Страна: Кіпр
мова: грецька
Джерело: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
ΚΛΑΡΙΘΡΟΜΥΚΊΝΗ
DELORBIS PHARMACEUTICALS LTD
J01FA09
CLARITHROMYCIN
125MG/5ML
POWDER FOR ORAL SUSPENSION
8000001318 - CLARITHROMYCIN - 125 MG
ORAL USE
Με Ιατρική Συνταγή
CLARITHROMYCIN
01 - 1 BOTTLE X 100ML - 100 - MILLILITRE - 990014601 - Εγκεκριμένο
PACKAGE LEAFLET: INFORMATION FOR THE USER CLERON 125 MG/5 ML POWDER 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 or your pharmacist. This medicine has been prescribed for your child only. Do not pass it on to others. It might harm them, even if their symptoms are the same as your child’s. If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Cleron powder for oral suspension 125 mg/5 ml is and what it is used for 2. What you need to know before giving Cleron powder for oral suspension 125 mg/5 ml 3. How to give Cleron powder for oral suspension 125 mg/5 ml 4. Possible side effects 5. How to store Cleron powder for oral suspension 125 mg/5 ml 6. Contents of the pack and other information 1. WHAT CLERON POWDER FOR ORAL SUSPENSION 125 MG/5 ML IS AND WHAT IT IS USED FOR Each 5 ml spoonful of Cleron powder for oral suspension 125 mg/5 ml contains 125 mg of the active ingredient clarithromycin. Cleron belongs to a group of medicines called macrolides antibiotics. Antibiotics stop the growth of bacteria (bugs) that cause infections. It is used to treat infections such as: 1. Chest infections, such as bronchitis and pneumonia 2. Throat and sinus infections 3. Skin and tissue infections 4. Ear infections particularly inflammation of the middle ear (acute otitis media). Cleron powder for oral suspension 125 mg/5 ml is used in children 6 months to 12 years old. 2. WHAT YOU NEED TO KNOW BEFORE GIVING CLERON POWDER FOR ORAL SUSPENSION 125 MG/5 ML DO NOT GIVE CLERON POWDER FOR ORAL SUSPENSION 125 MG/5 ML TO YOUR CHILD IF THEY: • are ALLERGIC to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of Cleron powd Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cleron 125 mg/5 ml Powder for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of reconstituted suspension contains 125 mg of the active ingredient Clarithromycin. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Consideration should be given to official quidance on the appropriate use of antibacterial agents. Cleron powder for oral suspension 125 mg/5 ml is indicated in children 6 months to 12 years. Cleron powder for oral suspension 125 mg/5 ml is indicated for the treatment of infections caused by susceptible organisms. Indications include: Lower respiratory tract infections. Upper respiratory tract infections. Skin and skin structure infections. Acute otitis media. Cleron powder for oral suspension 125 mg/5 ml 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_. 1 ANAEROBES: Macrolide-susceptible _Bacteroides fragilis_; _Clostridium perfringens_; _Peptococcus_ species; _Peptostreptococcus_ species; _Propionibacterium acnes_. Cleron powder for oral suspension 125 mg/5 ml has bactericidal activity against several bacterial strains. These organisms include _H._ _ _ _influenzae,_ _ _ _Streptococcus Прочитайте повний документ