Depo-Medrone 40 mg/ml Suspension for Injection 1 ml vial

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Methylprednisolone acetate

Tilgjengelig fra:

Pfizer Healthcare Ireland

ATC-kode:

H02AB; H02AB04

INN (International Name):

Methylprednisolone acetate

Dosering :

40 milligram(s)/millilitre

Legemiddelform:

Suspension for injection

Resept typen:

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

Terapeutisk område:

Glucocorticoids; methylprednisolone

Autorisasjon status:

Marketed

Autorisasjon dato:

1978-04-01

Informasjon til brukeren

Page 1 of 13
2022-0082236
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEPO-MEDRONE
® 40 MG/ML SUSPENSION FOR INJECTION
methylprednisolone acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
•
DEPO-MEDRONE 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 CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(read section 4. Possible side effects).
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, 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 (read section 4. Possible side effects 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
.
NOW READ THE REST OF THIS LEAFLET
. 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 or nurse.
- If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Depo-Medrone is and what it is used for
2.
What you need to know before you take Depo-Medrone
3.
How to take Depo-Medrone
4.
Possible side effects
5.
How to store Depo-Me

Preparatomtale

Health Products Regulatory Authority
25 September 2023
CRN00DGYF
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Depo-Medrone 40 mg/ml Suspension for Injection 1 ml vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Methylprednisolone acetate 40 mg/ml.
Each 1 ml vial contains 40mg methylprednisolone acetate.
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 is used in the management of corticosteroid disorders.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Depo‑Medrone may be used by any of the following routes:
intramuscular, intra‑articular, intralesional, intrarectal,
intrabursal,
periarticular or into the tendon sheath. It MUST NOT be used by the
intrathecal or intravenous routes (see section 4.3).
Undesirable effects may be minimised by using the lowest effective
dose for the minimum period (see section 4.4).
Depo‑Medrone vials are intended for single dose use only.
The following may serve as a guide:
_Adults:_ The usual dose is 20 to 120 mg daily or weekly, with
adjustment on the basis of the individual requirements of the
patient.
_ _
_Elderly:_ When used according to instructions, there is no
information to suggest that a change in dosage is warranted in the
elderly. Treatment of elderly patients, however, particularly if
long-term, should be planned bearing in mind the more serious
consequences of the common side-effects of corticosteroids in old age
and close clinical supervision is required (see section
4.4).
_Paediatric population: _Dosage depends principally on the condition
and to a lesser extent on body weight and age of the
patient.
_Intramuscular: _For sustained systemic effect:
- Allergic conditions (asthma, drug reactions); 80 – 120 mg (2 – 3
ml).
- Dermatological conditions; 40 – 120 mg (1 – 3 ml).
- Rheumatic disorders, collagen disease, SLE; 40 – 120 mg (1 – 3
ml) per week.
- Adrenogenital syndrome; 40