Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
AMOXICILLIN, CLAVULANIC ACID
Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia
J01CR02
AMOXICILLIN 1000 mg CLAVULANIC ACID 200 mg
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
AMOXICILLIN 1000 mg CLAVULANIC ACID 200 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-01-20
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER AMOXICILLIN/CLAVULANIC ACID APTAPHARMA 1000 MG/200 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION Amoxicillin/clavulanic acid 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. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Amoxicillin/clavulanic acid AptaPharma is and what it is used for 2. What you need to know before you have Amoxicillin/clavulanic acid AptaPharma 3. How Amoxicillin/clavulanic acid AptaPharma is given 4. Possible side effects 5. How to store Amoxicillin/clavulanic acid AptaPharma 6. Contents of the pack and other information 1. WHAT AMOXICILLIN/CLAVULANIC ACID APTAPHARMA IS AND WHAT IT IS USED FOR Amoxicillin/clavulanic acid AptaPharma is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening. Amoxicillin/clavulanic acid AptaPharma is used in adults and children to treat the following infections: • severe ear, nose and throat infections • respiratory tract infections • urinary tract infections • skin and soft tissue infections including dental infections • bone and joint infections • intra-abdominal infections • genital organ infections in women. Amoxicillin/clavulanic acid AptaPharma is used in adults and children to prevent infections associated with major surgical procedures. 2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE AMOXICILLIN/CLAVULANIC ACID APTAPHARMA YOU SHOULD NOT HAVE AMOXICILLIN/CLAVULANIC AC Soma hati kamili
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 16 1. NAME OF THE MEDICINAL PRODUCT Amoxicillin/clavulanic acid AptaPharma 1000 mg/200 mg powder for solution for injection/infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains sodium amoxicillin equivalent to 1000 mg amoxicillin and potassium clavulanate equivalent to 200 mg of clavulanic acid. 1 ml of reconstituted solution contains 50 mg of amoxicillin and 10 mg of clavulanic acid. Excipients with known effect Sodium 62.9 mg (2.7 mmol) per vial. Potassium 39.1 mg (1.0 mmol) per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion. White to almost white sterile powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxicillin/clavulanic acid AptaPharma is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): • Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms) • Acute exacerbations of chronic bronchitis (adequately diagnosed) • Community acquired pneumonia • Cystitis • Pyelonephritis • Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis • Bone and joint infections, in particular osteomyelitis • Intra-abdominal infections • Female genital infections. Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the: • Gastrointestinal tract • Pelvic cavity • Head and neck • Biliary tract surgery. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Page 3 of 16 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component. The dose of Amoxicillin/clavulanic acid AptaP Soma hati kamili