Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clarithromycin
Sun Pharma UK Ltd
J01FA09
Clarithromycin
25mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010500; GTIN: 5015525037375 5015525037368
PACKAGE LEAFLET: INFORMATION FOR THE USER CLARITHROMYCIN 125 MG/5 ML ORAL SUSPENSION CLARITHROMYCIN 250 MG/5 ML ORAL SUSPENSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING THIS MEDICINE TO YOUR CHILD BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOUR CHILD. Keep this leaflet. You may need to read it again. If you have any further questions, ask your _ _ doctor or pharmacist. This medicine has been prescribed for your child _ _ only. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. _ _ WHAT IS IN THIS LEAFLET 1. What Clarithromycin Oral Suspension is and what it is used for 2. What you need to know before you give Clarithromycin Oral Suspension 3. How to give Clarithromycin Oral Suspension 4. Possible side effects 5. How to store Clarithromycin Oral Suspension 6. Contents of the pack and other information 1. WHAT CLARITHROMYCIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR _ _ Clarithromycin is part of a group of antibiotics called macrolides. Clarithromycin works by destroying some types of bacteria that cause certain infections. Clarithromycin may be used to treat infections that are caused by bacteria in the chest, throat, sinuses and ear [particularly inflammation of middle ear (otitis media)] and infections of the skin and the layers of flesh just under the skin. Clarithromycin Oral Suspension is used in children 6 months to 12 years old. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE CLARITHROMYCIN ORAL SUSPENSION DO NOT GIVE CLARITHROMYCIN ORAL SUSPENSION, IF YOUR CHILD: - is allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of this medicine (listed in section 6). - has abnormally low levels of potassium in your blood (hypokalaemia) - has severe liver disorders combined with kidney disorders - or so Leggi il documento completo
OBJECT 1 CLARITHROMYCIN 125MG/5ML ORAL SUSPENSION Summary of Product Characteristics Updated 06-Apr-2018 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company 1. Name of the medicinal product Clarithromycin 125mg/5ml Oral Suspension 2. Qualitative and quantitative composition Each 5 ml of the constituted suspension contains clarithromycin 125 mg Excipients with known effect Each 5ml constituted suspension contains: 2928.50mg of sucrose 20mg of aspartame For the full list of excipients, see section 6.1. 3. Pharmaceutical form Granules for oral suspension White to off-white granular powder forming white to off-white suspension on reconstitution with water. 4. Clinical particulars 4.1 Therapeutic indications Clarithromycin 125mg/5ml Oral Suspension is indicated in children, 6 months to 12 years. Clarithromycin 125mg/5ml Oral Suspension is indicated for treatment of the following infections in children when caused by clarithromycin-susceptible organisms: - Lower respiratory tract infections (e.g. bronchitis, pneumonia) see section 4.4 and 5.1 regarding Sensitivity Testing). - Upper respiratory tract infections (e.g. pharyngitis, sinusitis). - Skin and skin structure infections (e.g. folliculitis, cellulitis, erysipelas) see section 4.4 and 5.1 regarding Sensitivity Testing). - Acute otitis media. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration POSOLOGY Paediatric patients under 12 years of age Clinical trials have been conducted using clarithromycin paediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin pediatric suspension The dosage of clarithromycin depends on the clinical condition of the patient and has to be defined in any case by the physician. Clarithromycin 125mg/5ml Oral Suspension The usual duration of treatment is 5 to 10 days depending on the pathogen involved and the severity of the condition. The recommended daily dose of Clarithromycin 1 Leggi il documento completo