TRIAXIPHIN 500 mg INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Ranbaxy (SA) (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH VIAL CONTAINS CEFTRIAXONE SODIUM EQUIVALENT TO CEFTRIAXONE 500,0 mg

Authorization status:

Registered

Authorization date:

2005-03-06

Patient Information leaflet

Page 1 of 10
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S4
TRIAXIPHIN 250 MG; TRIAXIPHIN 500 MG; TRIAXIPHIN 1 G Injection
CEFTRIAXONE
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING
TRIAXIPHIN

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 TRIAXIPHIN is and what it is used for
2.
What you need to know before you receive TRIAXIPHIN
3.
How to take TRIAXIPHIN
4.
Possible side effects
5.
How to store TRIAXIPHIN
6.
Contents of the pack and other information
1.
WHAT TRIAXIPHIN IS AND WHAT IT IS USED FOR
TRIAXIPHIN contains the active ingredient ceftriaxone sodium, which is
an antibacterial agent
used for treatment of infections caused by bacteria.
TRIAXIPHIN is an antibiotic used for the treatment of bacterial
infections. It is also used prior to
some surgical operations to reduce the risk of bacterial infections.
Page 2 of 10
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIAXIPHIN
TRIAXIPHIN should not be administered to you if:

If you are allergic to TRIAXIPHIN or other medicines containing
related antibiotics such
as cephalosporins or penicillins.

If TRIAXIPHIN is mixed together with calcium-containing solutions or
products, or if
TRIAXIPHIN is going to be administered to you through an intravenous
infusion line which
contains calcium- containing fluid, it could cause a precipitation of
ceftriaxone-calcium
salt.

If you have had a bad reaction to a lidocaine/lignocaine injection in
the past.
TRIAXIPHIN MUST NOT BE GIVEN TO BABIES IF:

If the baby is premature.

If the baby is newborn (up to 28 days) and has certain blood problems
or jaundice
(yellowing of the skin or the whites of the eyes) or is about to be
given another injection
that contains calcium.
WARNINGS AND PRECAUTIONS
Before starting treatment, make sure your doctor knows:

if you have both a liver and a kidney condition.

if you have recently received or are about

Summary of Product characteristics

I Page 1 of 25
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1.
NAME OF THE MEDICINE
TRIAXIPHIN 1 G
TRIAXIPHIN 250 MG
TRIAXIPHIN 500 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIAXIPHIN 250 MG
Each vial contains ceftriaxone in the form of the disodium salt
(approximately 83 mg (3,6 mEq)
of sodium per gram) equivalent to 250 mg ceftriaxone.
Sugar free
TRIAXIPHIN 500 G
Each vial contains ceftriaxone in the form of the disodium salt
(approximately 83 mg (3,6 mEq)
of sodium per gram) equivalent to 500 mg ceftriaxone.
Sugar free
TRIAXIPHIN 1 G
Each vial contains ceftriaxone in the form of the disodium salt
(approximately 83 mg (3,6 mEq)
of sodium per gram) equivalent to 1 g ceftriaxone.
Sugar free
For the full list of excipients, see section 6.1.
I Page 2 of 25
3.
PHARMACEUTICAL FORM
Injection.
Sterile, white to yellowish-orange powder in clear glass vials.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TRIAXIPHIN is indicated for the treatment of the following infections:
BACTERIAL
SEPTICEMIA
caused
by
Methicillin-sensitive
_Staphylococcus _
_aureus _
(MSSA),
_Streptococcus _
_pneumoniae_,
_Haemophilus _
_influenzae_,
_Escherichia _
_coli_,
or
_Klebsiella _
_pneumoniae._
MENINGITIS
caused
by
_Haemophilus _
_influenzae_,
_Neisseria _
_meningitidis_,
or
_Streptococcus _
_pneumoniae._
INTRA-ABDOMINAL INFECTIONS caused by _ Escherichia coli_, _ Klebsiella
pneumoniae_, Clostridium
species _(_Note: most strains of _Clostridium difficile are resistant)
_or _Peptostreptococcus _species.
SKIN AND SKIN STRUCTURE INFECTIONS caused by Methicillin-sensitive _
Staphylococcus aureus _
(MSSA), _Streptococcus pyogenes_,
_Streptococcus _
_viridans_
group,
_Escherichia _
_coli_,
_Enterobacter _
_cloacae_,
_Klebsiella _
_oxytoca_,
_Klebsiella _
_pneumoniae_,
_Proteus _
_mirabilis_,
_Morganella _
_morganii_,
_Serratia _
_marcescens_,
or
_Peptostreptococcus_ species.
BONE- AND JOINT INFECTIONS caused by Methicillin-sensitive _
Staphylococcus aureus_ (MSSA),
_Streptococcus pneumoniae_,
_Escherichia coli_, _Proteus mirabilis_, _Kl