Ceftriaxone PharmSol 1000 mg Powder for Solution for Injection/Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFTRIAXONE

Available from:

PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE 1000 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Composition:

CEFTRIAXONE 1000 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-11-10

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFTRIAXONE PHARMSOL 1000 MG 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 PharmSol is and what it is used for
2.
What you need to know before you are given Ceftriaxone PharmSol
3.
How Ceftriaxone PharmSol is given
4.
Possible side effects
5.
How to store Ceftriaxone PharmSol
6.
Contents of the pack and other information
1.
WHAT CEFTRIAXONE PHARMSOL IS AND WHAT IT IS USED FOR
Ceftriaxone PharmSol 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 PharmSol 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

Summary of Product characteristics

Page 1 of 17
SUMMARY OF THE CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceftriaxone PharmSol 1000 mg Powder for Solution for
Injection/Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 g Ceftriaxone as Ceftriaxone sodium
Excipient with known effect:
This medicinal product contains approximately 83 mg (3.6 mmol) of
sodium per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
Almost white or yellowish crystalline powder, slightly hygroscopic.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftriaxone PharmSol 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 PharmSol 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 PharmSol 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.
Page 2 of 17
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Th