natgillin/translations-raw huggingface dataset:
Aerinaze is used to treat the symptoms of seasonal allergic rhinitis (hayfever, inflammation of the nasal passages caused by an allergy to pollen) in patients who have nasal congestion (a blocked nose).
Zdravilo Aerinaze se uporablja za zdravljenje simptomov sezonskega alergijskega rinitisa (senenega nahoda, vnetja nosnih poti zaradi preobčutljivosti na cvetni prah) pri bolnikih s kongestijo nosne sluznice (zamašenim nosom).
In both studies, Aerinaze was compared with desloratadine alone and with pseudoephedrine alone.
V obeh študijah so zdravilo Aerinaze primerjali z desloratadinom kot samostojnim zdravilom in psevdoefedrinom kot samostojnim zdravilom.
What is Aerinaze used for?
Za kaj se zdravilo Aerinaze uporablja?
Treatment for more than 10 days is not advisable, as the medicine's effects on nasal congestion may wear off. Once the nose has cleared, patients can use desloratadine alone.
Zdravljenje, daljše od 10 dni, ni priporočljivo, saj učinek zdravila na kongestijo nosne sluznice sčasoma pojenja.
Aerinaze contains two active substances: desloratadine, an antihistamine, and pseudoephedrine, which is a nasal decongestant.
Zdravilo Aerinaze vsebuje dve zdravilni učinkovini: desloratadin, ki je antihistaminik, in psevdoefedrin, ki je nosni dekongestiv.
How has Aerinaze been studied?
Kako je bilo zdravilo Aerinaze raziskano?
How does Aerinaze work?
Kako zdravilo Aerinaze deluje?
How is Aerinaze used?
Kako se zdravilo Aerinaze uporablja?
Date of first authorisation: 25 July 2013.
Datum prve odobritve: 25. julij 2013.
There is no evidence that such an interaction would be harmful.
Ni dokazov, da bi bilo tako medsebojno delovanje škodljivo.
Find a comfortable, well-lit place.
Najdite udobno, dobro osvetljeno mesto.
*This is based on protein content only.
*To temelji le na vsebnosti beljakovine.
This could damage the safety device.
To bi lahko poškodovalo varnostni pripomoček.
The safety device will be activated immediately.
Varnostni pripomoček se takoj aktivira.
The relevance of these findings for humans is not known.
Pomen teh ugotovitev za človeka ni znan.
Proper treatment of your disease, however, requires close and constant co-operation with your doctor.
Pravilno zdravljenje vaše bolezni zahteva tesno in stalno sodelovanje z vašim zdravnikom.
CI = confidence interval
IZ = interval zaupanja
Healthy volunteers
Zdravi prostovoljci
The results of the study are presented in table 3.
Rezultati študije so predstavljeni v preglednici 3.
Date of latest renewal: 08 May 2018
Datum zadnjega podaljšanja: 08. maj 2018.
This antibody response can, in some cases, lead to undesirable effects or loss of efficacy.
Ta protitelesni odziv lahko v nekaterih primerih povzroči neželene učinke ali izgubo učinkovitosti.
This should be considered when interpreting bone-imaging results.
To je treba upoštevati pri razlagi rezultatov slikanja kosti.
Incidence (%)
Incidenca (%)
The incidence of FN varied according to age (from 14.3 % to 71.4 %), with the highest frequency in the oldest age group.
Incidenca FN se je glede na starost razlikovala (od 14,3 % do 71,4 %), pri čemer je bila največja pogostnost v najstarejši starostni skupini.
Your doctor will carry out regular blood tests in order to monitor various blood components and their levels.
Vaš zdravnik bo z rednimi krvnimi preiskavami zagotavljal nadzor nad različnimi sestavinami krvi in njihovimi ravnmi.
Do not give this medicine to children and adolescents under 18 years of age because there is only limited experience in children to show that this medicine is safe and works in this age group.
Tega zdravila ne dajajte otrokom in mladostnikom, starim manj kot 18 let, saj so izkušnje pri otrocih, ki bi dokazale, da je to zdravilo varno in da deluje v tej starostni skupini, omejene.
The first injection should be performed under direct medical supervision.
Prvo injiciranje je treba izvesti pod neposrednim zdravniškim nadzorom.
Frequency groupings are defined according to the following convention: 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).
Skupine pogostnosti so opredeljene v skladu z naslednjim dogovorom: 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).
The mean terminal half-lives in the fourth cycle were approximately 39 and 42 hours.
Povprečna končna razpolovna časa v četrtem ciklu sta bila približno 39 in 42 ur.
Nevertheless, pharmacodynamic effects were similar and independent from gender and injection site.
Kljub temu pa so bili farmakodinamični učinki podobni in neodvisni od spola in mesta injiciranja.
If there are particles in it or if it is cloudy, you must not use it.
Če so v njej delci ali je motna, je ne smete uporabiti.
Do not use this medicine if you notice that it is cloudy or there are particles in it.
Ne uporabljajte tega zdravila, če opazite, da je motno ali da so v njem delci.
Do not warm Lonquex in any other way (for example, do not warm it in a microwave or in hot water).
Zdravila Lonquex ne smete ogrevati na kak drug način (ne ogrevajte ga na primer v mikrovalovni pečici ali v vroči vodi).
If a patient fails to respond to treatment, the patient should undergo further evaluation.
Če se bolnik na zdravljenje ne odzove, ga je treba dodatno oceniti.
Some cases of splenic rupture were fatal.
Nekateri primeri raztrganja vranice so bili smrtni.
It is important to tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, as the doctor may decide that you should not use this medicine.
Pomembno je, da zdravniku poveste, ali ste noseči, menite, da ste noseči ali nameravate zanositi, saj se zdravnik lahko odloči, da zdravila ne smete uporabljati.
ITT = Intent-to-treat population (all randomised patients) SD = standard deviation d = days
ITT = populacija z namenom zdravljenja (Intent-to-treat) (vsi randomizirani bolniki) SD = standardna deviacija d = dni
Therefore, no adjustment of the dose is necessary for elderly patients.
Zato pri starejših bolnikih prilagoditev odmerka ni potrebna.
The average molecular mass is approximately 39 kDa of which the protein moiety constitutes approximately 48 %.
Povprečna molekulska masa je približno 39 kDa, od tega predstavlja beljakovinski del približno 48 %.
If white blood cells fall to a low level, there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Če pade število belih krvnih celic na nizko raven, jih morda v telesu ne bo dovolj za boj proti bakterijam in lahko boste izpostavljeni večjemu tveganju za okužbo.
If you have a fever or any of these symptoms, it is important to contact your doctor immediately.
Če imate zvišano telesno temperaturo ali katerega od teh simptomov, je pomembno, da se takoj posvetujete z zdravnikom.
● Risk Management Plan (RMP)
ZDRAVILA • Načrt za obvladovanje tveganj (RMP)
Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavju 5.2, vendar priporočil o odmerjanju ni mogoče dati.
These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease.
Te celice so zelo občutljive na učinke kemoterapije, ki lahko povzroči zmanjšanje števila teh celic v telesu.
White blood cells are important as they help your body fight infection.
Bele krvne celice so pomembne, saj telesu pomagajo v boju proti okužbam.
Median ANC (x 109 cells/l)
Mediana vrednost ANC (x 109 celic/l)
Tell your doctor if you experience these symptoms.
Povejte zdravniku, če se pri vas pojavijo ti simptomi.
Most biological medicinal products elicit some level of anti-drug antibody response.
Večina bioloških zdravil izzove določeno stopnjo protitelesnega odziva na zdravilo.
This may result in lowered pharmacodynamic responses in heavy patients (> 95 kg).
To lahko povzroči manjše farmakodinamične odzive pri debelih bolnikih (> 95 kg).
Your doctor may suggest that you learn how to inject yourself with this medicine.
Vaš zdravnik vam lahko predlaga, da se naučite, kako si zdravilo injicirate sami.
Your doctor or nurse will give you instructions on how to do this.
Vaš zdravnik ali medicinska sestra vas bosta o tem poučila.
● 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.
• 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).
Allergic reactions and immunogenicity
Alergijske reakcije in imunogenost
Take the medicine out of the refrigerator.
Zdravilo vzemite iz hladilnika.
How are the injections given?
Kako se dajejo injekcije?
If you have missed an injection, contact your doctor to discuss when you should inject the next dose.
Če ste izpustili injekcijo, se posvetujte z zdravnikom, kdaj naj si injicirate naslednji odmerek.
It is unknown whether the active substance in this medicine passes into the breast milk.
Ni znano, ali učinkovina tega zdravila prehaja v materino mleko.
Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
If you think you are having this type of reaction, you must stop your Lonquex injection and get medical help immediately.
Če menite, da imate to vrsto reakcije, morate prenehati z injiciranjem zdravila Lonquex in takoj poiskati zdravniško pomoč.
In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file.
Za izboljšanje sledljivosti bioloških zdravil je treba tržno ime in številko serije uporabljenega zdravila jasno zabeležiti v bolniško kartoteko.
See leaflet for further information.
Za več informacij glejte navodilo.
Self-administration of Lonquex should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Samoinjiciranje zdravila Lonquex lahko izvajajo le bolniki, ki so dobro motivirani, ustrezno usposobljeni in imajo dostop do nasveta strokovnjaka.
• if you are allergic to lipegfilgrastim or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na lipegfilgrastim ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Only use each syringe for one injection.
Vsako injekcijsko brizgo uporabite samo za eno injiciranje.
Do not remove the needle cover from the syringe until you are ready to inject.
Ne snemajte pokrovčka igle z injekcijske brizge, dokler niste pripravljeni na injiciranje.
Tell your doctor if you experience severe musculoskeletal pain.
Obvestite zdravnika, če se pri vas pojavi huda mišično-skeletna bolečina.
Pull straight as shown in pictures 2 and 3.
Potegnite ga naravnost, kot prikazujeta sliki 2 in 3.
Haematopoietic system
Hematopoetski sistem
If a serious allergic reaction occurs, appropriate therapy with close patient follow-up over several days should be administered.
Če se pojavi resna alergijska reakcija, je treba uvesti ustrezno zdravljenje in bolnika nekaj dni natančno spremljati.
The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Možnosti medsebojnega delovanja z litijem, ki prav tako spodbuja sproščanje nevtrofilcev, niso posebej preučili.
Consequent decrease in efficacy in these patients cannot be excluded on current data.
Na podlagi trenutnih podatkov ni mogoče izključiti posledične zmanjšane učinkovitosti pri teh bolnikih.
The use of three different chemotherapy regimens, with varying myelosuppressive effects and age distributions, complicated the comparison of efficacy across age groups (see section 4.2).
Zaradi uporabe treh različnih shem kemoterapije z različnimi mielosupresivnimi učinki in starostnimi porazdelitvami je bila primerjava učinkovitosti v starostnih skupinah zapletena (glejte poglavje 4.2).
This is known as a subcutaneous injection.
Temu se reče subkutana injekcija.
G-CSF also increases the antibacterial activities of neutrophils including the phagocytosis.
G-CSF poveča tudi protibakterijsko aktivnost nevtrofilcev, vključno s fagocitozo.
Pull straight as shown in pictures 1 and 2.
Potegnite ga naravnost, kot prikazujeta sliki 1 in 2.
The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Jakosti tega zdravila se ne sme primerjati z jakostjo drugih pegiliranih ali nepegiliranih beljakovin istega terapevtskega razreda.
It must be a clear and colourless liquid.
Tekočina mora biti bistra in brezbarvna.
Do not shake Lonquex vigorously as this may affect its activity.
Zdravila Lonquex ne stresajte močno, saj lahko to vpliva na njegovo aktivnost.
In clinical studies with a limited number of elderly patients, there was no relevant age-related difference with regard to the efficacy or safety profiles of lipegfilgrastim.
V kliničnih študijah z omejenim številom starejših bolnikov ni bilo pomembnih razlik zaradi starosti, povezanih s profili učinkovitosti ali varnosti lipegfilgrastima.
Do not use it if the date has passed the last day of the month shown.
Ne uporabite zdravila, če je zadnji dan navedenega meseca že potekel.
It belongs to a group of proteins called cytokines and is similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body.
Spada v skupino beljakovin, imenovanih citokini, in je zelo podobna naravni beljakovini (granulocitne kolonije stimulirajoči faktor [G-CSF]), ki jo izdeluje vaše lastno telo.
Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk.
Za bolnike z nedavno anamnezo pljučnih infiltratov ali pljučnice je lahko tveganje večje.
Then release the plunger.
Nato bat izpustite.
What you should do before your injection
Kaj morate narediti pred injiciranjem
Lipegfilgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood cells.
Lipegfilgrastim spodbuja kostni mozeg (tkivo, kjer nastajajo nove krvne celice) k tvorbi več belih krvnih celic.
*See section “Description of selected adverse reactions” below Description of selected adverse reactions
*glejte spodnje poglavje "Opis izbranih neželenih učinkov"
The concentration is 20.9 mg/ml (i.e. 12.6 mg per pre-filled syringe) if the PEG moiety and the carbohydrate linker are included.
Koncentracija je 20,9 mg/ml (tj. 12,6 mg na napolnjeno injekcijsko brizgo), če sta vključena tudi PEG in vezni ogljikov hidrat.
The solution should be visually inspected before use.
Raztopino morate pred uporabo vizualno pregledati.
Drug-specific antibodies emerging after start of treatment were detected in 0.86 % of the subjects receiving lipegfilgrastim, in 1.06 % of the subjects receiving pegfilgrastim and in 1.65 % of the subjects receiving placebo.
Protitelesa, specifična za zdravilo, ki so se pojavljala po začetku zdravljenja, so zaznali pri 0,86 % oseb, ki so prejemale lipegfilgrastim, pri 1,06 % oseb, ki so prejemale pegfilgrastim, in pri 1,65 % oseb, ki so prejemale placebo.
These results suggest that the G-CSF moiety of lipegfilgrastim confers the expected activity of this growth factor: stimulation of proliferation of haematopoietic progenitor cells, differentiation into mature cells and release into the peripheral blood.
Ti rezultati kažejo, da G-CSF del lipegfilgrastima daje pričakovano aktivnost tega rastnega faktorja: stimulacija proliferacije krvotvornih predniških celic, diferenciacija v zrele celice in sproščanje v periferno kri.
Blood and lymphatic system disorders - Splenic rupture including some fatal cases (see section 4.4) - Sickle cell crisis in patients with sickle cell anaemia (see section 4.4)
Bolezni krvi in limfatičnega sistema - ruptura vranice, vključno z nekaj smrtnimi primeri (glejte poglavje 4.4) - srpastocelična kriza pri bolnikih s srpastocelično anemijo (glejte poglavje 4.4)
Musculoskeletal pain is generally of mild to moderate severity, transient and can be controlled in most patients with standard analgesics.
Mišično-skeletna bolečina je običajno blaga do zmerna, prehodna in jo je mogoče pri večini bolnikov obvladati s standardnimi analgetiki.
• Do not put the cover back on used needles.
- Ne nameščajte pokrovčka nazaj na uporabljene igle.
These could be symptoms of a condition reported with frequency not known (cannot be estimated from the available data), called “capillary leak syndrome”, which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.
To so lahko simptomi stanja, o katerem so poročali z neznano pogostnostjo (ni mogoče oceniti iz razpoložljivih podatkov), imenovanega "sindrom kapilarne prepustnosti", ki povzroči puščanje krvi iz drobnih krvnih žilic v telesu in zahteva nujno zdravniško pomoč.
Table 3: DSN, SN and FN in cycle 1 of study XM22-04 (ITT) Placebo (n = 125)
Preglednica 3: THN, SN in FN v 1. ciklu študije XM22-04 (ITT) Placebo (n = 125)
These can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly-growing cells).
Povzroči ju lahko citotoksična kemoterapija (zdravila, ki uničijo hitrorastoče celice).
The experience in children is limited to a single-dose phase 1 study in 21 paediatric patients aged 2 to <18 years (see section 5.1), which did not indicate a difference in the safety profile of lipegfilgrastim in children compared to that in adults.
Izkušnje pri otrocih so omejene na študijo faze 1 z enim odmerkom pri 21 pediatričnih bolnikih, starih 2 do < 18 let (glejte poglavje 5.1), v kateri se niso pokazale razlike v varnostnem profilu lipegfilgrastima pri otrocih v primerjavi z odraslimi.
Study days, injection of lipegfilgrastim at day 0
Dnevi študije, injiciranje lipegfilgrastima na 0. dan
You should therefore interrupt breast-feeding during treatment..
Zato morate med zdravljenjem dojenje prekiniti.
Do not touch the needle or push the plunger.
Ne dotikajte se igle in ne pritiskajte na bat.
• It is important to contact your doctor immediately if you have any of the following symptoms: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
- Pomembno je, da se takoj posvetujete z zdravnikom, če imate katerega koli od naslednjih simptomov: oteklost ali zabuhlost, ki jo lahko spremlja manj pogosto odvajanje urina, težko dihanje, oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
• if you have sickle cell anaemia, which is an inherited disease characterised by sickle-shaped red blood cells.
- če imate srpastocelično anemijo, ki je dedna bolezen, za katero je značilna srpasta oblika rdečih krvnih celic.
When the main study was finalised, the incidence of death was 7.2 % (placebo) and 12.5 % (6 mg lipegfilgrastim) although after the 360-day follow-up period the overall incidence of death was similar between placebo and lipegfilgrastim (44.8 % and 44.0 %; safety population).
Ob zaključku glavne študije je bila incidenca smrti 7,2 % (placebo) oz. 12,5 % (6 mg lipegfilgrastim), čeprav je bila po 360dnevnem obdobju spremljanja splošna incidenca smrti med placebom in lipegfilgrastimom podobna (44,8 % oz. 44,0 %; populacijska študija varnosti).
This section contains information on how to give yourself an injection of Lonquex under the skin.
To poglavje vsebuje podatke o tem, kako si sami injicirate zdravilo Lonquex pod kožo.
The adverse reactions listed below in table 1 are classified according to system organ class.
Neželeni učinki so opredeljeni spodaj v preglednici 1 glede na organske sisteme.
The safety and efficacy of Lonquex in children and adolescents aged up to 17 years have not yet been established.
Pediatrična populacija Varnost in učinkovitost zdravila Lonquex pri otrocih in mladostnikih, starih do 17 let, še nista bili dokazani.
Pull slightly on the plunger to check that a blood vessel has not been punctured.
Nekoliko izvlecite bat, da se prepričate, da niste prebodli krvne žile.
Animal studies with G-CSF and derivatives do not indicate harmful effects with respect to fertility (see section 5.3).
Študije na živalih z G-CSF in derivati ne kažejo škodljivih učinkov na plodnost (glejte poglavje 5.3).
There could be a risk of reacting to Lonquex too.
Morda obstaja tveganje, da boste imeli tudi reakcijo na zdravilo Lonquex.
• Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
- vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.
Spleen size should therefore be carefully monitored (e.g. clinical examination, ultrasound).
Zaradi tega moramo velikost vranice skrbno spremljati (npr. s kliničnim pregledom, ultrazvokom).
Lipegfilgrastim binds to human the G-CSF receptor like filgrastim and pegfilgrastim.
Lipegfilgrastim se veže na receptorje humanega G-CSF, kot sta filgrastim in pegfilgrastim.
The most frequent undesirable effects are musculoskeletal pain and nausea.
Najpogostejša neželena učinka sta mišično-skeletna bolečina in navzea.
In vitro data indicate that lipegfilgrastim is has little or no direct or immune system-mediated effects on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5 activity.
Medsebojno delovanje z zdravili Podatki in vitro kažejo, da lipegfilgrastim neposredno ali preko imunskega sistema le malo ali sploh ne učinkuje na aktivnost encimov CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in CYP3A4/5.
Lipegfilgrastim is a long-acting modified protein produced by biotechnology in bacteria called Escherichia coli.
Lipegfilgrastim je dolgodelujoča modificirana beljakovina, ki jo izdelujejo biotehnološko v bakteriji, imenovani Escherichia coli.
After injecting the liquid, remove the needle and let go of your skin.
Po injiciranju tekočine odstranite iglo in spustite kožo.
Lonquex has no or negligible influence on the ability to drive and use machines.
Zdravilo Lonquex nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Before you give yourself a Lonquex injection, you must do the following:
Preden si daste injekcijo z zdravilom Lonquex, naredite naslednje:
Patients who are hypersensitive to G-CSF or derivatives are also at risk of hypersensitivity reactions to lipegfilgrastim due to possible cross-reactivity.
Pri bolnikih, preobčutljivih na G-CSF ali derivate, obstaja tudi tveganje za preobčutljivostne reakcije na lipegfilgrastim zaradi možne navzkrižne reaktivnosti.
• Musculoskeletal pains such as bone pain and pain in the joints, muscles, limbs, chest, neck or back.
• mišično-skeletna bolečina, kot so bolečina v kosteh in sklepih, mišicah, okončinah, prsnem košu, vratu ali hrbtu.
Elevations in alkaline phosphatase and lactate dehydrogenase most likely originate from the increase in neutrophils.
Zvišanje alkalne fosfataze in laktat dehidrogenaze najverjetneje izvira iz zvišanja števila nevtrofilcev.
The maximum blood concentrations were reached after a median time (tmax) of 23.9 hours, 30.0 hours and 95.8 hours, respectively.
Največje koncentracije v krvi so bile dosežene po medianem času (tmax) 23,9 ur, 30,0 ur oz. 95,8 ur.
Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology.
Zdravljenje z zdravilom Lonquex smejo uvesti in nadzirati samo zdravniki z izkušnjami v onkologiji ali hematologiji.
Therefore, lipegfilgrastim is not likely to affect metabolism via human cytochrome P450 enzymes.
Zato ni verjetno, da bi lipegfilgrastim vplival na presnovo prek humanih encimov citokroma P450.