Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ceftriaxone (ceftriaxone sodium)
Anfarm Hellas S.A.
J01DD04
ceftriaxone (ceftriaxone sodium)
1000mg
powder and solvent for solution for i/m injection
glass vial and solvent in ampoule 3.5ml
Prescription
Registered
2022-04-12
PACKAGE LEAFLET – INFORMATION FOR THE PATIENT MARION POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G MARION POWDER AND SOLVENT FOR SOLUTION FOR I.M. INJECTION 1G CEFTRIAXONE (AS CEFTRIAXONE SODIUM) 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, pharmacist 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Marion is and what it is used for 2. What you need to know before you are given MARION 3. How MARION is given 4. Possible side effects 5. How to store MARION 6. Contents of the pack and other information 1. WHAT MARION IS AND WHAT IT IS USED FOR MARION is an antibiotic given to adults and children (including newborn babies). It works by killing bacteria that cause infections. MARION contains a medicine called ceftriaxone. It belongs to a group of medicines called cephalosporins. MARION 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. It 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MARION YOU MUST NOT Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MARION _ _ Powder and Solvent for solution for I.M. injection 1g MARION _ _ Powder for solution for injection or infusion 1g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MARION _ _ Powder and Solvent for solution for I.M. injection 1g: Each vial contains ceftriaxone sodium equivalent to ceftriaxone 1g. Each ampoule of solvent contains lidocaine hydrochloride 35mg, water for injection qs 3.5ml MARION Powder for solution for injection or infusion 1g: Each vial contains ceftriaxone sodium equivalent to ceftriaxone 1g 3. PHARMACEUTICAL FORM Powder and solvent for solution for I.M. injection Powder for solution for injection or infusion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftriaxone 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 Marion 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 treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above Marion should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4). Consideration should be given to official guidel Read the complete document