Ceftriaxone 1g powder for solution for injection vials

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Ceftriaxone sodium

Boleh didapati daripada:

Wockhardt UK Ltd

Kod ATC:

J01DD04

INN (Nama Antarabangsa):

Ceftriaxone sodium

Dos:

1gram

Borang farmaseutikal:

Powder for solution for injection

Laluan pentadbiran:

Intravenous; Intramuscular

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 05010201; GTIN: 5012727903859 5012727909257

Risalah maklumat

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.
•

Ciri produk

OBJECT 1
CEFTRIAXONE 1G POWDER FOR SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 30-Apr-2018 | Wockhardt UK
Ltd
1. Name of the medicinal product
Ceftriaxone 1g Powder for solution for injection
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 (Powder for injection).
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, susceptibility, si