natgillin/translations-raw huggingface dataset:
The study reported 16 patients out of 22 (73%) did not require any hospitalisation for painful episodes when treated with hydroxycarbamide as compared with only 3 of 22 (14%) when treated with placebo.
Študija je pokazala, da 16 od 22 bolnikov (73 %) med zdravljenjem s hidroksikarbamidom ni potrebovalo nobene hospitalizacije zaradi bolečinskih epizod, medtem ko v skupini, ki se je zdravila s placebom, hospitalizacije niso potrebovali le 3 od 22 bolnikov (14 %).
Xromi will decrease the number of painful crises as well as the need for hospitalisation as a result of the disease.
Zdravilo zmanjša število bolečih kriz in potrebo po hospitalizaciji zaradi bolezni.
In the event of bone marrow suppression, haematological recovery usually occurs within two weeks of withdrawal of hydroxycarbamide.
V primeru supresije kostnega mozga pride do hematološkega okrevanja običajno v dveh tednih od prekinitve jemanja hidroksikarbamida.
Very common reversible oligo- and azoo-spermia have been observed in man, although these disorders are also associated with the underlying disease.
Pri ljudeh so opazili zelo pogoste reverzibilne primere oligospermije in azoospermije, čeprav sta ti bolezni povezani tudi z osnovno boleznijo.
The sickle cells also get stuck in blood vessels, blocking blood flow.
Srpaste celice se lahko tudi zataknejo v krvnih žilah in ovirajo pretok krvi.
What Xromi is and what it is used for What you need to know before you take Xromi How to take Xromi
Kaj je zdravilo Xromi in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xromi Kako jemati zdravilo Xromi
Syringes should be rinsed and washed with cold or warm water and dried completely before the next use.
Brizgi je treba pred naslednjo uporabo splakniti in umiti s hladno ali toplo vodo ter posušiti do suhega.
If you have kidney disease
Če imate ledvično okvaro
The estimated volume of distribution of hydroxycarbamide approximates total body water.
Ocenjeni volumen porazdelitve hidroksikarbamida je približno enak celotni količini vode v telesu.
Rare: may affect up to 1 in 1000 people
Redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov
In a single dose study in children with Sickle Cell Disease, the mean half-life was reported to be 1.7 hours.
V študiji enkratnega odmerka pri otrocih s srpastoceličnim sindromom so poročali o povprečnem razpolovnem času 1,7 ure.
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX05.
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX05.
Repeat the above for each dose as instructed by your doctor or pharmacist.
Za vsak odmerek ponovite zgoraj opisani postopek, kot vam je naročil zdravnik ali farmacevt.
Although the mechanism of action has not yet been clearly defined, hydroxycarbamide appears to act by interfering with synthesis of DNA by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or protein.
Čeprav njegov mehanizem delovanja še ni jasno opredeljen, se predvideva, da deluje tako, da posega v sintezo DNA, ker deluje kot inhibitor ribonukleotid-reduktaze, ne da bi posegal v sintezo ribonukleinske kisline ali beljakovin.
Teratogenic effects manifested as partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, and missing lumbar vertebrae.
Teratogeni učinki so se izražali kot delno osificirane lobanjske kosti, odsotnost očesnih votlin, hidrocefalija, dvodelne sternebrae in manjkajoča ledvena vretenca.
If you get any of the following side effects, talk to your doctor or go to hospital immediately:
Če opazite katerega koli izmed naslednjih neželenih učinkov, se takoj posvetujte z zdravnikom ali pojdite v bolnišnico:
Other medicines and Xromi
Druga zdravila in zdravilo Xromi
The macrocytosis may mask the incidental development of folic acid deficiency; regular determinations of serum folic acid are recommended.
Makrocitoza lahko prikrije naključno pomanjkanje folne kisline; priporočljivo je redno določanje folne kisline v serumu.
Hydroxycarbamide therapy can then be re-initiated at a lower dose (see section 4.2).
Nato se lahko zdravljenje s hidroksikarbamidom ponovno začne z nižjim odmerkom (glejte poglavje 4.2).
Anyone handling hydroxycarbamide should wash their hands before and after administering a dose.
Vsak, ki rokuje s hidroksikarbamidom, si mora pred dajanjem odmerka in po njem umiti roke.
In patients with a creatinine clearance (CrCl) ≤ 60 ml/min the initial hydroxycarbamide dose should be decreased by 50%.
Pri bolnikih z očistkom kreatinina (CrCl) ≤ 60 ml/min je treba začetni odmerek hidroksikarbamida znižati za 50 %.
If you are a parent or care giver administering the medicine, wash your hands before and after administering a dose.
Če ste starš ali skrbnik, ki daje zdravilo, si pred dajanjem odmerka in po njem umijte roke.
Other known pharmacological effects of hydroxycarbamide which may contribute to its beneficial effects in Sickle Cell Disease include decrease of neutrophils, improved deformability of sickled cells, and altered adhesion of red blood cells to the endothelium.
Drugi znani farmakološki učinki hidroksikarbamida, ki utegnejo prispevati k njegovim koristnim učinkom pri srpastoceličnem sindromu, so znižanje števila nevtrofilcev, boljša deformabilnost srpastih celic in spremenjena adhezijo rdečih krvničk na endotel.
The volume of distribution following oral dosing of hydroxycarbamide is approximately equal to total body water: adult values of 0.48 - 0.90 L/kg have been reported, whilst in children a population estimate of 0.7 L/kg has been reported.
Volumen porazdelitve po peroralnem odmerjanju hidroksikarbamida je približno enak celotni količini vode v telesu: pri odraslih so poročali o vrednostih 0,48-0,90 l/kg, pri otrocih pa so poročali o populacijski oceni 0,7 l/kg.
Both male and female patients should be advised to use contraceptive measures before and during treatment with hydroxycarbamide.
Bolnikom in bolnicam je treba svetovati, naj pred in med zdravljenjem s hidroksikarbamidom uporabljajo kontracepcijo.
Hydroxycarbamide may also delay plasma iron clearance and reduce the rate of iron utilisation by erythrocytes but it does not appear to alter the red blood cell survival time.
Hidroksikarbamid lahko tudi upočasni plazemski očistek železa in zmanjša stopnjo uporabe železa za nastajanje eritrocitov, vendar se zdi, da ne spremeni časa preživetja rdečih krvničk.
Pregnancy (see section 4.6)
Nosečnost (glejte poglavje 4.6).
The anaemia commonly observed has mainly been due to an infection with Parvovirus or a splenic sequestration.
Pogosto opažena anemija je v glavnem posledica okužbe s parvovirusom ali sekvestracije vranice.
HbF interferes with the polymerisation of HbS (sickle haemoglobin) and thus impedes the sickling of red blood cell.
HbF ovira polimerizacijo HbS (srpastega hemoglobina) in tako preprečuje nastanek srpaste oblike rdeče krvničke.
It is unknown whether this leukaemogenic effect is secondary to hydroxycarbamide or associated with the patient's underlying disease.
Ni znano, ali je levkemogeni učinek posledica hidroksikarbamida ali pa je povezan z bolnikovo osnovno boleznijo.
If neutropenia or thrombocytopenia occurs, hydroxycarbamide dosing should be temporarily withheld and full blood cell count with white cell differential should be monitored weekly.
Če se pojavi nevtropenija ali trombocitopenija, je treba odmerjanje hidroksikarbamida začasno prekiniti in tedensko spremljati število vseh krvnih celic,
Toxicology studies have also demonstrated testicular atrophy with decreased spermatogenesis and sperm count in rats and decreased testis weight and reduced sperm counts in mice as well.
Toksikološke študije so prav tako dokazale atrofijo mod z zmanjšano spermatogenezo in zmanjšanim številom semenčic pri podganah ter zmanjšano maso testisov in zmanjšano število semenčic pri miših.
To decrease the risk of exposure, parents and care givers should wear disposable gloves when handling hydroxycarbamide.
Za zmanjšanje tveganja izpostavljenosti morajo starši in skrbniki pri rokovanju s hidroksikarbamidom nositi rokavice za enkratno uporabo.
Clear, colourless to pale yellow viscous liquid.
Bistra, brezbarvna do bledo rumena viskozna tekočina.
The patient's antibody response to vaccines may be decreased.
Bolnikov odziv protiteles na cepivo je lahko zmanjšan.
The usual starting dose for adults, adolescents and children over the age of 2 years is 15 mg/kg each day and the usual maintenance dose is between 20-25 mg/kg.
Običajni začetni dnevni odmerek za odrasle, mladostnike in otroke, starejše od 2 let, je 15 mg/kg in običajni vzdrževalni odmerek je 2025 mg/kg.
Patients treated with hydroxycarbamide in combination with didanosine, stavudine, and indinavir showed a median decline in CD4 cells of approximately 100/mm3.
Pri bolnikih, zdravljenih s hidroksikarbamidom v kombinaciji z didanozinom, stavudinom in indinavirjem, so ugotovili mediano upadanja števila celic CD4 za približno 100/mm3.
Gradual dose titration is recommended to avoid more severe bone marrow suppressions (see section 4.2).
Priporoča se postopno titriranje odmerka za preprečitev hujše supresije kostnega mozga (glejte poglavje 4.2).
Cutaneous vasculitic toxicities
Toksični kožni vaskulitisi
Discard 12 weeks after first opening.
Zavrzite 12 tednov po prvem odprtju.
Patients were randomly assigned to receive either hydroxycarbamide first for 6 months, followed by placebo for 6 months, or placebo first, followed by hydroxycarbamide for 6 months.
Bolniki so bili naključno razvrščeni in so najprej šest mesecev prejemali hidroksikarbamid in nato še šest mesecev placebo, ali pa so najprej šest mesecev prejemali placebo in nato še šest mesecev hidroksikarbamid.
Hydroxycarbamide affects spermatogenesis, and hence oligospermia and azoospermia are very commonly reported.
Hidroksikarbamid vpliva na spermatogenezo, zato zelo pogosto poročajo o oligospermiji in azoospermiji.
In patients, whose CrCl was below 60 ml/min or patients with End Stage Renal Disease the mean exposure to hydroxycarbamide was approximately 64% higher than in patients with normal renal function.
Pri bolnikih, pri katerih je bil CrCl manjši od 60 ml/min, ali bolnikih s končno odpovedjo ledvic je bila povprečna izpostavljenost hidroksikarbamidu za približno 64 % večja kot pri bolnikih z normalnim delovanjem ledvic.
the virus which causes AIDS
(HIV), povzročitelja aidsa.
While in dogs reversible spermatogenic arrest was noted.
Pri psih so opazili reverzibilni zastoj spermatogeneze.
Patients should be monitored for vital signs, blood and urine chemistry, renal and hepatic function and full blood counts for at least 3 weeks.
Vsaj tri tedne je treba nadzirati bolnikove vitalne funkcije, kemično sestavo krvi in urina, delovanje ledvic in jeter ter število vseh krvnih celic.
Close monitoring of blood parameters is advised (see section 4.2).
Priporoča se natančno spremljanje krvnih parametrov (glejte poglavje 4.2).
If you forget to take Xromi Tell your doctor.
Če ste pozabili vzeti zdravilo Xromi O tem obvestite zdravnika.
Hydroxycarbamide treatment should be supervised by a physician or other healthcare professionals experienced in the management of patients with Sickle Cell Disease.
Zdravljenje s hidroksikarbamidom mora nadzirati zdravnik ali drug zdravstveni delavec, izkušen v obravnavanju bolnikov s srpastoceličnim sindromom.
Other commonly reported adverse effects also include nausea, constipation, headache, and dizziness.
Drugi pogosti neželeni učinki vključujejo tudi navzeo, zaprtost, glavobol in omotico.
The morphologic change resembles pernicious anaemia, but is not related to vitamin B12 or folic acid deficiency.
Morfološka sprememba je podobna perniciozni anemiji, vendar ni povezana s pomanjkanjem vitamina B12 ali folne kisline.
Bone marrow depression is more likely in patients who have previously received radiotherapy or cytotoxic cancer chemotherapeutic medicinal products; hydroxycarbamide should be used cautiously in such patients.
Depresija kostnega mozga je pogostejša pri bolnikih, ki so predhodno prejemali radioterapijo ali citotoksična kemoterapevtska zdravila za zdravljenje raka; pri teh bolnikih je treba hidroksikarbamid uporabljati previdno.
Male patients should be informed by their healthcare professionals about the possibility of sperm conservation (cryopreservation) before the start of therapy.
Zdravstveni delavci morajo bolnike pred začetkom terapije obvestiti o možnosti shranjevanja sperme
These effects lead to a reduction of circulating red, white and coagulation blood cells.
To vodi do zmanjšanja števila krožečih rdečih in belih krvničk ter krvnih ploščic.
Multi-centre study of hydroxycarbamide in Sickle Cell Anaemia (MSH) The MSH study was a multicentre, randomised, and double-blind study, which compared hydroxycarbamide with placebo in adults with Sickle Cell Anaemia (HbSS genotype only) with the objective of reducing the frequency of pain crises.
Multicentrična študija hidroksikarbamida pri srpastocelični anemiji (MSH) Študija hidroksikarbamida (MHS) je bila multicentrična, randomizirana in dvojno slepa študija, v kateri so pri odraslih s srpastoceličnim sindromom (samo genotip HbSS) hidroksikarbamid primerjali s placebom s ciljem zmanjšanja pogostnosti bolečih kriz.
Recently, hydroxycarbamide has shown to be associated with the generation of nitric oxide suggesting that nitric oxide stimulates cyclic guanosine monophosphatase (cGMP) production, which then activates a protein kinase and increases the production of HbF.
V zadnjem času se je pokazalo, da je hidroksikarbamid povezan z nastajanjem dušikovega oksida, kar kaže na to, da dušikov oksid spodbuja proizvodnjo cikličnega gvanozinmonofosfata (cGMP), ki nato aktivira protein-kinazo in poveča nastajanje HbF.
Once the blood count had recovered, treatment was restarted at 2.5 mg/kg per day less than the toxic dose.
Ko so se krvne slike izboljšale, se je ponovno začelo zdravljenje z dnevnim odmerkom, ki je bil za 2,5 mg/kg manjši od toksičnega odmerka.
Your doctor will also inspect your skin during routine follow-up visits.
Med rutinskimi kontrolnimi obiski vam bo kožo pregledal tudi zdravnik.
The extent of protein binding of hydroxycarbamide is unknown.
Obseg vezave hidroksikarbamida na beljakovine ni znan.
There are no data that support specific guidance for dose adjustment in patients with hepatic impairment, but, due to safety considerations, hydroxycarbamide is contraindicated in patients with severe hepatic impairment (see section 4.3).
Ni podatkov, ki bi podpirali posebne smernice za prilagajanje odmerkov pri bolnikih z okvaro jeter, vendar je hidroksikarbamid zaradi skrbi glede varnosti kontraindiciran pri bolnikih s hudo jetrno okvaro (glejte poglavje 4.3).
Close monitoring of blood parameters is advised in these patients.
Pri teh bolnikih se priporoča natančno spremljanje krvnih parametrov.
Cross-over comparison with placebo (Ferster et al 1996) A randomized cross-over study was conducted in 25 children and young adults (age range: 2 to 22 years) with homozygous sickle cell anaemia and severe clinical manifestations (defined as >3 vasoocclusive crises in the year before study entry and/or with previous history of stroke, acute chest syndrome, recurrent crises without a free interval, or splenic sequestration).
Navzkrižna primerjava s placebom (Ferster et al 1996) Randomizirana navzkrižna študija je bila opravljena na 25 otrocih in mlajših polnoletnih osebah (starostna skupina: od 2 do 22 let) s homozigotno srpastocelično anemijo in resnimi kliničnimi manifestacijami (opredeljenimi kot > 3 vazookluzivne krize letno pred sodelovanjem v študiji in/ali z zgodovino kapi, akutnega sindroma bolečine v prsih, ponavljajočih se kriz brez prostega intervala ali sekvestracije vranice).
Hydroxycarbamide distributes rapidly throughout the human body, enters the cerebrospinal fluid, appears in peritoneal fluid and ascites, and concentrates in leukocytes and erythrocytes.
Hidroksikarbamid se hitro porazdeli po telesu, vstopa v cerebrospinalno tekočino, se pojavi v peritonealni tekočini in ascitesu ter se zbira v levkocitih in eritrocitih.
Table 4: Comparison of the Number of Clinical Events before and after Intervention in the Hydroxycarbamide and Placebo Groups
Preglednica 4: Primerjava števila kliničnih dogodkov pred posredovanjem in po njem v skupinah, ki sta prejemali hidroksikarbamid oziroma placebo Hidroksikarbamid
In an open single-dose study in adult patients with Sickle Cell Disease the influence of renal function on pharmacokinetics of hydroxycarbamide was assessed.
V odprti študiji enkratnega odmerka pri odraslih bolnikih s srpastoceličnim sindromom je bil ocenjen vpliv delovanja ledvic na farmakokinetiko hidroksikarbamida.
Similar decreases were seen in blood transfusion rates, a surrogate for life-threatening illness.
Podobno se je zmanjšalo število transfuzij krvi, tj. nadomestila za življenjsko nevarno bolezen.
Evidence for the efficacy of hydroxycarbamide in reducing the vaso-occlusive complications of Sickle Cell Disease in patients older than 2 years comes from four randomised controlled trials (Charache et al 1995 [MSH Study]; Jain et al 2012, Ferster et al 1996; Ware et al 2015 [TWiTCH]).
starejših od dveh let, ki imajo srpastocelični sindrom, so bili pridobljeni v štirih randomiziranih kontroliranih preskušanjih (Charache et al 1995 [študija MSH]; Jain et al 2012, Ferster et al 1996;
Always use the syringes provided to take your medicine.
Za jemanje zdravila vedno uporabljajte priloženi brizgi.
Hydroxycarbamide may produce bone marrow suppression; leukopenia is generally its first and most common manifestation.
Hidroksikarbamid lahko povzroči supresijo kostnega mozga; njena prva in najpogostejša manifestacija je navadno levkopenija.
Xromi is a clear, colourless to pale yellow, oral solution.
Zdravilo Xromi je bistra, brezbarvna do bledo rumena peroralna raztopina.
Blood parameters for renal and hepatic impairment should be closely monitored, and hydroxycarbamide should be discontinued if necessary.
Natančno je treba spremljati krvne parametre za okvaro ledvic in jeter ter zdravljenje s hidroksikarbamidom po potrebi prekiniti.
Elderly patients may be more sensitive to the myelosuppressive effects of hydroxycarbamide, and may require a lower dosage regimen.
Starejši bolniki so lahko občutljivejši za mielosupresivne učinke hidroksikarbamida, zato morda potrebujejo nižje predpisane odmerke.
The digital distribution of these vasculitic ulcerations and progressive clinical behaviour of peripheral vasculitic insufficiency leading to digital infarct or gangrene were distinctly different than the typical skin ulcers generally described with Hydroxycarbamide.
Porazdelitev teh vaskulitičnih ulkusov po prstih in progresivno klinično vedenje periferne vaskulitične insuficience, ki povzroča infarkt prstov ali gangreno, sta se bistveno razlikovala od običajnih kožnih ulkusov, na splošno pripisanih hidroksikarbamidu.
A significant fraction of hydroxycarbamide is eliminated by nonrenal (mainly hepatic) mechanisms.
Znaten delež hidroksikarbamida izločijo nepravi (predvsem jetrni) mehanizmi.
Studies have shown that there is an analytical interference of hydroxycarbamide with the enzymes (urease, uricase, and lactic dehydrogenase) used in the determination of urea, uric acid, and lactic acid, rendering falsely elevated results of these in patients treated with hydroxycarbamide.
Študije so pokazale, da hidroksikarbamid povzroča analitične motnje pri encimih (ureaza, urikaza in laktat-dehidrogenaza), ki se uporabljajo za ugotavljanje sečnine, sečne kisline in mlečne kisline, zato se pri bolnikih, zdravljenih s hidroksikarbamidom, pojavijo lažno povišane vrednosti.
At concentrations ranging from 10 to 300 µM, hydroxycarbamide does not stimulate the in vitro ATPase activity of recombinant human P glycoprotein (P-gp), indicating that hydroxycarbamide is not a P-gp substrate.
Hidroksikarbamid v koncentracijah od 10 do 300 µm ne spodbuja dejavnosti ATPaze rekombinantnega humanega P-glikoproteina (P-gp) in vitro, kar kaže na to, da hidroksikarbamid ni substrat P-gp.
Pull the plunger of the syringe back so that the medicine is drawn from the bottle into the syringe.
Bat brizge za odmerjanje povlecite nazaj, tako da se zdravilo izčrpa iz steklenice v brizgo.
Hydroxycarbamide was started at low dose (15 mg/kg per day) and increased at 12- weekly intervals by 5 mg/kg per day until mild bone marrow depression was achieved, as judged by either neutropenia or thrombocytopenia.
Odmerek hidroksikarbamida je bil najprej majhen(15 mg/kg na dan), nato pa se je povečeval v 12-tedenskih intervalih za 5 mg/kg na dan, dokler ni bila dosežena blaga depresija kostnega mozga, kar se je lahko ocenilo z nevtropenijo ali trombocitopenijo.
One of the mechanisms by which hydroxycarbamide acts is the elevation of HbF concentrations in Sickle Cell Disease patients.
Eden od mehanizmov delovanja hidroksikarbamida je zvišanje koncentracije HbF pri bolnikih s srpastoceličnim sindromom.
Take as directed by your doctor using the dosing syringes provided.
Jemljite tako, kot vam je predpisal zdravnik, pri čemer uporabite priloženi brizgi za odmerjanje.
The Patient/carer guide shall contain the following key elements:
Vodnik za bolnike/skrbnike mora vsebovati naslednje bistvene elemente: - indikacijo;
The risk of vasculitic toxicities is increased in patients who receive prior or concomitant interferon therapy.
Tveganje za toksične vaskulitise se poveča pri bolnikih, ki so se prej zdravili ali se hkrati zdravijo z interferonom.
Accidental ingestion can be lethal for children.
Naključno zaužitje je lahko za otroke smrtno nevarno.
Before
Prej
There was a statistically significant reduction in time to peak concentration with hydroxycarbamide oral solution compared to the reference 500 mg capsule (0.5 versus 0.75 hours, p = 0.0467), indicating a faster rate of absorption.
Čas, v katerem je bila najvišja koncentracija dosežena s peroralno raztopino hidroksikarbamida, je bil statistično bistveno krajši v primerjavi z referenčno 500-miligramsko kapsulo (0,5 proti 0,75 ure, p = 0,0467), kar kaže na hitrejšo absorpcijo.
Swallow the dose of oral solution then drink some water, making sure no medicine is left in your mouth.
Pogoltnite odmerek peroralne raztopine in nato spije nekaj vode, da v ustih ne bo ostankov zdravila.
Women who are pregnant, planning to be or breast-feeding should not handle hydroxycarbamide.
Nosečnice in ženske, ki načrtujejo nosečnost, ter doječe matere ne smejo rokovati s hidroksikarbamidom.
What Xromi looks like and contents of the pack
Izgled zdravila Xromi in vsebina pakiranja
A target absolute neutrophil count 2000-4000/μL should be aimed for, whilst maintaining platelet count > 80,000/μL.
Ciljno absolutno število nevtrofilcev, ki bi ga bilo treba doseči, je 2.000-4.000/μl, pri čemer je treba število trombocitov ohraniti na > 80.000/μl.
It comes in glass bottles of 150 ml capped with a child-resistant closure.
Na voljo je v steklenici po 150 ml in ima za otroke varno zaporko.
• Dose to be increased by 5 mg/kg/day increments every 8 weeks
• vsakih osem tednov je treba dnevni odmerek postopno povečati za 5 mg/kg,
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Posodobljen RMP je treba predložiti: na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Turn the bottle back the right way up and carefully remove the syringe from the adaptor, holding it by the barrel rather than the plunger.
Steklenico obrnite nazaj s pravilno smerjo navzgor in pazljivo odstranite brizgo z nastavka, pri čemer je ne držite za bat, ampak za telo.
Warnings and precautions Test and checks
Opozorila in previdnostni ukrepi