Cefuroxime Dali Pharma, 750 mg, powder for solution for injection or infusion (10ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Available from:

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

ATC code:

J01DC02

INN (International Name):

CEFUROXIME SODIUM 750 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

CEFUROXIME SODIUM 750 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:

2022-05-30

Patient Information leaflet

1
PACKAGE LEAFLET
Page 2 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFUROXIME DALI PHARMA, 750 MG, POWDER FOR SOLUTION FOR INJECTION OR
INFUSION
CEFUROXIME DALI PHARMA, 1500 MG, POWDER FOR SOLUTION FOR INJECTION OR
INFUSION
_Cefuroximum _
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, 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, or nurse This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cefuroxime Dali Pharma
is and what it is used for
2.
What you need to know before you use Cefuroxime Dali Pharma
3.
How to use Cefuroxime Dali Pharma
4.
Possible side effects
5.
How to store Cefuroxime Dali Pharma
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME
IS AND WHAT IT IS USED FOR
Cefuroxime Dali Pharma is an antibiotic used in adults, adolescents
and children. It works by killing
bacteria that cause infections and which are sensitive to the active
substance cefuroxime
(as
cefuroxime
sodium). It belongs to a group of medicines called cephalosporins
_._
CEFUROXIME DALI PHARMA IS USED TO TREAT INFECTIONS OF:
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissue
•
the abdomen
Cefuroxime Dali Pharma is also used:
•
To prevent infections during surgery.
Your doctor may test the type of bacteria causing your infection and
monitor whether the bacteria are
sensitive to cefuroxime during your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CEFUROXIME DALI PHARMA
INVENTED NAME
MUST NOT BE GIVEN:
•
IF YOU ARE ALLERGIC TO
CEFUROXIME SODIUM OR ANY CEPHALOSPORIN ANTIBIOTICS
or any of the other
ingredients of Cefuroxime Dali Pharma (listed in section 6).
•
if you hav

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 13
1.
NAME OF THE MEDICINAL PRODUCT
Cefuroxime Dali Pharma, 750 mg, powder for solution for injection or
infusion
Cefuroxime Dali Pharma, 1500 mg, powder for solution for injection or
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefuroxime (Cefuroximum) as cefuroxime sodium.
1 vial contains 750 mg (as cefuroxime sodium).
1 vial contains 1500 mg (as cefuroxime sodium).
Cefuroxime Dali Pharma strength
Amount of sodium per vial
750 mg
40.6 mg
1500 mg
81.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White or almost white powder.
After the addition of an appropriate amount of water or other suitable
solvent, an off white suspension
is formed for intramuscular use or a yellowish solution for
intravenous administration..
The prepared solution has pH of 4.0 - 9.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefuroxime Dali Pharma is indicated for the treatment of the
infections listed below in adults,
adolescents and children, including neonates (from birth) (see
sections 4.4 and 5.1)
•
Community acquired pneumonia.
•
Acute exacerbations of chronic bronchitis.
•
Complicated urinary tract infections, including pyelonephritis.
•
Soft-tissue infections: cellulitis, erysipelas and wound infections.
•
Intra-abdominal infections (see section 4.4).
•
Prophylaxis against infection in gastrointestinal (including
oesophageal), orthopaedic,
cardiovascular, and gynaecological surgery (including caesarean
section).
In the treatment and prevention of infections in which it is very
likely that anaerobic organisms will be
encountered, cefuroxime should be administered with additional
appropriate antibacterial agents.
Consideration should be given to official guidelines on the
appropriate use of antibiotics.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Table 1. Adults, adolescents and children ≥ 40 kg _
_ _
Page 3 of 13
INDICATION
DOSAGE
Community acquired pneumonia and acute
exac