HOSPIRA CEFTRIAXONE SODIUM POWDER FOR INJECTION ceftriaxone (as sodium) 1 g powder for injection

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

ceftriaxone sodium

Dostopno od:

Pfizer Australia Pty Ltd

INN (mednarodno ime):

ceftriaxone sodium

Status dovoljenje:

Registered

Navodilo za uporabo

Hospira
TM
Ceftriaxone Sodium for Injection
Page 1
HOSPIRA
TM
CEFTRIAXONE SODIUM
POWDER FOR INJECTION
ceftriaxone sodium _(kef-try-AXE-own)_
CONSUMER MEDICINE INFORMATION
_date of dispensing _
_ _
_Patient name _
_Pharmacist name _
_ _
_Patient address _
_Pharmacist address _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Hospira
TM
Ceftriaxone Sodium
Powder for Injection. It does not
contain all the available
information. It does not take the
place of talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
ceftriaxone against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT HOSPIRA
TM
CEFTRIAXONE SODIUM
POWDER FOR INJECTION IS
USED FOR
Ceftriaxone is an antibiotic used
to treat infections in different parts
of the body caused by bacteria.
It is also used to prevent
infections following surgery.
Ceftriaxone will not work against
infections caused by viruses such
as colds or the flu.
Ceftriaxone belongs to a group of
antibiotics called cephalosporins
_(kef-a-low-SPOR-ins)._ These
antibiotics work by killing the
bacteria that are causing your
infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another reason.
This medicine is not addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
HOSPIRA
TM
CEFTRIAXONE
SODIUM POWDER FOR
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
_ _
HOSPIRA
TM CEFTRIAXONE SODIUM
POWDER FOR INJECTION SHOULD NOT
BE GIVEN TO YOU IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
ceftriaxone
•
other cephalosporin
antibiotics
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of the
face, li

Lastnosti izdelka

Product Information - Australia
Version 1.0
Page 1 of 11
HOSPIRA™ CEFTRIAXONE SODIUM POWDER FOR INJECTION
NAME OF THE MEDICINE
Ceftriaxone sodium
N
S
NH
2
O
N
H
N
OMe
N
S
COONa
S
N
N
N
O
ONa
Me
H
H
O
3.5 H
2
O
DESCRIPTION
Hospira™
Ceftriaxone
Sodium
Powder
for
Injection
is
a
sterile,
semisynthetic,
broad
spectrum
cephalosporin antibiotic for intravenous or intramuscular
administration.
Ceftriaxone sodium is Disodium
(6R,7R)-7-[[(2Z)-(2-aminothiazol-4-yl)(methoxyimino)acetyl]amino]-3-
[[(2-methyl-6-oxido-5-oxo-2,5-dihydro-1,2,4-triazin-3-yl)sulphanyl]methyl]-8-oxo-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-2-carboxylate 3.5 hydrate.
.
The chemical formula of ceftriaxone sodium is C
18
H
16
N
8
Na
2
O
7
S
3
3
½
H
2
O. It has a calculated molecular
weight of 661.59 (CAS registry number: 104376-79-6).
Ceftriaxone sodium is a white or yellowish crystalline powder which is
very soluble in water, sparingly
soluble
in
methanol
and
very
slightly
soluble
in
ethanol.
The
pH
of
a
5%
aqueous
solution
is
approximately 6 to 8. Ceftriaxone sodium solutions may be light yellow
to amber coloured in colour.
Hospira™ Ceftriaxone Sodium Powder for Injection contains
approximately 83 mg (3.6 mEq) of sodium
per gram of ceftriaxone activity.
PHARMACOLOGY
PHARMACOKINETICS
Ceftriaxone
is
absorbed
poorly
from
the
gastrointestinal
tract.
Average
plasma
concentrations
of
ceftriaxone following a single 30 minute intravenous (IV) infusion of
a 0.5, 1 or 2 g dose and intramuscular
(IM) administration of a single 0.5 or 1 g dose in healthy subjects
are presented in Table 1.
Product Information - Australia
Version 1.0
Page 2 of 11
TABLE 1
AVERAGE CEFTRIAXONE PLASMA CONCENTRATIONS AFTER SINGLE DOSE
ADMINISTRATION
.
DOSE/
ROUTE
AVERAGE PLASMA CONCENTRATIONS (MICROGRAMS/ML)
(TIME FORM END OF ADMINISTRATION)
0.5 hour
1 hour
2 hour
4 hour
6 hour
8 hour
12 hour
16 hour
24 hour
0.5 G I.V.
82
59
48
37
29
23
15
10
5
0.5 G I.M.
30
41
43
39
31
25
16
ND
ND
1 G I.V.
151
111
88
67
53
43
28
18
9
1 G I.M.
40
68
76
68
56
44
29
ND
ND
2 G I.V.
257
192
154
117
89
7