Vaxcel Methylprednisolone 1g for Injection

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

METHYLPREDNISOLONE SODIUM SUCCINATE

Available from:

KOTRA PHARMA (M) SDN. BHD.

INN (International Name):

METHYLPREDNISOLONE SODIUM SUCCINATE

Units in package:

10vial Vials; 1vial Vials

Manufactured by:

KOTRA PHARMA (M) SDN. BHD.

Summary of Product characteristics

MAL16025035AZ
METHYLPREDNISOLONE 1G
FOR INJECTION COMPOSITION:
Each vial contains: Methylprednisolone (as methylprednisolone sodium
succinate) 1g PRESENTATION:
A white or almost white, hygroscopic powder. The reconstituted
solution is clear and colourless. INDICATIONS:
Glucocorticoids should only be considered as a purely symptomatic
treatment, unless in case of some endocrine disorders, where
they are used as substitution treatment.
_Anti-Inflammatory Treatment :_
_Rheumatic Disorders (as adjunctive therapy for short-term
administration in the management of an acute episode or exacerbation)
: _
_Collagen Diseases (during an exacerbation or as maintenance therapy
in selected cases of) :_
_Dermatologic Diseases :_
_Allergic States (to control severe or incapacitating allergic
conditions intractable to adequate trials of conventional treatment
in) : _
_Ophthalmic Diseases (severe acute and chronic allergic and
inflammatory processes involving the eye) :_
_Gastrointestinal Diseases (to manage critical period of the disease
in) :_
- Ulcerative colitis (systemic therapy) - Crohn’s disease (systemic
therapy).
_Respiratory Diseases :_
_Edematous States :_
- To induce diuresis or remission of proteinuria in the nephrotic
syndrome, without uremia, of the idiopathic type or that due to lupus
erythematosus.
_Immunosuppressive Treatment :_
Organ transplantation.
_Treatment of Hematological and Oncological Disorders :_
_Hematologic Disorders :_
_Oncological Diseases (for palliative management of) :_
- Leukemias and lymphomas in adults - Acute leukemia of childhood.
_Treatment of Shock States :_
Shock secondary to adrenocortical insufficiency or shock unresponsive
to conventional therapy when adrenal cortical insufficiency
may be present. (Hydrocortisone is generally the drug of choice. When
mineralocorticoid activity is undesirable, methylprednisolone
may be preferred.) Hemorrhagic, traumatic and surgical shock
unresponsive to standard therapy. Although there are no well
controlled (double-blind placebo) clinical trials, da