Depo-Medrone 40mg/ml with Lidocaine 10mg/ml Suspension for Injection, 1ml vial

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Methylprednisolone acetate; Lidocaine hydrochloride

Доступна с:

Pfizer Healthcare Ireland

код АТС:

H02AB; H02AB04

ИНН (Международная Имя):

Methylprednisolone acetate; Lidocaine hydrochloride

дозировка:

40 + 10 milligram(s)/millilitre

Фармацевтическая форма:

Suspension for injection

Тип рецепта:

Product subject to prescription which may not be renewed (A)

Терапевтические области:

Glucocorticoids; methylprednisolone

Статус Авторизация:

Not marketed

Дата Авторизация:

1983-07-05

тонкая брошюра

Page 1 of 13
2022-0083128
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEPO-MEDRONE 40 MG/ML WITH LIDOCAINE 10 MG/ML, SUSPENSION FOR
INJECTION
methylprednisolone acetate and lidocaine hydrochloride monohydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
DEPO-MEDRONE WITH LIDOCAINE IS A STEROID MEDICINE
, prescribed for many different conditions,
including serious illnesses.
•
YOU NEED TO TAKE IT REGULARLY
to get the maximum benefit.
•
DON’T STOP TAKING THIS MEDICINE
without talking to your doctor – you may need to reduce the
dose gradually.
•
DEPO-MEDRONE WITH LIDOCAINE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(see section 4). Some
problems such as mood changes (feeling depressed, or “high”), or
stomach problems can happen
straight away. If you feel unwell in any way, keep taking Depo-Medrone
with Lidocaine, but
SEE
YOUR DOCTOR STRAIGHT AWAY.
•
SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS
. These include weakness of arms and
legs, or developing a round face (see section 4 for more information).
•
IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE “STEROID
CARD”.
Always keep it with
you and show it to any doctor or nurse treating you.
•
KEEP AWAY FROM PEOPLE WHO HAVE CHICKENPOX OR SHINGLES,
if you have never had them. They
could affect you severely. If you do come into contact with chickenpox
or shingles,
SEE YOUR
DOCTOR STRAIGHT AWAY.
READ ALL OF THIS LEAFLET CAREFULLY.
It includes other important information on the safe and effective use
of this medicine that might be especially important for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT DEPO-MEDRONE WITH LIDOCAINE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU US

Характеристики продукта

Health Products Regulatory Authority
15 March 2023
CRN00DG0L
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
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 monohydrate 10 mg.
Each vial contains 40 mg methylprednisolone acetate and 10 mg
lidocaine hydrochloride monohydrate.
Excipient with known effect:
Benzyl alcohol: 8.7 mg per ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for Injection.
Sterile white aqueous suspension.
4 CLINICAL PARTICULARS
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 be considered advantageous.
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 prior to administration whenever
suspension and container permit.
Therapy with Depo-Medrone with Lidocaine does not obviate the need for
the conventional measures usually employed.
Although this method of treatment will ameliorate symptoms, it is in
no sense a cure and the hormone has no effect on the
cause of the inflammation.
Depo-Medrone with Lidocaine may be used by any of the following
routes: intra-articular, periarticular, intrabursal, and into the
tendon sheath. It MUST NOT be used by the intrathecal or intravenous
routes (see sections 4.3 and 4.8).
Undesirable effects may be minimised by using the lowest effective
dose for the minimum period (see section 4.4).
Depo-Medrone with Lidocaine vials are intended for single dose use
only.
_ _
_Intra‑articular:_ Rheumatoid arthritis, osteo-arthritis. The dose
of Depo‑Medrone with Lidocaine d