Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
VANCOMYCIN HYDROCHLORIDE
Quimedical - Produtos Farmaceuticos, Lda.
J01XA01
VANCOMYCIN HYDROCHLORIDE
500 Milligram
Pdr/Conc/Soln for Infus
Product subject to prescription which may not be renewed (A)
Glycopeptide antibacterials
Authorised
2016-04-29
1. WHAT VANCOMYCIN IS AND WHAT IT IS USED FOR Vancomycin is an antibiotic which helps your body fight infections by eliminating certain bacteria that cause infections. Vancomycin is used for the treatment of the following serious infections: Infections of the bones, lung infections, skin and muscle (soft tissue) infection and infection of the valves or lining of the heart. Vancomycin can also be used before some types of surgery to prevent possible infections of the lining of the heart. Vancomycin may also be administered orally in the treatment of: • inflammation of the lining of the small and large intestine with damage to the mucosa (pseudomembranous colitis) caused by a certain type of bacteria (Clostridium difficile), as a result of treatment with antibiotics; • inflammation of the lining of the small and large intestine (enterocolitis) as a result of a certain type of bacteria (Staphylococci). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VANCOMYCIN DO NOT USE VANCOMYCIN • If you are allergic (hypersensitive) to vancomycin or any other ingredients of this medicine (listed in Section 6). Tell your doctor if you have had some problems with this product or with others in the past. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Vancomycin. Before treatment with vancomycin, make sure your doctor knows your medical history, especially: • If you have kidney problems • If you have difficulty hearing • If you are over 65 years old The rapid injection of Vancomycin can cause low blood pressure, shock, and rarely, cardiac arrest. Stopping the infusion usually results in immediate cessation of these reactions. Injection site pain, inflammation of the vein wall and blood coagulation may occasionally occur in severe form; slow administration can also reduce these side effects. If you are allergic to another antibiotic called teicoplanin, you may also be allergic to Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vancomycin 500mg powder for concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vancomycin 500 mg Powder for concentrate for solution for infusion Each vial contains 500 mg of vancomycin (as vancomycin hydrochloride), equivalent to not less than 525,000 IU. One ml of reconstituted solution contains 50 mg of vancomycin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Homogeneous solid, white to slightly brown. After reconstitution a solution is obtained with a pH between 2.5 – 4.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vancomycin is indicated in adults, infants, children aged one month to 12 years and adolescents over 12 years. Vancomycin solution, administered intravenously, is indicated in the therapy of severe, potentially life-threatening infections due to susceptible gram-positive microorganisms which cannot be treated with or failed to or are resistant to other antibiotics such as penicillins and cephalosporins. Vancomycin should be reserved for those cases where there is a specific indication, to minimize the chance of resistance emerging. Vancomycin is useful in the treatment of the following severe infections caused by susceptible microorganisms (see section 5.1): Endocarditis, Infections of the bones (osteomyelitis), Pneumonia, Soft tissue infections. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Endocarditis caused by enterococci, _Streptococcus viridans _or _S. bovis _should be treated with a combination of vancomycin and an aminoglycoside. Vancomycin may be used for the perioperative prophylaxis Belgenin tamamını okuyun