Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
CLARITHROMYCIN
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
J01FA09
CLARITHROMYCIN 250 mg/5ml
GRANULES FOR ORAL SUSPENSION
CLARITHROMYCIN 250 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 ® 250MG/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. See section 4. WHAT IS IN THIS LEAFLET: 1. What Klacid Granules for Oral Suspension is and what it is used for 2. What you need to know before giving Klacid Granules for Oral Suspension 3. How to give Klacid Granules for Oral Suspension 4. Possible side effects 5. How to store Klacid Granules for Oral Suspension 6. Contents of the pack and other information 1. WHAT KLACID GRANULES FOR ORAL SUSPENSION IS AND WHAT IT IS USED FOR Each 5ml spoonful of Klacid Granules for Oral Suspension contains 250 mg of the active ingredient clarithromycin. Klacid Granules for Oral Suspension belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) which cause infections. Klacid Granules for Oral 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 GRANULES FOR ORAL SUSPENSION DO NOT GIVE KLACID GRANULES FOR ORAL SUSPENSION TO YOUR CHILD IF YOU: know that that they are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of Klacid Granules for Oral Suspension. know they are taking medicines called ergot alkaloids, for example ergotamine or Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Klacid 250mg/5ml Granules for Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution as directed, each 5ml of suspension contains 250mg clarithromycin. Excipients with known effect: Also contains 2.276 g / 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, free-flowing granules with an odour of fruit. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Klacid Suspension is indicated for the treatment of infections caused by susceptible organisms. Indications include: o Lower respiratory tract infections (e.g. bronchitis, pneumonia) (see section 4.4 and 5.1 regarding Sensitivity Testing). o Upper respiratory tract infections (e.g. pharyngitis, sinusitis). o Skin and skin structure infections (e.g. folliculitis, cellulitis, erysipelas) (see section 4.4 and 5.1 regarding Sensitivity Testing). o Acute otitis media. Klacid 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 Suspension has bacteri Læs hele dokumentet