaesthetic effect would ...
4.2. Posology and method of administration
Depo‑Medrone with Lidocaine should not be mixed with any other preparation as flocculation of the product may occur. Parenteral drug products should be inspected visually for particulate matter and discoloration ...
4.3. Contraindications
Depo-Medrone with Lidocaine is contraindicated: in patients with known hypersensitivity to the active substances, other local anaesthetics of the amide type, or to any of the excipients listed in section ...
4.4. Special warnings and precautions for use
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 activity (see section ...
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 Methylprednisolone Corticosteroids cross the placenta. Animal studies have shown reproductive ...
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
Methylprednisolone Following overdosage the possibility of adrenal suppression should be guarded against by gradual diminution of dose levels over a period of time. Further traumatic episodes during that ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Glucocorticoids <b>ATC Code:</b> H02AB04 <b>Pharmacotherapeutic group:</b> Anaesthetics <b>ATC Code:</b> N01BB02 Methylprednisolone Methylprednisolone acetate is a synthetic ...
5.2. Pharmacokinetic properties
No pharmacokinetic studies have been performed with the combination product of methylprednisolone and lidocaine, however, data are provided from pharmacokinetic studies performed with the individual product ...
5.3. Preclinical safety data
Methylprednisolone Based on conventional studies of safety pharmacology and repeat-dose toxicity studies, no unexpected hazards were identified. The toxicities seen in the repeat-dose studies are those ...
6.1. List of excipients
Macrogol Sodium chloride Miripirium chloride Benzyl alcohol (E1519) Water for injections Sodium hydroxide Hydrochloric acid
6.2. Incompatibilities
In the absence of stability studies this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
<u>Unopened:</u> 2 years. Once opened, use immediately.
6.4. Special precautions for storage
Do not store above 25°C. Do not freeze. Keep the vials in the outer carton in order to protect from light.
6.5. Nature and contents of container
Type I flint glass vials with a butyl rubber cap. Each vial contains 1 ml of suspension. Vials packed singly and in 10 vial packs. Not all pack sizes may be marketed.
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
Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PA0822/123/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 05 July 1983 Date of last renewal: 28 January 2006
10. Date of revision of the text
December 2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
