Solu-Cortef Powder for Solution for Injection or Infusion 100mg

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

HYDROCORTISONE PH. EUR.

Prieinama:

Pfizer Healthcare Ireland

ATC kodas:

H02AB; H02AB09

INN (Tarptautinis Pavadinimas):

HYDROCORTISONE PH. EUR.

Dozė:

100 milligram(s)

Vaisto forma:

Powder and solvent for solution for injection/infusion

Recepto tipas:

Product subject to prescription which may not be renewed (A)

Gydymo sritis:

Glucocorticoids; hydrocortisone

Autorizacija statusas:

Marketed

Leidimo data:

1978-04-01

Pakuotės lapelis

Page 1 of 11
2022-0082235
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOLU-CORTEF
® POWDER FOR SOLUTION FOR INJECTION OR INFUSION 100 MG
hydrocortisone (as sodium succinate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
SOLU-CORTEF IS A STEROID MEDICINE
, prescribed for many different conditions, including
serious illnesses.
•
YOU NEED TO TAKE IT REGULARLY
to get the maximum benefit.
•
DON’T STOP TAKING THIS MEDICINE
without talking to your doctor – you may need to reduce
the dose gradually.
•
SOLU-CORTEF CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(read section 4. Possible side effects).
Some problems such as mood changes (feeling depressed, or “high”),
or stomach problems
can happen straight away. If you feel unwell in any way, keep taking
Solu-Cortef, but
SEE
YOUR DOCTOR STRAIGHT AWAY.
•
SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS
. These include weakness of arms
and legs, or developing a round face (read section 4. Possible side
effects for more
information).
•
IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE “STEROID
CARD”:
always keep it
with you and show it to any doctor or nurse treating you.
•
KEEP AWAY FROM PEOPLE WHO HAVE CHICKENPOX OR SHINGLES,
if you have never had them.
They could affect you severely. If you do come into contact with
chickenpox or shingles,
SEE YOUR DOCTOR STRAIGHT AWAY.
NOW READ THE REST OF THIS LEAFLET.
It includes other important information on the safe and
effective use of this medicine that might be especially important for
you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Solu-Cortef is and what it is used for
2.
What you need to know before you are given Solu-Cortef
3.
How Solu-Cortef is given to you
4

Prekės savybės

Health Products Regulatory Authority
25 September 2023
CRN00DGYF
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solu-Cortef Powder for Solution for Injection or Infusion 100mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains hydrocortisone sodium succinate 133.7mg equivalent
to hydrocortisone 100.0mg. (50mg/ml when
reconstituted as recommended)
Excipient with known effect
Each vial contains 10.1 mg of sodium.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion
Or
Powder and solvent for solution for injection or infusion
Vial containing white to off-white powder and vial containing sterile
water for injections.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solu-Cortef is indicated for any condition in which rapid and intense
corticosteroid effect is required such as:
1.
Endocrine disorders
Primary or secondary adrenocortical insufficiency.
2.
Collagen diseases
Systemic lupus erythematosus.
3.
Dermatological diseases
Severe erythema multiforme (Stevens-Johnson syndrome).
4.
Allergic states
Bronchial asthma, anaphylactic reactions.
5.
Gastro-intestinal diseases
Ulcerative colitis, Crohn’s disease.
6.
Respiratory diseases
Aspiration of gastric contents.
7.
Medical emergencies
Solu-Cortef is indicated in the treatment of shock secondary to
adrenocortical insufficiency or shock unresponsive to
conventional therapy when adrenocortical insufficiency may be present.
Health Products Regulatory Authority
25 September 2023
CRN00DGYF
Page 2 of 13
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Solu-Cortef may be administered by intravenous injection, by
intravenous infusion, or by intramuscular injection, the preferred
method for initial emergency use being intravenous injection.
Following the initial emergency period, consideration should be
given to employing a longer-acting injectable preparation or an oral
preparation.
Dosage usually ranges from 100 mg to 500 mg depending on the severity
of the condition, admini