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

merck sharp & dohme (australia) pty ltd - pneumococcal purified capsular polysaccharides, quantity: 50 microgram/ml - injection, solution - excipient ingredients: water for injections; phenol; sodium chloride - pneumovax 23 is indicated for immunisation of individuals in the following situations: all individuals over the age of 65 years; individuals with asplenia, either functional or anatomical, including sickle cell disease, in persons more than 2 years of age; where possible the vaccine should be given at least 14 days before splenectomy; immunocompromised patients at increased risk of pneumococcal disease (eg patients with hiv infection before the development of aids, nephrotic syndrome, multiple myeloma, lymphoma, hodgkin's disease and organ transplantation); aboriginal and torres strait islander people over 50 years of age; immunocompetent persons at increased risk of complications from pneumococcal disease because of chronic illness (eg chronic cardiac, renal or pulmonary disease, diabetes mellitus, alcoholism and cirrhosis); patients with cerebrospinal fluid leaks. in australia, the national health and medical research council (nhmrc) currently recommends the vaccination of tobacco smokers with the 23-valent polysaccharide pneumococcal vaccine. pneumovax 23 is indicated for immunisation only against pneumococcal disease caused by those pneumococcal types included in the vaccine. effectiveness of the vaccine in the prevention of pneumococcal pneumonia and pneumococcal bacteremia has been demonstrated. in australia, the national health and medical research council (nhmrc) currently recommeds the vaccination of tabacco smokers with the 23-valent polysaccharide pneumococcal vaccine. pneumovax 23 will not prevent disease caused by capsular types of pneumococcus othar those contained in the vaccine.

European Union - English - EMA (European Medicines Agency)

eli lilly nederland b.v. - necitumumab - carcinoma, non-small-cell lung - antineoplastic agents - portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (egfr) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.

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

eli lilly and company - necitumumab (unii: 2bt4c47rui) (necitumumab - unii:2bt4c47rui) - necitumumab 16 mg in 1 ml - portrazza™ is indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. portrazza is not indicated for treatment of non-squamous non-small cell lung cancer [see warnings and precautions (5.6) and clinical studies (14.2)] . none risk summary based on animal data and its mechanism of action, portrazza can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. disruption or depletion of egfr in animal models results in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development. the absence of egfr signaling has resulted in embryolethality as well as post-natal death in animals (see data) . no animal reproduction studies have been conducted with necitumumab. there are no available data for portrazza exposure in pregnant women. advise pregnant women of the potential risk to a fetus, and the risk to postnatal development. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data no animal studies have been conducted to evaluate the effect of necitumumab on reproduction and fetal development; however, based on its mechanism of action, portrazza can cause fetal harm or developmental anomalies. in mice, egfr is critically important in reproductive and developmental processes including blastocyst implantation, placental development, and embryo-fetal/postnatal survival and development. reduction or elimination of embryo-fetal or maternal egfr signaling can prevent implantation, can cause embryo-fetal loss during various stages of gestation (through effects on placental development) and can cause developmental anomalies and early death in surviving fetuses. adverse developmental outcomes were observed in multiple organs in embryos/neonates of mice with disrupted egfr signaling. human igg1 is known to cross the placenta; therefore, necitumumab has the potential to be transmitted from the mother to the developing fetus. in monkeys, administration of a chimeric anti-egfr antibody that binds to an epitope overlapping that of necitumumab during the period of organogenesis resulted in detectable exposure of the antibody in the amniotic fluid and in the serum of embryos from treated dams. while no fetal malformations or other clear teratogenic effects occurred in offspring, there was an increased incidence of embryolethality and abortions. risk summary there is no information regarding the presence of necitumumab in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions in breastfed infants from portrazza, advise a nursing woman not to breastfeed during treatment with portrazza and for three months following the final dose. contraception females based on its mechanism of action, portrazza can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with portrazza and for three months following the final dose. the safety and effectiveness of portrazza have not been established in pediatric patients. of the 545 patients in the portrazza plus gemcitabine and cisplatin arm in study 1, 213 (39%) were 65 years and over, while 108 (20%) were 70 years and over. in an exploratory subgroup analysis of study 1, the hazard ratio for overall survival in patients 70 years or older was 1.03 (95% ci: 0.75, 1.42). of the adverse reactions listed in table 1 [see adverse reactions (6.1)] , there was a higher incidence (≥3%) of venous thromboembolic events including pulmonary embolism in patients age 70 and over compared to those who were younger than age 70. no formal studies have been conducted to evaluate the effect of renal impairment on the exposure to necitumumab. renal function has no influence on the exposure to necitumumab based on the population pharmacokinetic analysis of data from clinical trials [see clinical pharmacology (12.3)] . no formal studies have been conducted to evaluate the effect of hepatic impairment on the exposure to necitumumab. mild or moderate hepatic impairment has no influence on the exposure to necitumumab based on the population pharmacokinetic analysis. no patients with severe hepatic impairment were enrolled in the clinical trials with portrazza [see clinical pharmacology (12.3)] .

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

merck sharp & dohme (australia) pty ltd - pneumococcal purified capsular polysaccharides, quantity: 50 microgram/ml - injection, solution - excipient ingredients: water for injections; phenol; sodium chloride - pneumovax 23 is indicated for immunisation of individuals in the following situations: all individuals over the age of 65 years; individuals with asplenia, either functional or anatomical, including sickle cell disease, in persons more than 2 years of age; where possible the vaccine should be given at least 14 days before splenectomy; immunocompromised patients at increased risk of pneumococcal disease (eg patients with hiv infection before the development of aids, nephrotic syndrome, multiple myeloma, lymphoma, hodgkin's disease and organ transplantation); aboriginal and torres strait islander people over 50 years of age; immunocompetent persons at increased risk of complications from pneumococcal disease because of chronic illness (eg chronic cardiac, renal or pulmonary disease, diabetes mellitus, alcoholism and cirrhosis); patients with cerebrospinal fluid leaks. in australia, the national health and medical research council (nhmrc) currently recommends the vaccination of tobacco smokers with the 23-valent

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

therapist support laboratory pty ltd - 41029 - orthosis, spinal, lumbosacral, corset, hernia/ptosis support - a garment made of elastic material designed to control and support the abdomen for hernias

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

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen (unii: re9a0h8oab) (neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen - unii:re9a0h8oab), neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen (unii: 2j57k2523t) (neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen - unii:2j57k2523t), neisseria meningitidis group y capsular polysaccharide diphtheria - neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen 4 ug in 0.5 ml - menactra® , meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, y and w-135. menactra is approved for use in individuals 9 months through 55 years of age. menactra does not prevent n meningitidis serogroup b disease. severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or crm197 -containing vaccine, or to any component of menactra [see description (11) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to menactra during pregnancy. to enroll in or obtain information about the registry, call sanofi pasteur at 1-800-822-2463. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects an