Country: Armenja
Lingwa: Ingliż
Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cefazolin (cefazolin sodium)
PharmaTech CJSC
J01DB04
cefazolin (cefazolin sodium)
1000mg
powder for solution for injection or infusion
(1) glass vial 10ml, (50) glass vials 10ml
Prescription
Registered
2021-12-21
PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel: +3741 74 14 10 Fax: +3741 73 46 43 1 Package leaflet: information for the Patient Zolacef 1.0 g powder for solution for injection or infusion cefazolin sodium Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness 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 this leaflet. See section 4. What is in this leaflet 1. What Zolacef is and what it is used for 2. What you need to know before you are given Zolacef 3. How Zolacef is given 4. Possible side effects 5. How to store Zolacef 6. Contents of the pack and other information 1. What Zolacef is and what it is used for This medicine contains the active substance cefazolin, which is an antibiotic. Zolacef is used to treat bacterial infections caused by cefazolin-susceptible bacteria, e.g: Infections of skin and soft tissue Infections of bones and joints Zolacef can also be used before, during and after surgery to prevent possible infections. 2. What you need to know before you are given Zolacef - if you are allergic to cefazolin or any of the other ingredients of this medicine (listed in section 6). - if you are allergic (hypersensitive) to any cephalosporin antibiotics. - have ever had a severe allergic (hypersensitive) reaction to any other type of beta lactam antibiotic (penicillins, monobactams and carbapenems). Warnings and precautions Talk to your doctor or pharmacist before using Zolacef if you: Are prone to allergic reactions (e.g. hay fever or bronchial asthma), since then the risk of severe allergic reactions to Zolacef is increased. PharmaTech CJSC 111 Raffi st. Yerevan, 0 Aqra d-dokument sħiħ
PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel: +3741 74 14 10 Fax: +3741 73 46 43 1 SUMMARY OF THE PRODUCT CHARACTERISTICS ZOLACEF ® POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G cefazolin sodium 1. NAME OF THE MEDICINAL PRODUCT Zolacef ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cefazolin Sodium (equivalent to cefazolin 1.0 g.) The sodium content is 48 mg (2.1 mEq) per 1 gram of cefazolin sodium. 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zolacef is indicated for the treatment of the following infections caused by cefazolin-susceptible micro- organisms: - skin and soft tissue infections - bone and joint infections. Perioperative prophylaxis. For surgical operations with increased risk of infections with anaerobic pathogens, e.g. colorectal surgery, a combination with an appropriate drug with activity against anaerobes is recommended. The use of cefazolin should be limited to cases where parenteral treatment is needed. Susceptibility of causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage as well as the method of administration are dependent on the location and severity of the infection and on the clinical and bacteriological progress. Local therapeutic guidance should be taken into consideration. ADULTS AND ADOLESCENTS (ABOVE 12 YEARS OF AGE AND ≥ 40 KG BODYWEIGHT) Infections caused by sensitive micro-organisms: 1 g - 2 g cefazolin per day divided into 2-3 equal doses. Infections caused by moderately sensitive micro-organisms: 3 g - 4 g cefazolin per day divided into 3-4 equal doses. PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel: +3741 74 14 10 Fax: +3741 73 46 43 2 In severe infections, doses of up to 6 g per day can be administered in three or Aqra d-dokument sħiħ