SOLU CORTEF 100 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

HYDROCORTISONE AS SODIUM SUCCINATE

Tilgjengelig fra:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC-kode:

H02AB09

Legemiddelform:

POWDER FOR SOLUTION FOR INJ/INF

Sammensetning:

HYDROCORTISONE AS SODIUM SUCCINATE 100 MG

Administreringsrute:

I.V, I.M

Resept typen:

Required

Produsert av:

PFIZER MANUFACTURING BELGIUM NV/SA

Terapeutisk gruppe:

HYDROCORTISONE

Terapeutisk område:

HYDROCORTISONE

Indikasjoner:

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.

Autorisasjon dato:

2023-11-30

Informasjon til brukeren

1
,ה/דבכנ ת/חקור ,ה/אפור
ינוי
2019
ןוכדע לע ךעידוהל וננוצרב
אפורל םינולעב
לש
SOLU CORTEF 100 MG
ו
-
SOLU CORTEF 500
.הרמחה העמשמ השגדה ,טסקט תקיחמ ועמשמ
הצוח וק ,טסקט תפסות ועמשמ יתחת וק
:קזוחו בכרה
Hydrocortisone (as sodium succinate) 100mg or 500mg
:היוותה
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.
:אפורל ןולעב םיירקיעה םינוכדעה ןלהל
PRECAUTIONS
OTHER:
Pheochromocytoma crisis, which can be fatal, has been reported after
administration of
systemic corticosteroids. In patients with suspected pheochromocytoma,
consider the
risk of pheochromocytoma crisis prior to administering
corticosteroids.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
No
adequate
studies
have
been
conducted
in
animals
to
determine
whether
corticosteroids have a potential for carcinogenesis or mutagenesis.
Steroids may increase or decrease motility and number of spermatozoa
in some
patients.
Corticosteroids have been shown to impair fertility in male rats.
ADVERSE REACTIONS
The following adverse reactions have been reported with SOLU-CORTEF or
other
corticosteroids:
…
Blood and lymphatic system disorders: Leukocytosis.
Neurologic/Psychiatric: …epidural lipomatosis.
Ophthalmic: Central serous chorioretinopathy…
םייונישה
מה
םישגדו
עקרב
בוהצ
םיווהמ
רמחה
ה
.
ומכ
ןכ
,
ועצוב
םייוניש
םיפסונ
םיללוכה
תפסות
עדימ
,
תטמשה
עדימ
ינוכדעו
חסונ
םניאש
םיווהמ
הרמחה
.
םינולעה
אפורל
םינונימהמ דחא לכ רובע
דרשמל וחלשנ םינ

Preparatomtale

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