KLARISTELL IV INJECTION

Negara: Afrika Selatan

Bahasa: Inggris

Sumber: South African Health Products Regulatory Authority (SAHPRA)

Tersedia dari:

Camox Pharmaceuticals (Pty) Ltd

Dosis:

See ingredients

Bentuk farmasi:

INJECTION

Komposisi:

EACH VIAL CONTAINS : CLARITHROMYCIN 500,0 mg

Status otorisasi:

Renewal -In Progress

Tanggal Otorisasi:

2020-01-09

Selebaran informasi

Camox Pharmaceuticals (Pty) Ltd, 490680, Klaristell IV, Lyophilised
powder for solution for
injection and 500 mg
2023.06.29 (v7) Page 1 of 15
APPROVED PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE:
KLARISTELL IV
SCHEDULING STATUS: S4
KLARISTELL IV 500 MG LYOPHILISED POWDER FOR SOLUTION FOR INJECTION CLARITHROMYCIN SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN KLARISTELL IV
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your
pharmacist.
WHAT IS IN THIS LEAFLET
1. What KLARISTELL IV is and what it is used for
2. What you need to know before you take KLARISTELL IV
3. How to take KLARISTELL IV
4. Possible side effects
5. How to store KLARISTELL IV
6. Contents of the pack and other information
1. WHAT KLARISTELL IV IS AND WHAT IT IS USED FOR
KLARISTELL IV contains clarithromycin, as the active ingredient, which
is an antibiotic of the
macrolides group that works by stopping the growth of certain bacteria
which cause infections.
It is used treat various types of bacterial infections such as:
Camox Pharmaceuticals (Pty) Ltd, 490680, Klaristell IV, Lyophilised
powder for solution for
injection and 500 mg
2023.06.29 (v7) Page 2 of 15
1.
Chest infections such as bronchitis and pneumonia
2.
Throat and sinus infections
3.
Skin and tissue infections
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLARISTELL IV
KLARISTELL IV SHOULD NOT BE ADMINISTERED TO YOU
•
if you are hypersensitive (allergic) to clarithromycin, other
macrolide antibiotics such as
erythromycin or azithromycin [,]or any of the other ingredients of
KLARISTELL IV (listed in
section 6)._ _
•
if
you
are
taking
medicines
called
ergot
alkaloid
tablets
(e.g.
ergotamine
or
dihydroergotamine) or use ergotamine inhalers (used to treat a
migraine type headache)
•
if you are taking midazolam tablets (used for sleeplessness)
•
if you are taking astemizole and terfenadine anti-histamine medicines
taken for hay fever and
allergies,
•
if you are taking cisapride (a medicine that wa

Karakteristik produk

Camox Pharmaceuticals (Pty) Ltd, 490680, KLARISTELL IV, Lyophilised
powder for
solution for injection and 500 mg
2023.06.29 (v6) Page 1 of 38
APPROVED PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE:
KLARISTELL IV
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
KLARISTELL IV 500 mg lyophilised powder for solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
KLARISTELL IV 500 mg lyophilised powder for solution for injection
Each vial contains clarithromycin 500 mg and lactobionic acid as a
solubilising agent.
Sugar free
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
KLARISTELL IV 500 mg lyophilised powder for solution for injection
KLARISTELL IV is a homogenous uniform white-coloured freeze-dried
powder which
on reconstitution with water for injection produces a clear,
colourless solution free of
particulate matter.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
KLARISTELL IV is indicated in the treatment of infections due to
susceptible organisms
in the following conditions whenever parenteral therapy is required:
Camox Pharmaceuticals (Pty) Ltd, 490680, KLARISTELL IV, Lyophilised
powder for
solution for injection and 500 mg
2023.06.29 (v6) Page 2 of 38
•
Lower respiratory tract infections, e.g. bronchitis, pneumonia.
•
Upper respiratory tract infections, e.g. pharyngitis and tonsillitis
due to _S.pyogenes_,
sinusitis.
•
Skin and soft tissue infections due to _ S.aureus. _ There is some
evidence that
disseminated and localised infections in HIV-positive adults, due to
_Mycobacterium _
_avium_
or
_Mycobacterium _
_intracellulare_
respond
to
clarithromycin.
Based
on
bacteriological results, KLARISTELL IV should be used in conjuction
with other
antimycobacterials. To a lesser extent localised infections due to
_Mycobacterium _
_kansasii_ have responded to clarithromycin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
The recommended dosage of KLARISTELL IV is 1,0 gram daily, divided
into 2 equal
doses, each infused, following further dilution with an app