natgillin/translations-raw huggingface dataset:
Uncommon side effects These may affect up to 1 in 100 people:
Ti se lahko pojavijo pri največ 1 od 100 bolnikov:
Don't take Tivicay:
Ne jemljite zdravila Tivicay z naslednjimi zdravili:
MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/003
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/892/003
• insomnia
• tesnoba
Uncommon Suicidal ideation*, suicide attempt*
Psihiatrične motnje pogosti nespečnost pogosti nenormalne sanje pogosti depresija pogosti anksioznost občasni samomorilne misli*, poskus samomora*
In paediatric patients the weight-based once daily dose should
Pri pediatričnih bolnikih je treba na podlagi telesne mase določeni dnevni odmerek podvojiti,
A single dose of 50 mg of dolutegravir was administered to 8 subjects with moderate hepatic impairment (Child-Pugh class B) and to 8 matched healthy adult controls.
Pugh B) in 8 usklajenih zdravih odraslih primerjalnih oseb, je prejelo enkratni odmerek 50 mg dolutegravirja.
In the presence of integrase class resistance, Tivicay should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations) (see section 5.2).
(zlasti pri bolnikih z mutacijami Q148) (glejte poglavje 5.2).
NAME OF THE MEDICINAL PRODUCT Tivicay 25 mg film-coated tablets dolutegravir
Tivicay 25 mg filmsko obložene tablete dolutegravir
Marketing Authorisation Holder ViiV Healthcare BV Huis ter Heideweg 62
Imetnik dovoljenja za promet z zdravilom ViiV Healthcare BV
Efavirenz ↔ (historical controls) (induction of UGT1A1 and CYP3A enzymes)
etravirin ↔ (indukcija encimov UGT1A1 in CYP3A)
Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (induction of UGT1A1 and CYP3A enzymes)
Učinkovine za zdravljenje infekcij z mikobakterijami rifampicin dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓ 72% (indukcija encimov UGT1A1 in CYP3A)
Other agents Antiarrhythmics Dofetilide
Druga zdravila in zdravilo Tivicay
NAME OF THE MEDICINAL PRODUCT Tivicay 50 mg film-coated tablets dolutegravir
Tivicay 50 mg filmsko obložene tablete dolutegravir
NAME OF THE MEDICINAL PRODUCT Tivicay 10 mg film-coated tablets dolutegravir
Tivicay 10 mg filmsko obložene tablete dolutegravir
Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions)
Multivitaminski pripravki dolutegravir↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32%
Therefore, Tivicay is recommended to be taken with food by patients infected with HIV with integrase class resistance (see section 4.2).
Zaradi tega se pri bolnikih z okužbo HIV in odpornostjo na zdravila iz skupine zaviralcev integraze priporoča jemanje zdravila Tivicay skupaj s hrano
Do not swallow the desiccant.
Pazite, da ne pogoltnete sušilnega sredstva.
• if they have been taking combination therapy for a long time
Verjetnost za pojav te bolezni je večja pri posameznikih: • ki jemljejo kombinirano terapijo dalj časa,
AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Antikonvulzivi karbamazepin dolutegravir ↓ AUC ↓ 49 % Cmax ↓ 33 % Cτ ↓ 73 %
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 25 mg film-coated tablets
PODATKI NA PRIMARNI OVOJNINI NALEPKA NA VSEBNIKU 25 mg filmsko obložene tablete
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers.
Priporočeni odmerek dolutegravirja za odrasle med sočasno uporabo s temi induktorji presnove je 50 mg dvakrat na dan.
• being sick (vomiting)
• slabost s siljenjem na bruhanje (navzea)
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with etravirine without boosted protease inhibitors.
Priporočeni odmerek dolutegravirja za odrasle med sočasno uporabo z etravirinom (brez okrepljenih zaviralcev proteaz) je 50 mg dvakrat na dan.
NAME OF THE MEDICINAL PRODUCT Tivicay 10 mg film-coated tablets
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 10 mg filmsko obložene tablete
HIV-1 RNA <50 copies/mL by baseline covariates
HIV-1 RNA < 50 kopij/ml po izhodiščnih sospremenljivkah Izhodiščno virusno breme
Uncommon Hepatitis Rare
Redki neželeni učinki
- Keep this leaflet.
(glejte Preglednico 2).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50mg film-coated tablets
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 50 mg filmsko obložene tablete
Integrase class resistance of particular concern
Protivirusno delovanje v kombinaciji z drugimi protivirusnimi sredstvi
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 25mg film-coated tablets
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 25 mg filmsko obložene tablete
blister (PVC/PVDC/alu) 50 x 1 tablets (unit dose)
Filmsko obložena tableta
In the meantime, the applicant withdrew the application in the Netherlands.
V tem času je predlagatelj umaknil svojo vlogo na Nizozemskem.
Whereas
Ob upoštevanju naslednjega
The decentralised procedure PT/H/1256/001/DC started on 04 June 2014.
Decentralizirani postopek PT/H/1256/001/DC se je začel 4. junija 2014.
The application was submitted to the reference Member State (RMS): Portugal and the concerned Member States (CMS): Germany, Netherlands and United Kingdom.
Vloga je bila predložena v referenčni državi članici: na Portugalskem in v zadevnih državah članicah: Nemčiji, na Nizozemskem in v Združenem kraljestvu.
• The Committee considered the referral under Article 29(4) of Directive 2001/83/EC.
• odbor je obravnaval napotitev v skladu s členom 29(4) Direktive 2001/83/ES;
• The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as potential serious risk to public health.
• odbor je proučil podatke, ki jih je predložil predlagatelj v odziv na zadržke glede morebitnih resnih tveganj za javno zdravje;
The reference medicinal product (Taxol) has a complex formulation for which it is known that the micellar formulation affects the pharmacokinetic profile of paclitaxel after intravenous administration.
Referenčno zdravilo (Taxol) ima kompleksno formulacijo, v zvezi s katero je znano, da micelarna formulacija vpliva na farmakokinetični profil paklitaksela po intravenski uporabi.
Day 60 of the CMDh procedure was on 29 March 2018 and as no agreement could be reached the procedure was referred to the CHMP.
60. dan postopka CMDh je nastopil 29. marca 2018 in ker ni bilo doseženo soglasje, je bila zadeva napotena na odbor CHMP.
On 29 March 2018 Portugal therefore triggered a referral under Article 29(4) of Directive 2001/83/EC.
Tako je Portugalska 29. marca 2018 sprožila napotitev v skladu s členom 29(4) Direktive 2001/83/ES.
The CMDh 60 day procedure was initiated on 29 January 2018.
60-dnevni rok za izvedbo postopka skupine CMDh je začel teči 29. januarja 2018.
On day 210, major issues on bioequivalence, raised by the Netherlands, remained unresolved; hence the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), under Article 29, paragraph 1 of Directive 2001/83/EC, by Portugal on 02 November 2017.
Na 210. dan postopka so bistveni zadržki v zvezi z bioekvivalenco, ki jih je izpostavila Nizozemska, ostali nerazrešeni, zato je Portugalska 2. novembra 2017 zadevo napotila na skupino za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila v humani medicini (CMDh) v skladu s členom 29(1) Direktive 2001/83/ES.
The applicant submitted a study report with results of the direct comparison of micelles' characteristics of Paclitaxel Hetero and Taxol and another publication containing data on the free drug fraction of Taxol in human plasma.
Predlagatelj je predložil poročilo o študiji z rezultati neposredne primerjave značilnosti micelov v zdravilu Paclitaxel Hetero in zdravilu Taxol ter druge publikacije s podatki o prosti frakciji zdravila Taxol v človeški plazmi.
The CHMP considered that it is essential in order to waive the bioequivalence study requirement to establish that the generic medicinal product and the reference medicinal product have the same behaviour in plasma and ultimately in vivo, i.e. a direct comparison of the free fraction between the two medicinal products should be considered in line with the “Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems” (EMA/CHMP/QWP/799402/2011
Odbor CHMP je menil, da je za opustitev izvedbe študij bioekvivalence treba ugotoviti, ali se generično in referenčno zdravilo obnašata enako v plazmi in nazadnje tudi in vivo, tj. neposredno primerjati prosto frakcijo obeh zdravil v skladu z “Razpravo o farmacevtskem razvoju zdravil za intravensko uporabo, ki vsebujejo učinkovino, topno v micelarnih sistemih” (EMA/CHMP/QWP/799402/2011)
In such case, in principle a biowaiver of in vivo bioequivalence study is only possible when there are adequate in vitro data to demonstrate similarity between generic and reference medicinal product.
V takšnem primeru je opustitev izvedbe študij bioekvivalence in vivo načeloma možna le, če so na voljo ustrezni podatki in vitro, ki izkazujejo podobnost med generičnim in referenčnim zdravilom.
An application was submitted under the decentralised procedure for Paclitaxel Hetero, 6 mg/mL, concentrate for solution for infusion on 15 May 2014.
Dne 15. maja 2014 je bila v okviru decentraliziranega postopka predložena vloga za pridobitev dovoljenja za promet z zdravilom Paclitaxel Hetero, 6 mg/ml, koncentrat za raztopino za infundiranje.
However, the additional data provided were not robust enough to establish equivalence between Paclitaxel Hetero and the EU reference medicinal product.
Toda dodatni predloženi podatki niso bili dovolj trdni, da bi lahko potrdili ekvivalentnost med zdravilom Paclitaxel Hetero in referenčnim zdravilom EU.
While there may be occasions where an indirect comparison may be acceptable to support a biowaiver, having assessed the literature provided, the CHMP concluded that the data was not sufficiently robust nor convincing enough to replace the need for a head-to-head comparison using identical methods and performed at the same time for test and reference product, and therefore should be understood as supportive only.
Medtem ko obstajajo določeni primeri, kadar se lahko posredna primerjava uporabi v podporo opustitvi izvedbe študij bioekvivalence, je odbor CHMP na podlagi proučitve predložene literature zaključil, da vsebovani podatki niso niti dovolj trdni niti dovolj prepričljivi, da bi lahko nadomestili potrebo po neposredni primerjavi ob uporabi identičnih metod, izvedenih sočasno za testno in referenčno zdravilo, zato jih je treba razumeti le kot podporne podatke.
Therefore, the Committee recommends the refusal of the marketing authorisation of Paclitaxel Hetero in the reference and concerned Member States.
Odbor tako priporoča zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Paclitaxel Hetero v referenčni državi članici in zadevnih državah članicah.
The Netherlands raised objections on the fact that the indirect comparison data on which the applicant based its claim for equivalence was not considered robust nor was convincing enough to support a biowaiver, and this was regarded to be a potential serious risk to public health.
Nizozemska je izrazila zadržek zaradi tega, ker posredna primerjava podatkov, na kateri je predlagatelj zasnoval svojo zahtevo za priznanje bioekvivalence, ni dovolj trdna in prepričljiva, da bi lahko ustrezno podprla opustitev izvedbe študij bioekvivalence, kar pomeni morebitno resno tveganje za javno zdravje.
The CHMP considered, as a consequence, that the benefit-risk balance of Paclitaxel Hetero is not favourable.
Zato je odbor CHMP menil, da razmerje med koristmi in tveganji zdravila Paclitaxel Hetero ni ugodno.
• The Committee considered that the data available was insufficient to establish equivalence between Paclitaxel Hetero and the EU reference medicinal product.
• odbor je menil, da razpoložljivi podatki niso bili zadostni za potrditev ekvivalentnosti med zdravilom Paclitaxel Hetero in referenčnim zdravilom EU; je odbor presodil, da razmerje med koristmi in tveganji zdravila Paclitaxel Hetero ni ugodno.
This may be repeated up to six times.
To bo morda treba ponoviti do šestkrat.
Duration of PV (months)*
Trajanje PV (meseci)*
• Wash your hands before you begin.
• Preden začnete, si umijte roke.
Do not apply further force.
Ne poskušajte z uporabo dodatne sile.
These elevations were mostly transient and occurred during the first treatment year.
Ta zvišanja so bila predvsem prehodna in so se pojavila med prvim letom zdravljenja.
Do not point towards your face or anyone else's face.
Peresnika ne usmerjajte v smer svojega obraza ali obraza katere koli druge osebe.
Patients recovered from the two events, one event was ongoing at the time of assessment.
Bolniki so po dveh dogodkih okrevali, en dogodek pa je v času ocene še potekal.
very rare blindness#
zelo redki slepota#
Do not use the pen if it appears damaged.
Ne uporabljajte peresnika, če je videti poškodovan.
If you are injecting this medicine yourself, you will get clear instructions on how to prepare and inject it.
Če si zdravilo injicirate sami, boste prejeli jasna navodila, kako ga pripraviti in injicirati.
Opened date:
Datum odprtja:
Thus, no valid estimation of the absolute bioavailability could be done.
Zato ni mogoče podati veljavne ocene absolutne biološke uporabnosti.
Empty pens must never be reused and must be properly discarded.
Praznih peresnikov se nikoli ne sme ponovno uporabiti in jih je treba pravilno zavreči.
Your doctor will tell you the dose you need.
Zdravnik vam bo povedal, kakšen odmerek potrebujete.
After 36 months of treatment, the complete haematological response was 70.5%.
Po 36 mesecih zdravljenja je bil popoln hematološki odziv 70,5 %.
- if you have severe kidney disease (with your kidneys working at less than 15% of their normal ability).
- če imate hudo bolezen ledvic (vaše ledvice delajo z manj kot 15 % normalne zmožnosti).
Your doctor will usually check your vision before starting your treatment.
Zdravnik bo pred začetkom zdravljenja običajno preveril vaš vid.
It will need a certain time to reach your individual optimal dose of Besremi.
Potrebno bo nekaj časa, da bo dosežen vaš individualni optimalni odmerek zdravila Besremi.
Characteristics of the study population are presented in Table 2.
Značilnosti populacije v študiji so predstavljene v Preglednici 2.
Presence of splenomegaly
Prisotnost splenomegalije
Effects on fertility was not assessed.
Učinkov na plodnost niso vrednotili.
The clicking sounds will stop when the injection is complete.
Klikajoči zvoki bodo prenehali, ko bo injiciranje končano.
A higher than proportional increase in exposure was observed.
Opazili so izpostavljenost, ki je bila več kot sorazmerna.
Needles must be discarded immediately after use.
Igle je treba zavreči takoj po uporabi.
During the titration phase the efficacy to reduce the cardiovascular and thromboembolic risk of the underlying disease may not be fully established.
Med fazo titracije učinkovitost za zmanjšanje srčno-žilnega in trombemboličnega tveganja obstoječe bolezni morda ni v celoti vzpostavljena.
Instead, get a new pen.
Namesto tega si priskrbite nov peresnik.
• Note: The blue protective sleeve locks automatically and the now visible red locking indicator covers the needle for your protection.
• Opomba: moder zaščitni tulec se avtomatsko zaskoči in sedaj vidni rdeči indikator zaklepa prekrije iglo za vašo zaščito.
After that, the dose may be adapted and/or the administration interval prolonged up to every four weeks, as appropriate for the patient.
Nato se odmerek lahko prilagodi in/ali interval odmerjanja podaljša do odmerjanja na vsake štiri tedne, kot je za bolnika primerno.
Your doctor will decide if it is necessary to treat you with another medicine for an early reduction of your blood cell number to prevent blood clots and bleeding.
Zdravnik bo odločil, če vas je treba zdraviti z drugim zdravilom za zgodnje zmanjšanje števila krvnih celic za preprečevanje krvnih strdkov in krvavitev.
Almost 50% of patients showed a complete haematological response with an improvement in disease burden after 36 months of treatment.
Pri skoraj 50 % bolnikov je prišlo do popolnega hematološkega odziva z izboljšanjem bremena bolezni po 36 mesecih zdravljenja.
Influenza like illness
Gripi podobna bolezen
You should inject the dose as soon as you remember.
Odmerek si injicirajte takoj, ko se spomnite.
• Before you begin, check that the product has not expired.
• Preden začnete, preverite, da ni potekel rok uporabnosti zdravila.
Control treatment arm (n=127)
Kontrolna skupina zdravljenja (n = 127)
Haematocrit (%)* Platelets (109/L)* Leukocytes (109/L)*
Haematokrit (%)* Trombociti (109/l)* Levkociti (109/l)*
Do not give this medicine to children and adolescents because no information is available on the use of Besremi in this age group.
Tega zdravila ne dajajte otrokom in mladostnikom, saj podatkov o uporabi zdravila Besremi pri tej starostni skupini ni na voljo.
• Your doctor will tell you if you may use the pen for a second injection.
• Zdravnik vam bo povedal, če lahko peresnik uporabite za drugo injiciranje.
• Pre-existing thyroid disease unless it can be controlled with conventional treatment
• obstoječa bolezen ščitnice, razen če jo je mogoče nadzorovati s konvencionalnim zdravljenjem,
If your vision worsens, your doctor may decide to discontinue your treatment.
Če se vaš vid poslabša, se zdravnik lahko odloči za prekinitev zdravljenja.
• You have to inject the medicine subcutaneously (under the skin).
• Zdravilo si morate injicirati subkutano (pod kožo).
Vogt-Koyanagi-Harada disease#, acute hypersensitivity reactions#**
Vogt-Koyanagi-Haradova bolezen#, akutne preobčutljivostne reakcije#**
What Besremi is and what it is used for 2.
Kaj je zdravilo Besremi in za kaj ga uporabljamo 2.
The dose at which stabilisation of the haematological parameters is achieved should be maintained in a two week administration interval for at least 1.5 years.
Odmerek, pri katerem pride do stabilizacije hematoloških parametrov, je treba vzdrževati z intervalom odmerjanja na vsaka dva tedna za obdobje najmanj 1,5 leta.
Your doctor will then increase your dose stepwise and may adjust your dose during treatment.
Zdravnik bo odmerek nato postopoma zvečeval in lahko med zdravljenjem vaš odmerek prilagodi.
Remove the pen from the refrigerator 15 minutes before the injection to let it reach room temperature.
Peresnik vzemite iz hladilnika 15 minut pred injiciranjem in ga pustite, da doseže sobno temperaturo.
This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
To storite zato, ker se lahko velike količine benzilalkohola nakopičijo v vašem telesu in povzročijo neželene učinke (imenovane »presnovna acidoza«).
The average molecular mass is approximately 60 kDa, of which the PEG moiety constitutes approximately 40 kDa .
Povprečna molekulska masa je približno 60 kDa, od tega predstavlja del PEG približno 40 kDa.
• Combination with telbivudine (see section 4.5)
• kombinacija s telbivudinom (glejte poglavje 4.5),
Your doctor will help you decide if you have to stop breast-feeding when you are using this medicine.
Zdravnik se vam bo pomagal odločiti, ali morate med uporabo tega zdravila prenehati z dojenjem.
• Take a new needle and remove the protective foil.
• Vzemite novo iglo in odstranite zaščitno folijo.
Endocrine system
Endokrini sistem
What you need to know before you use Besremi 3.
Kaj morate vedeti, preden boste uporabili zdravilo Besremi 3.
Adverse reactions are listed by system organ class and frequency (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) or not known (cannot be estimated from available data).
Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti: 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) oziroma neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Nuclear translocation of STAT proteins controls distinct gene-expression programs and exhibit various cellular effects.
STAT v jedru nadzira ekspresijo določenih programov izražanja genov in zavira različne celične učinke.
The potency of this medicinal product should not be compared to that of another pegylated or nonpegylated protein of the same therapeutic class (see section 5.1).
Jakosti tega zdravila se ne sme primerjati z jakostjo drugih pegiliranih ali nepegiliranih beljakovin iz istega terapevtskega razreda (glejte poglavje 5.1).
Any medicine remaining in the pre-filled pen after the second use and/or after 30 days must be discarded.
Zdravilo, ki je preostalo v peresniku po drugi uporabi in/ali 30 dneh, je treba zavreči.
There is no antidote for the medicinal product available.
Za to zdravilo antidota ni na voljo.
Get a new pen and start afresh.
Priskrbite si nov peresnik in začnite znova.
You should brush your teeth thoroughly twice daily and have regular dental checks.
Zobe si morate temeljito umiti dvakrat na dan in hoditi na redne zobozdravstvene kontrolne preglede.
• Keep the injection site clean until the small injection wound has closed.
• Mesto injiciranja ohranite čisto, dokler se majhna injekcijska rana ne zapre.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1,
The patients recovered completely after permanent medicinal product discontinuation.
Bolniki so po trajni ukinitvi zdravljenja popolnoma okrevali.
Transient rashes do not necessitate interruption of treatment.
Zaradi prehodnih izpuščajev prekinitev zdravljenja ni potrebna.
Insert the needle at a 90 degrees angle until the blue protective sleeve on the needle is no longer visible.
Iglo vstavite pod kotom 90 stopinj, dokler moder zaščitni tulec ni več viden.
The pre-filled pen may be used up to two times within these 30 days.
Napolnjen injekcijski peresnik lahko znotraj teh 30 dni uporabite do dvakrat.
The patient received a 10-time higher starting dose as recommended and developed flu-like symptoms for three days which were rated as non-serious.
Bolnik je prejel 10-krat večji začetni odmerek od priporočenega in razvil gripi podobne simptome, ki so trajali tri dni in jih niso ocenili kot resne.
Serious adverse reactions are depression (1.1%), atrial fibrillation (1.1%) and acute stress disorder
Resni neželeni učinki so depresija (1,1 %), atrijska fibrilacija (1,1 %) in akutna stresna reakcija
In case of appearance or worsening of this skin disorders, the stop of the treatment must be envisaged.
V primeru pojava ali poslabšanja teh kožnih bolezni je treba zdravljenje predvidoma ustaviti.
However, if more than 2 days have passed since you missed the dose, leave out the dose and inject the next dose when it is due.
Če pa je od izpuščenega odmerka minilo več kot 2 dneva, odmerek izpustite in si injicirajte naslednjega, ko je čas zanj.
- if you had an organ transplantation and you take medicines which suppress your immune system.
- če so vam opravili presaditev organa in jemljete zdravila za zaviranje vašega imunskega sistema;
b defined as the improvement of disease-related signs (clinically significant splenomegaly) and disease-related symptoms (microvascular disturbances, pruritus, headache).
b Določeno kot izboljšanje z boleznijo povezanih znakov (klinično pomembna splenomegalija) in z boleznijo povezanih simptomov (mikrovaskularne motnje, pruritus, glavobol).
Events were reported at various time points typically several months after starting treatment with interferon alfa.
O tem so poročali v različnih časovnih točkah, običajno več mesecev po začetku zdravljenja z interferonom alfa.
This medicine is for subcutaneous use which means that it is injected in the tissue under your skin.
To zdravilo je za subkutano uporabo, kar pomeni, da se injicira v podkožno tkivo.
Please note down your injection dates and dose as instructed by your doctor.
Zabeležite si datume injiciranja in odmerek, kot vam bo naročil zdravnik.
• If you do not see a droplet at the needle tip, repeat steps 5 and 6 up to six times until a droplet emerges.
• Če na konici igle ni videti kaplje, ponovite koraka 5 in 6 do šestkrat, dokler se kaplja ne pokaže.