Ceftriaxone 1g Powder for solution for injection or infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
18-05-2018
Summary of Product characteristics
(SPC)
28-10-2020
Active ingredient:
Ceftriaxone
Available from:
Wockhardt UK Limited
ATC code:
J01DD; J01DD04
INN (International Name):
Ceftriaxone
Dosage:
1 gram(s)
Pharmaceutical form:
Powder for solution for injection/infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Third-generation cephalosporins; ceftriaxone
Authorization status:
Marketed
Authorization date:
2003-09-19
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFTRIAXONE 1G POWDER FOR SOLUTION FOR INJECTION
CEFTRIAXONE 2G 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 1g powder for solution
for injection and ceftriaxone 2g powder for solution for injection
or infusion. In the rest of this leaflet it is called ceftriaxone for
injection.
WHAT IS IN THIS LEAFLET
1. What ceftriaxone for injection is and what it is used for
2. What you need to know before you take ceftriaxone for injection
3. How to take ceftriaxone for injection
4. Possible side effects
5. How to store ceftriaxone for injection
6. Contents of the pack and other information
1. WHAT CEFTRIAXONE FOR INJECTION 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.
•
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Summary of Product characteristics
Health Products Regulatory Authority
27 October 2020
CRN009Y8L
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 approximately82 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, suscept
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