Hydrocortisone Panpharma 100mg powder for solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROCORTISONE SODIUM, SUCCINATE

Available from:

Panpharma Z.I. DU CLAIRAY, 35133 LUITRE, France

ATC code:

H02AB09

INN (International Name):

HYDROCORTISONE SODIUM SUCCINATE 133.7 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

HYDROCORTISONE SODIUM SUCCINATE 133.7 mg

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2018-01-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Hydrocortisone Panpharma 100 mg powder for solution for
injection/infusion
Hydrocortisone sodium succinate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Hydrocortisone Panpharma is and what it is used for
2. What you need to know before you are given Hydrocortisone Panpharma
3. How Hydrocortisone Panpharma is given to you
4. Possible side effects
5. How to store Hydrocortisone Panpharma
6. Contents of the pack and other information
1. WHAT HYDROCORTISONE PANPHARMA IS AND WHAT IT IS USED FOR
Hydrocortisone Panpharma 100 mg powder for solution for
injection/infusion contains hydrocortisone
as hydrocortisone sodium succinate.
Hydrocortisone belongs to a group of medicines called corticosteroids
or steroids. Corticosteroids are
produced naturally in your body and are important for many body
functions.
Boosting your body with extra corticosteroid such as Hydrocortisone
can help when injected by a doctor
or nurse to treat
SHOCK
following surgery, injuries, hypersensitivity (
ANAPHYLACTIC
) reactions or other
stressful conditions. These include inflammatory or allergic
conditions affecting the:
•
BOWEL
and
GUT
e.g. Crohn’s disease (inflammation of the gut) or ulcerative
colitis (inflammation
of the lower bowel)
•
LUNGS
e.g. bronchial asthma or inflammation caused by breathing in
(aspirating) vomit or
stomach contents
•
SKIN
e.g. Stevens-Johnson syndrome (an autoimmune disorder in which an
immune system
causes the skin to blister and peel), or systemic lupus erythematosus
(lupus)
You must talk to a doctor if you do not feel better or if you feel
worse or are unsure why you have been
given this medicine.
2.

Summary of Product characteristics

SUMMARY OF
PRODUCT
CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone Panpharma 100mg powder for solution for
injection/infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
vial
contains
Hydrocortisone
Sodium
Succinate
133.7
mg
equivalent
to
hydrocortisone 100.0 mg.
Excipient with known effect:
Each vial contains 6.2 mg (0.3mmol) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to almost white powder for parenteral use.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Anti-inflammatory agent.
Hydrocortisone Panpharma is indicated for any condition in which rapid
and intense
corticosteroid effect is required such as:
1.
_Collagen diseases_
Systemic lupus erythematosus
2.
_Dermatological diseases_
Severe erythema multiforme (Stevens-Johnson syndrome)
3.
_Allergic states_
Bronchial asthma, anaphylactic reactions
4.
_Gastro-intestinal diseases_
Ulcerative colitis, Crohn's disease
5.
_Respiratory diseases_
Aspiration of gastric contents
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Hydrocortisone
Panpharma
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, administered by intravenous injection over a period of one
to ten minutes.
This dose may be repeated at intervals of 2, 4 or 6 hours as indicated
by the patient's
response and clinical condition.
In general high-dose corticosteroid therapy should be continued only
until the patient's
condition has stabilised - usually not beyond 48 to 72 hours. If
hydrocortisone therapy
must be continued beyond 48 to 72 hours hypernatraemia may occur,
therefore it may
be
preferable
to
replace
Hydrocortisone
with
a
corticosteroid
such
as
me