natgillin/translations-raw huggingface dataset:
Cellular resistance and sensitivity
Predvsem v celicah z visoko aktivnostjo dCK in nizko aktivnostjo deoksinukleotidaze, posebno v limfocitih in drugih hematopoetskih celicah, opažamo kopičenje aktivne CdATP.
7 Cladribine is a prodrug which is taken up rapidly in cells after parenteral administration, and is phosphorylated intracellularly to the active nucleotide 2-chlorodeoxyadenosine-5'-triphosphate (CdATP) by deoxycytidine kinase (dCK).
7 Citotoksičnost kladribina je odvisna od odmerka.
Non- haematologic tissues seem to be unaffected, explaining the low incidence of non-haematopoietic toxicity of the cytostatic medicinal product.
Videti je, da nehematološka tkiva niso prizadeta, kar razlaga nizko pojavnost nehematopoetske toksičnosti citostatičnega zdravila.
Unlike other nucleoside analogues cladribine is toxic in rapidly proliferating cells as well as in resting cells.
Za razliko od drugih nukleozidnih analogov je kladribin toksičen v hitro proliferirajočih kot tudi mirujočih celicah.
The mechanism of action of cladribine is attributed to the incorporation of CdATP into DNA strands: the synthesis of new DNA in dividing cells is blocked and the DNA repair mechanism is inhibited resulting in an accumulation of DNA strand breaks and a decrease of NAD (nicotinamide adenine dinucleotide) and ATP concentration even in resting cells.
Mehanizem delovanja kladribina pripisujemo vgrajevanju CdATP v verige DNA: tvorba nove DNA v delečih se celicah je onemogočena, zavrt je tudi mehanizem popravljanja DNA, kar povzroči kopičenje prelomov verige DNA in znižanje koncentracij NAD (nikotinamid adenin dinukleotid) in ATP tudi v mirujočih celicah.
Clinical pharmacokinetics Absorption Cladribine shows complete bioavailability after parenteral administration; the mean area under the concentration versus time curve (AUC) in plasma is comparable after continuous or intermittent 2- hour intravenous infusion and after subcutaneous injection.
Klinična farmakokinetika Absorpcija Kladribin izkazuje popolno biološko razpoložljivost po parenteralnem dajanju; povprečno področje pod krivuljo koncentracije po času (AUC) v plazmi je primerljivo po neprekinjeni ali intermitentni 2 - urni intravenski infuziji in po subkutanem injiciranju.
Distribution The steady-state plasma concentration of cladribine amounts to about 7 ng/ ml and is reached within 5 to 8 hours after the start of a 2-hour infusion.
Porazdelitev Plazemska koncentracija kladribina v stanju dinamičnega ravnovesja je približno 7 ng/ ml in je dosežena v 5 do 8 urah po začetku 2- urne infuzije.
A maximum plasma concentration Cmax of 48 ng/ ml is measured on average 112 minutes after the infusion.
Najvišjo plazemsko koncentracijo Cmax 48 ng/ ml so izmerili povprečno 112 minut po infuziji.
After subcutaneous bolus injection a maximum plasma concentration Cmax of 91 ng/ ml is reached on average after 20 minutes only (dose:
Po subkutanem bolusnem injiciranju je najvišja plazemska koncentracija Cmax 91 ng/ ml dosežena po povprečno samo 20 minutah (odmerek:
0.14 mg/ kg body weight/ day).
0, 14 mg/ kg telesne mase/ dan).
In another study using a dose of 0.10 mg/ kg body weight/ day, the maximum plasma concentration Cmax after continuous intravenous infusion was 5.1 ng/ ml (tmax:
V drugi študiji, kjer so uporabljali odmerek 0, 10 mg/ kg telesne mase/ dan, je bila najvišja plazemska koncentracija Cmax po neprekinjeni intravenski infuziji 5, 1 ng/ ml (tmax:
12 hours) compared to 51 ng/ ml after subcutaneous bolus injection (tmax:
12 ur) v primerjavi z 51 ng/ ml po subkutanem bolusnem injiciranju (tmax:
25 minutes).
25 minut).
The clinical relevance of the different peak plasma concentrations after intravenous and subcutaneous administration of cladribine has not been examined.
Kliničnega pomena različnih najvišjih plazemskih koncentracij po intravenskem in subkutanem dajanju kladribina niso raziskovali.
Intracellular concentration of cladribine exceeds plasma drug concentration by 128 to 375 times.
Znotrajcelična koncentracija kladribina presega plazemsko koncentracijo zdravila za 128 - do 375- krat.
The mean volume of distribution of cladribine is 9.2 l/ kg.
Povprečni volumen porazdelitve kladribina je 9, 2 l/ kg.
Plasma protein binding of cladribine is 25% on average with a wide interindividual variation (5 - 50%).
Plazemska vezava kladribina na beljakovine je povprečno 25% s širokim razponom razlikovanja med posamezniki (5- 50%).
Intrathecal concentrations of cladribine average 18 - 25% of the plasma concentrations in studies with intravenous administration.
V študijah z intravenskim dajanjem so intratekalne koncentracije kladribina povprečno 18- 25% plazemskih koncentracij.
Peak cerebrospinal fluid concentrations of 6 and 2 ng/ ml, respectively, could be measured after intermittent 2-hour infusion or continuous intravenous infusion (dose:
Po intermitentni 2- urni infuziji ali neprekinjeni intravenski infuziji (odmerek:
0.12 mg/ kg body weight/ day).
0, 12 mg/ kg telesne mase/ dan) so izmerili najvišje koncentracije v cerebrospinalni tekočini 6 oziroma 2 ng/ ml.
In one single patient administered LITAK by subcutaneous bolus, intrathecal concentration after 2 hours reached 8.75% of the plasma concentration, but further experience is needed.
Pri enem samem bolniku, ki je prejel LITAK s subkutanim bolusom, je intratekalna koncentracija po 2 urah dosegla 8, 75% plazemske koncentracije, vendar so potrebne nadaljnje izkušnje.
Metabolism Intracellular cladribine is metabolised predominantly by deoxycytidine kinase to 2-chlorodeoxyadenosine-5'-monophosphate that is further phosphorylated to the diphosphate by nucleoside monophosphate kinase and to the active metabolite 2-chlorodeoxyadenosine- 5'-triphosphate (CdATP) by nucleoside diphosphate kinase.
Presnova Znotrajcelični kladribin se presnavlja predvsem z deoksicitidinsko kinazo v 2- klorodeoksiadenozin- 5 '- monofosfat, ki se nadalje fosforilira v difosfat z nukleozidno monofosfatno kinazo in v aktivni presnovek 2- klorodeoksiadenozin- 5' - trifosfat (CdATP) z nukleozidno difosfatno kinazo.
Elimination Pharmacokinetic studies in humans showed that the plasma concentration curve of cladribine fits a 2- or 3-compartment model with α - and β -half-lives of on average 35 minutes and 6.7 hours, respectively.
Izločanje Farmakokinetične študije pri človeku so pokazale, da krivulja plazemske koncentracije kladribina ustreza modelu z 2 ali 3 razdelki z α - in β- razpolovnimi časi povprečno 35 minut oziroma 6, 7 ur.
The terminal plasma half-life t1/ 2 amounted to 7 - 10 hours after continuous intravenous administration for 7 days (0.10 mg/ kg body weight/ day) and was on average 19.5 hours after
Terminalni plazemski razpolovni čas t1/ 2 se giblje od 7 do 10 ur po neprekinjenem 7- dnevnem intravenskem dajanju (0, 10 mg/ kg telesne mase/ dan) in je bil povprečno 19, 5 ur po intermitentni 2 - urni intravenski infuziji 5 zaporednih dni (0, 14 mg/ kg telesne mase/ dan).
The biexponential decline of the serum concentration of cladribine after subcutaneous bolus injection is comparable to elimination parameters after 2-hour intravenous infusion with an initial and terminal half-life of approximately 2 hours and 11 hours, respectively.
Bieksponentni padec serumske koncentracije kladribina po subkutani bolusni injekciji je primerljiv z eliminacijskimi spremenljivkami po 2- urni intravenski infuziji z začetnim in terminalnim razpolovnim časom približno 2 uri oziroma 11 ur.
Half-lives t1/ 2 of initially 15 hours and subsequently more than 30 hours were measured in leukaemic cells.
Znotrajcelični retencijski čas kladribinovih nukleotidov in vivo je jasno podaljšan v primerjavi z retencijskim časom v plazmi: v levkemičnih celicah so izmerili razpolovne čase t1/ 2 ob začetku 15 ur in kasneje več kot 30 ur.
Cladribine is eliminated mainly by the kidneys.
8 Kladribin se izloča predvsem preko ledvic.
The renal excretion of unmetabolised cladribine occurs within 24 hours and accounts for 15% and 18% of the dose after 2-hour intravenous and subcutaneous administration, respectively.
Ledvično izločanje nepresnovljenega kladribina se pojavi v 24 urah in predstavlja 15% oziroma 18% odmerka po 2- urni intravenskem oziroma subkutanem dajanju.
The mean plasma clearance amounts to 794 ml/ min after intravenous infusion and to 814 ml/ min after subcutaneous bolus injection at a dose of 0.10 mg/ kg body weight/ day.
Povprečni plazemski očistek je 794 ml/ min po intravenski infuziji in 814 ml/ min po subkutani bolusni injekciji v odmerku 0, 10 mg/ kg telesne mase/ dan.
Pharmacokinetics in special populations There are no studies available using cladribine in patients with renal or hepatic impairment (see also Section 4.2 Posology and method of administration and Section 4.4 Special warnings and special precautions for use).
Farmakokinetika v posebnih skupinah bolnikov O uporabi kladribina pri bolnikih z okvarjenim delovanjem ledvic ali jeter ni nobenih študij (glej tudi poglavje 4. 2 Odmerjanje in način uporabe ter poglavje 4. 4 Posebna opozorila in previdnostni ukrepi).
Clinical experience is very limited and safety of LITAK in these patients is not well established.
Klinične izkušnje so zelo omejene, varnost LITAKA pri teh bolnikih ni zadostno ugotovljena.
LITAK is contraindicated in patients with moderate to severe renal impairment or with moderate to severe hepatic impairment.
LITAK je pri bolnikih z zmerno do hudo okvarjenim delovanjem ledvic ali z zmerno do hudo okvarjenim delovanjem jeter kontraindiciran.
The use of LITAK in children has not been investigated.
Uporabe LITAKA pri otrocih niso raziskovali.
Experience with patients older than 75 years is limited.
Izkušanje pri bolnikih, starejših od 75 let, so omejene.
Cladribine is moderately acutely toxic to mice, with an LD50 of 150 mg/ kg by intraperitoneal administration.
Kladribin je zmerno akutno toksičen za miši, z LD50 150 mg/ kg pri intraperitonealnem dajanju.
In 7- to 14-day continuous intravenous infusion studies in Cynomolgus monkeys, the target organs were the immune system (≥ 0.3 mg/ kg/ day), bone marrow, skin, mucous membranes, nervous system and testes (≥ 0.6 mg/ kg/ day) and kidneys (≥ 1 mg/ kg/ day).
V študijah neprekinjene 7 - do 14- dnevne intravenske infuzije pri opicah Cynomolgus so bili tarčni organi imunski sistem (≥ 0, 3 mg/ kg/ dan), kostni mozeg, koža, sluznice, živčevje in moda (≥ 0, 6 mg/ kg/ dan) ter ledvice (≥ 1 mg/ kg/ dan).
Cladribine is teratogenic in mice (at doses of 1.5 – 3.0 mg/ kg/ day, given on gestation days 6 – 15).
Kladribin je teratogen pri miših (v odmerkih od 1, 5– 3, 0 mg/ kg/ dan, danih na dneve gestacije 6– 15).
Effects on sternal ossification were seen at 1.5 and 3.0 mg/ kg/ day.
Učinke na zakostenevanje prsnice so opažali pri 1, 5 in 3, 0 mg/ kg/ dan.
Increased resorptions, reduced live litter sizes, reduced foetal weights and increased foetal malformations of the head, trunk and appendages were seen at 3.0 mg/ kg/ day.
Pri odmerku 3, 0 mg/ kg/ dan so opažali povečane resorpcije, zmanjšano število živih potomcev, znižane telesne mase plodov in povečano pojavnost malformacij glave, trupa in okončin ploda.
In rabbits, cladribine is teratogenic at doses of 3.0 mg/ kg/ day (given on gestation days 7 – 19).
Pri kuncih je kladribin teratogen v odmerkih 3, 0 mg/ kg/ dan (danih na dneve gestacije 7– 19).
At this dosage, severe limb anomalies were seen as well as a significant decrease in the mean foetal weight.
Pri tem odmerjanju so opažali hude anomalije okončin, pa tudi značilno znižanje povprečne telesne mase ploda.
Reduced ossification was observed at 1.0 mg/ kg/ day.
Zmanjšano zakostenevanje so opažali pri 1, 0 mg/ kg/ dan.
Carcinogenesis/ mutagenesis Long-term studies in animals to evaluate the carcinogenic potential of cladribine have not been conducted.
Kancerogeneze/ mutageneza Dolgotrajnih študij pri živalih, da bi ovrednotili kancerogeni potencial kladribina, niso opravili.
Impairment of fertility The effects of cladribine on fertility have not been studied in animals.
Okvara plodnosti Učinkov kladribina na plodnost pri živalih niso preučevali.
However, a toxicity study conducted with Cynomolgus monkeys has shown that cladribine suppresses maturation of rapidly generating cells, including testicular cells.
Vendar pa je študija toksičnosti pri opicah Cynomolgus pokazala, da kladribin zavira dozorevanje hitro nastajajočih celic, vključujoč testikularne celice.
Antineoplastic agents, such as cladribine, which interfere with DNA, RNA and protein synthesis, might be expected
Za zdravila z delovanjem na novotvorbe, kot je kladribin, ki motijo tvorbo DNA, RNA in beljakovin, bi lahko pričakovali, da imajo neželene učinke na gametogenezo pri človeku (glej poglavje 4. 4 Posebna opozorila in previdnostni ukrepi).
Sodium chloride Sodium hydroxide Hydrochloric acid Water for injections
9 Klorovodikova kislina Voda za injekcije
LITAK must not be mixed with other medicinal products.
LITAKA ne smemo mešati z drugimi zdravili.
From a microbiological point of view, unless the opening precludes the risk of microbiological contamination, the product should be used immediately.
Z mikrobiološkega vidika, če odprtje ne izključi nevarnosti mikrobiološkega onesnaženja, je treba zdravilo uporabiti nemudoma.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če ga ne uporabimo takoj, so časi shranjevanja, ko je enkrat v uporabi, in pogoji predmet odgovornosti uporabnika.
Store at 2oC - 8oC (in a refrigerator).
Shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku).
10 ml type I glass vial with rubber stopper (bromobutyl) and flip-off aluminium cap.
10 ml viala iz stekla tipa I z gumijasto zaporko (bromobutil) in "flip- off" aluminijastim pokrovčkom.
Packs contain 1 or 5 vials each with 5 ml of solution.
Pakiranje vsebujejo 1 ali 5 vial, od katerih vsaka vsebuje 5 ml raztopine.
6.6 Instructions for use, handling and disposal
6. 6 Navodila za pripravo in ravnanje z zdravilom ter odlaganje
The use of disposable gloves and protective garments is recommended when handling and administering LITAK.
Pri ravnanju in dajanju LITAKA priporočamo uporabo rokavic za enkratno uporabo in zaščitnih oblačil.
If LITAK contacts the skin or mucous membranes, rinse the area immediately with copious amounts of water.
V kolikor LITAK pride v stik s kožo ali sluznicami, področje nemudoma sperite z obilnimi količinami vode.
Remaining contents should be disposed of appropriately.
Neuporabljeno vsebino je treba ustrezno odstraniti.
Lipomed GmbH Schönaugasse 11 D-79713 Bad Säckingen
Lipomed GmbH Schönaugasse 11 D- 79713 Bad Säckingen Nemčija
MARKETING AUTHORISATION NUMBER(S)
10 DODATEK II
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Lipomed GmbH Schönaugasse 11 D-79713 Bad Säckingen Germany
Lipomed GmbH Schönaugasse 11 D- 79713 Bad Säckingen Nemčija
Summary of Product Characteristics, 4.2).
Povzetek glavnih značilnosti zdravila, 4. 2).
LABELLING
14 PODATKI NA ZUNANJI OVOJNINI ALI STIČNI OZ.
LITAK 2 mg/ ml solution for injection cladribine
LITAK 2 mg/ ml raztopina za injiciranje kladribin
5 ml solution for injection contain cladribine 10 mg (2 mg/ ml)
5 ml raztopine za injiciranje vsebuje 10 mg kladribina (2 mg/ ml)
Handle with caution (see package leaflet)
Z zdravilom ravnajte previdno (glej navodilo za uporabo)
Exp. date
"EXP":
Store at 2°C – 8°C (in a refrigerator)
Shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku)
16 Do not freeze
15 Ne zamrzujte
Any portion of the contents remaining after use should be disposed of appropriately
Kakršenkoli del neuporabljene vsebine je treba ustrezno odstraniti
Lipomed GmbH Schönaugasse 11 D-79713 Bad Säckingen Germany
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Batch no.
Serija
Use as directed by medical practitioner
Uporabite po navodilih zdravstvenega delavca
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
18 Do not freeze
17 Ne zamrzujte
Even if their symptoms are the same as yours, it may harm them.
Njim bi lahko celo škodovalo, čeprav imajo simptome bolezni, enake vašim.
What LITAK is and what is it used for 2.
Kaj je zdravilo LITAK in za kaj ga uporabljamo 2.
Before you use LITAK 3.
Kaj morate vedeti, preden boste uporabili zdravilo LITAK 3.
How to use LITAK 4.
Kako uporabljati zdravilo LITAK 4.
Storing LITAK 6.
Shranjevanje zdravila LITAKA 6.
Information on how to inject LITAK
Informacije o tem, kako injicirati zdravilo LITAK
The active substance is cladribine.
Zdravilna učinkovina je kladribin.
Each vial contains 10 mg of cladribine in 5 ml of solution (2 mg per ml solution).
Vsaka viala vsebuje 10 mg kladribina v 5 ml raztopine (2 mg na ml raztopine).
The other ingredients are sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.
Pomožne snovi so natrijev klorid, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
LITAK is a solution for injection.
LITAK je raztopina za injiciranje.
Pack sizes with 1 vial or 5 vials of 5 ml of solution are available.
Na voljo so velikosti pakiranj s po 1 vialo ali s 5 vialami po 5 ml raztopine.
LITAK has been prescribed by your doctor for the treatment of hairy cell leukaemia, a malignant disease of white blood cells.
LITAK vam je predpisal vaš zdravnik za zdravljenje dlakavocelične levkemije, maligne bolezni belih krvničk.
BEFORE YOU USE LITAK
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO LITAK
Do not use LITAK
Ne uporabljajte LITAKA
• if you are hypersensitive (allergic) to cladribine or to any of the other ingredients in LITAK,
• če ste preobčutljivi za (alergični na) kladribin ali katerokoli sestavino LITAKA,
22 • if you are pregnant or breast-feeding,
• če ste noseči ali dojite,
• if you are less than 16 years of age,
21 • če ste mlajši od 16 let,
• if you have moderate to severe kidney or liver dysfunction,
• če imate zmerno do hudo okvarjeno delovanje ledvic ali jeter,
• if you take other medicines, which inhibit the production of blood cells in bone marrow.
• če jemljete druga zdravila, ki zavirajo izdelovanje krvnih celic v kostnem mozgu.
Please tell your doctor
Prosimo, povejte svojemu zdravniku
if you are suffering or have suffered from:
če imate ali ste imeli:
• infections,
• okužbe,
• fever,
• povišano telesno temperaturo,
• liver disease,
• obolenje jeter,
• kidney disease.
• obolenje ledvic.
You should know before taking LITAK that
Preden uporabite LITAK, bi morali vedeti, da
- your treatment with LITAK has been prescribed by a qualified doctor experienced in cancer
- vam je zdravljenje z LITAKOM predpisal usposobljeni zdravnik, izkušen pri zdravljenju raka s
chemotherapy.
kemoterapijo.
If you suffer from an infection, this will be treated before treatment with LITAK.
Če ste zboleli z okužbo, vam jo bodo pozdravili pred začetkom zdravljenja z LITAKOM.
If you notice any signs of fever or infections (such as flu-like symptoms) during or after treatment with LITAK, be sure to inform your doctor immediately.
Če opazite kakršnekoli znake povišane telesne temperature ali okužb (kot so gripi podobni simptomi) med ali po zdravljenju z LITAKOM, nemudoma obvestite vašega zdravnika.
Before you start treatment with LITAK and during treatment, you will have regular blood tests to check whether it is safe for you to continue with your treatment.
Pred začetkom zdravljenja z LITAKOM in med njim boste imeli redne preiskave krvi za preverjanje, ali je varno, da nadaljujete z vašim zdravljenjem.
Your doctor may decide that you should receive blood transfusions or that you should receive an additional medicine containing the active substance allopurinol in order to reduce excess of uric acid.
Vaš zdravnik se bo morda odločil, da boste prejemali transfuzije krvi ali dodatno zdravilo z zdravilno učinkovino alopurinolom, da bi znižali presežek sečne kisline.
If you want to father a child, please tell your doctor before treatment with LITAK is started.
Če želite spočeti otroka, to povejte svojemu zdravniku pred začetkom zdravljenja z LITAKOM.
You should not father a child up to 6 months after treatment with LITAK.
Do 6 mesecev po zdravljenju z LITAKOM ne smete spočeti otroka.
Your doctor may advise you about the possibility to store deep-frozen sperm.
Vaš zdravnik vam bo morda svetoval o možnosti shranjevanja globoko zmrznjene sperme.
LITAK must not be used if you are pregnant or if you are planning to become pregnant since it may cause harm to the unborn baby.
LITAKA ne smete uporabljati, če ste noseči ali nameravate zanositi, ker lahko poškoduje nerojenega otroka.
You must take adequate contraceptive precautions during therapy and for at least three months after LITAK is no longer administered to you.
Med zdravljenjem in vsaj še tri mesece po prenehanju dajanja LITAKA morate uporabljati učinkovito kontracepcijo.
You must not breast-feed while you are treated with LITAK.
Med zdravljenjem z LITAKOM ne smete dojiti.
LITAK has a major effect on the ability to drive and use machines since it may make you feel drowsy or dizzy.
LITAK ima velik vpliv na sposobnost upravljanja vozil in strojev, ker lahko povzroči, da se počutite zaspane ali omotične.
If you feel drowsy or dizzy, you should not drive a vehicle or operate machines.
Če se počutite zaspani ali omotični, ne smete upravljati vozil ali strojev.
Take special care with LITAK if you are using any other medicines that affect the production of blood cells (e. g. other anti-cancer medicines or steroids).
Bodite posebej previdni med zdravljenjem z LITAKOM, če uporabljate kakršnakoli druga zdravila, ki vplivajo na tvorbo krvnih celic (npr. druga zdravila proti raku ali steroide).
Please tell your doctor:
Prosimo, povejte svojemu zdravniku:
23 • if you are using any other medicines which have been prescribed by a doctor for any other condition (e. g. antiviral medicines),
22 • če uporabljate katerakoli druga zdravila, ki vam jih je predpisal zdravnik za katerokoli drugo stanje (npr. protivirusna zdravila),
• if you are using any other medicines that you have bought for yourself without a prescription.
• če uporabljate katerakoli druga zdravila, ki ste jih dobili brez recepta.
HOW TO USE LITAK
KAKO UPORABLJATI ZDRAVILO LITAK
LITAK will be injected under your skin (subcutaneous use).
LITAK vam bodo injicirali pod kožo (subkutana uporaba).
LITAK should be injected at about the same time each day.
LITAK vam morajo injicirati vsak dan ob približno isti uri.
The correct dosage will be calculated by your doctor and the treatment schedule will be explained to you in detail.
Pravilno odmerjanje vam bo izračunal vaš zdravnik in vam podrobno razložil časovni razpored zdravljenja.
The dosage depends on your body weight.
Odmerjanje je odvisno od vaše telesne mase.
The recommended dosage is a single course of LITAK at a dose of 0.14 mg per kg body weight per day for five consecutive days.
Priporočeno odmerjanje je enkratna kura LITAKA v odmerku 0, 14 mg na kg telesne mase na dan pet zaporednih dni.
LITAK is supplied as ready-to-use solution for subcutaneous injection.
LITAK je na voljo kot raztopina za subkutano injiciranje, pripravljena za uporabo.
The recommended dose is directly withdrawn by a syringe and injected without dilution.
Priporočeni odmerek se z brizgo neposredno odvzame in injicira brez redčenja.
Allow LITAK to warm up to room temperature before administration.
Pred dajanjem naj se LITAK ogreje na sobno temperaturo.
Do not use vials which are damaged, or if the solution is not clear or if it contains any particles.
Ne uporabljajte poškodovanih vial ali vial, v katerih raztopina ni prozorna ali vsebuje delce.
LITAK should be handled with caution.
Z LITAKOM je treba ravnati previdno.
Avoid contact by pregnant women.
Nosečnice naj se izogibajo stiku.
The use of disposable gloves and protective garments is recommended when handling and administering LITAK.
Pri ravnanju z LITAKOM in dajanju LITAKA priporočamo uporabo rokavic za enkratno uporabo in zaščitnih oblačil.
If LITAK contacts the skin or eyes, rinse the involved surface immediately with copious amounts of water.
Če LITAK pride v stik s kožo ali očmi, prizadeto površino nemudoma sperite z obilnimi količinami vode.