Ceftriaxone Venus Pharma 1g powder for solution for injection or infusion

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Venus Pharma GmbH Am Bahnhof 1-3, Werne, D 59368, Germany

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE 1 g

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Composition:

CEFTRIAXONE 1 g

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-10-10

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFTRIAXONE VENUS PHARMA 1 G POWDER FOR SOLUTION FOR INJECTION OR
INFUSION
CEFTRIAXONE VENUS PHARMA 2 G POWDER FOR SOLUTION FOR INJECTION OR
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 Venus Pharma is and what it is used for
2.
What you need to know before you are given Ceftriaxone Venus Pharma
3.
How Ceftriaxone Venus Pharma is given
4.
Possible side effects
5.
How to store Ceftriaxone Venus Pharma
6.
Contents of the pack and other information
1. WHAT CEFTRIAXONE VENUS PHARMA IS AND WHAT IT IS USED FOR
Ceftriaxone Venus Pharma 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 Venus Pharma 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.
2
•
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 day

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceftriaxone Venus Pharma 1 g powder for solution for injection or
infusion
Ceftriaxone Venus Pharma 2 g powder for solution for injection or
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftriaxone Venus Pharma 1 g powder for solution for injection or
infusion
Each vial contains Ceftriaxone Sodium equivalent to Ceftriaxone 1 g
Ceftriaxone Venus Pharma 2 g powder for solution for injection or
infusion
Each vial contains Ceftriaxone Sodium equivalent to Ceftriaxone 2 g
Each gram of ceftriaxone sodium contains approximately 3.6 mmol (82.8
mg) sodium. For the
full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
Almost white or yellowish, crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftriaxone Venus Pharma 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
2
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