Ceftriaxone 1 g powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ceftriaxone sodium

Available from:

AS Kalceks

ATC code:

J01DD; J01DD04

INN (International Name):

Ceftriaxone sodium

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

Third-generation cephalosporins; ceftriaxone

Authorization status:

Not marketed

Authorization date:

2023-01-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFTRIAXONE 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION
CEFTRIAXONE 2 G POWDER FOR SOLUTION FOR INJECTION/INFUSION
ceftriaxone
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.
–
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.
This medicine can be given:
•
to treat specific sexually transmitted infections (gonorrhoea and
syphilis);
•
to treat patients with low white blood cell counts (neutropenia) who
have fever due to bacterial
infection;
•
to treat infections of the chest in adults with chronic bronchitis;
•
to treat Lyme disease (caused by tick bites) in adults and children
including newborn babies
from 15 days of age;
•
to prevent infections during surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFTRIAXONE
YOU MUST NOT BE GIVEN CEFTRIAXONE IF:
•
you are allergic to ceftriaxone or any of the other ingredients of
this medicine (listed in
section 6);
•
you have had a sudden or se

Summary of Product characteristics

Health Products Regulatory Authority
13 January 2023
CRN00CJTS
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceftriaxone 1 g powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 g of ceftriaxone (as ceftriaxone sodium).
Sodium content per vial: 83 mg (equivalent to 3.6 mmol).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
Almost white or yellowish 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 should be given to official guidelines on the
appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Health Products Regulatory Authority
13 January 2023
CRN00C