KEFLIN NEUTRAL 1g powder for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefalotin, Quantity: 1 g

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium bicarbonate

Administration route:

Intramuscular, Intravenous

Units in package:

10 X 1g vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

KEFLIN is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Culture and susceptibility studies should be performed. Therapy may be instituted before results of susceptibility studies are obtained (See notes under Microbiology). Respiratory tract infections caused by S. pneumoniae, staphylococci (penicillinase and non-penicillinase-producing), group A beta-haemolytic streptococci, Klebsiella, and H. influenzae. Skin and soft-tissue infections, including peritonitis, caused by staphylococci (penicillinase and non-penicillinase-producing), group A beta-haemolytic streptococci, E. coli, Pr. mirabilis, and Klebsiella. Genito-urinary tract infections caused by E. coli, Pr. mirabilis and Klebsiella. Septicaemia, including endocarditis, caused by S. pneumoniae, staphylococci (penicillinase and non-penicillinase-producing), group A beta-haemolytic streptococci, S. viridans; E. coli, Pr. mirabilis, and Klebsiella. Bone and joint infections caused by staphylococci (penicillinase and non-penicillinase-producing). Prophylactically in vaginal hysterectomy, head and neck surgery, insertion of prosthetic heart valves, and prosthetic arthroplasty. Cephalothin is not recommended for G.I. procedures or other sites where anaerobic organisms such as bacteroides tend to prevail. Dosage is required pre-, intra- and post- operatively (i.e. perioperatively - See DOSAGE and ADMINISTRATION). If signs of postoperative infection develop, specimens should be cultured to identify the causative organism so that appropriate therapy can be instituted. NOTE: If the susceptibility tests show that the causative organism is resistant to KEFLIN, other appropriate antibiotic therapy should be instituted.

Product summary:

Visual Identification: A white to off-white crystalline powder; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1991-09-05

Patient Information leaflet

KEFLIN
® NEUTRAL
_cefalotin sodium_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about KEFLIN Neutral. It
does not contain all the available
information and does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, TALK TO
YOUR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT KEFLIN NEUTRAL
IS USED FOR
KEFLIN Neutral contains cefalotin
(as cefalotin sodium) as the active
ingredient. It belongs to a group of
medicines called cephalosporins.
KEFLIN Neutral is an antibiotic used
to treat serious infections in different
parts of the body caused by bacteria.
It is also used to prevent possible
infections before, during and after
surgery.
KEFLIN Neutral works by killing the
bacteria that are causing the
infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY KEFLIN
NEUTRAL HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is available only with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN KEFLIN
NEUTRAL IF YOU HAVE HAD AN ALLERGIC
REACTION TO:
•
cefalotin
•
sodium bicarbonate.
Signs of an allergic reaction may
include shortness of breath, wheezing
or difficulty in breathing; swelling of
the face, lips, tongue or any other
parts of the body; rash, itching or
hives on the skin.
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE HAD A SERIOUS
ALLERGIC REACTION TO ANY OTHER
CEPHALOSPORIN ANTIBIOTIC OR
PENICILLIN ANTIBIOTIC.
If you are allergic to a cephalosporin
or a penicillin, you may have an
increased chance of being allergic to
KEFLIN Neutral.
YOU MUST NOT BE GIVEN THIS
MEDICINE AFTER THE EXPIRY DATE HAS
PASSED OR IF THE PACKAGING IS TORN
OR SHOWS SIGNS OF TAMPERING.
IF

Summary of Product characteristics

1
PRODUCT INFORMATION
KEFLIN
®
CEFALOTIN SODIUM FOR INJECTION
NEUTRAL
DESCRIPTION
KEFLIN (cefalotin sodium), Neutral, is a semisynthetic cephalosporin
antibiotic for
parenteral use. It is the sodium salt of 7-(thiophene-2-acetamido)
cephalosporanic
acid. Sodium bicarbonate has been added to result in reconstituted
solutions having
a pH ranging between 6 and 8.5. The total sodium content is
approximately 63 mg
(2.8 mEq. sodium ion) per g of KEFLIN Neutral.
MICROBIOLOGY/PHARMACOLOGY
Microbiology - The in-vitro bactericidal action of cefalotin results
from inhibition of
cell-wall synthesis. In general, cefalotin has higher activity against
Gram positive
than Gram negative organisms, the latter varying greatly in their
sensitivity to the
drug. The range of antibiotic concentrations at which bacteria are
inhibited may
vary substantially according to the isolate, therefore susceptibility
testing is highly
desirable. KEFLIN is usually active against the following organisms
in-vitro:
Beta-haemolytic and other streptococci (most strains of enterococci,
e.g.
_Streptococcus faecalis _are resistant).
Staphylococci, including coagulase-positive, coagulase-negative, and
penicillinase-producing strains. Methicillin-resistant staphylococci
are
resistant.
_Streptococcus pneumoniae_
_ _
_Haemophilus influenzae_
_ _
_Escherichia coli_
_ _
_Klebsiella_
_ _
_Proteus mirabilis_
NOTE: _Pseudomonas _organisms are resistant to KEFLIN, as are most
indole-
producing _Proteus _species and motile _Enterobacter _species.
Susceptibility Plate Tests - If the Bauer-Kirby-Sherris-Turck method
of disc
susceptibility testing is used, a disc containing 30 mcg cefalotin
should give a zone of
over 17 mm when tested against a cefalotin-susceptible bacterial
strain, and a zone of over 14 mm with an organism of intermediate
susceptibility.
2
Human Pharmacology - KEFLIN is not absorbed significantly following
oral
administration. It is intended for parenteral administration only.
After
administration of a 500 mg dose intramuscularly to normal volunteers,