SOLU CORTEF 500

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HYDROCORTISONE AS SODIUM SUCCINATE

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

H02AB09

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJ/INF

Composition:

HYDROCORTISONE AS SODIUM SUCCINATE 500 MG/VIAL

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

PFIZER MANUFACTURING BELGIUM NV/SA

Therapeutic group:

HYDROCORTISONE

Therapeutic area:

HYDROCORTISONE

Therapeutic indications:

Solu-Cortef is indicated to treat any condition in which IM or IV corticosteroid treatment is required such as: - allergic states, - dermatologic diseases, - endocrine disorders, - gastrointestinal diseases,- hematologic disorders, - neoplastic diseases, - nervous system disorders, - ophthalmic diseases, - renal diseases, - respiratory diseases, - rheumatic disorders,- certain medical emergencies.

Authorization date:

2023-08-31

Patient Information leaflet

רזייפ
יא ףא יפ
מ"עב לארשי הקיטבצמרפ
רקנש 'חר
9
.ד.ת ,
12133
לארשי ,חותיפ הילצרה
46725
:לט
972-9-9700500
:סקפ
972-9-9700501
ירפא
ל
2021
,ה/דבכנ ת/חקור ,ה/אפור
והל וננוצרב
כדע לע ךעיד
םינו
ולעב
ן
אפורל
לש
רישכתה
SOLU CORTEF 500
:
קזוחו בכרה
:
Hydrocortisone (as sodium succinate) 500mg
יוותה
:ה
Solu-Cortef is indicated to treat any condition in which IM or IV
corticosteroid treatment is required
such as: allergic states, dermatologic diseases, endocrine disorders,
gastrointestinal diseases,
hematologic disorders, neoplastic diseases, nervous system disorders,
ophthalmic diseases, renal
disorders, certain medical emergencies.
diseases, respiratory diseases, rheumatic ןלהל
ה
וכדע
ן
ירקיעה
רל ןולעב
סה אוה אפו
רמוח תר רמשמ
מ
רישכתה סממ
סותו
הרמחה תפ
:
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
DESCRIPTION
Each 4 ML contains (when mixed):
Hydrocortisone sodium succinate equiv. to 500 mg Hydrocortisone
Monobasic sodium phosphate monohydrate
Dibasic sodium phosphate dried
Benzyl alcohol added as preservative
Sodium hydroxide
Water for injections
The solvent, as part of the packaging presentation for the ACT-O-VIAL
™
system, is comprised of Water for
Injection only, and does not contain any preservative.
CONTRAINDICATIONS
…
SOLU-CORTEF
®
500 Sterile Powder is contraindicated for use in premature infants
because the formulation
contains benzyl alcohol.
WARNINGS
…
GENERAL:
This product contains benzyl alcohol which is potentially toxic when
administered locally to neural tissue.
Exposure to excessive amounts of benzyl alcohol has been associated
with toxicity (hypotension, metabolic
acidosis), particularly in neonates, and an increased incidence of
kernicterus, particularly in small preterm
infants. There have been rare reports of deaths, primarily in prete

Summary of Product characteristics

Solu Cortef 100 mg LPD CC 13 June 2021
1
2019-0050135
SOLU CORTEF
® 100 MG
NAME OF THE MEDICINAL PRODUCT
SOLU CORTEF
®
100 MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in SOLU CORTEF
®
is hydrocortisone sodium succinate equivalent
to 100 mg hydrocortisone.
For the full list of excipients, see section "
DESCRIPTION
" below.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION
DESCRIPTION
SOLU CORTEF
®
Sterile Powder is an anti-inflammatory glucocorticoid that contains
hydrocortisone sodium succinate as the active ingredient. SOLU CORTEF
®
is available
in several packages for intravenous or intramuscular administration.
100 MG PLAIN VIAL
Each vial contains Hydrocortisone sodium succinate equivalent to 100
mg
hydrocortisone.
Monobasic sodium phosphate monohydrate 0.9 mg
Dibasic sodium phosphate dried 8.8mg
Sodium Hydroxide
Water for injections
SOLU CORTEF 100 mg plain does not contain diluent (see
DOSAGE AND
ADMINISTRATION
,
PREPARATION OF SOLUTIONS
).
When necessary, the pH was adjusted with sodium hydroxide so that the
pH of the
reconstituted solution is within the USP specified range of 7 to 8.
The chemical name for hydrocortisone sodium succinate is
pregn-4-ene-3,20-dione,21-
(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11β)-
and its molecular
weight is 484.52.
The structural formula is represented below:
Solu Cortef 100 mg LPD CC 13 June 2021
2
2019-0050135
Hydrocortisone sodium succinate is a white or nearly white, odorless,
hygroscopic
amorphous solid. It is very soluble in water and in alcohol, very
slightly soluble in
acetone, and insoluble in chloroform.
CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are
readily absorbed from the gastrointestinal tract.
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-
retaining properties, are used as replacement therapy in
adrenocortical deficiency states.
Their synthet