natgillin/translations-raw huggingface dataset:
Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Aktivni venski tromboembolični zapleti ali venski tromboembolični zapleti v anamnezi, vključno s trombozo globokih ven, pljučno embolijo in trombozo retinalnih ven.
- The active substance is raloxifene hydrochloride.
- Zdravilna učinkovina je raloksifenijev klorid.
However, there was an increase in death due to stroke in women assigned to raloxifene.
Vendar je bilo pri ženskah, ki so dobivale raloksifen, več smrti zaradi kapi.
Optruma contains the active substance raloxifene hydrochloride.
Zdravilo Optruma vsebuje zdravilno učinkovino raloksifenijev klorid.
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
Optruma 60 mg filmsko obložene tablete raloksifenijev klorid
Compared to placebo, raloxifene was not associated with spotting or bleeding or endometrial hyperplasia.
V primerjavi s placebom uporaba raloksifena ni pokazala povezave s krvavim izcedkom,
In a 2-year carcinogenicity study in rats, an increase in ovarian tumors of granulosa/theca cell origin was observed in high-dose females (279 mg/kg/day).
V 2-letni raziskavi kancerogenosti zdravila na podganah so pri samicah, ki so prejemale visoke odmerke (279 mg/kg/dan), ugotovili povečanje pogostnosti pojava tumorjev ovarija, ki so izvirali iz granulozne ali tekalne plasti celic ovarijskih foliklov.
In a study of 7,705 postmenopausal women with a mean age of 66 years and with osteoporosis or osteoporosis with an existing fracture, Optruma treatment for 3 years reduced the incidence of vertebral fractures by 47 % (RR 0.53, CI 0.35, 0.79; p < 0.001) and 31 % (RR 0.69, CI 0.56, 0.86; p < 0.001) respectively.
i) Incidenca zlomov: V raziskavi pri 7.705 ženskah po menopavzi s srednjo starostjo 66 let in z osteoporozo je 3-letno zdravljenje z zdravilom Optruma zmanjšalo incidenco zlomov vretenc za 47 % (relativno tveganje (RR) 0,53 pri 95 % intervalu zaupanja (CI) 0,35-0,79; p < 0,001), pri ženskah z osteoporozo in obstoječim zlomom pa je bila incidenca zlomov vretenc zmanjšana za 31 % (RR 0,69 pri 95 % CI 0,56-0,86; p < 0,001).
However, modest decreases in the prothrombin time have been observed, and if raloxifene is given concurrently with warfarin or other coumarin derivatives, the prothrombin time should be monitored.
Če bolnico zdravimo sočasno z raloksifenom in varfarinom ali drugimi kumarinskimi derivati, je torej treba spremljati protrombinski čas.
EU/1/98/074/001 14 film coated tablets EU/1/98/074/002 28 film coated tablets EU/1/98/074/003 84 film coated tablets
EU/1/98/074/002 28 filmsko obloženih tablet
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER BOX FILM COATED TABLETS:
ŠKATLA S PRETISNIM OMOTOM S FILMSKO OBLOŽENIMI TABLETAMI:
Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg raloxifene.
Vsaka tableta vsebuje 60 mg raloksifenijevega klorida, kar ustreza 56 mg raloksifena.
Optruma mimics some of the helpful effects of oestrogen after the menopause.
Po menopavzi zdravilo Optruma posnema nekatere koristne učinke estrogena.
In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
Pri odraslih bolnikih, ki so vzeli več kot 120 mg raloksifena naenkrat, so poročali o simptomih krčev in omotice.
Optruma 60 mg film coated tablets
IME ZDRAVILA Optruma 60 mg filmsko obložene tablete
• If you are being treated or have been treated for blood clots in the legs (deep vein thrombosis),
• Če vas trenutno zdravijo zaradi krvnih strdkov ali so vas v preteklosti zdravili zaradi krvnih strdkov v nogah (tromboza globokih ven), v pljučih (pljučna embolija) ali v očeh (tromboza retinalnih ven).
In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0 % or 3.88 cases per 1,000 patient-years in the raloxifene group and 1.4 % or 2.70 cases per 1,000 patient-years in the placebo group.
1.000 bolnških let v skupini raloksifena in 1,4 % ali 2,70 primerih na 1.000 bolnških let v skupini placeba.
The recommended dose is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals.
Bolnica jo lahko vzame ob kateremkoli času dneva, ne glede na obroke.
In the osteoporosis treatment study, significantly fewer Optruma-treated patients required initiation of hypolipidaemic therapy compared to placebo.
uvedba hipolipemične terapije potrebna pri značilno manjšem številu v primerjavi s placebom.
Very common: Gastrointestinal symptoms a such as nausea, vomiting, abdominal pain, dyspepsia
Zelo pogosti: gastrointestinalni simptomia, kot so navzea, bruhanje, bolečine v trebuhu,
Optruma and oestrogen affect bone remodelling and calcium metabolism similarly.
iii) Kinetika kalcija: Zdravilo Optruma in estrogen imata podoben vpliv na prestrukturiranje kostnega tkiva in presnovo kalcija.
A similar frequency of increases was noted among placebo patients.
Podobno pogostnost zvišanja so opazili tudi pri bolnicah,
Optruma treatment for 4 years reduced the incidence of vertebral fractures by 46 % (RR 0.54, CI 0.38, 0.75) and 32 % (RR 0.68, CI 0.56, 0.83) in patients with osteoporosis or osteoporosis with an existing fracture respectively.
Štiriletno zdravljenje z zdravilom Optruma je pri bolnicah z osteoporozo zmanjšalo incidenco zlomov vretenc za 46 % (RR 0,54 pri 95 % CI 0,38-0,75), pri bolnicah z osteporozo in obstoječim zlomom pa je incidenca zmanjšana za 32 % (RR 0,68 pri 95 % CI 0,56
Raloxifene treated women consistently had an endometrial thickness which was indistinguishable from placebo.
Pri ženskah, zdravljenih z raloksifenom, ves čas ni bilo razlike v debelini endometrija v primerjavi z debelino endometrija pri tistih, ki so prejemale placebo.
Uncommon: Fatal strokes
Občasni: smrtne kapi Žilne bolezni
Single doses of raloxifene given to patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) produced plasma concentrations of raloxifene which were approximately 2.5 times the controls.
Ko so bolnicam s cirozo in blago jetrno okvaro (razred A po Child-Pughu) dali en odmerek raloksifena, so izmerili plazemske koncentracije raloksifena, ki so bile približno 2,5-krat višje od tistih, ki so jih ugotovili pri preiskovankah iz kontrolne skupine.
Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause.
Osteoporoza je bolezen, zaradi katere se zmanjša gostota kosti in te postanejo krhke.
It is important that you continue taking Optruma for as long as your doctor prescribes the medicine, Optruma can treat or prevent your osteoporosis only if you continue to take the tablets.
Zdravilo Optruma lahko zdravi in preprečuje osteoporozo samo, če nadaljujete z jemanjem tablet.
Superficial vein thrombophlebitis occurred in a frequency of less than 1 %.
Tromboflebitis povrhnjih ven se je pojavljal s pogostnostjo, manjšo od
No cases of raloxifene overdose were reported during clinical trials.
Med temi kliničnimi študijami niso poročali o prevelikem odmerjanju raloksifena.
Common: Headache, including migraine a
Bolezni živčevja Pogosti: glavobol, vključno z migrenoa
Optruma is only for use in postmenopausal women.
Zdravilo Optruma je namenjeno le za zdravljenje žensk po menopavzi.
A relative risk of 1.60 (CI 0.95, 2.71) was observed in Optruma treated patients compared to placebo.
Pri bolnicah, zdravljenih z zdravilom Optruma, je bilo v primerjavi s tistimi, ki so prejemale placebo, ugotovljeno relativno tveganje 1,60 (CI 0,95, 2,71).
Based on these risk factors, prevention of osteoporosis with Optruma is indicated for women within ten years of menopause, with BMD of the spine between 1.0 and 2.5 SD below the mean value of a normal young population, taking into account their high lifetime risk for osteoporotic fractures.
Glede na naštete dejavnike tveganja je preventiva osteoporoze z zdravilom Optruma indicirana v obdobju desetih let po nastopu menopavze pri tistih ženskah, ki imajo vrednosti BMD za hrbtenico za
Slightly decreased (6-10 %) platelet counts have been reported during raloxifene treatment in placebocontrolled clinical trials of raloxifene in osteoporosis.
Med zdravljenjem z raloksifenom v s placebom nadzorovanih kliničnih študijah raloksifena pri osteoporozi so opažali tudi rahlo znižanje (6-10 %) števila trombocitov.
14 film coated tablets 28 film coated tablets 84 film coated tablets
84 filmsko obloženih tablet
In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8 % of 2,557 Optruma treated patients and 11.1 % of 2,576 placebo treated patients.
od 2557 bolnic, zdravljenih z zdravilom Optruma, in pri 11,1 % od 2576 bolnic, ki so prejemale placebo.
Co-administration of raloxifene and warfarin does not alter the pharmacokinetics of either compound.
Sočasna uporaba raloksifena in varfarina ne spremeni farmakokinetike nobene od teh snovi, opaženo pa je bilo zmerno skrajšanje protrombinskega časa.
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Vsaka filmsko obložena tableta vsebuje 60 mg raloksifenijevega klorida, kar ustreza 56 mg raloksifena.
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
Ena filmsko obložena tableta vsebuje 60 mg raloksifenijevega klorida, kar ustreza 56 mg proste baze raloksifena.
In clinical trials, Optruma did not stimulate the postmenopausal uterine endometrium.
c) Vplivi na endometrij in medenično dno V kliničnih preskušanjih zdravilo Optruma ni stimuliralo postmenopavzalnega materničnega endometrija.
Common: Mild breast symptoms a such as pain, enlargement and tenderness
Pogosti: blagi simptomi v dojkaha, kot so bolečina, povečanje in občutljivost za dotik
In female mice, an increased incidence of ovarian tumours in animals given 9 to 242 mg/kg (0.3 to 32 times the AUC in humans) included benign and malignant tumours of granulosa/theca cell origin and benign tumours of epithelial cell origin.
Pri mišjih samicah je povečana incidenca ovarijskih tumorjev pri tistih živalih, ki so prejele 9 do 242 mg/kg (0,3- do 32-kratne AUC za človeka),
Fewer Optruma treated women than placebo treated women required surgical intervention for uterine prolapse.
V skupini, zdravljeni z zdravilom Optruma, je manj žensk potrebovalo kirurški poseg zaradi prolapsa maternice kot v skupini, ki je prejemala placebo.
Peak concentrations of raloxifene are reduced with co-administration with ampicillin.
Sočasno jemanje ampicilina zmanjša najvišje koncentracije raloksifena.
Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Med zdravljenjem je treba skrbno spremljati vrednosti serumskih koncentracij celokupnega bilirubina, gama-glutamil transferaze,
Talk to your doctor or pharmacist before you take Optruma.
Pred začetkom jemanja zdravila Optruma se posvetujte s svojim zdravnikom ali s farmacevtom.
The frequencies for postmarketing reports were calculated from placebo-controlled clinical trials (comprising a total of 15,234 patients, 7,601 on raloxifene 60 mg and 7,633 on placebo) in postmenopausal women with osteoporosis, or established coronary heart disease (CHD) or increased risk for CHD, without comparison to the frequencies of adverse events in the placebo assignment groups.
Pogostnosti za poročila v obdobju trženja so bile preračunane iz placebo nadzorovanih kliničnih preskušanj (v katera je bilo vključenih 15234 bolnic, 7601 jih je prejemalo 60 mg raloksifena in 7633
100 film coated tablets
28 filmsko obloženih tablet
Optruma
dispepsija
Optruma contains lactose
Škatle s pretisnimi omoti vsebujejo po
Optruma must not be taken by women of child bearing potential.
Zdravila Optruma ne smejo jemati ženske v rodni dobi.
So any vaginal bleeding while you take Optruma is unexpected.
Malo verjetno je, da bi zdravilo Optruma povzročilo krvavitev iz nožnice, zato je vsaka krvavitev iz nožnice v času jemanja zdravila Optruma nepričakovana in morate prositi svojega zdravnika, naj vas pregleda.
Anhydrous lactose Lactose monohydrate Crospovidone
Jedro tablete: povidon polisorbat 80 brezvodna laktoza laktoza monohidrat krospovidon magnezijev stearat
In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/kg).
Pri podganah so se pojavili zastoj razvoja ploda, valovita rebra in ledvične ciste (≥
The hazard ratio for all VTE events in the RUTH study was HR = 1.44 (1.06 - 1.95).
HR = 1,44, (1,66 - 1,95).
Titanium dioxide (E 171) Polysorbate 80
Filmska obloga tablete: titanov dioksid (E171) polisorbat 80 hipromeloza makrogol 400 karnauba vosek
Film coated tablet.
FARMACEVTSKA OBLIKA Filmsko obložena tableta
Gastrointestinal disorders
Občasni: trombocitopenijaa
How to store Optruma
Shranjevanje zdravila Optruma
Magnesium stearate
Stopnje holecistomije za raloksifen
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (ALL BLISTER PACKS):
PRETISNI OMOT (VSE VELIKOSTI PAKIRANJ PRETISNIH OMOTOV):
Optruma reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
Pri ženskah s postmenopavzalno osteoporozo zdravilo Optruma zmanjša tveganje za zlome vretenc.
Raloxifene was not genotoxic in any of the extensive battery of test systems applied.
Z nobenim od velikega števila uporabljenih testnih sistemov niso ugotavljali genotoksičnih učinkov raloksifena.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJ ZA PROMET Datum pridobitve dovoljenja za promet: 5. avgust 1998
OTHER
V
The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology.
Pri bolnicah, pri katerih obstaja tveganje za pojav venskih tromboemboličnih zapletov kakršnekoli etiologije, je treba upoštevati razmerje med koristnostjo jemanja zdravila in tveganjem, ki ga jemanje zdravila povzroča.
Tablet coating:
Bolezni prebavil
Propylene glycol Indigo carmine (E 132)
šelak propilenglikol indigotin (E132) 6.2 Inkompatibilnosti Navedba smiselno ni potrebna.
BATCH NUMBER
PRILOGA I
Tell your doctor or pharmacist.
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
EU/1/98/074/004
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/98/074/004
Tablet core:
Ledvična okvara:
It is therefore difficult to recommend an optimum method.
Zaradi tega je težko priporočiti optimalno metodo.
The significance of these changes is unknown.
Pomen teh sprememb ni znan.
These can be taken from you or from a donor.
Te lahko odvzamejo od vas ali od darovalca.
These will be monitored by your doctor.
To bo spremljal vaš zdravnik.
10291 Prigorje Brdovečko Croatia
10291 Prigorje Brdovečko Hrvaška
Date of first authorisation: 08 June 2010 Date of latest renewal: 27 May 2015
Datum prve odobritve: 08 junij 2010 Datum zadnjega podaljšanja: 27 maj 2015
The syringe is now ready for use.
Brizga je zdaj pripravljena za uporabo.
If you are a stem cell donor, you must be aged between 16 and 60 years.
Če ste darovalec matičnih celic, morate biti stari med 16 in 60 let.
Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Čeprav tega medsebojnega delovanja formalno niso raziskovali, pa ni nobenih dokazov, da je tako medsebojno delovanje škodljivo.
Wash your hands thoroughly with soap and water.
Temeljito si umijte roke z milom in vodo.
cells mean that direct comparison between different studies is difficult.
+ celic pomeni, da je neposredna primerjava med različnima študijama težavna.
These changes all reversed after discontinuation of treatment.
Vse te spremembe so po prenehanju zdravljenja izzvenele.
The most suitable places for injection are:
Najprimernejša mesta za injiciranje so:
European Retrospective Study (2004)
Evropska retrospektivna študija (2004)
The subcutaneous route is preferred in most cases.
Subkutana pot uporabe je v večini primerov najprimernejša.
Do not increase the dose your doctor has given you.
Ne povečajte odmerka, ki vam ga je dal zdravnik.
You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home.
Vi oziroma osebe, ki skrbijo za vas, se lahko naučite, kako dajati podkožne injekcije tako, da lahko zdravljenje nadaljujete doma.
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:
NASLEDNJE INFORMACIJE SO NAMENJENE SAMO ZDRAVSTVENEMU OSEBJU:
Your healthcare professional should always record the exact product you are using.
Vaš zdravstveni delavec mora vedno zabeležiti točno ime zdravila, ki ga uporabljate.
This should be considered when interpreting bone-imaging results.
To je treba upoštevati pri interpretaciji izvidov slikanja kosti.
9/L, with the median dose frequency being 3 days per week.
9/l, pri čemer je bila mediana pogostnost odmerjanja 3 dni na teden.
• Antiseptic wipes (if recommended by your doctor or nurse).
• antiseptične robčke (če sta vam jih priporočila zdravnik ali medicinska sestra).
Regular monitoring of blood counts is recommended (see above).
Priporočljivo je redno spremljanje krvne slike (glejte zgoraj).
Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Rastni faktorji so beljakovine, ki jih telo naravno proizvaja, vendar pa jih je mogoče izdelati tudi s pomočjo biotehnologije za uporabo kot zdravilo.
You will need to have your injections at about the same time every day.
Injekcije si boste morali dajati vsak dan ob približno istem času.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
Dose adjustment is not required in these circumstances.
V teh primerih ni potrebna prilagoditev odmerka.
This medicine may cause dizziness.
To zdravilo lahko povzroči omotico.
At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Po tem obdobju se zdravila ne sme shraniti nazaj v hladilnik in ga je potrebno uničiti.
• NEVER put used syringes into your normal household waste bin.
• Uporabljenih brizg NIKOLI ne odlagajte med običajne gospodinjske odpadke.
How is Nivestim given and how much should I take?
Kako se daje zdravilo Nivestim in koliko ga moram vzeti?
However, you should not attempt this unless you have been properly trained first by your healthcare provider.
Vendar pa tega ne poskušajte, če vas zdravstveni delavec za to ni najprej ustrezno usposobil.
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA:
ANC = absolute neutrophil count
ANC = absolutno število nevtrofilcev (absolute neutrophil count)
Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 10
Levkaferezo je treba začeti 5. dan in z njo nadaljevati do 6. dne, če je potrebno, da bo zbranih 4 x 10
The only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population.
Edini neželen dogodek, ki so ga dosledno poročali, je bil mišično-skeletna bolečina, to pa se ne razlikuje od izkušenj pri odraslih populaciji.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Po enem ali dveh tednih zdravljenja je možno začetni odmerek podvojiti ali razpoloviti, odvisno od bolnikovega odziva.
A risk to the newborns/infants cannot be excluded.
Tveganja za dojenega novorojenčka/otroka ne moremo izključiti.
For intravenous or subcutaneous use.
za intravensko ali subkutano uporabo
For reversal of neutropenia:
Za odpravljanje nevtropenije:
Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Zdravnik vas bo morda želel pozorno spremljati, glejte poglavje 4 v teh navodilih za uporabo.
The clinical relevance of this finding to multiple dose administration is not clear.
Klinični pomen te ugotovitve pri uporabi večkratnih odmerkov ni jasen.
The frozen pre-filled syringes can be thawed and then refrigerated for future use.
Zamrznjene napolnjene brizge je možno odmrzniti in jih nato shraniti na hladnem za nadaljnjo uporabo.
It is important to tell your doctor if you: - are pregnant or breast-feeding; - think you may be pregnant; or - are planning to have a baby.
Pomembno je, da svojemu zdravniku poveste, če: - ste noseči ali dojite, - mislite da ste noseči ali - načrtujete nosečnost.
• trouble sleeping (insomnia)
• težave s spanjem (nespečnost)
When the response has been obtained the minimal effective dose to maintain this level should be established.
Ko je dosežen odziv, je treba določiti minimalni učinkoviti odmerek za ohranjanje te vrednosti.
If your nurse or doctor recommends it, clean the area of skin with an antiseptic wipe.
Če zdravnik ali medicinska sestra to priporočata, očistite izbrani del kože z antiseptičnim robčkom.
• The active substance is filgrastim.
• Učinkovina je filgrastim.
a Analysis includes studies involving BM transplant during this period; some studies used GM-CSF.
Analiza je vključevala študije presaditve kostnega mozga v tem obdobju; v nekaterih študijah so uporabili GM-CSF.
Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific dosage recommendations cannot be made.
V klinična preskušanja s filgrastimom je bilo vključeno majhno število starejših bolnikov, vendar pri tej skupini niso bile opravljene posebne študije, zato ni mogoče podati posebnih priporočil za odmerjanje.
Yields in excess of this appear to correlate with more rapid recovery, those below with slower recovery.
Zdi se, da so deleži, večji od teh najmanjših deležev, povezani s hitrejšo obnovo, manjši deleži pa s počasnejšo obnovo.
• increase of certain enzymes in the blood
• zvišanje določenih encimov v krvi
This medicine contains 50 mg sorbitol in each ml.
To zdravilo vsebuje 50 mg sorbitola v vsakem ml raztopine.
How long will I have to take Nivestim?
Koliko časa bom moral jemati zdravilo Nivestim?
• unusual change in the urine
• neobičajne spremembe urina
Find a comfortable well lit working place to give your injection and check the dose that you have been prescribed.
Najdite prijetno in dobro osvetljeno delovno mesto, kjer si boste dali injekcijo zdravila, in preverite odmerek, ki vam ga je predpisal zdravnik.
Learning to give your own injections will mean that you will not have to wait at home for a nurse to call, nor will you have to go to the hospital or clinic every day to receive your injections.
Če se boste naučili, kako si lahko zdravilo injicirate sami, vam ne bo treba čakati doma, da pride medicinska sestra ali vsak dan oditi v bolnišnico oziroma na kliniko, da prejmete injekcijo.
The passive needle guard will NOT activate unless the ENTIRE dose has been given.
Pasivna zaščita za iglo se NE aktivira, razen če aplicirate CELOTEN odmerek.
Rate of generation of antibodies against filgrastim is generally low.
Stopnja nastajanja protiteles proti filgrastimu je na splošno nizka.
If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine.
Če imate (ali ima vaš otrok) dedno intoleranco za fruktozo, redko genetsko bolezen, vi (ali vaš otrok) ne smete dobiti tega zdravila.
Perform the injection using the technique described above.
Injicirajte si zdravilo na način, kot je opisano zgoraj.
With your other hand, insert the needle at an approximate 45˚ angle.
Z drugo roko vbodite iglo v kožo pod kotom približno 45˚.
The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Pri izbiri mobilizacijske metode je treba upoštevati splošne cilje zdravljenja pri posameznem bolniku.