Australia - engleză - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml - injection, suspension - excipient ingredients: monobasic sodium phosphate; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and other pathogens known to infect the liver.

Australia - engleză - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram - injection, suspension - excipient ingredients: dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate; sodium chloride; monobasic sodium phosphate; water for injections - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and other pathogens known to infect the liver.

Australia - engleză - APVMA (Australian Pesticides and Veterinary Medicines Authority)

virbac (australia) pty ltd - recombinant omega interferon of feline origin - unknown - recombinant omega interferon of feline origin vaccine active 0.0 - active constituent

Regatul Unit - engleză - MHRA (Medicines & Healthcare Products Regulatory Agency)

consilient health ltd - telmisartan; hydrochlorothiazide - tablet - 40mg ; 12.5mg

Regatul Unit - engleză - MHRA (Medicines & Healthcare Products Regulatory Agency)

consilient health ltd - telmisartan; hydrochlorothiazide - tablet - 80mg ; 12.5mg

Regatul Unit - engleză - MHRA (Medicines & Healthcare Products Regulatory Agency)

consilient health ltd - hydrochlorothiazide; telmisartan - tablet - 25mg ; 80mg

Arabia Saudită - engleză - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

glaxo saudi arabia ltd, saudi arabia - recombinant neisseria meningitidis group b nhba fusion protein the nhba,recombinant neisseria meningitidis group b nhba fusion protein the nhba i,recombinant n meningitidis serogroup b nada protein,recombinant n meningitidis serogroup b nada protein i,recombinant n meningitidis serogroup b fhbp fusion protein,recombinant n meningitidis serogroup b fhbp fusion protein i,outer membrane vesicles from n meningitidis serogroup b strain nz98254 - suspension for injection in pre-filled syringe - 50,50,50,50,50,50,50 µg,

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - recombinant cholera toxin b subunit 1mg; vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated); vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated); vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) - oral suspension - active: recombinant cholera toxin b subunit 1mg vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated) vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated) vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate dihydrate citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate - active immunisation of adults and children from two years of age, who will be visiting areas with an ongoing or anticipated epidemic or who will be spending an extended period of time in areas in which cholera infection is a risk. the vaccine should be considered for foreign aid workers and others intending to visit or spend an extended period of time in areas endemic or epidemic for cholera.

Israel - engleză - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 1000 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.

Israel - engleză - Ministry of Health

bayer israel ltd - recombinant human coagulation factor viii - powder and solvent for solution for injection - recombinant human coagulation factor viii 2000 iu - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). kovaltry can be used for all age groups.