Cefotaxime Sodium for Injection 1g powder for solution for injection or infusion

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

CEFOTAXIME SODIUM

Disponível em:

Villerton Invest S.A. Rue Edward Steichen 14, 2540, Luxembourg

Código ATC:

J01DD01

DCI (Denominação Comum Internacional):

CEFOTAXIME SODIUM 1/4.4 g/ml

Forma farmacêutica:

SOLUTION FOR INJECTION/INFUSION

Composição:

CEFOTAXIME SODIUM 1/4.4 g/ml

Tipo de prescrição:

POM

Área terapêutica:

ANTIBACTERIALS FOR SYSTEMIC USE

Status de autorização:

Withdrawn

Data de autorização:

2019-07-16

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFOTAXIME SODIUM FOR INJECTION 500MG, 1G
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or your pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or your pharmacist.
In this leaflet:
1. What Cefotaxime Injection is and what it is used for.
2. Before you are given Cefotaxime Injection.
3. How Cefotaxime Injection is given.
4. Possible side effects.
5. How to store Cefotaxime Injection
6. Further information.
The name of your medicine is “Cefotaxime sodium for injection”
(referred to AS CEFOTAXIME INJECTION
throughout this leaflet).
1. WHAT CEFOTAXIME INJECTION IS AND WHAT IT IS USED FOR
Cefotaxime is an antibiotic. It belongs to a group of antibiotics that
are called cephalosporins. These types of
antibiotic are similar to penicillin.
Cefotaxime kills bacteria and it can be used to treat infections of
the:
•
Kidneys and bladder
•
Blood (septicaemia)
•
Skin and flesh immediately under the skin
•
Bones
•
Heart valves
•
Brain (meningitis)
•
Abdomen (peritonitis)
•
Some sexually transmitted infections (gonorrhoea)
It can also be used to prevent and treat infections following surgical
operations.
2. BEFORE YOU ARE GIVEN CEFOTAXIME INJECTION
YOU SHOULD NOT BE GIVEN CEFOTAXIME INJECTION IF:
•
you are allergic (hypersensitive) to cefotaxime
•
you are allergic to any similar antibiotics (known as
“cephalosporins”)
•
you have ever had a serious allergic reaction when given penicillin or
similar antibiotics
•
you are allergic to lidocaine
Tell your doctor or nurse if any of the above apply to you.
BEFORE YOU ARE GIVEN CEFOTAXIME INJECTION
You must tell the doctor or nurse if any of the foll

Características técnicas

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cefotaxime Sodium for Injection 500mg, 1g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefotaxime (as cefotaxime sodium)
per vial
Diluent to be added
Final concentration of
solution
500 mg
2 ml
500 mg/2.2 ml
1 g
4 ml
1 g/4.4 ml
A quantity of cefotaxime sodium equivalent to 1 g cefotaxime contains
approximately 50 mg (2.2 mmol) of sodium
For excipients see 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
Vials containing a white to slightly yellow powder, which when
dissolved in
Water for Injections forms a straw coloured solution. The intensity of
the
colour of the solution may vary but this does not indicate differences
in
potency or safety.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
Cefotaxime sodium is indicated for the treatment of the following
severe
infections when known or thought very likely to be due to organisms
that are
susceptible to cefotaxime.
▪
Infections of the lower respiratory tract
▪
Infections of the kidneys and urinary tract
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▪
Infections of the skin and soft tissue
▪
Genital infections caused by gonococci, particularly when penicillin
has
failed or is unsuitable
▪
Intra-abdominal infections (including Peritonitis)
▪
Lyme-borreliosis (especially stages II and III)
▪
Acute Meningitis in case of gram-negative microorganisms in
combination
with another suitable antibiotic
▪
Sepsis in case of gram-negative microorganism in combination with
another suitable antibiotic
▪
Endocarditis in case of gram-negative microorganism in combination
with
another suitable antibiotic
Peri-operative prophylaxis in surgical procedures such as colorectal,
gastrointestinal, prostatic, urogenital and gynaecological surgery in
patients
who have a definite risk of post-operative infections. Cefotaxime
should be
used in combination with another antibiotic that can provide anaerobi