Israel - English - Ministry of Health

merck sharp & dohme israel ltd - cilastatin sodium; imipenem as monohydrate - powder for solution for infusion - cilastatin sodium 500 mg/vial; imipenem as monohydrate 500 mg/vial - imipenem and enzyme inhibitor - imipenem and enzyme inhibitor - 1.1 lower respiratory tract infectionstienam for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible strains of staphylococcus aureus (penicillinase-producing isolates), acinetobacter species, enterobacter species, escherichia coli, haemophilus influenzae, haemophilus parainfluenzae, klebsiella species, serratia marcescens.1.2 urinary tract infections (complicated and uncomplicated) tienam is indicated for the treatment of urinary tract infections (complicated and uncomplicated) caused by susceptible strains of enterococcus faecalis, staphylococcus aureus (penicillinase-producing isolates), enterobacter species, escherichia coli, klebsiella species, morganella morganii, proteus vulgaris, providencia rettgeri, pseudomonas aeruginosa.1.3 intra-abdominal infections tienam is indicated for the treatment of intra-abdominal infections caused by susceptible strains of enterococcus faecalis, staphylococcus aureus (penicillinase-producing isolates), staphylococcu

Singapore - English - HSA (Health Sciences Authority)

pharmeng technology pte. ltd. - a/vietnam/1203/2004 (h5n1) - injection, suspension - 7.5µg haemagglutinin per 0.5ml - a/vietnam/1203/2004 (h5n1) 7.5µg haemagglutinin per 0.5ml

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - cilastatin sodium eqv cilastatin; imipenem - injection, powder, for solution - 500 mg/vial - cilastatin sodium eqv cilastatin 500 mg/vial; imipenem 500 mg/vial

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

msd (pty) ltd - injection - see ingredients - each vial contains cilastatin sodium equivalent to cilastatin 500 mg imipenem 500 mg

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human; immunization; disease outbreaks - vaccines - active immunisation against h5n1 subtype of influenza a virus.this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from a/vietnam/1194/2004 nibrg-14 (h5n1) (see section 5.1).prepandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals 3.75 µg should be used in accordance with official guidance.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - imipenem; cilastatin sodium -

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

merck sharp & dohme b.v. - imipenem (imipenem monohydrate), cilastatin (cilastatin sodium) - powder for solution for infusion - 500mg+500mg

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - influenza vaccine whole virion, vero cell derived, inactivated 7.5ug (a(h5n1) (a/vietnam/1203/2004));   - suspension for injection - 7.5 mcg/0.5ml - active: influenza vaccine whole virion, vero cell derived, inactivated 7.5ug (a(h5n1) (a/vietnam/1203/2004))   excipient: polysorbate 80 sodium chloride trometamol water for injection - prophylaxis of influenza in an officially declared pandemic situation. the vaccine may only be marketed or distributed in accordance with the directives contained in the current version of the new zealand influenza pandemic action plan.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - influenza vaccine whole virion, vero cell derived, inactivated 7.5ug (ha per dose a(h5n1)(a/vietnam/1203/2004)) - suspension for injection - 7.5 mcg/0.5ml - active: influenza vaccine whole virion, vero cell derived, inactivated 7.5ug (ha per dose a(h5n1)(a/vietnam/1203/2004)) excipient: polysorbate 80 sodium chloride trometamol water for injection - active immunisation against h5n1 subtype of influenza a virus. this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards as well as immunocompromised and chronically ill subjects following administration of two doses of vaccine prepared with h5n1 subtype strains. vepacel may only be marketed or distributed in accordance with the directives contained in the current version of the new zealand influenza pandemic action plan.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human - vaccines - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.