Philippines - English - FDA (Food And Drug Administration)

cadila pharamceuticals limited - drug - montelukast (as sodium) - aerokids

Philippines - English - FDA (Food And Drug Administration)

akums drugs & pharmaceuticals ltd. (plant iii-injectables) - drug - metronidazole - promeddazole

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

mitton p/j support belts - 41030 - orthosis, spinal, lumbosacral, pendulous abdomen support - this product is intended for use during the peripartum, either pre-natal or postnatal to offer support to the pelvic joints when hormonal changes cause laxity of these in response to the pregnancy. these hormonal changes ,although temporary for most women can be distressing and cause extreme pain and loss of mobility and independence, leading to an inability to function either at work or caring for family and other children. the belt applies gentle yet firm compression around the pelvis, is non invasive and can be adjusted for growth. can also be used following pelvic trauma where support is required

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - pipotiazine palmitate 50 mg/ml;   - solution for injection - 50 mg/ml - active: pipotiazine palmitate 50 mg/ml   excipient: nitrogen sesame oil - piportil depot is a long-acting phenothiazine neuroleptic indicated for the maintenance treatment of schizophrenia and paranoid psychoses, and prevention of relapse, especially where compliance with oral medication is a problem.

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)

zimmer biomet pty ltd - 45966 - pacing lead, external, transthoracic, temporary - the unique features of mce's bi-polar pacing wires have been combined in our quad-polar wire confirurations. it places four electrodes with only one needle pass through chest wall. with just one wire the physician will be able to pace both atrium and ventricle the mce temporary pacing wires (tpw), are intended for temporary artial and ventricular pacing and sensing for contemplated implant duration of 7 days or less

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

johnson & johnson medical pty ltd - 45966 - pacing lead, external, transthoracic, temporary - uninsulated multifilament wire electrode and an insulated multifilament coated conductor attached to straight keith needle at proximal end, with or without preformed wave at distal end attached to a curved needle. for use in temporary cardiac pacing or monitoring

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

stryker australia pty ltd - 45353 - transport wheelchair, non-collapsible - designed to transport occupants in the seated position with their associated medical equipment. the chair is intended to support and transport the occupant in an upright, seated position with their back against the seat back and their feet and arms on the provided resting surfaces with their associated medical equipment.

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

zoll medical australia pty ltd - 36289 - transport electric ventilator - designed to be used in emergency and transportation situations to control ventilation inside and outside the hospital environment.

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

biomedical solutions - 36289 - transport electric ventilator - an electrically-powered device designed to provide invasive and non-invasive automated, alveolar ventilatory support for infants, children and adults during emergency situations and inter-hospital or intra-hospital transport settings, for example in ambulances or in field hospitals. it is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. it is suitable for long-term ventilation. the ventilator is available in different feature levels and can be used by first responders as well as for ground, water or air transport. it usually includes an airway pressure monitor and low and high pressure alarms.