Depo-Medrone 120mg/3ml suspension for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methylprednisolone acetate

Available from:

Pfizer Ltd

ATC code:

H02AB04

INN (International Name):

Methylprednisolone acetate

Dosage:

40mg/1ml

Pharmaceutical form:

Suspension for injection

Administration route:

Intraarticular; Intrabursal; Periarticular; Intramuscular; Intralesional

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010202; GTIN: 5012882007072 5012882007089

Patient Information leaflet

Page 1 of 23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEPO-MEDRONE
® 40 MG/ML
methylprednisolone acetate
[company logo]
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION 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
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 ARE GIVEN DEPO-MEDRONE
3.
HOW DEPO-MEDRONE IS GIVEN TO YOU
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DEPO-MEDRONE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT DEPO-MEDRONE IS AND WHAT IT IS USED FOR
Depo-Medrone contains methylprednisolone acetate.
Methylprednisolone belongs to a group of medicines called
corticosteroids or steroids.
Corticosteroids are produced naturally in your body and are important
for many body
functions.
Boosting your body with extra corticosteroid such as Depo-Medrone can
help when injected
into the body by a doctor or nurse, such as in or near a joint, to
treat local symptoms caused
by inflammatory or rheumatic conditions such as:

BURSITIS: inflammation in the fluid containing spaces around the
shoulder, knee
and/or elbow joints. For this condition this medicine will be injected
directly into one
or more of these spaces.

OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS: inflammation located in
between the
joints. For these conditions this medicine will be injected directly
into one or more
joint spaces.

PLANTAR FASCIITIS: inflammation of the tissues of the sole of the
foot.

SKIN PROBLEMS: such as alopecia areata (patchy baldness), keloids
(scar tissue),
lichen planus or simplex (small, purplish raised patches of skin or
spots), discoid
lupus (round-shaped patches, often on the face) or granuloma annulare
(circular warty
growths).

EPICON

Summary of Product characteristics

OBJECT 1
DEPO-MEDRONE 40MG/ML PL 00057/0963
Summary of Product Characteristics Updated 15-May-2018 | Pfizer
Limited
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. Clinical particulars
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,
intrabursal, intralesional or into the tendon sheath. It must not be
used by the intrathecal or intravenous
routes (see section 4.3 and section 4.8).
INTRAMUSCULAR ADMINISTRATION:
1. Rheumatic disorders
Rheumatoid arthritis
2. Collagen diseases/arteritis
Systemic lupus erythematosus
3. Dermatological diseases
Severe erythema multiforme (Stevens-Johnson syndrome)
4. Allergic states
Bronchial asthma
Severe seasonal and perennial allergic rhinitis
Drug hypersensitivity reactions
Angioneurotic oedema
5. Gastro-intestinal diseases
Ulcerative colitis
Crohn's disease
6. Respiratory diseases
Fulminating or disseminated tuberculosis (with appropriate
antituberculous chemotherapy)
Aspiration of gastric contents
7. Miscellaneous
TB meningitis (with appropriate antituberculous chemotherapy)
INTRA-ARTICULAR ADMINISTRATION:
Rheumatoid arthritis
Osteo-arthritis with an inflammatory component
SOFT TISSUE ADMINISTRATION (INTRABURSAL, PERIARTICULAR, INTO TENDON
SHEATH):
Synovitis not associated with infection
Epicondylitis
Tenosynovitis
Plantar fasciitis
Bursitis
INTRALESIONAL:
Keloids
Localized lichen planus
Localized lichen simplex
Granuloma annulare
Discoid lupus erythematosus
Alopecia areata
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
d