MACLEODS HYDROCORTISONE INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Macleods Pharmaceuticals SA (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH VIAL CONTAINS HYDROCORTISONE SODIUM SUCCINATE EQUIVALENT TO HYDROCORTISONE 100,0 mg

Authorization status:

Registered

Authorization date:

2016-09-06

Patient Information leaflet

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APPROVED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
MACLEODS HYDROCORTISONE INJECTION
Contains hydrocortisone sodium succinate equivalent to 100 mg of
hydrocortisone
Contains phosphate buffer as excipient
This medicine contains less than 1 mmol sodium (23 mg) per vial that
is to say is essentially 'sodium
free'.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MACLEODS
HYDROCORTISONE
INJECTION
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
MACLEODS HYDROCORTISONE INJECTION has been prescribed for you
personally and
you should not share your medicine with other people. It may harm
them, even if their
symptoms are the same as yours.
WHAT IS IN THIS LEAFLET
1. What MACLEODS HYDROCORTISONE INJECTION is and what it is used for
2. What you need to know before you take MACLEODS HYDROCORTISONE
INJECTION
3. How to take MACLEODS HYDROCORTISONE INJECTION
4. Possible side effects
5. How to store MACLEODS HYDROCORTISONE INJECTION
6. Contents of the pack and other information
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1. WHAT MACLEODS HYDROCORTISONE INJECTION IS AND WHAT IT IS USED FOR
MACLEODS HYDROCORTISONE INJECTION is a corticosteroid medicine,
prescribed for many
different conditions, including serious illnesses, such as:
•
Shock as a result of your adrenal glands not producing enough
corticosteroids of their own.
•
Systemic lupus erythematosus (rash with fever, arthritis, inflammation
of blood vessels, kidney
problems and problems affecting the brain).
•
If the adrenal glands are not working properly for any reason, so that
the body does not make
enough of its own steroids naturally.
•
Allergic disorders and disorders of the immune system, where
antibodies are formed against
several different parts of the body.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MACLEODS HYDROCORTISONE
INJECTION
Do not take MACLEODS HYDROCORTISONE INJECT

Summary of Product characteristics

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APPROVED PROFESSIONAL INFORMATION
SCHEDULING STATUS: S4
1. NAME OF THE MEDICINE
MACLEODS HYDROCORTISONE INJECTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains hydrocortisone sodium succinate equivalent to 100
mg of hydrocortisone.
Contains phosphate buffer as excipient.
EXCIPIENTS:
This medicine contains less than 1 mmol sodium (23 mg) per vial that
is to say is essentially 'sodium
free'.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
A white powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MACLEODS HYDROCORTISONE INJECTION is indicated for any condition in
which a rapid and
intense corticosteroid effect is required, such as:
SEVERE SHOCK (ADJUNCTIVE THERAPY)
In severe shock adjunctive use of intravenous MACLEODS HYDROCORTISONE
INJECTION may
aid in achieving haemodynamic restoration. MACLEODS HYDROCORTISONE
INJECTION therapy
should not replace standard methods of combating shock, but present
evidence indicates that
concurrent use of large doses of corticoids with other measures may
improve survival rates.
ACUTE HYPERSENSITIVITY REACTIONS
In status asthmaticus, MACLEODS HYDROCORTISONE INJECTION is used as
adjunctive therapy
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to epinephrine (adrenaline) in anaphylactic reactions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
MACLEODS HYDROCORTISONE INJECTION 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 period,
consideration should be given to employing a
longer acting injectable preparation or an oral preparation.
Therapy is initiated by administering MACLEODS HYDROCORTISONE
INJECTION intravenously
over a period of 30 seconds (100 mg) to 10 minutes (500 mg). This dose
may be repeated at intervals
of 4 to 6 hours, as indicated by the patient’s response and clinical
condition. While the dose may be
reduced for