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temsirolimus has been associated with phospholipidosis in rats.
temsirolimus je povezan s fosfolipidozom u štakora.
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the significance of phospholipidosis in humans is unknown.
značaj fosfolipidoze u ljudi nije poznat.
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phospholipidosis occurs at acceptable human to animal safety margins and was reversible.
pojava fosfolipidoze bila je unutar prihvatljivih sigurnosnih margina s obzirom na omjer izloženosti između životinja i ljudi, te je bila reverzibilna.
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phospholipidosis in pulmonary macrophages due to accumulation of memantine in lysosomes was observed in rodents.
kod glodavaca je primijećena fosfolipidoza u plućnim makrofazima zbog nakupljanja memantina u lizosomima.
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phospholipidosis (vacuolation of the cells of the liver, adrenal gland and lung) also occurred.
fosfolipidoza (vakuolizacija stanica jetre, nadbubrežne žlijezde i pluća) se pojavila.
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phospholipidosis has not been observed in mice or monkeys treated with temsirolimus, nor has it been documented in patients treated with temsirolimus.
fosfolipidoza nije opažena u miševa ili majmuna liječenih temsirolimusom, niti je zabilježena u bolesnika liječenih temsirolimusom.
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phospholipidosis (foamy macrophages) has been observed with the administration of netupitant after repeated administration in rats and dogs.
fosfolipidoza (pjenasti makrofazi) opažena je uz primjenu netupitanta nakon ponavljane primjene u štakora i pasa.
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of all species, pigment-laden and/or foamy macrophages were also seen in various tissues, consistent with phospholipidosis.
u mps svih vrsta, sukladno fosfolipidozi, u različitim tkivima uočeni su makrofagi ispunjeni pigmentom i/ili pjenušavi makrofagi.
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in chronic toxicity studies, slight and reversible phospholipidosis (accumulation of foamy macrophages) was observed in mesenteric lymph nodes mainly in the rat.
u ispitivanjima kronične toksičnosti primijećena je blaga i reverzibilna fosfolipidoza (akumulacija pjenastih makrofaga) u mezenterijskim limfnim čvorovima, uglavnom u štakora.
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although phospholipidosis has not been shown to be a risk for patients administered temsirolimus, it is possible that combined administration of temsirolimus with other amphiphilic agents such as amiodarone or statins could result in an increased risk of amphiphilic pulmonary toxicity.
iako se pokazalo da nema rizika od fosfolipidoze u bolesnika kojima se daje temsirolimus, moguće je da kombinirana primjena temsirolimusa s drugim amfifiličnim sredstvima, kao što su amiodaron ili statini, dovede do povećanja rizika od amfifilične plućne toksičnosti.
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alveolar foamy macrophages (confirmed phospholipidosis) were seen in the lungs of rats, but not in monkeys, and the lymph nodes of rats and monkeys had macrophage aggregates.
alveolarni pjenasti makrofagi (potvrđena fosfolipidoza) uočeni su u plućima štakora, ali ne u majmuna, a limfni čvorovi štakora i majmuna imali su nakupine makrofaga.
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phospholipidosis was seen mainly in the lungs in rodents (at exposures similar to humans) and monkeys (at exposures greater than 12 fold higher than human).
fosfolipidi su uglavnom uočeni u plućima glodavaca (u izloženosti sličnoj onoj u ljudi) i u majmuna (u izloženostima većim od 12 puta od one u ljudi).
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adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to or even lower than clinical exposure levels and with possible relevance to clinical use, were as follows: pancreatic islet cell vacuolation (rat), testicular tubular degeneration (mouse, rat and monkey), lymphoid atrophy (mouse, rat and monkey), mixed cell inflammation of the colon/caecum (monkey), and pulmonary phospholipidosis (rat).
nuspojave koje nisu bile primijećene u kliničkim ispitivanjima, ali su bile opažene u životinja izloženih sličnim ili čak nižim razinama od kliničkih, i koje bi mogle biti važne za kliničku primjenu bile su sljedeće: vakuolizacija stanica otočića gušterače (štakor), degeneracija testikularnih kanalića (miš, štakor i majmun), limfoidna atrofija (miš, štakor i majmun), upala s miješanim upalnim stanicama u debelom crijevu/cekumu (majmun) te plućna fosfolipidoza (štakor).
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