Solu-Medrone 2g powder and solvent for solution for injection vials

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Methylprednisolone sodium succinate

Disponível em:

Pfizer Ltd

Código ATC:

H02AB04

DCI (Denominação Comum Internacional):

Methylprednisolone sodium succinate

Dosagem:

2gram

Forma farmacêutica:

Powder and solvent for solution for injection

Via de administração:

Intramuscular; Intravenous

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 06030200; GTIN: 5012882001094

Folheto informativo - Bula

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PFIZER
SOLU-MEDRONE
® 2 GRAM
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, ask your doctor or pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT SOLU-MEDRONE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SOLU-MEDRONE
3.
HOW SOLU-MEDRONE IS GIVEN TO YOU
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SOLU-MEDRONE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SOLU-MEDRONE IS AND WHAT IT IS USED FOR
Solu-Medrone 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 Solu-Medrone can
help following surgery (e.g.
organ transplants), immediately following severe spinal injuries or
other stressful conditions.
These include inflammatory or allergic conditions affecting the:

BRAIN caused by a tumour or tuberculosis meningitis

BOWEL and GUT e.g. ‘Crohn’s disease’ and ‘ulcerative
colitis’

LUNGS caused by asthma, severe allergy or hypersensitivity,
tuberculosis or breathing in
(aspirating) vomit or stomach contents

SKIN e.g. Stevens-Johnson Syndrome.
Solu-Medrone may be prescribed to treat conditions other than those
listed above.
Talk to your doctor if you are unsure why you have been given this
medicine, if you do not feel better
or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SOLU-MEDRONE
DO NOT USE SOLU-MEDRONE:

If you think you have ever suffered an ALLERGIC REACTION, or any other
type of reaction after
being given Solu-

Características técnicas

OBJECT 1
SOLU-MEDRONE 2 GRAM
Summary of Product Characteristics Updated 14-Jun-2017 | Pfizer
Limited
1. Name of the medicinal product
Solu-Medrone 2 gram or methylprednisolone sodium succinate for
injection.
2. Qualitative and quantitative composition
Solu-Medrone 2 g: Methylprednisolone sodium succinate 2.652 grams
equivalent to 2 grams of
methylprednisolone.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for injection.
4. Clinical particulars
4.1 Therapeutic indications
Solu-Medrone 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
anti-tuberculous chemotherapy)
5. Neurological disorders
Cerebral oedema secondary to cerebral tumour
6. Miscellaneous
T.B. meningitis (with appropriate antituberculous chemotherapy)
Transplantation
7. Acute spinal cord injury. The treatment should begin within eight
hours of injury.
4.2 Posology and method of administration
Solu-Medrone may be administered intravenously or intramuscularly, the
preferred method for
emergency use being intravenous injection given over a suitable time
interval. When administering Solu-
Medrone in high doses intravenously it should be given over a period
of at least 30 minutes. Doses up to
250 mg should be given intravenously over a period of at least five
minutes.
For intravenous infusion the initially prepared solution may be
diluted with 5% dextrose in water, isotonic
saline solution, or 5% dextrose in isotonic saline solution. To avoid
compatibility problems with other
drugs Solu-Medrone should be administered separately, only in the
solutions mentioned.
Undesirable effects may be minimised by