MYCIBACT IV POWDER

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Austell Pharmaceuticals (Pty) Ltd

Dosage:

500,0 mg

Pharmaceutical form:

POWDER

Composition:

EACH VIAL CONTAINS AZITHROMYCIN DIHYDRATE EQUIVALENT TO AZITHROMYCIN

Authorization status:

Registrered

Patient Information leaflet

Austell Pharmaceuticals, 530193, MYCIBACT IV 500 mg Powder for
solution for infusion
15 August 2023 (v0.01) Page 1 of 12
APPROVED PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE:
MYCIBACT IV
SCHEDULING STATUS: S4
MYCIBACT IV, 500MG POWDER FOR SOLUTION FOR INJECTION AZITHROMYCIN DIHYDRATE
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MYCIBACT
IV_ _
•
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.
WHAT IS IN THIS LEAFLET
1. What MYCIBACT IV is and what it is used for
2. What you need to know before you receive MYCIBACT IV
3. How to receive MYCIBACT IV
4. Possible side effects
5. How to store MYCIBACT IV
6. Contents of the pack and other information
1.
WHAT MYCIBACT IV IS AND WHAT IT IS USED FOR
MYCIBACT IV belongs to a group of antibiotics called macrolides. It is
used to treat localised infections caused by bacteria. It is indicated
for the
treatment of serious infections or when oral treatment cannot be used.
It is
used for treatment of pneumonia (lung infection), caused by
susceptible
microorganisms.
Austell Pharmaceuticals, 530193, MYCIBACT IV 500 mg Powder for
solution for infusion
15 August 2023 (v0.01) Page 2 of 12
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE MYCIBACT IV
MYCIBACT IV SHOULD NOT BE ADMINISTERED TO YOU
•
if you are hypersensitive (allergic) to azithromycin or any of the
other
ingredients of MYCIBACT IV (listed in section 6)_ _
•
If you are taking any ergot derivative such as ergotamine used to
treat migraine_ _
•
if you have a liver problem.
WARNINGS AND PRECAUTIONS
Tell your doctor or health care provider before being given MYCIBACT
IV:
•
if you have an allergic reaction such as red or white spots on the
skin,
itching and skin irritation, swelling of the skin, larynx (throat) or
tongue,
and difficulty in breathing, in which case you should stop treatment
with
MYCIBACT IV
•
if you have or have had kidney problems
•
if you have or have had li

Summary of Product characteristics

Austell Pharmaceuticals, 530193, MYCIBACT IV 500 mg Powder for
solution for infusion
15 August 2023 (v0.01)
Page 1 of 23
APPROVED PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE:
MYCIBACT IV
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
MYCIBACT IV 500 MG POWDER FOR SOLUTION FOR INFUSION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains azithromycin dihydrate equivalent to 500 mg of
azithromycin,
which after reconstitution results in a 100 mg/mL azithromycin
solution. The
concentrate should be further diluted to 1 mg/mL or 2 mg/mL.
Sugar free.
Contains 114 mg (4,96 mmol) sodium per vial.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for infusion. A white to off-white lyophilised
powder. The
reconstituted solution is clear and colourless, free of undissolved
particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MYCIBACT IV is indicated for the treatment of community acquired
pneumonia
caused by susceptible organisms, including _ Legionella pneumophila, _
in patients
who require initial intravenous therapy.
The safety and efficacy of MYCIBACT IV for the treatment of infections
in children
has not been established.
Austell Pharmaceuticals, 530193, MYCIBACT IV 500 mg Powder for
solution for infusion
15 August 2023 (v0.01)
Page 2 of 23
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For more severe infections, the recommended dose of MYCIBACT IV_ _for
the
treatment of adult patients with community acquired pneumonia
requiring
hospitalisation due to the indicated organisms is 500 mg as a single
daily dose by
the intravenous route for at least two days. Intravenous therapy
should be
followed by azithromycin by the oral route as a single daily dose of
500 mg to
complete a 7 to 10 day course of therapy. The timing of the conversion
to oral
therapy should be_ _done at the discretion of the medical practitioner
and in
accordance with clinical response.
SPECIAL POPULATIONS
ELDERLY POPULATION
No dosage adjustment is necessary in elderly patients requi