Ceftriaxone 1g Powder for solution for injection or infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ceftriaxone

Available from:

Pinewood Laboratories Ltd

ATC code:

J01DD; J01DD04

INN (International Name):

Ceftriaxone

Dosage:

1 gram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

Third-generation cephalosporins; ceftriaxone

Authorization status:

Marketed

Authorization date:

2003-09-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFTRIAXONE 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
CEFTRIAXONE 2 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE, BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have 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.
The name of your medicine is Ceftriaxone 1 g powder for solution for
injection or infusion and Ceftriaxone 2
g powder for solution for injection or infusion. In the rest of this
leaflet it is called Ceftriaxone.
WHAT IS IN THIS LEAFLET
1. What Ceftriaxone is and what it is used for
2. What you need to know before you take Ceftriaxone
3. How to take Ceftriaxone
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 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

Summary of Product characteristics

Health Products Regulatory Authority
26 November 2021
CRN00CKJN
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceftriaxone 1g Powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains ceftriaxone sodium equivalent to 1g of ceftriaxone.
Excipient with known effect
Each gram of ceftriaxone contains approximately 82 mg (3.6mmol) of
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion (Powder for
injection/infusion).
White to pale yellow crystalline powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceftriaxone is indicated in 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 guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose depends on the severity, susce