Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Tigecycline
Pfizer Europe MA EEIG
J01AA12
tigecycline
Antibacterials for systemic use,
Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections
Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: , Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections, Complicated intra-abdominal infections (cIAI) , Tygacil should be used only in situations where other alternative antibiotics are not suitable. Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents.,
Revision: 34
Authorised
2006-04-24
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER TYGACIL 50 MG POWDER FOR SOLUTION FOR INFUSION tigecycline READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Tygacil is and what it is used for 2. What you need to know before you receive Tygacil 3. How Tygacil is given 4. Possible side effects 5. How to store Tygacil 6. Contents of the pack and other information 1. WHAT TYGACIL IS AND WHAT IT IS USED FOR Tygacil is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections. Your doctor has prescribed Tygacil because you or your child at least 8 years old has one of the following types of serious infections: Complicated infection of the skin and soft tissues (the tissue below the skin), excluding diabetic foot infections. Complicated infection in the abdomen. Tygacil is only used when your doctor thinks other antibiotics are not suitable. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE TYGACIL DO NOT USE TYGACIL If you are allergic to tigecycline, or any of the other ingredients of this medicine (listed in section 6). If you are allergic to tetracycline class antibiotics (e.g., minocycline, doxycycline, etc.), you may be allergic to tigecycline. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR NURSE BEFORE RECEIVING TYGACIL: If you have poor or slow wound healing. If you are suffering from diarrhoea before you are given Tygacil. If you develop diarrhoea during or after your treatment, tell your doctor at once. Do not take any diarrhoea medicine without first checking with your doctor. If you have or previously had any side effects due to antibiotics belonging Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tygacil 50 mg powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml Tygacil vial contains 50 mg of tigecycline. After reconstitution, 1 ml contains 10 mg of tigecycline. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion (powder for infusion). Orange cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1): Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4); Complicated intra-abdominal infections (cIAI). Tygacil should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The recommended dose is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days. _Children and adolescents (8 to 17 years of age)_ Children aged 8 to <12 years: 1.2 mg/kg of tigecycline every 12 hours intravenously to a maximum dose of 50 mg every 12 hours for 5 to 14 days. Adolescents aged 12 to <18 years: 50 mg of tigecycline every 12 hours for 5 to 14 days. The duration of therapy should be guided by the severity, site of the infection, and the patient’s clinical response. _Elderly_ No dosage adjustment is necessary in elderly patients (see section 5.2). 3 _Hepatic impairment_ No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B). In patients (including paediatrics) with severe hepatic impairment (Child Pugh C), the dose of tigecycline should be reduced by 50 %. Adult dose should be reduced to 25 mg every 12 hours following the 100 mg loading dose. Patients wit Прочетете целия документ