natgillin/translations-raw huggingface dataset:
Should Ceplene related toxicities occur (such as hypotension, headache), the injection time can be increased from 5 minutes to a maximum duration of 15 minutes. 
V primeru pojava toksičnih dogodkov zaradi uporabe zdravila Ceplene (kot je na primer hipotenzija, glavobol) se lahko čas trajanja injiciranja zdravila podaljša od 5 minut na največ 15 minut.
• For the first 18 weeks: you will use IL-2 and Ceplene daily for 3 weeks, followed by a 3 week break (no treatment at all). 
• Prvih 18 tednov: IL-2 in zdravilo Ceplene boste uporabljali vsak dan 3 tedne, obdobju zdravljenja pa bodo sledili 3 tedni premora (brez kakršnega koli zdravljenja).
The usual dose of Ceplene is 0.5 mL of solution twice a day given as a slow subcutaneous injection (in the layer of tissue just under the skin). 
Običajni odmerek zdravila Ceplene je 0,5 mL raztopine dvakrat na dan, dan s počasnim subkutanim injiciranjem (v plast tkiva neposredno pod kožo).
The diluted IL-2 (aldesleukin) is aseptically drawn up into sterile polypropylene tuberculin syringes and capped for each patient at 1 µg/kg dose, with a minimum standard dosage volume of 0.25 mL (50 µg) and a maximum dose of 0.5 mL (100 µg). 
Razredčeni IL-2 (aldeslevkin) aseptično izvlecite v sterilne polipropilenske tuberkulinske brizge s pokrovčkom, za vsakega bolnika v odmerku 1 µg/kg telesne mase, z najmanjšim standardnim odmernim volumnom 0,25 mL (50 µg) in največjim odmerkom 0,5 mL (100 µg).
In subjects with severe renal impairment, there were decreases in systolic and diastolic blood pressure at plasma histamine concentrations which caused no appreciable decrease in blood pressure in other subjects. 
Pri preiskovancih s hudo ledvično okvaro je pri plazemskih koncentracijah histamina prišlo do znižanja sistoličnega in diastoličnega krvnega tlaka, pri drugih preiskovancih pa znižanje krvnega tlaka ni bilo opazno.
Sodium chloride, water for injections, and sodium hydroxide and/or hydrochloric acid to adjust the pH. 
Natrijev klorid, voda za injekcije in natrijev hidroksid in/ali klorovodikova kislina za uravnavanje pH.
Concurrent administration of medicinal products with cardiotoxicity or blood pressure lowering effects may increase the toxicity of Ceplene. 
Sočasno zdravljenje s kardiotoksičnimi zdravili ali zdravili, ki znižujejo krvni tlak, lahko poveča toksičnost zdravila Ceplene.
Your doctor may decide that it would be more convenient for you to inject IL-2 and Ceplene yourself. 
Zdravnik se lahko odloči, da si lahko IL-2 in zdravilo Ceplene injicirate sami.
IL-2 has to be injected first. 
Najprej je treba injicirati IL-2.
Ceplene and IL-2 are administered for 10 treatment cycles: each cycle consists of a treatment period of 21 days (3 weeks) followed by a three-week or six-week treatment-free period. 
Zdravili Ceplene in IL-2 se uporabljata v 10 ciklih zdravljenja: vsak cikel predstavlja 21-dnevno obdobje zdravljenja (3 tedni), temu pa sledi obdobje treh ali šestih tednov brez zdravljenja.
Vial 
Viala
NOTE: The vial of Ceplene contains an overfill to facilitate the dose extraction of a single 0.5 mL dose. 
OPOMBA: Viala zdravila Ceplene vsebuje presežek za lažji izvlek enkratnega 0,5 mL odmerka.
w.58 
t. 58
With the needle cover on, pull back the plunger and draw air into the syringe to the level (number of millilitres) instructed by your doctor. 
S pokrovčkom na igli potegnite bat brizge nazaj in v brizgo potegnite zrak do ravni (število mililitrov) v skladu z navodili zdravnika.
The adverse reactions considered at least possibly related to the treatment of low-dose IL-2 with Ceplene in AML studies (n=280 for the IL-2 and Ceplene treatment arm) are listed below by body system organ, class and frequency. 
Neželeni učinki za katere se ocenjuje, da so vsaj verjetno povezani z zdravljenjem z majhnim odmerkom IL-2 skupaj z zdravilom Ceplene v študijah z bolniki z akutno mieloično levkemijo (n=280 za skupino, zdravljeno z IL-2 in zdravilom Ceplene), so navedeni spodaj glede na razrede organskih sistemov in pogostnost.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. 
Zelo pomembno je, da si ne poskušate zdravila injicirati sami, preden vas zdravnik ali medicinska sestra o tem ustrezno ne pouči.
Table 1: For treatment cycles 1-3 with Ceplene and IL-2 
Preglednica 1: Za cikle zdravljenja 1-3 z zdravilom Ceplene in IL-2.
Dilute IL-2 dispensed in capped polypropylene tuberculin syringes is to be prepared by the pharmacy in a controlled aseptic environment and stored in a refrigerator at 2°C - 8°C. 
Razredčeni IL-2, odmerjen v polipropilenske tuberkulinske brizge s pokrovčkom, mora pripraviti farmacevt v kontroliranih aseptičnih pogojih in hraniti v hladilniku pri temperaturi 2°C - 8°C.
A study was performed to measure the PK of histamine in normal volunteers compared to patients with mild, moderate, and severe hepatic impairment. 
Izvedena je bila študija za primerjavo farmakokinetike histamina pri zdravih prostovoljcih v primerjavi z bolniki z blagimi, zmernimi ali hudimi jetrnimi okvarami.
The most common adverse reactions experienced by 30% or more of patients receiving IL-2 and Ceplene (listed in descending order of frequency) were: flushing, headache, fatigue, injection site granuloma, pyrexia and injection site erythema. 
Najpogostejši neželeni učinki, ki so se pojavili pri 30 % bolnikov ali več, zdravljenih z IL-2 in zdravilom Ceplene (padajoče navedeni glede na pogostnost), so bili: zardevanje, glavobol, utrujenost, granulom na mestu injiciranja, povišana telesna temperatura in eritem na mestu injiciranja.
The vials contain 0.70 mL of solution (including overfill) to facilitate the dose extraction of a single 0.5 mL dose. 
Viale vsebujejo 0,70 mL raztopine (vključno s presežkom), kar omogoča izvlek odmerka za enkraten 0,5 mL odmerek.
Ceplene should be used with caution in patients with moderate to severe hepatic impairment (see section 5.2). 
Pri bolnikih z zmerno do hudo jetrno okvaro je treba zdravilo Ceplene uporabljati previdno (glejte poglavje 5.2).
2 mL type I glass vial, with bromobutyl rubber stopper and flip-off aluminium over seal, containing 0.5 mL of solution (0.70 mL including overfill). 
2 mL steklena viala tipa I, z bromobutilnim gumijastim zamaškom in odstranljivo aluminijasto zaporko, ki vsebuje 0,5 mL raztopine (0,70 mL vključno s presežkom).
The pharmacokinetics of histamine are similar in healthy volunteers with normal renal function compared to volunteers with mild, moderate, or severe renal impairment. 
Farmakokinetika histamina je podobna pri zdravih prostovoljcih z normalnim delovanjem ledvic in pri prostovoljcih z blago, zmerno ali hudo ledvično okvaro.
Your doctor will let you know how much it is and how to inject it. 
Zdravnik vam bo predpisal količino odmerka in način injiciranja.
• If you have received a stem cell transplant (a kind of bone marrow transplant) from a donor. 
• če so vam presadili matične celice (vrsta presaditve kostnega mozga).
to w.81 
do t. 81
• Altered taste (dysgeusia) 
• spremenjen okus (disgevzija)
Histamine dihydrochloride was not teratogenic in rats or rabbits at doses resulting in several hundredfold greater systemic exposures than the clinical exposure. 
Histaminijev diklorid pri podganah ali kuncih v odmerkih z nekaj stokrat večjo sistemsko izpostavljenostjo kot pri klinični izpostavljenosti ni bil teratogen.
If you feel faint or dizzy during or after the injections, tell your doctor before injecting your next dose. 
Če med ali po injiciranju občutite omedlevico ali vrtoglavico, pred naslednjim injiciranjem o tem obvestite zdravnika.
Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia (AML) in first remission concomitantly treated with interleukin-2 (IL-2). 
Vzdrževalno zdravljenje z zdravilom Ceplene je indicirano pri odraslih bolnikih z akutno mieloično levkemijo (AML) ob prvi remisiji, ob sočasnem zdravljenju z interlevkinom-2 (IL-2).
12 Take the needle out of the vial. 
Iglo vzemite iz viale.
Beta-blockers and other anti-hypertensive agents should be used with caution during treatment with Ceplene. 
Antagoniste adrenergičnih receptorjev beta in druga antihipertenzivna zdravila je treba v času zdravljenja z zdravilom Ceplene uporabljati previdno.
Apply gentle pressure with the alcohol wipe over the injection site without rubbing it. 14. 
Nežno pritisnite na mesto injiciranja z alkoholno krpico, vendar ga pri tem ne drgnite.
w.13 to w.15 (Days 1-21) 
t. 13 do t. 15 (dnevi 1-21)
What Ceplene looks like and contents of the pack 
Izgled zdravila Ceplene in vsebina pakiranja
Blood and lymphatic system disorders anaemia 
Bolezni krvi in limfatičnega sistema anemija pogosti
The MAH shall provide yearly updates on any new information concerning efficacy and safety of the product in patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2). 
Imetnik dovoljenja za promet z zdravilom mora letno predložiti posodobitev vseh novih podatkov o učinkovitosti in varnosti zdravila pri bolnikih z akutno mieloično levkemijo ob prvi remisiji, ob sočasnem zdravljenju z interlevkinom-2 (IL-2).
The first dose of Ceplene and IL-2 on day 1 of the initiation of the first cycle of treatment should be administered in the clinic under direct supervision by a physician. 
Prvo injiciranje odmerka zdravila Ceplene in IL-2 na prvi dan prvega cikla zdravljenja naj poteka na kliniki pod neposrednim nadzorom zdravnika.
Side effects observed when Ceplene is used as described in this package leaflet: 
Neželeni učinki, ki so jih opazili pri uporabi zdravila Ceplene, kot je navedena v tem navodilu za uporabo:
to w.48 
do t. 48
Slowly pull back the plunger to draw the solution into the syringe, filling it to the level (number of millilitres) instructed by your doctor. 
Počasi potegnite bat nazaj in v brizgo potegnite raztopino do ravni (število mililitrov), kot vam je naročil vaš zdravnik.
• Certain anti-psychotics such as chlorpromazine, flupenthixol, thoridazine, clozapine and risperidone. 
• Določeni antipsihotiki, kot so klorpromazin, flupentiksol, tioridazin, klozapin in risperidon.
Abnormal WBC counts - the dose of IL-2 can be reduced by 20% for the remaining duration of the treatment course and if abnormal WBC counts re-occur during the following cycle a permanent IL-2 reduction is recommended. 
Nenormalno število belih krvnih telesc - odmerek IL-2 lahko za preostali čas zdravljenja zmanjšate za 20 %, če pa se nenormalno število belih krvnih telesc med naslednjim ciklom zdravljenja ponovno pojavi, je priporočeno trajno zmanjšanje odmerka IL-2.
If you want to stop taking Ceplene you should try to consult your doctor in advance. 
Če ste prenehali uporabljati zdravilo Ceplene Če želite prenehati z jemanjem zdravila Ceplene, se prej posvetujte z zdravnikom.
Clear, colourless aqueous solution. 
Bistra, brezbarvna vodna raztopina.
Nervous system disorders headache, dizziness, dysgeusia Very common 
Bolezni živčevja glavobol, omotičnost, disgevzija zelo pogosti
IL-2 (aldesleukin) should be aseptically reconstituted, diluted and dispensed in capped polypropylene tuberculin syringes by the pharmacy based on the individual patient's weight (see administration chart for aldesleukin below) at the recommended dose of 16 400 IU/kg (1 µg/kg). 
IL-2 (aldeslevkin) farmacevt v aseptičnih pogojih rekonstituira, razredči in odmeri v polipropilenske tuberkulinske brizge s pokrovčkom glede na telesno maso posameznega bolnika (glejte tabelo odmerjanja aldeslevkina, spodaj) v priporočenem odmerku 16.400 i.e./kg telesne mase (1 µg/kg).
Ceplene is for subcutaneous use only. 
Način uporabe Zdravilo Ceplene je samo za subkutano uporabo.
Histamine concentrations and PK were highly variable across studies, as well as within the normal volunteer and patient groups. 
Koncentracije histamina in farmakokinetika so se med študijami zelo spreminjale, tako pri skupinah zdravih prostovoljcev kot pri bolnikih.
Ceplene maintenance therapy should be administered following completion of consolidation therapy in patients concomitantly treated with IL-2 under the supervision of a physician experienced in the management of acute myeloid leukaemia. 
Vzdrževalno zdravljenje z zdravilom Ceplene je namenjeno uporabi po zaključku utrditvene terapije pri bolnikih, sočasno zdravljenih z IL-2 pod nadzorom zdravnika z izkušnjami na področju zdravljenja akutne mieloične levkemije.
If you accidentally inject more than you were told to, contact your doctor or pharmacist immediately. 
Če ste si po nesreči injicirali večji odmerek zdravila, kot bi smeli, se nemudoma obrnite na zdravnika ali farmacevta.
The role of IL-2 is to promote the functions of NK cells and T cells by activating the anti-leukaemic properties of these cells and by expanding these cell populations by inducing cell cycle proliferation. 
IL-2 spodbuja delovanje celic ubijalk (NK) in T celic tako, da aktivira njihove protilevkemične lastnosti, z induciranjem proliferacije celic pa vpliva tudi na povečevanje populacije teh celic.
Although the degree of renal impairment has no demonstrable effect on the pharmacokinetic disposition of Ceplene, caution is warranted when Ceplene is administered to patients with severe renal impairment. 
Čeprav stopnja ledvične okvare nima nobenih očitnih učinkov na farmakokinetiko zdravila Ceplene, je pri predpisovanju zdravila bolnikom s hudo ledvično okvaro potrebna previdnost.
Ceplene/IL-2 is an immunotherapy which aims to induce immune-mediated destruction of residual myeloid leukaemic cells and thereby to prevent relapse of leukaemia. 
Zdravljenje z zdravilom Ceplene in IL-2 je imunoterapija, katere namen je inducirati imunsko uničevanje preostalih mieloičnih levkemičnih celic in tako preprečiti relaps levkemije.
IL-2 is injected twice daily as a subcutaneous injection (in the layer of tissue just under the skin) 1 to 3 minutes before the injection of Ceplene. 
IL-2 se injicira dvakrat na dan v obliki subkutane injekcije (v plast tkiva neposredno pod kožo), 1 do 3 minute pred injiciranjem zdravila Ceplene.
• If you have further questions, please ask your doctor, pharmacist or nurse. 
• Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
• Abnormal redness of the skin (erythema), increased sweating (hyperhidrosis), night sweats and itching (pruritus) 
• nenormalna pordelost kože (eritem), povečano potenje (hiperhidroza), nočno potenje in srbenje
Always vary the site that you inject. 
Vedno menjajte mesto injiciranja.
No clinical data are available on the effects of Ceplene on fertility. 
O vplivu zdravila Ceplene na plodnost ni na voljo kliničnih podatkov.
Common side effects (may affect up to 1 in 10 people) 
Pogosti neželeni učinki (pojavijo se lahko pri 1 od 10 bolnikov)
Skin and subcutaneous tissue disorders dry skin 
Bolezni kože in podkožja suha koža zelo pogosti
Dispensing of dilute IL-2 (aldesleukin) for each patient 
Odmerjanje razredčenega IL-2 (aldeslevkin) za posameznega bolnika
Studies have shown chemical stability and sterility of diluted aldesleukin (dispensed in capped polypropylene tuberculin syringes) for up to three weeks when prepared in a controlled aseptic environment and stored under refrigeration at 2°C - 8°C. 
Kemična stabilnost in sterilnost razredčenega aldeslevkina (odmerjenega v polipropilenske tuberkulinske brizge z zamaškom) sta bili v študijah dokazani za tri tedne, če je bilo redčenje opravljeno v kontroliranih, aseptičnih pogojih in aldeslevkin shranjen v hladilniku pri temperaturi 2°C - 8°C.
• Cough, difficulty in breathing (dyspnoea) 
• kašljanje, težave pri dihanju (dispneja)
Study AML-1 was exploratory, enrolling 39 AML patients in remission to determine the dose and feasibility of Ceplene administered together with IL-2. 
V študijo AML-1, ki je bila raziskovalna, je bilo vključenih 39 bolnikov z akutno mieloično levkemijo v remisiji za določitev odmerka in možnosti sočasne uporabe zdravila Ceplene in IL-2.
w.31 
t. 31
Treatment can be resumed by administering Ceplene at the full dose and IL-2 at 50%. 
Zdravljenje lahko nadaljujete z dajanjem polnega odmerka zdravila Ceplene in 50 % odmerka IL-2.
• Hives, bruising, rash and swelling at the injection site, weakness (asthenia) and chest pain 
• koprivnica, modrice, izpuščaji in otekline na mestu injiciranja, oslabelost (astenija) in bolečine v prsih
w.7 to w.9 (Days 1-21) 
t. 7 do t. 9 (dnevi 1-21)
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections 
6.1 Seznam pomožnih snovi natrijev klorid natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH) voda za injekcije
H1 receptor blocking antihistamines or neuroleptics (anti-psychotics) with H1 receptor blocking properties that might decrease efficacy of Ceplene should be avoided. 
Antihistaminiki iz skupine antagonistov receptorjev H1 ali nevroleptiki (antipsihotiki) z antagonističnim delovanjem na receptorje H1 lahko zmanjšajo učinkovitost zdravila Ceplene in se jim je zato treba izogibati.
• Beta-blockers, such as propranolol, metoprolol, atenolol. 
• Antagonisti adrenergičnih receptorjev beta, kot so propranolol, metoprolol, atenolol.
By inhibiting oxidase function and reducing ROS production, Ceplene protects IL-2-activated NK cells and T cells from oxygen free radical-induced inhibition and apoptosis. 
S preprečevanjem oksidaze in zmanjševanjem nastajanja kisikovih reaktivnih vrst, zdravilo Ceplene varuje z IL-2 aktivirane celice ubijalke (NK) in T celice, pred inhibicijo in apoptozo zaradi kisikovih prostih radikalov.
If you are taking any of the following medicines, please be sure to discuss this with your doctor or pharmacist before using Ceplene. 
Če jemljete katero koli od spodaj navedenih zdravil, se pred uporabo zdravila Ceplene o tem pogovorite s svojim zdravnikom ali farmacevtom.
Withdraw and discard the syringe as instructed. 
Iglo potegnite ven in brizgo odstranite v skladu z navodili.
They are used to treat stomach ulcers, indigestion (dyspepsia) or heartburn (see above “Do not use Ceplene”). 
Uporabljajo se za zdravljenje želodčnih razjed, slabe prebave (dispepsije) ali zgage (glejte poglavje zgoraj „Ne uporabljajte zdravila Ceplene“).
Although the degree of renal impairment has little effect on the PK disposition of histamine, caution should be used in the administration of histamine to patients with severe renal impairment. 
Čeprav stopnja ledvične okvare le malo vpliva na farmakokinetične lastnosti histamina, je pri predpisovanju histamina bolnikom s hudo ledvično okvaro potrebna previdnost.
• Increase in the number of a certain type of white blood cells in the blood (eosinophilia) and decrease in the number of blood platelets (thrombocytopenia) 
• povečano število določenih belih krvnih celic v krvi (eozinofilija) in upad števila trombocitov
PREPARATION FOR INJECTION OF CEPLENE 
PRIPRAVA ZA INJICIRANJE ZDRAVILA CEPLENE
Ceplene inhibits NAPDH oxidase which initiates the formation and release of ROS from phagocytes. 
Zdravilo Ceplene zavira NAPDH oksidazo, ki sproži nastanek in sproščanje kisikovih reaktivnih vrst (ROS) iz fagocitov.
You will have to inject Ceplene and IL-2 twice a day by subcutaneous injection (in the layer of tissue just under the skin), according to the directions provided by your doctor. 
Zdravilo Ceplene in IL-2 si morate injicirati dvakrat na dan s subkutanim injiciranjem (v plast tkiva neposredno pod kožo) v skladu z navodili zdravnika.
Animal studies revealed no adverse effects on fertility apart from a slight reduction in implantations and viable foetuses (see section 5.3). 
Študije na živalih niso pokazale vpliva na sposobnost razmnoževanja, razen nekoliko slabše možnosti vsaditve in števila za preživetje sposobnih zarodkov (glejte poglavje 5.3).
Ceplene is a clear, colourless liquid. 
Zdravilo Ceplene je prozorna, brezbarvna tekočina.
Endocrine disorders hypothyroidism 
Bolezni endokrinega sistema hipotiroidizem pogosti
The two medicines, IL-2 and Ceplene, are both injected twice a day, with a minimum of 6 hours between injections. 
Oba, IL-2 in zdravilo Ceplene se injicirata dvakrat na dan, med injiciranjema pa naj preteče vsaj 6 ur.
Thus, subjects with severe renal impairment may be more sensitive to the blood pressure lowering effects of exogenously administered histamine than subjects with normal renal function or subjects with mild or moderate renal impairment. 
To pomeni, da so preiskovanci s hudo ledvično okvaro morda bolj občutljivi na vplive eksogeno vnešenega histamina na zniževanja krvnega tlaka kot preiskovanci z normalnim delovanjem ledvic ali preiskovanci z blago ali zmerno ledvično okvaro.
If bubbles appear in the syringe, push the solution slowly back into the vial and withdraw the solution again. 
Če se v brizgi pojavijo mehurčki, raztopino ponovno iztisnite iz brizge nazaj v vialo in nato ponovno napolnite brizgo.
- IL-2 can be discontinued for 24 hours and then restarted at a 20% dose reduction level. 
Povišana telesna temperatura - zdravljenje z IL-2 prekinite za 24 ur, nato pa ponovno pričnite z 20-odstotno zmanjšanim odmerkom.
6.6 Special precaution for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Gastrointestinal disorders nausea, dyspepsia, diarrhoea Very common vomiting, abdominal pain upper, dry mouth, gastritis, abdominal distention 
Bolezni prebavil navzea, dispepsija, diareja zelo pogosti bruhanje, bolečine v zgornjem delu trebuha, suha usta, gastritis, trebušna distenzija pogosti
The preferred injection areas are the thighs and the abdomen. 
Priporočeno mesto injiciranja so stegna in trebuh.
w.28 
t. 28
The concomitant administration of Ceplene and IL-2 therefore aims to optimise the anti-leukaemic functions of NK cells and T cells. 
Sočasna uporaba zdravila Ceplene in IL-2 tako teži k optimizaciji protilevkemičnega delovanja celic ubijalk (NK) in T celic.
There is no information about the use of Ceplene in pregnant women. 
Ni kliničnih podatkov o uporabi zdravila Ceplene pri nosečnicah.
You must be monitored to check how you respond to treatment. 
Ob začetku zdravljenja je potreben nadzor vašega odzivanja na zdravilo.
to w.66 
do t. 66
• Tricyclic antidepressant medicines such as amitryptiline, imipramine, or monoamine oxidase inhibitors, such as phenelzine, isocarboxazide, tranylcypromine or moclobemide. 
• Triciklični antidepresivi, kot so amitriptilin, imipramin ali zaviralci monoaminooksidaze, kot so fenelzin, izokarboksazid, tranilcipromin ali moklobemid.
Metabolism and nutrition disorders anorexia 
Presnovne in prehranske motnje anoreksija pogosti
A maximum delay of one treatment cycle can be considered for the resolution of grade 3 and 4 events. 
Za razrešitev dogodkov 3. in 4. stopnje toksičnosti lahko preučite možnost odložitve največ enega cikla zdravljenja.
Also, if you are to have an operation or special X-ray investigation requiring an injection, first make sure that your doctor knows that you are receiving Ceplene. 
Če boste v kratkem operirani ali boste imeli rentgensko preiskavo na način, ki zahteva injiciranje, o jemanju zdravila Ceplene predhodno obvestite lečečega zdravnika.
Ceplene 0.5 mg/0.5 mL solution for injection 
Ceplene 0,5 mg/0,5 mL raztopina za injiciranje
It is recommended that you always have someone with you when injecting this medicine, such as an adult family member, friend or other care provider who could help you if you feel light-headed or faint. 
Priporoča se, da je pri samoinjiciranju zdravila vedno nekdo prisoten, na primer odrasel družinski član, prijatelj ali drug skrbnik, ki vam lahko pomaga v primeru omotičnosti ali omedlevice.
System organ class 
Organski sistemi
to w.54 
do t. 54
to w.75 
do t. 75
INSTRUCTIONS FOR SELF-INJECTION OF CEPLENE 
NAVODILA ZA SAMOINJICIRANJE ZDRAVILA CEPLENE
Monoamine oxidase inhibitors, anti-malarial, and anti-trypanosomal active substances may alter the metabolism of Ceplene and should be avoided (see section 4.4). 
Zaviralci monoaminooksidaze, antimalariki in zdravila za zdravljenje tripanosomoze lahko spremenijo presnovo zdravila Ceplene in se jim je zato treba izogibati (glejte poglavje 4.4).
• Tingling, prickling or numbness of the skin (paraesthesia) 
• zbadanje, mravljinci ali odrevenelost kože (parestezija)