DBL CEPHALOTIN SODIUM 1g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefalotin sodium, Quantity: 1.058 g (Equivalent: cefalotin, Qty 1 g)

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium bicarbonate

Administration route:

Intravenous, Intramuscular

Units in package:

10 x 10mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS: Cephalothin Sodium for injection is indicated for 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. However, therapy may be instituted before results of susceptibility studies are obtained (see PHARMACOLOGY: Microbiology). Respiratory tract: Infections caused by S. pneumoniae, Staphylococci (penicillinase and nonpenicillinase producing), group A Beta-haemolytic Streptococci, Klebsiella, and H. influenzae. Skin and soft tissue: Infections, including peritonitis, caused by Staphylococci (penicillinase and nonpenicillinase producing), group A Beta-haemolytic Streptococci, E.coli, Pr. mirabilis and Klebsiella. Genitourinary tract: Infections caused by E. coli, Pr. mirabilis and Klebsiella. Septicaemia, including endocarditis: Infections caused by S. pneumoniae, Staphylococci (penicillinase and nonpenicillinase producing), group A Beta-haemolytic Streptococci, S. viridans, E. coli, Pr. mirabilis and Klebsiella. Bone and joint: Infection 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 gastrointestinal procedures or other sites where anaerobic organisms such as Bacteriodes tend to prevail. Dosage is required pre-, intra-and postoperatively (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 cephalothin, other appropriate antibiotic therapy should be instituted.

Product summary:

Visual Identification: white to almost white powder or plug in a 10mL type III clear glass vial, with a rubber stopper closure and aluminium flip-off top.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-11-11

Patient Information leaflet

DBL™ CEPHALOTHIN FOR INJECTION
1
DBL™ CEPHALOTHIN
SODIUM FOR INJECTION
_Cefalotin Sodium (ke-fä-lö-thin) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Cephalothin
Sodium 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 benefits and
risks. Your doctor has weighed the
risks of you being given DBL
Cephalothin Sodium for Injection
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT DBL
CEPHALOTHIN SODIUM
FOR INJECTION IS USED
FOR
DBL Cephalothin Sodium for
Injection is an antibiotic used to
treat infections in different parts of
the body caused by bacteria.
This medicine will not work against
infections caused by viruses such as
colds or the flu.
Cefalotin sodium belongs to a group
of antibiotics called cephalosporins
(ke-fä-lö-spör-ins).
It works by killing the bacteria
causing your infection or by
stopping its growth.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CEFALOTIN
SODIUM HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
There is no evidence that cefalotin
sodium is addictive.
BEFORE YOU ARE GIVEN
DBL CEPHALOTHIN
SODIUM FOR INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU SHOULD NOT BE GIVEN DBL
CEPHALOTHIN SODIUM FOR INJECTION
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
cefalotin sodium
•
any other cephalosporins
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include skin rash,
itching, difficulty breathing,
swelling of the face, lips or tongue.
•
you have had a serious allergic
reaction to penicillins
•
the packaging is torn or shows
signs of tampering
•
the expiry date on the pack has
pa

Summary of Product characteristics

Version: pfpcephv20619
Supersedes: pfpceph10619
Page 1 of 12
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
CEPHALOTHIN
SODIUM
FOR
INJECTION (CEFALOTIN SODIUM)
1.
NAME OF THE MEDICINE
Cefalotin sodium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL™ Cephalothin Sodium for Injection contains the active ingredient
cefalotin sodium and
sodium bicarbonate. A 10% or 25% solution of cefalotin sodium in water
has a pH of 4.5 to
7. However, precipitation may occur in solutions with a pH of less
than 5. Therefore,
sodium bicarbonate has been added to result in reconstituted solutions
having a pH ranging
between 6 and 8.5.
1.06 g of cefalotin sodium is approximately equivalent to 1 g of
Cefalotin. Each gram of
cefalotin sodium represents 2.39 mmol of sodium. The total sodium
content is approximately
63 mg (sodium ion 2.8 mEq) per gram of DBL™ Cephalothin Sodium for
Injection.
For the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
DBL™ Cephalothin Sodium for injection is a powder for injection that
occurs as a white to
off white, almost odourless, crystalline powder. The drug is freely
soluble in water, sodium
chloride 0.9% solution and in glucose solutions. It is slightly
soluble in dehydrated alcohol,
and practically insoluble in ether and most other organic solvents.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DBL™ Cephalothin Sodium for Injection is indicated for 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. However,
therapy may be instituted
before results of susceptibility studies are obtained (see Section 5.1
Pharmacodynamic
properties).
_Respiratory tract:_
Infections caused by
_S. pneumoniae, Staphylococci_
(penicillinase and
nonpenicillinase
producing),
group
A
beta
haemolytic
_Streptococci, _
_Klebsiella_
,
and
_H. _
_influenzae. _
_Skin and soft tissue:_
Infections, including peritonitis, caused by
_Staphylococci_
(penicillinase