Methylprednisolone sodium succinate 500mg powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methylprednisolone sodium succinate

Available from:

Kent Pharma (UK) Ltd

ATC code:

H02AB04

INN (International Name):

Methylprednisolone sodium succinate

Dosage:

500mg

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intravenous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 5060061160667

Patient Information leaflet

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481384/1216
148 x 560 mm
Black
P.273
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METHYLPREDNISOLONE 500 MG POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION/INFUSION
METHYLPREDNISOLONE 1000 MG POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION/INFUSION
Methylprednisolone sodium succinate
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
please ask your doctor or pharmacist
•
This medicine has been prescribed
for you. Do not pass it on to others. It
may harm them even if their signs of
illness are the same as yours
•
If you get any side effects, talk to
your doctor or pharmacist. This
includes any side effects not listed in
this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Methylprednisolone is and
what it is used for
2. What you need to know before you
are given Methylprednisolone
3. How Methylprednisolone is given to
you
4. Possible side effects
5. How to store Methylprednisolone
6. Contents of the pack and other
information.
1.
W
HAT
M
ETHYLPREDNISOLONE IS AND
WHAT IT IS USED FOR
Methylprednisolone contains
methylprednisolone sodium succinate.
Methylprednisolone belongs to a group
of medicines called corticosteroids
(steroids). Corticosteroids are produced
naturally in your body and are
important for many body functions.
Boosting your body with extra
corticosteroid such as
Methylprednisolone can help following
surgery (e.g. organ transplants), flare-
ups of the symptoms of multiple
sclerosis or other stressful conditions.
These include inflammatory or allergic
conditions affecting the:
•
BRAIN caused by a tumour or
meningitis
•
BOWEL and GUT e.g. ‘Crohn’s disease’
and ‘ulcerative colitis’
•
LUNGS caused by asthma, severe
allergy or hypersensitivity,
tuberculos

Summary of Product characteristics

OBJECT 1
METHYLPREDNISOLONE 500 MG POWDER AND SOLVENT
FOR SOLUTION FOR INJECTION/INFUSION
Summary of Product Characteristics Updated 25-Jan-2017 | Beacon
Pharmaceuticals
1. Name of the medicinal product
Methylprednisolone 500 mg powder and solvent for solution for
injection/infusion
2. Qualitative and quantitative composition
Each vial of powder contains methylprednisolone sodium succinate 663.0
mg equivalent to 500 mg of
methylprednisolone. After reconstitution in water for injections, each
ml of solution contains the
equivalent of 59.6 mg of methylprednisolone.
Each ampoule of solvent contains 7.8 ml of water for injections.
Sodium content: the 500 mg methylprednisolone vials contain the
equivalent of 37.4 mg (1.6 mmol) of
sodium.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Powder and solvent for solution for injection/infusion.
Each vial of methylprednisolone sodium succinate contains a white or
almost white amorphous powder.
Each ampoule of solvent contains water for injections.
4. Clinical particulars
4.1 Therapeutic indications
Methylprednisolone powder and solvent for injection/infusion is
indicated to treat any condition in which
rapid and intense corticosteroid effect is required such as:
1. Dermatological disease
Severe erythema multiforme (Stevens Johnson syndrome)
2. Allergic states
Bronchial asthma
Severe seasonal and perennial allergic rhinitis
Angioneurotic oedema
Anaphylaxis
3. Gastro intestinal diseases
Ulcerative colitis
Crohn's disease
4. Respiratory diseases
Aspiration of gastric contents
Fulminating or disseminated tuberculosis (with appropriate
antituberculous chemotherapy)
5. Neurological disorders
Cerebral oedema secondary to cerebral tumour
Acute exacerbations of multiple sclerosis superimposed on a
relapsing/remitting background.
6. Miscellaneous
T.B. meningitis (with appropriate antituberculous chemotherapy)
Transplantation
4.2 Posology and method of administration
Posology
Methylprednisolone powder for injection/infusion may be administered
intravenously or in