natgillin/translations-raw huggingface dataset:
• to undertake a visual examination of the feet prior to each application of Qutenza and at subsequent clinic visits to detect skin lesions related to underlying neuropathy and vascular insufficiency in patients with painful diabetic peripheral neuropathy
• pregledu stopal, ki ga je treba opraviti pri bolnikih z bolečo diabetično periferno nevropatijo pred zdravljenjem z zdravilom Qutenza in na poznejših pregledih, da bi ugotovili kožne spremembe, povezane z osnovno nevropatijo in žilno insuficienco
SACHET OF ONE PATCH
VREČKA Z ENIM OBLIŽEM
• to clinically assess patients for increased sensory loss prior to each application of Qutenza in all patients with pre-existing sensory deficits.
• klinični oceni bolnikov, ki že imajo senzorične izpade, glede znakov poslabšanja senzorične prizadetosti pred nadaljevanjem zdravljenja z zdravilom Qutenza
Dermal assessment
za dermalno uporabo
Disposable socks may be worn on top of the Qutenza patches if your feet are being treated.
Pri aplikaciji obližev Qutenza na stopalih si je mogoče prek obližev obuti nogavice za enkratno uporabo.
It is common for the skin to sting or become red and burn during Qutenza treatment.
Običajno se v koži med zdravljenjem z zdravilom Qutenza pojavi zbadajoč in pekoč občutek ali rdečina.
There is a diagonal cut in the release liner to aid in its removal.
Za lažje odstranjevanje je zaščitna podloga diagonalno prerezana.
A thorough history should be reviewed prior to initiating treatment and an alternative pain reduction strategy put in place prior to Qutenza treatment in patients with suspected high opioid tolerance.
Pri bolnikih, pri katerih obstaja sum na visoko toleranco na opioide, je treba pred pričetkom zdravljenja z zdravilom Qutenza pregledati celotno anamnezo in oblikovati alternativno strategijo za lajšanje bolečin.
Backing layer
dermalni obliž
The following information is intended for medical or healthcare professionals only: A complete Summary of Product Characteristics (SPC) is provided with this leaflet.
Naslednje informacije so namenjene samo zdravstvenemu osebju:
Nitrile gloves should be worn at all times while handling Qutenza and cleaning treatment areas.
Med rokovanjem z zdravilom Qutenza in čiščenjem zdravljenih predelov je treba ves čas nositi nitrilne rokavice.
Eye disorders Uncommon
Očesne bolezni Občasni draženje oči
Hypertension
Odmerjanje
itching, muscle spasms, shingles, swelling of limbs.
Občasni motnje okusa, hipestezija, pekoč občutek
Pain in extremity
Pogosti bolečine v okončini
Talk to your doctor before using Qutenza
Pred začetkom uporabe zdravila Qutenza se posvetujte z zdravnikom.
The European Commission granted a marketing authorisation valid throughout the European Union for Fycompa on 23 July 2012.
Evropska komisija je dovoljenje za promet z zdravilom Fycompa, veljavno po vsej Evropski uniji, izdala 23. julija 2012.
Secondary generalisation occurs when the excessive electrical activity subsequently reaches the whole brain.
Do sekundarne generalizacije pride, ko prekomerna električna dejavnost postopoma zajame celotne možgane.
This is a type of epilepsy where too much electrical activity in one part of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
To je vrsta epilepsije, pri kateri prevelika električna dejavnost v enem delu možganov povzroči simptome, kot so nenadni sunkoviti gibi enega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
The full EPAR for Fycompa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fycompa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is available as tablets (2, 4, 6, 8, 10 and 12 mg) and as an oral suspension (0.5 mg/ml, to be taken by mouth).
Na voljo je v obliki tablet (2, 4, 6, 8, 10 in 12 mg) in kot peroralna suspenzija (0,5 mg/ml za peroralno uporabo).
Fycompa oral suspension can be taken with or without food and should always be taken in the same way (i.e. always with food or always without food).
Peroralna suspenzija Fycompa se lahko jemlje s hrano ali brez nje in jo je treba vedno jemati enako (tj. vedno s hrano ali vedno brez nje).
Fycompa tablets can be taken with or without food and should not be chewed, crushed or split.
Tablete Fycompa se lahko jemljejo s hrano ali brez nje in se ne smejo žvečiti, zdrobiti ali prelomiti.
What measures are being taken to ensure the safe and effective use of Fycompa?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Fycompa?
Neurotransmitters are naturally-occurring chemicals in the nervous system that allow nerve cells to communicate with each other.
Živčni prenašalci so naravno prisotne kemične snovi v živčnem sistemu, ki omogočajo medsebojno komunikacijo živčnih celic.
All patients were also taking other antiepileptic medicines.
Vsi bolniki so prejemali tudi druga zdravila proti epilepsiji.
This is a summary of the European public assessment report (EPAR) for Fycompa.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fycompa.
Glutamate is the main stimulatory neurotransmitter in nerve cells which can trigger and maintain seizures.
Glutamat je glavni spodbujevalni živčni prenašalec v živčnih celicah, ki lahko sproži in vzdržuje napade.
For more information about treatment with Fycompa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Fycompa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fycompa have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Fycompa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fycompa.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Therefore, the CHMP decided that Fycompa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Fycompa večje od z njim povezanih tveganj in priporočil, da se zanj izda dovoljenje za promet.
Other information about Fycompa
Druge informacije o zdravilu Fycompa
Although the precise mechanism by which Fycompa works is not fully understood, it is thought to block the action of the neurotransmitter glutamate.
Čeprav natančen mehanizem delovanja zdravila Fycompa ni povsem znan, se meni, da zavira delovanje živčnega prenašalca glutamata.
For primary generalised tonic-clonic seizures Fycompa was shown to be effective in a study involving 164 patients with idiopathic generalised epilepsy.
Pri primarno generaliziranih tonično-kloničnih napadih se je zdravilo Fycompa izkazalo kot učinkovito v študiji, v kateri je sodelovalo 164 bolnikov z idiopatsko generalizirano epilepsijo.
The recommended dose at the start of treatment is 2 mg per day, and if it is well tolerated the doctor may progressively increase it by increments of 2 mg/day to a maximum dose of 12 mg per day.
Priporočeni odmerek ob začetku zdravljenja je 2 mg na dan, če ga pa bolnik dobro prenaša, lahko zdravnik odmerek postopoma povečuje za 2 mg na dan vse do največjega dovoljenega odmerka 12 mg na dan.
Fycompa at doses from 4 mg to 12 mg was shown to be more effective than placebo in reducing the frequency of epileptic seizures.
Izkazalo se je, da je zdravilo Fycompa v odmerkih od 4 mg do 12 mg učinkovitejše od placeba pri zmanjševanju pogostosti epileptičnih napadov.
Supportive evidence from patients treated for up to 2 years suggested that the benefit was maintained with longer treatment and that some patients could benefit from doses up to 12 mg.
Podporni dokazi iz evidenc bolnikov, ki so jih zdravili do dve leti, kažejo, da se je učinek zdravila pri daljšem zdravljenju ohranil in da so pri nekaterih bolnikih odmerki do 12 mg pokazali določene koristi.
The most common side effects with Fycompa (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Najpogostejša neželena učinka zdravila Fycompa (opažena pri več kot 1 bolniku od 10) sta omotica in zaspanost.
Fycompa is also used in patients from 12 years of age to treat primary generalised tonic-clonic seizures (major fits or convulsions, where the person becomes unconscious, falls down if standing, and jerks or shakes) associated with idiopathic generalised epilepsy (epilepsy with no apparent cause that is thought to have a genetic origin and that affects the whole brain).
Zdravilo Fycompa se prav tako uporablja pri bolnikih, starejših od 12 let, za zdravljenje primarno generaliziranih napadov s tonično-kloničnimi krči (hujših napadov ali konvulzij, pri katerih lahko pride do nezavesti, padca, če je oseba v stoječem položaju, ter krčev in tresavice), povezanih z idiopatsko generalizirano epilepsijo (epilepsijo brez znanega vzroka, za katero se šteje, da je genetskega izvora in prizadene celotne možgane).
The main measure of effectiveness was the percentage of patients who experienced at least a 50% decrease in seizure frequency.
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih je pogostost napadov upadla za vsaj 50 %.
What benefit has Fycompa shown during the studies?
Kakšne koristi je zdravilo Fycompa izkazalo v študijah?
The CHMP considered that Fycompa, taken together with other anti-epileptic medicines, showed a consistent reduction in the frequency of epileptic fits and that no serious toxicity has been identified.
CHMP je menil, da je bilo za zdravilo Fycompa, uporabljeno sočasno z drugimi zdravili proti epilepsiji, dokazano, da dosledno zmanjšuje pogostost epileptičnih napadov in ne povzroča resne toksičnosti.
Fycompa is used to treat adults and children from 12 years of age with partial-onset seizures (epileptic fits) with or without secondary generalisation.
Zdravilo Fycompa se uporablja za zdravljenje odraslih in otrok, starejših od 12 let, ki imajo napade parcialnega izvora (epileptične napade) s sekundarno generalizacijo ali brez nje.
For the full list of all side effects and restrictions with Fycompa, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Fycompa glejte navodilo za uporabo.
In these studies, Fycompa was given at a dose of 2, 4, 8 or 12 mg per day for up to 19 weeks.
V teh študijah so zdravilo Fycompa bolnikom dajali največ 19 tednov v odmerkih 2, 4, 8 ali 12 mg na dan.
In the management of partial onset seizures, Fycompa has been compared with placebo (a dummy treatment) in three main studies involving a total of 1,491 patients aged 12 years and older with partial-onset seizures who did not respond to other treatments.
Pri uravnavanju napadov parcialnega izvora so zdravilo Fycompa primerjali s placebom (zdravilom brez zdravilne učinkovine) v treh glavnih študijah, v katerih je skupno sodelovalo 1 491 bolnikov, starejših od 12 let, z napadi parcialnega izvora, ki se niso odzivali na druga zdravila.
The third study showed a significant decrease in seizure frequency only in patients taking 4 mg and 8 mg Fycompa but not in patients taking a dose of 2 mg.
Tretja študija je pokazala znatno zmanjšanje pogostosti napadov samo pri bolnikih, ki so jemali 4- in 8-miligramski odmerek zdravila Fycompa, ne pa pri bolnikih, ki so jemali 2-miligramski odmerek.
What is the risk associated with Fycompa?
Kakšna tveganja so povezana z uporabo zdravila Fycompa?
For patients with primary generalised tonic-clonic seizures Fycompa was also more effective than placebo: 47 of 81 patients (58%) given Fycompa had at least a 50% reduction in frequency of seizures, compared with 29 of 81 (36%) of those given the dummy treatment.
Pri bolnikih s primarno generaliziranimi tonično-kloničnimi napadi je bilo zdravilo Fycompa učinkovitejše od placeba: do najmanj 50-odstotnega zmanjšanja pogostosti napadov je prišlo pri 47 od 81 (58 %) bolnikov, ki so prejemali zdravilo Fycompa, medtem ko je pri bolnikih, ki so prejemali placebo, do takšnega zmanjšanja prišlo pri 29 od 81 (36 %) bolnikov.
Treatment was started at a dose of 2 mg of Fycompa and gradually increased over 4 weeks to a maximum of 8 mg if tolerated, then continued for a further 13 weeks.
Zdravljenje se je začelo z 2-miligramskim odmerkom zdravila Fycompa, ki so ga v obdobju štirih tednov povečali na največji dovoljeni odmerek 8 mg, če so bolniki zdravilo dobro prenašali, nato pa dajanje zdravila nadaljevali nadaljnjih 13 tednov.
Fycompa is taken by mouth once a day at bedtime.
Zdravilo Fycompa se jemlje peroralno enkrat dan pred spanjem.
Fycompa is a medicine that contains the active substance perampanel.
Fycompa je zdravilo, ki vsebuje zdravilno učinkovino perampanel.
Why has Fycompa been approved?
Zakaj je bilo zdravilo Fycompa odobreno?
The active substance in Fycompa, perampanel, is an anti-epileptic medicine.
Zdravilna učinkovina v zdravilu Fycompa, perampanel, je zdravilo proti epilepsiji.
Fycompa was compared with placebo as an addition to patients' existing epilepsy treatment.
Zdravilo Fycompa so primerjali s placebom, pri čemer so ju dodajali bolnikovim obstoječim zdravilom proti epilepsiji.
Fycompa must only be used as an ‘add-on' therapy to other anti-epileptic medicines.
Zdravilo Fycompa se lahko uporablja samo kot dodatek k drugim zdravilom proti epilepsiji.
In the first study, the percentage of patients who experienced a decrease in seizure frequency of at least 50% was 37.6% for patients taking 8 mg Fycompa and 36.1% for patients taking 12 mg Fycompa, compared with 26.4% of patients taking placebo.
V prvi študiji je delež bolnikov, pri katerih je prišlo do najmanj 50-odstotnega upada pogostosti napadov, znašal 37,6 % pri bolnikih, ki so jemali 8-miligramski odmerek zdravila Fycompa, ter 36,1 % pri bolnikih, ki so jemali 12-miligramski odmerek, medtem ko je ta delež pri bolnikih, ki so jemali placebo, znašal 26,4 %.
The dose should not exceed 8 mg per day in patients with mildly or moderately reduced liver function.
Pri bolnikih z blažjo ali zmerno okvaro jeter odmerek ne sme preseči 8 mg na dan.
How has Fycompa been studied?
Kako je bilo zdravilo Fycompa raziskano?
In the second study, 33.3% and 33.9% of patients taking 8 mg and 12 mg Fycompa respectively showed a decrease in seizure frequency of at least 50%, compared with 14.7% of patients taking placebo.
V drugi študiji je najmanj 50-odstotni upad pogostosti napadov imelo 33,3 % bolnikov, ki so jemali 8-miligramski odmerek zdravila Fycompa, in 33,9 % bolnikov, ki so jemali 12-miligramski odmerek, medtem ko je ta delež pri bolnikih, ki so prejemali placebo, znašal 14,7 %.
What is Fycompa?
Kaj je zdravilo Fycompa?
What is Fycompa used for?
Za kaj se zdravilo Fycompa uporablja?
How is Fycompa used?
Kako se zdravilo Fycompa uporablja?
Therefore by blocking glutamate's actions, Fycompa is thought to stop epileptic seizures from occurring.
Zdravilo Fycompa naj bi tako posledično z zaviranjem delovanja glutamata ustavilo pojav epileptičnih napadov.
How does Fycompa work?
Kako zdravilo Fycompa deluje?
It is currently difficult to explain if this phenomenon is treatment related or not.
Trenutno je težko razložiti, ali je ta pojav povezan z zdravljenjem ali ne.
In this case, your doctor will postpone the vaccination.
V tem primeru bo vaš zdravnik odložil cepljenje.
Tell your doctor:
Obvestite svojega zdravnika:
Dispose of in accordance with local requirements.
Zavrzite v skladu z lokalnimi zahtevami.
You and your child may need to read it again.
Morda ga boste želeli vi ali vaš otrok ponovno prebrati.
1 produced in Vero cells
1 proizvedeno v celicah Vero
If the vaccine has been frozen it should not be used.
Če je bilo cepivo zamrznjeno, ga ne smete uporabiti.
Safety and tolerability was evaluated in the entire study population.
Varnost in prenašanje so ocenili v celotni študijski populaciji.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in ostale oblike interakcij
Please note that:
Upoštevajte naslednje:
The pre-filled syringe is for single use only and should not be used for more than one person.
Napolnjena injekcijska brizga je samo za enkratno uporabo in je ne smete uporabiti za več kot eno osebo.
◊Negative Pre-Vaccination titers were imputed to 5.
◊Negativnim titrom pred cepljenjem je bilo prišteto 5.
Mathematical modelling was applied to project the average duration of protection.
Matematični model je bil uporabljen za napovedovanje povprečnega trajanja zaščite.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Ker študije kompatibilnosti niso bile izvedene, se to zdravilo ne sme mešati z drugimi zdravili.
All of the 198 subjects treated were included in the ITT and Safety Populations.
Vseh 198 zdravljenih oseb je osodelovalo v populaciji ITT in varnostni populaciji.
The vaccine causes the body to produce its own protection (antibodies) against this disease.
Cepivo vzpodbudi telo k proizvajanju lastne zaščite (protiteles) proti tej bolezni.
This virus is mainly found in Asia and is transmitted to humans by mosquitoes that have bitten an infected animal (like pigs).
Ta virus običajno najdemo v Aziji in se na ljudi prenaša prek komarjev, ki so pičili okuženo žival (kot so prašiči).
Non-clinical toxicity data are limited.
Nekliničnih podatkov o toksičnosti ni veliko.
Date of first authorisation: 31 March 2009 Date of latest renewal: 22 November 2018
Datum prve odobritve: 31. marec 2009 Datum zadnjega podaljšanja: 28. februar 2014
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil, je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
If the primary immunization of two injections is not completed, full protection against the disease might not be achieved.
Če primarna imunizacija z dvema odmerkoma ni zaključena, popolna zaščita proti bolezni morda ne bo dosežena.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede periodično posodobljenih poročil o varnosti tega zdravila so opredeljene na seznamu referenčnih datumov Unije (seznamom EURD), ki je naveden v členu 107c(7) Direktive 2001/83/ES in vseh naknadnih posodobitvah ter objavljen na spletnem portalu Evropske agencije za zdravila.
Long-term seroprotection following a booster-dose is not known.
Dolgoročna serološka zaščita po obnovitvenem odmerku ni znana.
However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
Vendar pa je treba pripomniti, da ni podatkov o klinični učinkovitosti, ki bi podprli subkutano dajanje.
Immunogenicity data were evaluated in 64 subjects.
Podatki o imunogenosti so bili ocenjeni pri 64 preiskovancih.
In patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immune response may not be obtained.
Pri bolnikih, ki so prejeli imunosupresijsko zdravljenje, ali bolnikih z oslabljenim imunskim odgovorom morda ne bo mogoče doseči primernega imunskega odgovora.
Administration must be postponed in persons with acute severe febrile conditions.
Uporabo cepiva je treba pri osebah z akutnimi hudimi febrilnimi stanji odložiti.
Many infected people develop mild symptoms or no symptoms at all.
Pri mnogih okuženih ljudeh se pojavijo le blagi simptomi ali pa teh sploh ni.
The majority of the side effects listed below have been observed during clinical trials.
Večino neželenih učinkov, ki so navedeni spodaj, so opazili med kliničnimi preskušanji.
Confusion and agitation also occur in the early stage of disease.
V zgodnji fazi bolezni se lahko pojavita tudi zmedenost in razdražljivost.
This product might contain traces of residual sodium metabisulfite which is below detection limit.
To zdravilo lahko vsebuje sledove ostankov natrijevega metabisulfita, ki so pod mejo zaznavanja.
corresponding to a potency of ≤ 460 ng ED50
ki ustreza jakosti ≤ 460 ng ED50
Blank white foil without any printed information.
Prazen bel omot brez natisnjenih podatkov.
Data are limited but there were no differences in the safety profile between the 0.25 ml and the 0.5 ml dose in this age group.
Podatki so omejeni, vendar razlik v profilu varnosti med odmerkoma 0,25 ml in 0,5 ml v tej starostni skupini ni bilo.
ATC code: J07BA02
Oznaka ATC: J07BA02
Time point after primary immunization
Časovna točka po primarni imunizaciji
If you have any further questions, ask your doctor.
• Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom.
Email: infoixiaro@valneva.com
E-pošta: infoixiaro@valneva.com
In animal studies findings of unclear clinical relevance have been identified (see section 5.3).
Klinični pomen ugotovitev v študijah pri živalih je nejasen (glejte poglavje 5.3).
As with any other vaccine, vaccination with IXIARO may not result in protection in all cases.
Kot pri drugih cepivih, cepljenje s cepivom IXIARO morda ne bo dalo zaščite v vseh primerih.
Your doctor will discuss with you the possible risks and benefits of receiving IXIARO.
Vaš zdravnik se bo z vami pogovoril o morebitnih tveganjih in koristih cepljenja s cepivom IXIARO.
Longterm immunogenicity data were evaluated in 23 children, mean age 14.3 years, range 3 - 18 years).
Podatki o dolgoročni imunogenosti so bili ocenjeni pri 23 otrocih, povprečna starost 14,3 leta, razpon 3-18 let.
Pre-Vaccination 30% (3/10) Day 56 Month 7
Pred cepljenjem 30% (3/10) 56. dan 7. mesec
Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”.
• Tega zdravila ne smete uporabiti po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki za besedo „EXP“.
If not, you and/or your child may not be fully protected against the disease.
nasprotnem primeru morda vi in/ali vaš otrok ne boste popolnoma zaščiteni pred boleznijo.
If a needle is not provided, use a sterile needle.
Če igla ni priložena, uporabite sterilno iglo.
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Pri shranjevanju se lahko pojavi fina bela usedlina s čistim, brezbarvnim supernatantom.
The safety and efficacy of IXIARO in children younger than 2 months has not been established.
Varnost in učinkovitost cepiva IXIARO pri otrocih, mlajših od 2 mesecev, nista bili dokazani.
Make sure you and/or your child finish the complete vaccination course of 2 injections.
Poskrbite, da boste vi in/ali vaš otrok dokončali cikel cepljenja z dvema injekcijama.
The pre-filled syringe is ready to use.
Napolnjena injekcijska brizga je pripravljena za uporabo.
IXIARO has no or negligible influence on the ability to drive and use machines.
Cepivo IXIARO nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
As with all injectable vaccines, appropriate medical treatment and supervision should always be available to treat rare cases of anaphylactic reactions following the administration of the vaccine.
Kot pri vseh cepivih, ki se injicirajo, morajo biti vedno na voljo ustrezni terapevtski ukrepi in nadzor za zdravljenje redkih primerov anafilaktičnih reakcij po uporabi cepiva.
Subcutaneous administration could lead to a suboptimal response to the vaccine (see section 4.4).
Subkutano dajanje lahko povzroči manj optimalen odziv na cepivo (glejte poglavje 4.4).