Ceftriaxone powder for solution for injection

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiva substanser:

ceftriaxone (ceftriaxone sodium)

Tillgänglig från:

CR GoSun Pharma

ATC-kod:

J01DD04

INN (International namn):

ceftriaxone (ceftriaxone sodium)

Dos:

1000mg

Läkemedelsform:

powder for solution for injection

Enheter i paketet:

(10) glass vials

Receptbelagda typ:

Prescription

Bemyndigande status:

Registered

Tillstånd datum:

2020-02-06

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFTRIAXONE
(as Ceftriaxone Sodium)
1G
POWDER FOR SOLUTION FOR INJECTION/INFUSION
Read all of this leaflet carefully before you start using 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 or your nurse.
• If you get any side effects talk to your doctor 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 will be 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.
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 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 severe allergic reaction to penicillin or
similar
antibiotics
(such
as
cepha

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceftriaxone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1g ceftriaxone as ceftriaxone sodium
Excipient with known effect:
Each vial of Ceftriaxone contains approximately 83mg (3.6mmol) of
sodium per gram of ceftriaxone.
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion
Almost white or yellowish crystalline 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
The dose depends on the severity, susceptibility, site and type of
infection and on the age and hepato-renal function of the
patient.
The doses recommended in the tables below are the generally
recommended doses in these indicati