SOLU-MEDROL FOR INJECTION 500 mg8 ml

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
12-12-2023
Shusha Tabia za bidhaa (SPC)
22-11-2022

Viambatanisho vya kazi:

METHYLPREDNISOLONE SODIUM SUCCINATE EQV METHYLPREDNISOLONE

Inapatikana kutoka:

PFIZER PRIVATE LIMITED

ATC kanuni:

H02AB04

Kipimo:

500 mg/8 ml

Dawa fomu:

INJECTION, POWDER, FOR SOLUTION

Tungo:

METHYLPREDNISOLONE SODIUM SUCCINATE EQV METHYLPREDNISOLONE 500 mg/8 ml

Njia ya uendeshaji:

INTRAVENOUS, INTRAMUSCULAR

Dawa ya aina:

Prescription Only

Viwandani na:

PFIZER MANUFACTURING BELGIUM NV

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

1990-06-13

Taarifa za kipeperushi

                                SOLU-MEDROL
TABLE OF CONTENT
_Please click on either of the following links to access the required
information:_
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
1.
NAME OF THE MEDICINAL PRODUCT
SOLU-MEDROL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Methylprednisolone Sodium Succinate.
Methylprednisolone Sodium Succinate is available for IV or IM
administration as:
VIAL (MAY BE PACKAGED WITH A DILUENT)
500 mg/8 mL Vial containing methylprednisolone sodium succinate
equivalent to 500 mg
methylprednisolone.
1 g/16 mL Vial containing methylprednisolone sodium succinate
equivalent to 1 g
methylprednisolone.
2 g/32 mL Vial containing methylprednisolone sodium succinate
equivalent to 2 g
methylprednisolone.
Not all strengths may be available locally.
3.
PHARMACEUTICAL FORM
Sterile powder for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Methylprednisolone sodium succinate is indicated in the following
conditions:
ENDOCRINE DISORDERS

primary
or
secondary
adrenocortical
insufficiency
(in
conjunction
with
mineralocorticoids, where applicable);

acute adrenocortical insufficiency (mineralocorticoid supplementation
may be
necessary);

shock secondary to adrenocortical insufficiency, or shock unresponsive
to
conventional therapy when adrenal cortical insufficiency may be
present (when
mineralocorticoid activity is undesirable);

pre-operatively, or in the event of serious trauma or illness, in
patients with known
adrenal insufficiency or when adrenocortical reserve is doubtful;

congenital adrenal hyperplasia;

non-suppurative thyroiditis;

hypercalcemia associated with cancer.
RHEUMATIC DISORDERS
(as adjunctive therapy for short-term administration in the
management of an acute episode or exacerbation)

post-traumatic osteoarthritis;

synovitis of osteoarthritis;
Page 1 of 9

rheumatoid arthritis, including juvenile rheumatoid arthritis;

acute and subacute bursitis;

epicondylitis;

acute non-specific tenosynovitis;

acute gouty arthritis;

                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                SOLU-MEDROL
TABLE OF CONTENT
_Please click on either of the following links to access the required
information:_
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page 1 of 19
1.
NAME OF THE MEDICINAL PRODUCT
SOLU-MEDROL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Methylprednisolone Sodium Succinate.
Methylprednisolone Sodium Succinate is available for IV or IM
administration as:
VIAL (MAY BE PACKAGED WITH A DILUENT)
500 mg/8 mL Vial containing methylprednisolone sodium succinate
equivalent to
500 mg methylprednisolone.
1 g/16 mL Vial containing methylprednisolone sodium succinate
equivalent to 1 g
methylprednisolone.
2 g/32 mL Vial containing methylprednisolone sodium succinate
equivalent to 2 g
methylprednisolone.
Not all strengths may be available locally.
3.
PHARMACEUTICAL FORM
Sterile powder for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Methylprednisolone sodium succinate is indicated in the following
conditions:
ENDOCRINE DISORDERS

primary
or
secondary
adrenocortical
insufficiency
(in
conjunction
with
mineralocorticoids, where applicable);

acute adrenocortical insufficiency (mineralocorticoid supplementation
may be
necessary);

shock
secondary
to
adrenocortical
insufficiency,
or
shock
unresponsive
to
conventional therapy when adrenal cortical insufficiency may be
present (when
mineralocorticoid activity is undesirable);

pre-operatively, or in the event of serious trauma or illness, in
patients with known
adrenal insufficiency or when adrenocortical reserve is doubtful;

congenital adrenal hyperplasia;

non-suppurative thyroiditis;

hypercalcemia associated with cancer.
RHEUMATIC DISORDERS (as adjunctive therapy for short-term
administration in the
management of an acute episode or exacerbation)

post-traumatic osteoarthritis;

synovitis of osteoarthritis;
Page 2 of 19

rheumatoid arthritis, including juvenile rheumatoid arthritis;

acute and subacute bursitis;

epicondylitis;

acute non-specific tenosynovitis;

acute gout
                                
                                Soma hati kamili