natgillin/translations-raw huggingface dataset:
Impermeable disposable protective gloves should be provided at the point of sale with the product and must be worn when handling and administering the veterinary medicinal product. 
Rokavice je treba nositi pri ravnanju z zdravilom in njegovem dajanju.
Do not leave the tube out of its child-proof container except during the application phase. 
Ko tube ne uporabljate, je ne puščajte zunaj njenega vsebnika z zaporko, varno za otroke.
Children must not be present when applying the treatment to the cat. 
Pri nanosu zdravila na mačko otroci ne smejo biti prisotni.
The efficacy and safety of the veterinary medicinal product has not been established in cats weighing less than 2.1 kg or more than 7.0 kg (see also section 4.9). 
Učinkovitost in varnost zdravila pri mačkah, težkih manj kot 2,1 kg ali več kot 7,0 kg, nista bili ugotovljeni
Inhibition of 5-HT2 and histamine H1 receptors may account for the orexigenic effects of the molecule. 
Oreksigen učinek molekule lahko povzroči zaviranje receptorjev 5-HT2 in histaminskih receptorjev H1.
Do not use in cats treated with cyproheptadine, tramadol or monoamine oxidase inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the veterinary medicinal product as there may be an increased risk of serotonin syndrome (see “Contraindications”). 
Ne uporabite pri mačkah, ki se zdravijo s ciproheptadinom, tramadolom ali zaviralci monoaminooksidaze (MAOI) ali so bile z MAOI zdravljene v zadnjih 14 dneh, ker lahko pride do povečanega tveganja za serotoninski sindrom (glejte poglavje „Kontraindikacije“).
Do not use in breeding, pregnant or lactating cats. 
Ne uporabite pri vzrejnih živalih ali v obdobju brejosti in laktacije.
Step 2: Twist cap on tube counter clockwise to open. 
2. korak: Odprite zaporko na tubi tako, da jo zavrtite v nasprotni smeri urinega kazalca.
Do not use in cats treated with monoamine oxidase inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the veterinary medicinal product due to an increased risk of serotonin syndrome (see also “special warnings”). 
Ne uporabite pri mačkah, ki se zdravijo z zaviralci monoaminooksidaze (MAOI) ali so bile z MAOI zdravljene v zadnjih 14 dneh, ker lahko pride do povečanega tveganja za serotoninski sindrom (glejte poglavje „Posebna opozorila“).
Marketing authorisation holder: Aniserve GmbH Geyerspergerstr. 
IMETNIK DOVOLJENJA ZA PROMET Aniserve GmbH
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release 
Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij Klifovet AG
The product may be harmful after ingestion. 
Zdravilo ima lahko škodljive učinke pri zaužitju.
Diethylene glycol monoethyl ether Caprylocaproyl polyoxyglycerides Oleyl alcohol 
6.1 Seznam pomožnih snovi makrogol 400 makrogol 3350 dietilenglikolmonoetileter polioksigliceridi kaprilat kaprinat oleilalkohol butilhidroksitoluen (E321) dimetikon polimetil silseskvioksan iz škroba tapioke
Excipients: Butylhydroxytoluene (E321; as antioxidant) 0.01 mg 
Vsak odmerek 0,1 g vsebuje: mirtazapin (v obliki hemihidrata) 2 mg Pomožne snovi: butilhidroksitoluen (E321; kot antioksidant) 0,01 mg Nemastno, homogeno, belo do umazano belo mazilo.
The tube must be stored in the child resistant bottle with cap and returned to the bottle and capped immediately after every use. 
Po vsaki uporabi jo morate vrniti v plastenko in nanjo nemudoma namestiti zaporko.
Plastic bottle 
PODATKI NA ZUNANJI OVOJNINI Plastenka
Avoid contact with the treated animal for the first 12 hours after each daily application and until the application site is dry. 
Prvih 12 ur po vsakem nanosu, in dokler mesto nanosa ni suho, se izogibajte stiku z zdravljeno živaljo.
Klifovet AG Geyerspergerstrasse 27 80689 Muenchen Germany 
Geyerspergerstrasse 27
Tube 
ZDRAVILA
For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions (see section 5.1). 
Za povečanje telesne mase pri mačkah, ki imajo slab apetit in hujšajo zaradi kroničnih bolezenskih stanj
Do not use in pregnant or lactating cats.. 
Ne uporabite v obdobju brejosti in laktacije.
Butylhydroxytoluene (E321) Dimethicone 
mirtazapin (v obliki hemihidrata) 2 mg Pomožne snovi: butilhidroksitoluen (E321)
To apply the veterinary medicinal product: 
Postopek nanosa zdravila:
Transdermal ointment 
OVOJNINAH Tuba
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” 
BESEDILO „ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM“ Zdravilo shranjujte nedosegljivo otrokom.
BATCH NUMBER 
ŠTEVILKA SERIJE Lot {številka}
This overview was last updated in 11/2019. 
Povzetek je bil nazadnje posodobljen 11-2019.
The main measure of effectiveness was the change in symptoms. 
Glavno merilo učinkovitosti je bila sprememba simptomov.
Further information on Remsima can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/remsima. 
Nadaljnje informacije za zdravilo Remsima so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/remsima.
What measures are being taken to ensure the safe and effective use of Remsima? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Remsima?
Some side effects, including infections, may be more common in children than in adults. 
Nekateri neželeni učinki, vključno z okužbami, utegnejo biti pogostejši pri otrocih kot pri odraslih.
This means that Remsima is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
Remsima received a marketing authorisation valid throughout the EU on 10 September 2013. 
Za zdravilo Remsima je bilo 10. septembra 2013 izdano dovoljenje za promet, veljavno po vsej EU.
How often the treatment is repeated depends on which disease is being treated, and on the patient's response to the medicine. 
Kako pogosto je treba zdravljenje ponavljati, je odvisno od bolezni, ki se zdravi, in od bolnikovega odziva na zdravilo.
Why is Remsima authorised in the EU? 
Zakaj je bilo zdravilo Remsima odobreno v EU?
An overview of Remsima and why it is authorised in the EU 
Pregled zdravila Remsima in zakaj je odobreno v EU
What benefits of Remsima have been shown in studies? 
Kakšne koristi zdravila Remsima so se pokazale v študijah?
Remsima is also used in patients aged between 6 and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments. 
Zdravilo Remsima se uporablja tudi pri bolnikih v starosti med šest in 17 let z resno, aktivno Crohnovo boleznijo ali resnim, aktivnim ulceroznim kolitisom, kadar se na drugo zdravljenje ali zdravila niso odzvali ali kadar jih ne smejo prejemati.
It also allows patients the convenience of having their treatment at home. 
Tako lahko bolniki zdravljenje izvajajo tudi v domačem okolju.
What is Remsima and what is it used for? 
Kaj je zdravilo Remsima in za kaj se uporablja?
The most common side effects with Remsima (which may affect more than 1 in 10 people) are viral infections (such as flu or cold sores), headache, upper respiratory-tract infection (nose and throat infections), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain. 
Najpogostejši neželeni učinki zdravila Remsima (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so virusne okužbe (na primer gripa ali herpes), glavobol, okužbe zgornjih dihal (okužbe nosu in žrela), sinusitis (vnetje sinusov), navzeja (slabost), bolečine v trebuhu, reakcije, povezane z infuzijo, in bolečine.
By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases. 
Z zaviranjem TNF-alfa infliksimab izboljša vnetna stanja in druge simptome obolenj.
Other information about Remsima 
Druge informacije o zdravilu Remsima
As for all medicines, data on the use of Remsima are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Remsima stalno spremljajo.
Remsima must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body). 
Zdravilo Remsima se ne sme uporabljati pri bolnikih s tuberkulozo, drugimi hudimi okužbami ali zmernim do hudim srčnim popuščanjem (nezmožnostjo srca, da črpa dovolj krvi po telesu).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Remsima have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Remsima upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Remsima are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Remsima, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
For more information about using Remsima, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Remsima glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
After 30 weeks of treatment, Remsima was as effective as Remicade with around 60% of patients responding to treatment with either medicine. 
Po 30 tednih zdravljenja je bilo zdravilo Remsima enako učinkovito kot zdravilo Remicade, pri čemer se je približno 60 % bolnikov odzvalo na zdravljenje z enim od omenjenih zdravil.
All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. 
Pri vseh bolnikih je treba preverjati, ali med infundiranjem in še najmanj eno do dve uri po njem ni prišlo do pojava kakršnih koli reakcij.
Remsima is used with methotrexate (another medicine that acts on the immune system); 
Zdravilo Remsima se uporablja skupaj z metotreksatom (drugim zdravilom, ki učinkuje na imunski sistem);
After 22 weeks, the reduction of symptoms was comparable for treatment given by infusion into a vein and by injection under the skin. 
Po 22 tednih je bilo zmanjšanje simptomov primerljivo z zdravljenjem, ki se daje z infuzijo v veno in z injekcijo v podkožje.
What are the risks associated with Remsima? 
Kakšna tveganja so povezana z zdravilom Remsima?
Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha). 
Infliksimab je bil zasnovan tako, da se v telesu veže na kemijskega prenašalca, imenovanega tumorje nekrozitirajoči faktor-alfa (TNF-alfa).
Remsima must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remsima. 
Zdravila Remsima ne smejo uporabljati bolniki, pri katerih je v preteklosti prišlo do preobčutljivosti (alergije) na infliksimab, ali bolniki, ki so preobčutljivi za (alergični na) mišje beljakovine ali katero koli drugo sestavino zdravila Remsima.
All these data were considered sufficient to conclude that Remsima will behave in the same way as Remicade in terms of effectiveness and safety in its authorised uses. 
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Remsima pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Remicade.
The safety of Remsima has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Remicade. 
Varnost zdravila Remsima je bila ocenjena, na podlagi vseh izvedenih študij pa so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Remicade.
The active substance in Remsima, infliximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body. 
Učinkovina v zdravilu Remsima, infliksimab, je monoklonsko protitelo, tj. vrsta beljakovine, ki je bila zasnovana tako, da prepozna določeno strukturo (imenovano antigen) v telesu in se veže nanjo.
The company that markets Remsima will provide a card to patients that includes information about the medicine and can be used to record tests they have taken. 
Podjetje, ki trži zdravilo Remsima, bo priskrbelo kartico za bolnike z informacijami o zdravilu in s pomočjo katere se lahko vodi evidenca o preskušanjih, ki so jih opravili.
Because Remsima is a biosimilar medicine, the studies on effectiveness and safety of infliximab carried out with Remicade do not all need to be repeated for Remsima. 
Zdravilo Remsima je „podobno biološko zdravilo“, zato vseh študij o učinkovitosti in varnosti infliksimaba, izvedenih z zdravilom Remicade, z zdravilom Remsima ni treba ponavljati.
To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Remsima or the infusion may be slowed down. 
Za zmanjšanje tveganja za pojav reakcij, povezanih z infundiranjem, lahko bolniki pred zdravljenjem z zdravilom Remsima ali med njim prejemajo druga zdravila ali pa se hitrost infundiranja upočasni.
Remsima is an anti-inflammatory medicine that contains the active substance infliximab. 
Remsima je protivnetno zdravilo, ki vsebuje učinkovino infliksimab.
Remsima can only be obtained with a prescription and treatment should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remsima can be used to treat. 
Predpisovanje in izdaja zdravila Remsima je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere se zdravilo Remsima uporablja.
It is usually used when other medicines or treatments have failed, in adults with the following immune-system diseases: 
Navadno se uporablja pri odraslih z naslednjimi boleznimi imunskega sistema, kadar druga zdravila ali zdravljenja niso bila učinkovita:
• Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulas, abnormal passageways between the gut and other organs); 
• Crohnova bolezen (obolenje, ki povzroča vnetje prebavnega trakta), kadar je obolenje zmerno do močno izraženo ali pa prihaja do fistulizacije (s pojavljanjem fistul, tj. nenormalnih prehodov med črevesjem in drugimi organi);
A study was also carried out in 250 patients with ankylosing spondylitis to show that Remsima given by infusion into a vein produces levels of the active substance in the body that are comparable to the reference medicine, Remicade. 
Izvedli so tudi študijo z 250 bolniki z ankilozirajočim spondilitisom, s katero so dokazali, da zdravilo Remsima, ki se daje z infuzijo v veno, dosega primerljive ravni učinkovine v telesu kot referenčno zdravilo Remicade.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Remsima has a highly similar structure, purity and biological activity to Remicade and is distributed in the body in the same way. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Remsima po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Remicade in da se po telesu enako prenaša.
This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Remsima is used to treat. 
Ta prenašalec sodeluje pri povzročanju vnetja in ga je mogoče v velikih koncentracijah najti pri bolnikih z obolenji, za zdravljenje katerih se uporablja zdravilo Remsima.
In addition, studies in rheumatoid arthritis and ankylosing spondylitis have shown that the safety and effectiveness of Remsima are equivalent to those of Remicade in the conditions. 
Poleg tega so s študijami pri revmatoidnem artritisu in ankilozirajočem spondilitisu dokazali, da sta varnost in učinkovitost zdravila Remsima pri teh boleznih enakovredni varnosti in učinkovitosti zdravila Remicade.
Patients received Remsima by infusion twice, two weeks apart and subsequent treatments were given either by infusion or injection under the skin. 
Bolniki so prejeli zdravilo Remsima v obliki infuzije dvakrat v razmaku dveh tednov, nadaljnje zdravljenje pa je potekalo v obliki infuzije ali injekcije v podkožje.
The reference medicine for Remsima is Remicade. 
Referenčno zdravilo za zdravilo Remsima je zdravilo Remicade.
Patients received either Remsima or Remicade in addition to methotrexate for 30 weeks. 
Bolniki so 30 tednov prejemali bodisi zdravilo Remsima bodisi zdravilo Remicade skupaj z metotreksatom.
Therefore, the Agency's view was that, as for Remicade, the benefits of Remsima outweigh the identified risks and it can be authorised for use in the EU. 
Agencija je menila, da koristi zdravila Remsima, enako kot pri zdravilu Remicade, odtehtajo znana tveganja in da se zdravilo lahko odobri za uporabo v EU.
Remsima given by injection under the skin for rheumatoid arthritis is as effective as Remsima given by infusion and the safety profile is acceptable. 
Zdravilo Remsima, ki se za zdravljenje revmatoidnega artritisa daje v obliki injekcije v podkožje, je enako učinkovito kot zdravilo Remsima, ki se daje v obliki infuzije, varnostni profil pa je sprejemljiv.
Remsima is a ‘biosimilar' medicine. 
Zdravilo Remsima je „podobno biološko zdravilo“.
How is Remsima used? 
Kako se zdravilo Remsima uporablja?
For treatment of rheumatoid arthritis, Remsima is also available as a solution for injection under the skin in a pre-filled syringe or pen. 
Za zdravljenje revmatoidnega artritisa je zdravilo Remsima na voljo tudi v obliki raztopine za injiciranje pod kožo v napolnjeni injekcijski brizgi ali peresniku.
• psoriasis (a disease causing red, scaly patches on the skin). 
• psoriaza (bolezen, ki povzroča rdeče, luskaste zaplate na koži).
For rheumatoid arthritis, after two treatments with infliximab have been given by infusion, Remsima can be given by injection under the skin for subsequent treatments. 
Pri zdravljenju revmatoidnega artritisa se po dveh zdravljenjih z infliksimabom v obliki infuzije zdravilo Remsima za nadaljnje zdravljenje lahko daje v obliki injekcije v podkožje.
Patients can inject Remsima themselves once they have been trained. 
Bolniki si lahko po ustreznem usposabljanju zdravilo Remsima injicirajo sami.
For the full list of all side effects of Remsima, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Remsima, glejte navodilo za uporabo.
• rheumatoid arthritis (a disease causing inflammation of the joints). 
• revmatoidni artritis (bolezen, ki povzroča vnetje sklepov).
Remsima is available as a powder to be made up into a solution for infusion (drip) into a vein. 
Zdravilo Remsima je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
• ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine); 
• ankilozirajoči spondilitis (bolezen, ki povzroča vnetje in bolečine v sklepih v hrbtenici);
Laboratory studies comparing Remsima with Remicade have shown that the active substance in Remsima is highly similar to that in Remicade in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Remsima primerjali z zdravilom Remicade, so pokazale, da je učinkovina v zdravilu Remsima po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Remicade.
In addition, Remsima and Remicade given by infusion into a vein were compared in one main study involving 606 adults with rheumatoid arthritis. 
Poleg tega so v eni glavni študiji s 606 odraslimi bolniki z revmatoidnim artritisom primerjali zdravili Remsima in Remicade, ki so ju dajali v obliki infuzije v veno.
• ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut); 
• ulcerozni kolitis (bolezen, ki povzroča vnetje in razjede v črevesni sluznici);
• psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints); 
• psoriatični artritis (bolezen, ki povzroča nastajanje rdečih in luskinastih zaplat na koži in vnetje sklepov);
How does Remsima work? 
Kako zdravilo Remsima deluje?
Remsima is given as an infusion into a vein lasting one or two hours. 
Zdravilo Remsima se daje v obliki eno- ali dveurne infuzije v veno.
Remsima injection to be given under the skin was shown to be as effective as Remsima given by infusion into a vein in a study involving 343 patients with rheumatoid arthritis. 
V študiji s 343 bolniki z revmatoidnim artritisom so dokazali, da je zdravilo Remsima v obliki injekcije, ki se daje v podkožje, enako učinkovito kot zdravilo Remsima v obliki infuzije v veno.
This usually takes between 15 and 30 minutes. 
Običajno to traja od 15 do 30 minut.
At the final analysis, 1 653 deaths were reported. 
Ob končni analizi so poročali o 1.653 smrtih.
Date of first authorisation: 18 December 2007 Date of latest renewal: 15 November 2012 
Datum prve odobritve: 18. december 2007 Datum zadnjega podaljšanja: 15. november 2012
Make the next injection as soon as you remember. 
Naslednjo injekcijo uporabite takoj, ko se spomnite.
This requires urgent treatment. 
To zahteva nujno zdravljenje.
Adults donating their own blood 
Odrasli, ki darujejo lastno kri
• anaemia from other causes 
• anemijo iz drugih vzrokov
Thus, the volume of distribution is slightly greater than the plasma space. 
Volumen porazdelitve je torej nekoliko večji kot plazemski prostor.
The recommended dosing regimen is described in the following diagram*: 
Priporočeni režim odmerjanja je opisan v spodnjem diagramu*:
It may affect other treatments or test results. 
To lahko vpliva na druga zdravljenja ali izvide preiskav.
• Skin rashes, which may result from an allergic reaction. 
• Kožni izpuščaji, ki je lahko posledica alergijske reakcije.
• if you know, or think that it may have been accidentally frozen, or 
• če veste ali mislite, da bi lahko bilo po pomoti zamrznjeno, ali
• if the seal is broken, 
• če je pečat pretrgan,
Influenza-like illness may occur especially at the start of treatment. 
Gripi podobna bolezen se lahko pojavi zlasti na začetku zdravljenja.
• if there has been a refrigerator failure. 
• če je prišlo do okvare hladilnika.
• porphyria (a rare blood disorder) 
• porfirijo (redko krvno bolezen)
• Or under the skin (subcutaneously). 
• bodisi pod kožo (subkutano).
Overall, these studies have methodological limitations but treatment was associated with positive trends towards higher haemoglobin levels. 
Na splošno imajo te študije metodološke omejitve, vendar je bilo zdravljenje povezano s pozitivnimi trendi proti višjim ravnem hemoglobina.
Treatment with Retacrit is divided into two stages - correction and maintenance phase. 
Zdravljenje z zdravilom Retacrit poteka v dveh stopnjah - korekcijska in vzdrževalna faza.
Frequency estimate: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1 000 to <1/100); rare (>1/10 000 to <1/1 000); very rare (<1/10 000), not known (cannot be estimated from the available data). 
Ocenjena pogostnost: zelo pogosti (>1/10); pogosti (>1/100 do <1/10); občasni (>1/1.000 do <1/100); redki (>1/10.000 do <1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Patients should only be switched from one ESA to another under appropriate supervision. 
Prehod z enega ESA na drugega mora potekati pod ustreznim nadzorom.
Your doctor or nurse may have shown you how to do this. 
Zdravnik ali medicinska sestra vam bosta pokazala, kako.
No unexpected adverse events were reported (see section 4.2). 
O nepričakovanih neželenih učinkih niso poročali (glejte poglavje 4.2).
Administer over at least one to five minutes, depending on the total dose. 
Odmerek injicirajte najmanj 1 do 5 minut, odvisno od celotnega odmerka.
• Take a syringe out of the refrigerator. 
• Brizgo vzemite iz hladilnika.