देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
CLARITHROMYCIN
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
J01FA09
CLARITHROMYCIN 125 mg/5ml
GRANULES FOR ORAL SUSPENSION
CLARITHROMYCIN 125 mg/5ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-11-19
Package leaflet: Information for the user KLACID ® PAEDIATRIC SUSPENSION 125MG/5ML, GRANULES FOR ORAL SUSPENSION (clarithromycin) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE THIS MEDICINE TO YOUR CHILD BECAUSE IT CONTAINS IMPORTANT INFORMATION. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s. - If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Klacid Paediatric Suspension is and what it is used for 2. What you need to know before giving Klacid Paediatric Suspension 3. How to give Klacid Paediatric Suspension 4. Possible side effects 5. How to store Klacid Paediatric Suspension 6. Contents of the pack and other information 1. WHAT KLACID PAEDIATRIC SUSPENSION IS AND WHAT IT IS USED FOR Each 5ml spoonful of Klacid Paediatric Suspension contains 125 mg of the active ingredient clarithromycin. Klacid Paediatric Suspension belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) which cause infections. Klacid Paediatric Suspension is used to treat infections such as: 1. Chest infections, such as bronchitis and pneumonia 2. Throat and sinus infections 3. Skin and soft tissue infections such as cellulitis, folliculitis or erysipelas 4. Ear infections particularly inflammation of the middle ear (acute otitis media) 2. WHAT YOU NEED TO KNOW BEFORE GIVING KLACID PAEDIATRIC SUSPENSION DO NOT GIVE KLACID PAEDIATRIC SUSPENSION TO YOUR CHILD IF YOU: know that they are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of Klacid Paediatric Suspension. know they are taking medicines called ergot alkaloids, for example ergotamine or पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Klacid Paediatric Suspension 125mg/5ml, Granules for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted as directed in section 4.2, each 5ml or sachet contains 125mg clarithromycin. Excipients with known effect: Also contains 2.75g / 5ml sachet of sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension. White to off-white granules for oral suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Klacid Paediatric Suspension is indicated for the treatment of infections caused by susceptible organisms. Indications include • Lower respiratory tract infections (e.g. bronchitis, pneumonia) (see sections 4.4 and 5.1 regarding Sensitivity Testing) • Upper respiratory tract infections (e.g. pharyngitis, sinusitis) • Skin and skin structure infections (e.g. pharyngitis, sinusitis) (see sections 4.4 and 5.1 regarding Sensitivity Testing) • Acute otitis media Klacid Paediatric Suspension is usually active against the following organisms _in vitro_ : GRAM-POSITIVE BACTERIA : _Staphylococcus aureus_ (methicillin susceptible); _Streptococcus _ _pyogenes_ (Group A beta-haemolytic streptococci); alpha-haemolytic streptococci (viridans group); _Streptococcus (Diplococcus) pneumoniae; Streptococcus agalactiae; _ _Listeria monocytogenes_ . GRAM-NEGATIVE BACTERIA : _Haemophilus influenzae, Haemophilus parainfluenzae, _ _Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae; Legionella pneumophila, _ _Bordetella pertussis, Helicobacter pylori; Campylobacter jejuni_ . MYCOPLASMA : _Mycoplasma pneumoniae; Ureaplasma urealyticum_ . OTHER ORGANISMS : _Chlamydia trachomatis; Mycobacterium avium; Mycobacterium _ _leprae; Chlamydia pneumoniae_ . ANAEROBES : Macrolide-susceptible _Bacteroides fragilis_ ; _Clostridium perfringens_ ; _Peptococcus_ species; _Peptostreptococcus_ species; _Propionibacterium acnes_ . Klacid Paediatric Suspension has bactericidal activity against seve पूरा दस्तावेज़ पढ़ें