nvesatim Things To Know Before You Buy

nvesatim Things To Know Before You Buy

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Advise the client to read the FDA-approved affected individual labeling (Affected individual INFORMATION and Instructions for Use). Overview the methods for direct affected person administration with individuals and caregivers. Coaching by the Health care provider should really purpose to make sure that people and caregivers can correctly complete each of the actions during the Recommendations for Use of NIVESTYM vial and prefilled syringe, such as demonstrating the individual or caregiver how to measure the necessary dose, significantly if a patient is on the dose other than your entire prefilled syringe.

Do smanjenja broja belih krvnih zrnaca (neutropenije) može doći iz više razloga, a ona dovodi do oslabljene sposobnosti organizma da se bori protiv infekcija. Lek Nivestim stimuliše koštanu srž da brzo stvara nova bela krvna zrnca.

Lek Nivestim ćete primati sve dok se broj belih krvnih zrnaca ne normalizuje. Neophodno je redovno praćenje laboratorijske analize krvi, kako bi se pratio broj belih krvnih zrnaca u Vašem organizmu. Vaš lekar će vam reći koliko dugo je potrebno da primate ovaj lek.

Cutaneous vasculitis may perhaps come about, which may be signaled by purpura or erythema. Advise patients to report indicators or indications of vasculitis for their medical doctor promptly [see WARNINGS AND Safeguards]. mikrograma/kg/dan) i blago smanjenje stope preživljavanja (100 mikrograma/kg/dan).|Nivestym (filgrastim-aafi) is usually a leukocyte expansion aspect indicated to: lower the incidence of infection??as manifested by febrile neutropenia??in clients with nonmyeloid malignancies acquiring myelosuppressive anti-most cancers medication linked to an important incidence of severe neutropenia with fever; reduce the time to neutrophil recovery as well as the length of fever, adhering to induction or consolidation chemotherapy treatment method of clients with acute myeloid leukemia (AML); decrease the length of neutropenia and neutropenia-connected scientific sequelae??e.|Adverse events with ??two% bigger incidence in filgrastim people in comparison to placebo and connected with the sequelae in the underlying malignancy or cytotoxic chemotherapy included diarrhea, constipation, and transfusion response.|Neupotrebljivi lekovi se predaju apoteci u kojoj je istaknuto obaveštenje da se u toj apoteci prikupljaju neupotrebljivi lekovi od građana. Neupotrebljivi lekovi se ne smeju bacati u kanalizaciju ili zajedno sa komunalnim otpadom. Ove mere će pomoći u zaštiti životne sredine.|Obično su asimptomatski slučajevi splenomegalije i rupture slezine zabeleženi kod pacijenata i zdravih donora nakon primene filgrastima. Pojedini slučajevi rupture slezine bili su sa smrtnim ishodom. Zbog toga veličinu slezine treba pažljivo pratiti (npr. kliničkim pregledima, ultrazvukom).|Svaki napunjeni injekcioni špric ima pričvršćenu iglu zaštićenu štitnikom za iglu koji sadrži epoksipren, derivat lateksa (prirodne gume), koji može doći u kontakt sa iglom.|Ako dođe do gubitka odgovora ili neuspeha u održavanju odgovora na terapiju filgrastimom, Vaš lekar će ispitati razloge zbog čega se ovo dogodilo uključujući i mogućnost da su se razvila antitela koja neutrališu aktivnost filgrastima.|uočite natečenost lica ili zglobova, primetite krv u mokraći ili braonkasto prebojenu mokraću ili primetite da mokrite manje nego obično (glomerulonefritis),|Lek Nivestim se NE SME primeniti ukoliko je bio izložen temperaturi zamrzavanja duže od 24 sata ili je zamrznut više od jednog puta.|Rupture or enlargement with the spleen may possibly take place. Signs and symptoms include still left upper quadrant abdominal soreness or left shoulder soreness. Advise sufferers to report discomfort in these spots for their medical doctor immediately [see WARNINGS AND Safeguards].|Kod pacijenata sa klinički značajnom preosetljivošću treba trajno prekinuti primenu leka Nivestim. Ne treba primenjivati lek Nivestim kod pacijenata kod kojih u anamnezi postoji reakcija preosetljivosti na filgrastim ili pegfilgrastim.|Pokazano je da primena filgrastim-mobilisanih PBPC smanjuje težinu i dužinu trajanja trombocitopenije nakon mijelosupresivne i mijeloablativne hemioterapije.|Preporučuje se redovno praćenje broja trombocita i hematokrita. Potreban je poseban oprez kada se, sami ili u kombinaciji, primenjuju hemioterapeutski lekovi za koje se zna da uzrokuje tešku trombocitopeniju.|Lek Nivestim je jedan iz grupe lekova koji stimulišu stvaranje belih krvnih zrnaca. Vaš lekar mora uvek da vodi tačnu evidenciju o leku koji ste primili. Drugi lekovi i lek Nivestim}

The suggested starting up dosage in sufferers with Congenital Neutropenia is six mcg/kg being a 2 times daily subcutaneous injection and also the advised starting up dosage in individuals with Idiopathic or Cyclic Neutropenia is five mcg/kg as one day by day subcutaneous injection. mikrograma/kg/dan) i blago smanjenje stope preživljavanja (a hundred mikrograma/kg/dan).|If a client or caregiver is not able to exhibit which they can evaluate the dose and administer the products properly, you ought to think about whether or not the client can be an proper applicant for self-administration of NIVESTYM or whether or not the client would get pleasure from a special NIVESTYM presentation.|Spoljašnje pakovanje je složiva kartonska kutija u kojoj se nalazi pet napunjenih injekcionih špriceva i Uputstvo za lek.|ako se lečite zbog teške hronične neutropenije i imate prisustvo krvi u mokraći (hematurija). Vaš lekar ćeredovno sprovoditi laboratorijske analize Vašeg urina iu isto vreme će kontrolisati vrednosti proteina umokraći (proteinurija).|Slučajevi neželjenih reakcija na plućima, naročito intersticijalna pneumonija, prijavljeni su posle primene website G- CSF. Pacijenti sa anamnestičkim podacima o skorašnjoj plućnoj infiltraciji ili pneumoniji mogu imati povećan rizik. Pojava znakova na nivou pluća, kao što su kašalj, groznica-povišena telesna temperatura i dispneja sa radiološkim znacima plućne infiltracije i pogoršanja plućne funkcije mogu biti znaci koji prethode respiratornom distres sindromu kod odraslih (engl.|Should you be getting NIVESTYM since you are obtaining chemotherapy, your dose of NIVESTYM needs to be injected at the least 24 several hours right before or 24 several hours right after your dose of chemotherapy.|Variation in product or service focus of your NIVESTYM prefilled syringe compared to the NIVESTYM vial. When switching clients within the NIVESTYM prefilled syringe to the NIVESTYM vial, or vice versa, make certain that sufferers recognize the right volume to become administered since the focus of NIVESTYM differs concerning the prefilled syringe as well as vial.|ishodom. Potrebno je da lekari budu oprezni pri primeni filgrastima kod pacijenata sa naslednim obeležjem srpastih ćelija ili oboljenjem srpastih ćelija.|Kada prođe time period smanjenja neutrofila na najmanje vrednosti, dnevnu dozu filgrastima treba titrirati u odnosu na odgovor neutrofila na sledeći način:|Kako bi se poboljšala sledljivost (praćenje) biološkog medicinskog proizvoda, ime i broj serije primenjenog leka moraju biti jasno zabeleženi.|Bezbednost i efikasnost filgrastima je slična kod odraslih i kod dece koja primaju citotoksičnu hemioterapiju.|When NIVESTYM is used to mobilize PBPCâ???tumor cells might be released within the marrow and subsequently collected from the leukapheresis product or service. The influence of reinfusion of tumor cells hasn't been perfectly examinedâ???as well as minimal info obtainable are inconclusive.|The pharmacokinetics of filgrastim in pediatric patients immediately after chemotherapy are much like those in adult people getting exactly the same pounds-normalized doses, suggesting no age-connected differences from the pharmacokinetics of filgrastim merchandise [see Use In Particular Populations].|Ako se ne primeni odmah, vreme i uslovi čuvanja pre primene predstavljaju odgovornost korisnika i obično ne smeju biti duži od 24 sata na temperaturi od twoºC do8ºC, osimako jerazblaživanje sprovedeno u kontrolisanim i validiranim aseptičnim uslovima.|Step 2: Go ahead and take carton made up of the NIVESTYM prefilled syringe out in the fridge and depart it unopened on your get the job done surface for at least half-hour in order that it reaches place temperature. Put the original carton with any unused prefilled syringes back during the fridge.}

Slučajno izlaganje temperaturi zamrzavanja u trajanju do 24 sata neće uticati na stabilnost leka Nivestim. Ukoliko je došlo do zamrzavanja koje je trajalo manje od 24 sata, napunjeni injekcioni špric se može otopiti i nakon toga ponovo odložiti u frižider do trenutka primene.

Obavesite Vašeg lekara ili farmaceuta ukoliko uzimate, donedavno ste uzimali ili ćete možda uzimati bilo koje druge lekove.

Do not drive the needle guard in excess of the needle address ahead of the injection. This will activate or lock the needle guard. See Figure D that displays a needle guard which has not still been activated. This is how the prefilled syringe appears ahead of use.

NIVESTYM is indicated for Long-term administration to decrease the incidence and length of sequelae of neutropenia (e.

The following adverse reaction data in Table two are from three randomized, placebo-managed experiments in sufferers with:

NIVESTYM is indicated to lower the incidence of an infectionâ???as manifested by febrile neutropeniaâ???in sufferers with nonmyeloid malignancies acquiring myelosuppressive anti-most cancers drugs linked to a substantial incidence of critical neutropenia with fever [see Clinical Scientific tests].}