Cefotaxime 1g powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefotaxime sodium

Available from:

Bowmed Ibisqus Ltd

ATC code:

J01DD01

INN (International Name):

Cefotaxime sodium

Dosage:

1gram

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intramuscular; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5060130130027

Patient Information leaflet

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

Summary of Product characteristics

OBJECT 1
CEFOTAXIME 1G POWDER FOR SOLUTION FOR
INJECTION VIALS
Summary of Product Characteristics Updated 26-Apr-2022 | Bowmed
Ibisqus Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Cefotaxime Sodium for Injection 500 mg/1 g
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 appropr