Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clarithromycin
Viatris UK Healthcare Ltd
J01FA09
Clarithromycin
500mg
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010500; GTIN: 5013158086715
MKP-00709-2017_d5 FRONT PATIENT INFORMATION LEAFLET ON ® IV 500 mg Powder for Concentrate for Solution for Infusion Clarithromycin Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet. See section 4. What is in this leaflet: 1. What Klaricid IV is and what it is used for 2. What you need to know before receiving Klaricid IV 3. How is Klaricid IV given? 4. Possible side effects 5. How to store Klaricid IV 6. Contents of the pack and other information 1. What Klaricid IV is and what it is used for Klaricid IV contains the active ingredient clarithromycin. Klaricid belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) that cause infections. Klaricid IV is used whenever an intravenous (injection into the vein) antibiotic is required to treat severe infections or, alternatively, if a patient cannot swallow Klaricid tablets. 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 Klaricid IV is indicated in adults and children 12 years and older. 2. What you need to know before receiving Klaricid IV Do not receive Klaricid IV if you; • know that you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients in Klaricid IV. • are taking medicines called ergot alkaloid tablets (e.g. ergotamine or dihydroergotamine) or use ergotamine inhalers for migraine. • are taking medicines called terfenadine or astemizole (widely taken for h Belgenin tamamını okuyun
OBJECT 1 KLARICID IV 500MG (SMPC) Summary of Product Characteristics Updated 14-May-2018 | Mylan Products Limited 1. Name of the medicinal product Klaricid IV 500 mg, Powder for Concentrate for Solution for Infusion 2. Qualitative and quantitative composition One vial contains 739.5 mg clarithromycin lactobionate, corresponding to 500mg clarithromycin For a full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for Concentrate for Solution for Infusion White to off-white caked, lyophilized powder 4. Clinical particulars 4.1 Therapeutic indications Klaricid IV 500 mg is indicated in adults and children 12 years and older. Klaricid IV 500 mg is indicated whenever parenteral therapy is required for treatment of infections caused by susceptible organisms in the following conditions; - Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia (see section 4.4 and 5.1 regarding Sensitivity Testing). - Upper respiratory tract infections for example, sinusitis and pharyngitis. - Skin and soft tissue infections (e.g. folliculitis, cellulitis, erysipelas) (see section 4.4 and 5.1 regarding Sensitivity Testing). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration For intravenous administration only. Intravenous therapy may be given for 2 to 5 days in the very ill patient and should be changed to oral clarithromycin therapy whenever possible as determined by the physician. ADULTS: The recommended dosage of Klaricid IV 500 mg is 1.0 gram daily, divided into two 500mg doses, appropriately diluted as described below. CHILDREN OLDER THAN 12 YEARS: As for adults. CHILDREN UNDER 12 YEARS: Use of Klaricid IV 500 mg is not recommended for children younger than 12 years. Use Klaricid Paediatric Suspension. ELDERLY: As for adults. RENAL IMPAIRMENT: In patients with renal impairment who have creatinine clearance less than 30ml/min, the dosage of clarithromycin should be reduced to one half of the n Belgenin tamamını okuyun