Leaflet AMPICILINA/SULBACTAM APTAPHARMA 1g / 0.5g powder for solution for injection / infusion

Indicated for: bacterial infections

Route of administration: injectable / infusion

Substance: ampicillin + sulbactam (penicillin antibiotic + beta-lactam antibiotic)

ATC: J01CR01 (Antiinfectives for systemic use | Beta-lactam antibacterials, penicillins | Combinations of penicillins, incl. beta-lactamase inhibitors)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Colitis / severe diarrhea
Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Ampicillin + sulbactam is a combination of an antibiotic and a beta-lactamase inhibitor used to treat resistant bacterial infections. Sulbactam protects ampicillin from beta-lactamase enzymes produced by bacteria, allowing ampicillin to remain effective against resistant strains.

This combination is indicated for upper and lower respiratory tract infections (sinusitis, pneumonia), urinary tract infections, intra-abdominal infections, skin and soft tissue infections, as well as gynecological and septic infections.

Ampicillin + sulbactam is available as an injectable solution and is administered intravenously or intramuscularly, usually in a hospital setting under medical supervision.

Side effects may include nausea, diarrhea, skin rashes, pain at the injection site, and, rarely, severe allergic reactions (anaphylaxis). It is important to take it as prescribed by a doctor and to complete the full course of treatment to prevent bacterial resistance.

General data about AMPICILINA/SULBACTAM APTAPHARMA 1g / 0.5g

  • Substance: ampicillin + sulbactam
  • Date of latest medicines list: 01-06-2026
  • Product code: W68435001
  • Concentration: 1g / 0.5g
  • Pharmaceutical form: powder for solution for injection / infusion
  • Quantity: 10
  • Product type: Generic medicine
  • Price: 181.73 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: MITIM S.R.L. - ITALIA
  • Holder: APTA MEDICA INTERNACIONAL D.O.O. - SLOVENIA
  • Number: 14211/2021/01
  • Shelf life: 2 years

Concentrations available for ampicillin + sulbactam

  • 1000mg/500mg
  • 1g/0.5g
  • 1g/500mg
  • 2000mg/1000mg
  • 2g/1g
  • 500mg/250mg

Compensation lists for AMPICILINA/SULBACTAM APTAPHARMA 1g / 0.5g Apta Medica International

B - Sublist B with 50% discount from the reference price

Price

Copayment

Patient

181.73 RON

90.87 RON

90.87 RON

NHP 1.A (C2) - People with HIV/AIDS and post-exposure treatment

Price

Copayment

Patient

181.73 RON

181.73 RON

0.00 RON