New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - adefovir dipivoxil 10mg;   - tablet - 10 mg - active: adefovir dipivoxil 10mg   excipient: croscarmellose sodium lactose monohydrate magnesium stearate purified talc starch - hepsera is indicated for the treatment of patients 12 years and older with chronic hepatitis b infection and evidence of hepatitis b viral replication. for adult patients this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag-/hbvdna+ chronic hepatitis b with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. for adolescent patients (12 to <18 years of age), the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus with compensated liver function.

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - adefovir dipivoxil - hepatitis b, chronic - nucleoside and nucleotide reverse transcriptase inhibitors - hepsera is indicated for the treatment of chronic hepatitis b in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (alt) levels and histological evidence of active liver inflammation and fibrosis. initiation of hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1);decompensated liver disease in combination with a second agent without cross-resistance to hepsera.

United States - English - NLM (National Library of Medicine)

excella gmbh - adefovir dipivoxil (unii: u6q8z01514) (adefovir - unii:6gqp90i798) - adefovir 10 mg - hepsera is indicated for the treatment of chronic hepatitis b in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag- chronic hepatitis b with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. for patients 12 to <18 years of age, the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus infection with compensated liver function. hepsera is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies of hepsera in pregnant women. chroni

United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - adefovir dipivoxil (unii: u6q8z01514) (adefovir - unii:6gqp90i798) - adefovir dipivoxil 10 mg - hepsera is indicated for the treatment of chronic hepatitis b in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag- chronic hepatitis b with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. for patients 12 to less than 18 years of age, the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus infection with compensated liver function. hepsera is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to

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

gilead sciences pty ltd - adefovir dipivoxil -

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - adefovir dipivoxil - tablets - adefovir dipivoxil 10 mg - adefovir dipivoxil - adefovir dipivoxil - hepsera is indicated for the treatment of chronic hepatitis b in adults with: • compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and fibrosis. initiation of hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.• decompensated liver disease in combination with a second agent without cross‐resistance to hepsera

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

gilead sciences pty ltd - adefovir dipivoxil -

United States - English - NLM (National Library of Medicine)

boumatic, llc - phosphoric acid (unii: e4ga8884nn) (phosphoric acid - unii:e4ga8884nn), benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y), n-alkyl ethylbenzyl dimethyl ammonium chloride (c12-c14) (unii: g258tfn61x) (n-alkyl ethylbenzyl dimethyl ammonium (c12-c14) - unii:85440928rv) - phosphoric acid 1500 mg in 10 l - concentrated hoof bath enhancer not for human use directions for hoofbath syst ems to help prevent hoof rot and hairy heel warts dilute and mix 0.5 gallon (2 l) of this product with half the normal amount of footbath additive diluted to 50 gallons (190 l) with water. for example: 0.5 gallon (2 l) of this product plus 25 pounds (11 kg) of copper sulfate diluted to 50 gallons (190 l) is equal to or better than 50 pounds (23 kg) of copper sulfate diluted to 50 gallons (190 l). rinse and clean footbaths when solution becomes excessively contaminated. recommendation: to increase efficacy of stepsept cse-200, use a cleaning foot bath in conjunction with boumatic’s stepsept pb-50, a pre-bath hoof cleaner concentrate to help maintain clean treatment solutions. active ingredients (phosphoric acid 20%, third generation quaternary ammonium chloride 10%) inactive ingredients (ethanol, water, fd(and)c blue no. 1)

United States - English - NLM (National Library of Medicine)

boumatic, llc - urea sulfate (unii: 087cn75v0l) (urea - unii:8w8t17847w) - urea sulfate 856 mg in 1 l - concentrated footbath enhancer for external use only usage directions for use in footbath systems dilute and mix 0.5 gallon (1.9 l) of this product with half the normal amount of footbath additive. dilute to 50 gallons (189.3 l) with water. for example: 0.5 gallon (1.9 l) of this product plus 25 pounds (11.34 kg) of copper sulfate diluted to 50 gallons (189.3 l) with water is equal to 50 pounds (22.68 kg) of sulfate diluted to 50 gallons (189.3 l) with water. rinse and clean footbaths when solution becomes excessively contaminated. treatment for cows with interstitial dermatitis (foot rot) and digital dermatitis (hairy heel warts): treat cows every day for 5 consecutive days. continue once a day treatment until improvement if severe foot rot or heel warts persist. prevention therapy for cows who are susceptible to interstitial dermatitis (foot rot) and digital dermatitis (hairy heel warts): treat cows once a week. recommendation: to increase efficacy of stepsept ph-down, use a cleaning footbath in conjunction

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - adefovir dipivoxil - tablet - 10 mg - adefovir dipivoxil 10 mg