METHYLPREDNISOLONE VIATRIS 1 G

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

METHYLPREDNISOLONE AS HEMISUCCINATE

Tilgængelig fra:

GENMEDIX , ISRAEL

ATC-kode:

H02AB04

Lægemiddelform:

LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Sammensætning:

METHYLPREDNISOLONE AS HEMISUCCINATE 1 G/VIAL

Indgivelsesvej:

I.V

Recept type:

Required

Fremstillet af:

VIATRIS SANTE, FRANCE

Terapeutisk gruppe:

METHYLPREDNISOLONE

Terapeutisk område:

METHYLPREDNISOLONE

Terapeutiske indikationer:

Methylprednisolone Mylan is indicated to treat any condition in which IV corticosteroid treatment is required such as: endocrine disorders, rheumatic disorders, collagen diseases, immune complex diseases, dermatologic diseases, allergic states, ophthalmic diseases, gastrointestinal diseases, respiratory diseases, hematologic disorders, management of neoplastic diseases, edematous states, nervous system disorders and organ transplantation.

Autorisation dato:

2017-08-31

Produktets egenskaber

Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
METHYLPREDNISOLONE VIATRIS 500 MG
METHYLPREDNISOLONE VIATRIS 1 G
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methylprednisolone Viatris 500 mg:
Methylprednisolone hemisuccinate:
633.50 mg
Quantity equivalent to methylprednisolone base: 500.00 mg
Per vial
Excipient with known effect
Methylprednisolone Viatris 500 mg contains 1.0 mmol (or 41 mg) sodium
per dose.
Methylprednisolone Viatris 1 g:
Methylprednisolone hemisuccinate: 1267.00 mg
Quantity equivalent to methylprednisolone base: 1000.00 mg
Per vial
Excipient with known effect
Methylprednisolone Viatris 1 g contains 2.0 mmol (or 81 mg) sodium per
dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilized powder for solution for injection or infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Methylprednisolone Viatris is indicated to treat any condition in
which IV corticosteroid treatment
is required such as: endocrine disorders, rheumatic disorders,
collagen diseases, immune complex
diseases, dermatologic diseases, allergic states, ophthalmic diseases,
gastrointestinal diseases,
respiratory diseases, hematologic disorders, management of neoplastic
diseases, edematous states,
nervous system disorders and organ transplantation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The first administration must be done in a hospital.
5 mg of prednisone is equivalent in terms of anti-inflammatory potency
to 4 mg of
methylprednisolone.
This proprietary medicinal product is not suitable for inhalation
using a nebulizer.
This drug is reserved for cases requiring high dose corticosteroid
therapy.
Page 2 of 26
Dosage:
•
acute symptoms of rheumatoid arthritis, extra-renal symptoms of
certain systemic diseases, certain
cases of systemic necrotizing vasculitis, initial treatment for
certain cases of glomerulopathy: 500
mg to 1 g per day,
•
organ transplantation, graft rejection: 10 to 15 mg/kg/day,
•
graft versus host reaction: 10 to 20 mg/kg/day and up t