Ceftriaxone 2g Powder for Solution for infusion

Land: Verenigd Koninkrijk

Taal: Engels

Bron: myHealthbox

Werkstoffen:

ceftriaxone sodium

Beschikbaar vanaf:

Midas Pharma GmbH

ATC-code:

J01DD04

INN (Algemene Internationale Benaming):

ceftriaxone sodium

Dosering:

2.38g

farmaceutische vorm:

Powder for solution for infusion

Toedieningsweg:

intravenous infusion

Eenheden in pakket:

20 ml glass vial

Prescription-type:

POM - Prescription Only Medicine

Geproduceerd door:

Midas Pharma GmbH

Therapeutische categorie:

Antibacterials for systemic use, Third generation cephalosporins

therapeutische indicaties:

It is indicated for the treatment of the following infections in adults and children including term neonates (from birth): • Bacterial Meningitis • Community acquired pneumonia • Hospital acquired pneumonia • Acute otitis media • Intra-abdominal infections • Complicated urinary tract infections (including pyelonephritis) • Infections of bones and joints • Complicated skin and soft tissue infections • Gonorrhoea • Syphilis • Bacterial endocarditis

Autorisatie-status:

Authorised

Autorisatie datum:

2015-04-02

Bijsluiter

1 
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

CEFTRIAXONE 500 MG POWDER FOR SOLUTION FOR INJECTION 
CEFTRIAXONE 2 G POWDER FOR SOLUTION FOR INFUSION 
CEFTRIAXONE (AS CEFTRIAXONE SODIUM) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions, ask your doctor, pharmacist or
nurse. 
- 
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if 
their signs of illness are the same as yours. 
- 
If  you get any side effects, talk to your doctor,
pharmacist or nurse.

This includes any possible side 
effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET 
1. 
What CEFTRIAXONE  is and what it is used for 
2. 
What you need to know before you are  

given CEFTRIAXONE   
3. 
How CEFTRIAXONE  is given 
4. 
Possible side effects 
5. 
How to store CEFTRIAXONE 
6. 
Contents of the pack and other  
information 

1. 
WHAT CEFTRIAXONE  IS AND WHAT IT IS USED FOR 
CEFTRIAXONE is an antibiotic given to adults and children
(including newborn babies). It works by killing 
bacteria that cause infections. It belongs to a
group of medicines called cephalosporins_. _ 
CEFTRIAXONE is used to treat infections of  
•  the brain (meningitis).  
•  the lungs.  
•  the middle ear.  
•  the abdomen and abdominal wall (peritonitis).  
•  the urinary tract and kidneys.  
•  bones and joints.  
•  the skin or soft tissues.  
•  the blood.  
•  the heart.  
It can be given:  
•  to treat specific sexually transmitted infections
(gonorrhoea and syphilis).  
•  to treat patients with low white blood cell counts
(neutropenia) who have f

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
CEFTRIAXONE 2 g Powder for Solution for infusion 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each vial contains 2.38 g ceftriaxone sodium equivalent to 2
g ceftriaxone. Sodium 
content per vial: 166 mg (equivalent to 7.2 mmol). 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Powder for solution for infusion. 
Almost white or slightly yellowish, crystalline powder. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
CEFTRIAXONE  is indicated for the treatment
of the following infections in adults and 
children including term neonates (from birth):  
•

Bacterial Meningitis  
•

Community acquired pneumonia  
•

Hospital acquired pneumonia  
•

Acute otitis media  
•

Intra-abdominal infections  
•

Complicated urinary tract infections (including pyelonephritis)  
•

Infections of bones and joints  
•

Complicated skin and soft tissue infections  
•

Gonorrhoea  
•

Syphilis  
•

Bacterial endocarditis 
CEFTRIAXONE  may be used:  
For treatment of acute exacerbations of chronic obstructive
pulmonary disease in 
adults.  
For treatment of disseminated Lyme borreliosis (early (stage II)
and late (stage III)) in 
adults and children including neonates from 15 days of age.  
For Pre-operative prophylaxis of surgical site infections.  
In the management of neutropenic patients with fever that is
suspected to be due to a 
bacterial infection.  
In the treatment of patients with bacteraemia that occurs in
association with, or is 
suspected to be associated with, any of the infections listed
above.  
CEFTRIAXONE should be co-administered with other
antibacterial agents whenever the 
possible range of causative bacteria would not fall within
its spectrum (see section 
4.4).  

Consideration shoul