Israel - Englisch - Ministry of Health

kamada ltd, israel - leuprorelin acetate - powder and solvent for solution for injection - leuprorelin acetate 7.5 mg - eligard 7.5 mg is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localized and locally advanced hormone dependent prostate cancer combination with radiotherapy.

Kanada - Englisch - Health Canada

kamada ltd - rabies immunoglobulin (human) - solution - 150unit - rabies immunoglobulin (human) 150unit - serums

Kanada - Englisch - Health Canada

kamada ltd - rabies immunoglobulin (human) - solution - 150unit - rabies immunoglobulin (human) 150unit - serums

Israel - Englisch - Ministry of Health

kamada ltd, israel - human normal immunoglobulin - solution for infusion - human normal immunoglobulin 50 mg/ml - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, and children and adolescents (0-18 years) in:• primary immunodeficiency syndromes (pid) with impaired antibody production• secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of <4 g/l* psaf = failure to mount at least a 2-fold rise in igg antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.immunomodulation in adults, and children and adolescents (0-18 years) in:• primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count• guillain barré syndrome• kawasaki disease (in conjunction with acetylsalicylic acid)• chronic inflammatory demyelinating poliradiculoneuropathy (cidp)• multifocal motor neuropathy (mmn)

Kenia - Englisch - Pharmacy and Poisons Board

kamada ltd beit kama85325 israel - rho (d) immunoglobulin ( anti-d ) - injection - rho (d) immunoglobulin (anti-d) 150 mcg/ml - specificimmunoglobulins

Neuseeland - Englisch - Medsafe (Medicines Safety Authority)

takeda new zealand limited - alpha1-proteinase inhibitor 20 mg/ml - solution for injection - 1000 mg/50ml - active: alpha1-proteinase inhibitor 20 mg/ml excipient: monobasic sodium phosphate dihydrate sodium chloride water for injection - chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (a1-pi), also known as alpha1-antitrypsin (aat) deficiency.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

kamada ltd. - human cytomegalovirus immune globulin (unii: 129l90a25n) (human cytomegalovirus immune globulin - unii:129l90a25n) - cytomegalovirus immune globulin intravenous (human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. in transplants of these organs other than kidney from cmv seropositive donors into seronegative recipients, prophylactic cmv-igiv should be considered in combination with ganciclovir. cytogam® should not be used in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. persons with selective immunoglobulin a deficiency have the potential for developing antibodies to immunoglobulin a and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin a, including cytogam® .

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

kamada ltd. - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - hepagam b [hepatitis b immune globulin intravenous (human)] is an intravenous immune globulin indicated for the following: including - acute exposure to hbsag-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc.), - perinatal exposure of infants born to hbsag-positive mothers, - sexual exposure to hbsag-positive persons, and - household exposure to persons with acute hbv infection. - individuals known to have anaphylactic or severe systemic reactions to the parenteral administration of human globulin preparations should not receive hepagam b. - individuals who are deficient in iga may have the potential to develop anti-iga antibodies and have an anaphylactoid reaction. hepagam b contains less than 40 micrograms per milliliter of iga. - hepagam b contains less than 40 micrograms per milliliter of iga. - for postexposure prophylaxis indications, hepagam b must be administered intramuscularly only. in patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, hepagam b should be given only if the expected benefits outweigh the potential risks. pregnancy category c. animal reproduction studies have not been conducted with hepagam b. it is also not known whether hepagam b can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. hepagam b should be given to a pregnant woman only if clearly indicated. it is not known whether hepagam b is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when hepagam b is administered to a nursing mother. safety and effectiveness have not been established in pediatric patients. however, for postexposure prophylaxis, the safety and effectiveness of similar hepatitis b immune globulins have been demonstrated in infants and children 8 . clinical studies of hepagam b did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

kamada ltd. - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - varizig ® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: - immunocompromised children and adults, - newborns of mothers with varicella shortly before or after delivery, - premature infants, - neonates and infants less than one year of age, - adults without evidence of immunity, - pregnant women. varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. - there is no convincing evidence that varizig reduces the incidence of chickenpox infection after exposure to vzv. - there is no convincing evidence that established infections with vzv can be modified by varizig administration. - there is no indication for the prophylactic use of varizig in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone marrow transplantation. - individuals known to have anaphylactic or severe systemic (hypersensitivity) reactions to human immune globulin preparations should not receive varizig. - iga-deficient patients with antibodies against iga and a history of hypersensitivity may have an anaphylactoid reaction. - varizig contains less than 40 micrograms per milliliter of iga. animal reproduction studies have not been conducted with varizig. it also is not known whether varizig can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. varizig should be given to a pregnant woman only if clearly needed. the safety and effectiveness of varizig have been evaluated for post-exposure prophylaxis in clinical trials in 166 pregnant women [see 6adverse reactions and 14clinical studies ]. it is not known whether varizig is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when varizig is administered to a nursing mother. the dosing recommendations in the treatment of pediatric patients are by body weight [see 2dosage and administration ]. the safety and effectiveness of varizig have been evaluated for post-exposure prophylaxis in the varizig expanded access clinical trial in 374 pediatric patients, including immunocompromised pediatric patients: - 94 preterm newborns and infants, - 53 term newborns, - 45 infants and toddlers, - 176 children and, - 43 adolescents. in the eap, follow up data were available for 110 varizig treatments in infants (including newborns, pre-term infants, and infants less than 1 year old). three severe infections were reported, all three with pox count greater than 100, one of which also had pneumonia and another one also developed probable varicella encephalitis. clinical studies of varizig administered intramuscularly for post-exposure prophylaxis did not include sufficient numbers of geriatric subjects (aged 65 and over) to determine whether they respond differently from younger subjects. use caution when administering varizig to patients aged 65 and over who are judged to be at increased risk of thrombotic events [see 5warnings and precautions ]. do not exceed recommended doses and administer varizig intramuscularly only. in the eap, both adult (n=37) and pediatric immunocompromised subjects (n=235) were treated. twelve immunocompromised subjects developed clinical varicella and none developed varicella pneumonitis; however at least five are reported to have received concomitant acyclovir and due to incomplete reporting, it is not known if others also received acyclovir.

Israel - Englisch - Ministry of Health

kamada ltd - immunoglobulin normal human 5 %w/v - liquid - immunoglobulins, normal human, for intravascular adm. - replacement therapy in: primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia common variable immunodeficiency severe combined immunodeficiency wiskott aldrich syndrome myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital aids and recurrent infections. immunomodulation: idiopathic thrombocytopenic purpura (itp) in children or adults at high risk of bleeding spontaneously or prior to surgery to correct the platelet count guillain barre syndrome and kawasaki disease. allogeneic bone marrow transplantation.