Ampicillin/sulbactam AptaPharma 1 g/0,5 g powder for solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

A, S

Available from:

Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia

ATC code:

J01CR01

INN (International Name):

Ampicillin Sodium 1 g Sulbactam Sodium 0.5 g

Pharmaceutical form:

SOLUTION FOR INJECTION/INFUSION

Composition:

Ampicillin Sodium 1 g Sulbactam Sodium 0.5 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:

2021-07-16

Patient Information leaflet

PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
AMPICILLIN/SULBACTAM APTAPHARMA 1 G/0.5 G POWDER FOR SOLUTION FOR
INJECTION/INFUSION
AMPICILLIN/SULBACTAM APTAPHARMA 2 G/1 G POWDER FOR SOLUTION FOR
INJECTION/INFUSION
ampicillin and sulbactam
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 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 Ampicillin/sulbactam AptaPharma is and what it is used for
2.
What you need to know before you use Ampicillin/sulbactam AptaPharma
3.
How to use Ampicillin/sulbactam AptaPharma
4.
Possible side effects
5.
How to store Ampicillin/sulbactam AptaPharma
6.
Contents of the pack and other information
1.
WHAT AMPICILLIN/SULBACTAM APTAPHARMA IS AND WHAT IT IS USED FOR
Ampicillin/sulbactam AptaPharma is a broad-spectrum antibiotic. It
treats infections caused by
bacteria, which are susceptible to ampicillin and sulbactam.
Ampicillin belongs to a group of medicines called ‘penicillins’
(type of beta-lactam antibiotics).
It works by inhibiting the formation of the bacterial cell wall during
the stage of bacterial
multiplication (biosysnthesis).
Sulbactam’s antibacterial activity is effective on bacterial strains
which are not sensitive to
ampicillin.
Your doctor can give you Ampicillin/sulbactam AptaPharma injection to
treat the following
bacterial infections:
•
upper respiratory tract infections including sinusitis, inflammation
of middle ear (otitis media)
or of larynx (epiglottitis)
•
lower respiratory tract infections including inflammation of the lung
(pneumonia)
•
urinary tract infections including inflammation of the kidney
(pyelonephritis)
•
intra-abdominal infections (including peritonitis), inflammation of
the gall bladder

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Ampicillin/sulbactam AptaPharma 1 g/0.5 g powder for solution for
injection/infusion
Ampicillin/sulbactam AptaPharma 2 g/1 g powder for solution for
injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Ampicillin/sulbactam AptaPharma 1 g/0.5 g powder for solution for
injection/infusion _
Each vial contains 1.0 g of ampicillin (as ampicillin sodium) and 0.5
g of sulbactam (as sulbactam
sodium).
_Ampicillin/sulbactam AptaPharma 2 g/1 g powder for solution for
injection/infusion _
Each vial contains 2.0 g of ampicillin (as ampicillin sodium) and 1 g
sulbactam (as sulbactam sodium).
Excipients with known effect:
Each vial of Ampicillin/sulbactam AptaPharma 1 g/0.5 g powder for
solution for injection/infusion
contains 115 mg (5 mmol) sodium.
Each vial of Ampicillin/sulbactam AptaPharma 2 g/1 g powder for
solution for injection/infusion
contains 230 mg (10 mmol) sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to off-white crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infections caused by susceptible microorganisms, in the following
conditions:
•
upper and lower respiratory tract infections (including sinusitis,
otitis media, epiglottitis; bacterial
pneumonias);
•
urinary tract infections and pyelonephritis;
•
intra-abdominal infections (including peritonitis), gynaecological
infections (cholecystitis,
endometritis and pelvic cellulitis);
•
skin and soft tissue infections;
•
bone and joint infections;
•
gonococcal infections;
•
pre-or post-operatively to reduce the incidence of wound infections in
patients undergoing
abdominal or pelvic surgery;
•
treatment of patients with bacteraemia that occurs in association
with, or is suspected to be
associated with any of infections stated above.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY