Riik: Malta
keel: inglise
Allikas: Medicines Authority
CEFTRIAXONE
Roche Products Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
J01DD04
CEFTRIAXONE 1 g
POWDER FOR SOLUTION FOR INJECTION
CEFTRIAXONE 1 g
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2006-03-14
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START HAVING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or nurse. • If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. IN THIS LEAFLET: 1. What Rocephin is and what it is used for 2. Before you are given Rocephin 3. How Rocephin will be given 4. Possible side effects 5. How Rocephin is stored 6. Further information 1. WHAT ROCEPHIN IS AND WHAT IT IS USED FOR Rocephin contains a medicine called ceftriaxone. This belongs to a group of medicines called antibiotics. • Rocephin is used to treat infections caused by bacteria. • It can be used to treat infections in different parts of the body including the lungs (pneumonia), blood (septicaemia), skin, other soft body parts (tissues), bone, and for infections such as meningitis and gonorrhoea (a sexually transmitted infection). • It can be used to treat infections in people with low numbers of white blood cells (neutropenia). • It can also be given before and after operations to stop infections from happening. It works by stopping the bacteria from growing properly. This causes the bacteria to die. 2. BEFORE YOU ARE GIVEN ROCEPHIN YOU MUST NOT BE GIVEN ROCEPHIN IF: • You are allergic (hypersensitive) to ceftriaxone (the only ingredient in Rocephin). • You are allergic to antibiotics called ‘cephalosporins’. These include cefalexin, cefaclor and cefuroxime. • You have had a SUDDEN OR SEVERE allergic reaction to penicillin or similar antibiotics (such as amoxicillin or flucloxacillin). The signs include sudden swelling of the throat or face which might make it difficult to breathe or swallow, sudden swelling of the hands, feet and ankles, and a severe rash that develops quickly. • You are allergic to lidocaine and you are to be given Rocephin as an injection into a Lugege kogu dokumenti
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rocephin 1g vials. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1g vial contains 1g ceftriaxone as 1.19g hydrated disodium ceftriaxone. 3. PHARMACEUTICAL FORM Powder for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftriaxone is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible micro-organisms (see section _5.1_) and when parenteral therapy is required: Pneumonia. septicaemia. Meningitis. Bone, skin and soft tissue infections. Infections in neutropenic patients. Gonorrhoea. Peri-operative prophylaxis of infections associated with surgery. Treatment may be started before the results of susceptibility tests are known. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Rocephin may be administered by deep intramuscular injection, slow intravenous injection, or as a slow intravenous infusion, after reconstitution of the solution according to the directions given below. Diluents containing calcium, (e.g. Ringer’s solution or Hartmann’s solution), should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mix Lugege kogu dokumenti