Land: Sverige
Språk: svensk
Kilde: Läkemedelsverket (Medical Products Agency)
erytromycinlaktobionat
Stragen Nordic A/S
J01FA01
erythromycin
1 g
Pulver till infusionsvätska, lösning
erytromycinlaktobionat 1,49 g Aktiv substans
Receptbelagt
Avregistrerad
2015-12-10
_SE/H/1486/001_ 1 06805 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ERYTHROMYCIN STRAGEN 1 G POWDER FOR SOLUTION FOR INFUSION erythromycin 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 Erythromycin Stragen is and what it is used for 2. What you need to know before you use Erythromycin Stragen 3. How to use Erythromycin Stragen 4. Possible side effects 5. How to store Erythromycin Stragen 6. Contents of the pack and other information 1. WHAT ERYTHROMYCIN STRAGEN IS AND WHAT IT IS USED FOR Erythromycin Stragen is a powder for solution for infusion. Erythromycin lactobionate, the active substance of this medicine, belongs to the group of antibacterial substances for systemic use (suitable for intravenous injection). Erythromycin Stragen disrupts the production of proteins by bacteria, and thereby prevents the bacteria from multiplying. Erythromycin Stragen is used primarily for various bacterial infections of the airways such as pneumonia, whooping cough and diphtheria. Erythromycin Stragen is also used for vaginal infections and for eye inflammation and pneumonia in new-born infants caused by _Chlamydia_ bacteria. Erythromycin Stragen is also used in the treatment of pneumonia, infections of the skin and soft tissues in people who are intolerant to penicillin or where penicillin is unsuitable for some other reason. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ERYTHROMYCIN STRAGEN DO NOT USE ERYTHROMYCIN STRAGEN: - if you are allergic to erythromycin; - if you are allergic to any other of antibiotics from the same group such as clarithomycin or azithromycin; - if you have certain heart disorders (long QT syndrome, or acquired QT prolongation). - if you are ta Les hele dokumentet
_SE/H/1486/001_ 06805 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT Erythromycin Stragen 1 g powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains erythromycin lactobionate equivalent to 1g erythromycin. 3. PHARMACEUTICAL FORM Powder for solution for infusion White to slightly yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pneumonia caused by _Legionella_ , _Mycoplasma pneumoniae_ , _Chlamydia psittaci_ (ornithosis) or _Chlamydia pneumoniae_ (TWAR). Pertussis. Diphtheria. Urogenital infections caused by _Chlamydia _ _trachomatis_ . Conjunctivitis and pneumonia in newborns caused by _Chlamydia trachomatis_ . Given the following indications, Erythromycin Stragen should be reserved for patients who are hypersensitive to penicillin or where penicillin is unsuitable for other reasons: nosocomial pneumonia; skin and soft tissue infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ _Adults and children over 12years old or weighing more than 40 kg_ : 15 20 mg/kg/day. Where necessary the dose may be increased to 4 g/day. May be given in divided doses every 6 or 8 hours (intermittent intravenous infusion) or as a continuous intravenous infusion. _Use in children up to 12 years old or weighing up to 40 kg_ _1 month to up to 12 years old:_ The daily dose for infants and children up to 12 years old for most infections is 15-20 mg of erythromycin/kg of body weight divided over 3-4 single doses. This dose may be doubled depending on the indication. _Use in term newborn infants (birth to 1 month)_ 10-15 mg/kg/day divided over 3 singles doses. _Elderly:_ No special dose recommendations. _Method of administration_ Because rapid infusion is closely associated with arrhythmias or hypotension it is recommended that Erythromycin Stragen should be administered slowly. This should be particularly noted in patients with risk factors or previous signs of arrhythmias. A low infusion rate is also recommended for patients with heart disease and for pr Les hele dokumentet