Ceftriaxone DALI Pharma 250 mg Powder for Solution for Injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFTRIAXONE SODIUM

Available from:

DALI Pharma GmbH Brehmstrasse 56, 40239, Dusseldorf,, Germany

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE SODIUM 250 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

CEFTRIAXONE SODIUM 250 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:

2021-08-19

Patient Information leaflet

Page 1 of 13
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFTRIAXONE DALI PHARMA 250 MG POWDER FOR SOLUTION FOR INJECTION
CEFTRIAXONE DALI PHARMA 500 MG POWDER FOR SOLUTION FOR INJECTION
CEFTRIAXONE DALI PHARMA 1 G POWDER FOR SOLUTION FOR INJECTION
_Ceftriaxone _
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, pharmacist or
nurse.
−
Ifyou 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 DALI Pharma is and what it is used for
2.
What you need to know before you are given Ceftriaxone DALI Pharma
3.
How Ceftriaxone DALI Pharma is given
4.
Possible side effects
5.
How to store Ceftriaxone DALI Pharma
6.
Contents of the pack and other information
1.
WHAT CEFTRIAXONE DALI PHARMA IS AND WHAT IT IS USED FOR
Ceftriaxone DALI Pharma contains the active substance ceftriaxone
which 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 DALI 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;
−
bones and joints;
−
the skin or soft tissues;
−
the blood;
−
the heart.
Ceftriaxone DALI Pharma 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.
Page

Summary of Product characteristics

Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceftriaxone DALI Pharma 250 mg Powder for Solution for Injection
Ceftriaxone DALI Pharma 500 mg Powder for Solution for Injection
Ceftriaxone DALI Pharma 1 g Powder for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftriaxone DALI Pharma 250 mg Powder for Solution for Injection
Each vial contains 250 mg of ceftriaxone as ceftriaxone sodium.
Each vial contain 20.7 mg (0.9 mmol) sodium / vial.
Ceftriaxone DALI Pharma 500 mg Powder for Solution for Injection
Each vial contains 500 mg of ceftriaxone as ceftriaxone sodium.
Each vial contain 41.5 mg (1.8 mmol) sodium / vial.
Ceftriaxone DALI Pharma 1 g Powder for Solution for Injection
Each vial contains 1 g of ceftriaxone as ceftriaxone sodium.
Each vial contain 82.9 mg (3.6 mmol) sodium / vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
Almost white or yellowish crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftriaxone DALI 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.
Page 2 of 20
Ceftriaxone DALI Pharma 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 t