Ceftriaxone 1g powder for solution for injection/infusion

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Ceftriaxone sodium

थमां उपलब्ध:

JED Pharma Limited

ए.टी.सी कोड:

J01DD04

INN (इंटरनेशनल नाम):

Ceftriaxone sodium

फार्मास्यूटिकल फॉर्म:

Solution for injection/infusion

चिकित्सीय क्षेत्र:

ceftriaxone

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2023-03-10

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFTRIAXONE
1G POWDER FOR SOLUTION FOR INJECTION/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 1g powder for solution for injection/infusion is
and what it is used for
2. What you need to know before you are given Ceftriaxone 1g powder
for solution for
injection/infusion
3. How Ceftriaxone 1g powder for solution for injection/infusion is
given
4. Possible side effects
5. How to store Ceftriaxone 1g powder for solution for
injection/infusion
6. Contents of the pack and other information
1. WHAT CEFTRIAXONE 1G POWDER FOR SOLUTION FOR INJECTION/INFUSION IS
AND WHAT IT IS USED
FOR
Ceftriaxone 1g powder for solution for injection/infusion 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 1g powder for solution for injection/infusion 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 adult

उत्पाद विशेषताएं

Health Products Regulatory Authority
10 March 2023
CRN00CLM6
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceftriaxone 1g powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains ceftriaxone sodium equivalent to 1g of ceftriaxone.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion
Almost white or yellowish powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceftriaxone 1g powder for solution for injection/infusion 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 1g powder for solution for injection/infusion 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 1g powder for solution for injection/infusion 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
The dose depends on the severity, susceptibility, site and type of
infection