natgillin/translations-raw huggingface dataset:
Overall, the most frequently reported skin reactions are by decreasing order various types of rashes without any specificity (162 cases), pruritus (94 cases), Erythema Multiforme (48 cases), urticaria (47 cases), Toxic Epidermal Necrolysis (35 cases), angioedema (34 cases), Stevens-Johnson Syndrome (31 cases), erythema (28 cases), toxic skin eruption (19 cases), skin exfoliation (16 cases), dermatitis bullous, Not Otherwise Specified (NOS) (16 cases) and DRESS Syndrome (7 cases).
Na splošno so neželeni učinki na kožo, o katerih so najpogosteje poročali, po padajočem vrstnem redu različne vrste izpuščajev brez kakršnih koli posebnosti (162 primerov), pruritus (94 primerov), multiformni eritem (48 primerov), urtikarija (47 primerov), toksična epidermalna nekroliza (35 primerov), angioedem (34 primerov), Stevens-Johnsonov sindrom (31 primerov), eritem (28 primerov), toksični kožni izpuščaj (19 primerov), eksfoliacija kože (16 primerov), bulozni dermatitis, neželeni učinki, ki niso drugače opredeljeni (16 primerov) in sindrom DRESS (7 primerov).
In view of the unpredictability of this type of adverse reactions, a restricted indication would not be an effective risk minimisation measure.
Omejitev indikacije zaradi nepredvidljivosti omenjenih vrst neželenih učinkov ne bi bila učinkovit ukrep za zmanjšanje tveganja.
The PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited clinical efficacy of tetrazepam in its approved indications.
PRAC je menil, da razpoložljivi podatki o učinkovitosti, vključno s podatki, ki so postali na voljo po odobritvi prvega dovoljenja za promet z zdravilom, kažejo na zelo majhno klinično učinkovitost tetrazepama pri odobrenih indikacijah.
Based on the above, the PRAC concluded that tetrazepam is associated with safety concerns in relation to serious, potentially fatal, skin reactions and shows limited clinical efficacy.
Na podlagi vsega navedenega je PRAC zaključil, da je tetrazepam povezan z varnostnimi tveganji, povezanimi z resnimi kožnimi reakcijami, ki so lahko tudi smrtne, njegova klinična učinkovitost pa je majhna.
This included data from the Member States and published literature data which became available since the original marketing authorisations, as well as the MAH responses and the Stakeholders submissions.
Med njimi so bili podatki, ki so jih predložile države članice, in podatki iz literature, ki so bili objavljeni po odobritvi prvih dovoljenj za promet, ter tudi odgovori imetnika dovoljenja za promet z tetrazepamom in vloge zainteresiranih strani;
The MAH presented its views on the possible mechanism of cutaneous reactions induced by tetrazepam: a structural difference between tetrazepam and other benzodiazepines (i.e. the substituted cyclohexenyl ring of tetrazepam) may be linked to the various cutaneous hypersensitivity reactions observed for tetrazepam.
promet je predstavil svoje mnenje o možnem mehanizmu kožnih reakcij, povezanih s tetrazepamom: različne preobčutljivostne kožne reakcije, ki so jih opazili pri uporabi tetrazepama, bi lahko bile posledica razlike v strukturi tetrazepama in drugih benzodiazepinov (tj. substituirani cikloheksenilov obroč pri tetrazepamu).
• The PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited clinical efficacy of tetrazepam in its approved indications.
• PRAC je menil, da razpoložljivi podatki o učinkovitosti, vključno s podatki, ki so postali na voljo po odobritvi prvega dovoljenja za promet z zdravilom, kažejo na zelo majhno klinično učinkovitost tetrazepama pri odobrenih indikacijah;
The PRAC considered that the risk minimisations measures discussed during the assessment, including reduction of duration of treatment and restricted indication, were not sufficient to reduce the risk.
PRAC je menil, da ukrepi za zmanjšanje tveganja, ki so bili obravnavani med ocenjevanjem, vključno s skrajšanjem časa zdravljenja in omejitvijo indikacije, ne zadostujejo za zmanjšanje tveganja.
Tetrazepam is a benzodiazepine indicated for painful contractures in rheumatology or spasticity.
Tetrazepam je benzodiazepin, indiciran za boleče mišične krče pri revmatoloških boleznih ali za spastičnost.
Overall, more than 40% of the reported cases are related to the skin disorder SOC; severe Cutaneous Adverse Reactions to Drugs (SCARs), such as SJS, TEN, DRESS Syndrome and EM were diagnosed upon tetrazepam treatment and 11 fatal cases were reported; in 8 cases, it was reported as the result of the skin reaction and in 3 cases, it was related to an associated reaction.
Skupno je bilo več kot 40 % primerov, o katerih so poročali, povezanih z organskim sistemom „bolezni kože‟; pri zdravljenju s tetrazepamom so diagnosticirali resne neželene učinke zdravila na kožo, kot so SJS, TEN, sindrom DRESS in multiformni eritem, ter poročali o 11 smrtnih primerih; v 8 primerih je bila smrt posledica kožne reakcije, v 3 primerih pa z njo povezane reakcije.
• The PRAC noted that serious adverse cutaneous reactions have been reported with tetrazepam, including fatal cases.
• PRAC je upošteval, da so pri uporabi tetrazepama poročali o resnih neželenih učinkih na kožo, med katerimi so bili tudi smrtni primeri;
In view of the above, the PRAC considered that tetrazepam, compared to the medicines of the same pharmacological class, is associated with an increased risk of serious cutaneous adverse reactions including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis , Erythema Multiform and DRESS syndrome which can be life threatening and fatal.
Ob upoštevanju vsega naštetega je PRAC menil, da je tetrazepam v primerjavi z zdravili iz iste farmakološke skupine povezan z večjim tveganjem za resne neželene učinke na kožo, vključno s Stevens-Johnsonovim sindromom (SJS), toksično epidermalno nekrolizo, multiformnim eritemom in sindromom DRESS, ki so lahko življenjsko nevarni in tudi smrtni.
Overall, the efficacy of tetrazepam in the painful contractures indication is supported mainly by two small double blind placebo-controlled clinical trial (Arbus 1987
Na splošno učinkovitost tetrazepama pri indikaciji za boleče mišične krče podpirata predvsem dve manjši dvojno slepi s placebom nadzorovani klinični študiji (Arbus 1987 in Salzmann 1993), v kateri je bilo skupno vključenih 70 bolnikov (50 oziroma 20 bolnikov).
Tetrazepam is a benzodiazepine indicated for painful contractures in rheumatology and in spastic syndromes across the Members States.
Tetrazepam je benzodiazepin, ki je v državah članicah indiciran za boleče mišične krče pri revmatoloških boleznih in spastične sindrome.
• The PRAC considered that the risk minimisations measures discussed during the assessment, including reduction of duration of treatment and restricted indication, were not sufficient to reduce the risk of serious cutaneous reactions.
• PRAC je menil, da ukrepi za zmanjšanje tveganja, ki so bili obravnavani med ocenjevanjem, vključno s skrajšanjem časa zdravljenja in omejitvijo indikacije, ne zadostujejo za zmanjšanje tveganja za resne neželene učinke na kožo.
• The PRAC considered, after having reviewed the available data that tetrazepam, compared to the medicines of the same pharmacological class, is associated with an increased risk of serious cutaneous adverse reactions including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis , Erythema Multiform and Drug Reaction of Eosinophilia Systemic Symptoms (DRESS) which can be life threatening and fatal.
• PRAC je po pregledu razpoložljivih podatkov menil, da je tetrazepam v primerjavi z zdravili iz iste farmakološke skupine povezan z večjim tveganjem za resne neželene učinke na kožo, vključno s Stevens-Johnsonovim sindromom (SJS), toksično epidermalno nekrolizo, multiformnim eritemom in neželenimi učinki z eozinofilijo in sistemskimi simptomi (DRESS), ki so lahko življenjsko nevarni in tudi smrtni;
This evaluation highlighted an increased cutaneous risk of tetrazepam in addition to the pharmacological expected ADRs of benzodiazepines: half of the ADRs reported with tetrazepam were cutaneous and amongst the 648 serious cases reported, 305 cases were reported under the System Organ Class (SOC) “Skin and subcutaneous disorders”: 33 cases of Stevens - Johnson syndrome (SJS), 33 of Toxic Epidermal Necrolysis (TEN), 59 Erythema Multiforme (EM) and 15 cases of Drug Reaction (or Rash) with Eosinophilia and Systemic Symptoms (DRESS Syndrome) were detected with fatal outcome in 11 cases.
Med pregledom so poleg pričakovanih neželenih učinkov zaradi farmakološkega delovanja benzodiazepinov opazili povečano tveganje za kožne reakcije, povezano z uporabo tetrazepama: polovica neželenih učinkov, o katerih so poročali pri uporabi tetrazepama, je bila povezanih s kožo, pri čemer je bilo z organskim sistemom „bolezni kože in podkožja‟ povezanih 305 od 648 poročil o resnih primerih: poročali so o 33 primerih Stevens-Johnsonovega sindroma (SJS), 33 primerih toksične epidermalne nekrolize (TEN), 59 primerih multiformnega eritema in 15 primerih neželene reakcije (ali izpuščaja) z eozinofilijo in sistemskimi simptomi (sindrom DRESS), pri čemer se je 11 primerov končalo s smrtnim izidom.
1 Sanchez I et al. Stevens-Johnson syndrome from tetrazepam.
1 Sanchez, I. et al., „Stevens-Johnson syndrome from tetrazepam‟, Allergol Immunopathol, št. 26, 1998, str.
Results of clinical studies with the use of tetrazepam in both indications have been published since the marketing authorisations of tetrazepam.
Po odobritvi dovoljenj za promet s tetrazepamom so bili objavljeni rezultati kliničnih študij uporabe tetrazepama pri obeh indikacijah.
2 Camarasa JG et al. Tetrazepam allergy detected by patch test.
2 Camarasa, J. G. et al., „Tetrazepam allergy detected by patch test‟, Contact Dermatitis, št. 22, 1990, str. 246.
Grounds for PRAC recommendation
Podlaga za priporočilo PRAC Ob upoštevanju:
• The PRAC considered the totality of the data available for tetrazepam containing products in relation to the risk of cutaneous adverse reactions.
• PRAC je preučil vse razpoložljive podatke v zvezi s tveganjem za neželene učinke na kožo, povezanim z zdravili, ki vsebujejo tetrazepam.
Tetrazepam affinity for skin could explain the localization of the hypersensitivity reaction.
Afiniteta tetrazepama do kože bi lahko pojasnila, zakaj se preobčutljivostne reakcije pojavljajo na tem mestu.
Skin adverse events were also submitted in responses from other MAHs and the Stakeholders submissions.
Podatke o neželenih dogodkih, povezanih s kožo, so v odgovoru predložili tudi drugi imetniki dovoljenj za promet s tetrazepamom in zainteresirane strani.Imetnik dovoljenja za
A specific analysis about the most relevant serious adverse cutaneous reactions reported by the MAH in relationship of their nature and severity was made in the MAH's response to the PRAC list of questions.
V odgovoru na seznam vprašanj, ki jih je zastavil PRAC, je imetnik dovoljenja za promet izvedel posebno analizo vrste in resnosti najpomembnejših poročanih resnih neželenih učinkov na kožo.
J Investig Allergol Clin Immunol 2007;17(3):205-6 Delesalle F et la.
5 Cabreizo Ballesteros et al., „Erythema multiforme to tetrazepam‟, J Investig Allergol Clin Immunol, št. 17(3), 2007, str. 205-6.
However the imputability of tetrazepam is strong in a high number of cases.
Vendar pa je bil v velikem številu primerov z neželenimi učinki zelo verjetno povezan tetrazepam.
Toxic epidermal necrolysis caused by tetrazepam.
6 Delesalle, F. et al., „Toxic epidermal necrolysis caused by tetrazepam‟, International Journal of Dermatology,
Allergy 1997;52(11):1145-6 10 LagnouiR et al.
Blanco, R. et al., „Delayed hypersensitivity to tetrazepam‟, Allergy, št. 52(11), 1997, str. 1145-6.
J Investig Allergol Clin Immunol 2008;18(5):404-406 9 Blanco R et la.
18(5), 2008, str. 404-406.
Dermatol Venereol 2008;22(7):887-8 Cabreizo Ballesteros et al. Erythema multiforme to tetrazepam.
3 Quinones, D. et al., „Photodermatitis from tetrazepam‟, Contact Dermatitis, št. 39(2), 1998, str. 84. 4 Bachmeyter, C., „Probable drug rash with eosinophilia and systemic symptoms syndrome related to tetrazepam‟, J Eur Acad Dermatol Venereol, št. 22(7), 2008, str. 887-8.
Allergy 1999;54(11):1226-27 Sanchez-Morillas L et al.
Del Pozo, M. D. et al., „Tetrazepam Allergy‟, Allergy, št. 54(11), 1999, str. 1226-27.
The PRAC considered risk minimisations measures, including reduction of duration of treatment to 6 days and a restricted indication, to mitigate the risk of serious cutaneous adverse reactions.
PRAC je preučil ukrepe za zmanjšanje tveganja za resne neželene učinke na kožo, ki so vključevali skrajšanje trajanja zdravljenja na 6 dni in omejitev indikacije.
Fatal toxic epidemal necrolysis associated with tetrazepam.
Lagnoui, R. et al., „Fatal toxic epidemal necrolysis associated with tetrazepam‟, Therapie, št. 56(2), 2001, str.
J Eur Acad
Priloga II
International Journal of Dermatology 2006;45(4):480 Del Pozo MD et al. Tetrazepam Allergy.
št. 45(4), 2006, str. 480.
Where can I get more information?
Kje lahko dobite več informacij?
What else do I need to know?
Kaj še morate vedeti?
What should I do with this card?
Kaj morate storiti s to kartico?
This can be fatal.
Ta je lahko smrtna.
In particular, tell your doctor:
Še zlasti morate zdravniku povedati:
Date of first authorisation: 13 July 2017 Date of latest renewal:
Datum prve odobritve: 13. julij 2017 Datum zadnjega podaljšanja:
• if you are taking medicines for high blood pressure.
• če jemljete zdravila za visok krvni tlak.
No additional safety signals were identified.
Pri tem niso zaznali nobenih novih varnostnih signalov.
However, the possible risk for the development of solid tumours cannot be excluded at this time.
Vendar pa možnega tveganja za razvoj solidnih tumorjev za zdaj ni mogoče izključiti.
It also includes your name and doctor's name and phone number on the back.
Na hrbtni strani sta zapisani tudi vaše in zdravnikovo ime ter telefonska številka.
• if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries.
• če menite, da boste v kratkem potrebovali katero koli cepljenje, vključno s cepljenji, ki bi jih potrebovali za potovanje v druge države.
• you have a severe active infection at the moment
• imate trenutno hudo, aktivno okužbo;
There are no adequate and well-controlled data from studies in pregnant women,
Za nosečnice ni zadostnih in dobro nadzorovanih podatkov iz študij.
95.1%b CI (−3.2%, 24.3%) a
95,1 %b IZ (−3,2 %, 24,3 %) a
Key results from all four studies are summarised in Table 6.
Ključni rezultati vseh štirih preskušanj so povzeti v preglednici 6.
This is usually given every 3 weeks up to 8 times.
Ta se po navadi daje na 3 tedne, do osemkrat.
- CI = confidence interval.
IZ = interval zaupanja.
• What to do if you think you might be getting an infection.
• Kaj storite, če menite, da imate morda okužbo
Survival Time (Months)
Čas preživetja (meseci)
Similar effects have been observed in animal studies (see section 5.3).
Podobne učinke so opažali v študijah na živalih (glejte poglavje 5.3).
Complete remission at 12 and 18 months
Popolna remisija po 12 in 18 mesecih
Proportion of patients with no erosive change
Delež bolnikov brez erozivnih sprememb
Three cases had no reported adverse event.
V treh primerih niso poročali o nobenem neželenem dogodku.
It is important that you keep this Alert Card and show it to your partner or caregiver.
Pomembno je, da to kartico hranite pri sebi in da jo pokažete vašemu partnerju ali skrbniku.
The final efficacy analysis included all patients randomised to both parts of the study.
Končna analiza učinkovitosti je vključevala vse bolnike, ki so bili randomizirani v oba dela študije.
These cases occurred in non-approved indications and the majority of patients were HIV positive.
Ti primeri so se pojavili pri neodobrenih indikacijah, večina bolnikov je bila HIV-pozitivna.
Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
This card tells you:
V tej kartici je opisano:
Two patients were re-treated twice in the study.
Dva bolnika sta bila v študiji dvakrat ponovno zdravljena.
* at end of maintenance/observation; final analysis results based on median follow-up of 73 months.
* ob koncu vzdrževalnega zdravljenja/spremljanja; rezultati končne analize temeljijo na mediani spremljanja 73 mesecev.
• Keep this card with you all the timesuch as in your wallet or purse.
• Kartico imejte vedno ob sebi, na primer v denarnici ali torbici.
Your doctor may change this, depending on how you respond to the medicine.
Zdravnik lahko to spremeni, odvisno od tega, kako se odzovete na zdravilo.
From a microbiological point of view, the prepared infusion solution should be used immediately.
Z mikrobiološkega stališča je treba pripravljeno infuzijsko raztopino uporabiti takoj.
- * Worst case imputation a Non-inferiority was demonstrated since the lower bound (−3.2%) was higher than the pre-determined non-inferiority margin (− 20%).
* Imputacija za najslabši primer a Neinferiornost je bila dokazana, ker je bila spodnja meja (−3,2 %) višja od vnaprej opredeljene meje neinferiornosti (−20 %).
When these symptoms go away, or improve, the infusion can be continued.
Ko ti simptomi izginejo ali se izboljšajo, se lahko infuzija nadaljuje.
Most side effects are mild to moderate but some may be serious and require treatment.
Večina neželenih učinkov je blagih do zmernih, a nekateri so lahko resni in zahtevajo zdravljenje.
Standard tests to investigate mutagenicity have not been carried out, since such tests are not relevant for this molecule.
Standardni testi za raziskovanje mutagenosti niso bili izvedeni, kajti tovrstni testi za to molekulo niso relevantni.
The syndrome frequently manifests itself within one or two hours of initiating the first infusion.
Sindrom se pogosto pokaže v eni do dveh urah po začetku prve infuzije.
20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republic of Korea
20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republika Koreja
Do not have Ritemvia if you have an active infection or a serious problem with your immune system.
Zdravila Ritemvia ne smete prejeti, če imate aktivno okužbo ali resno težavo s svojim imunskim sistemom.
Look out for the following possible signs of infection:
Bodite pozorni na naslednje znake okužbe:
The median follow up of patients was 53 months.
Mediana spremljanja bolnikov je bila 53 mesecev.
These patients should be very closely monitored throughout the first infusion.
Te bolnike moramo v celotnem teku prve infuzije natančno opazovati.
Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped.
Nemudoma povejte osebi, ki vam daje infuzijo, če se pri vas pojavi kateri od teh simptomov, ker bo morda treba infuzijo upočasniti ali jo ustaviti.
Care must be taken to ensure the sterility of prepared solutions.
Treba je paziti, da zagotovimo sterilnost pripravljene raztopine.
Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Bolnikom je treba naročiti, naj o svojem zdravljenju obvestijo partnerja ali skrbnike, ker bodo morda ti opazili simptome, ki se jih bolniki ne zavedajo.
The incidence of serious infections was similar in both arms (approximately 12%).
Pojavnost resnih okužb je bila v obeh skupinah podobna (približno 12%).
Primary efficacy
Primarna učinkovitost
b The 95.1% confidence level reflects an additional 0.001 alpha to account for an interim efficacy analysis.
b 95,1-% interval zaupanja vključuje dodatni 0,001 alfa na račun vmesne analize učinkovitosti.
Ritemvia may also cause changes in laboratory tests carried out by your doctor.
Zdravilo Ritemvia lahko vpliva tudi na spremembe laboratorijskih preiskav, ki jih naroči vaš zdravnik.
Patients should receive Ritemvia for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Bolniki morajo zdravilo Ritemvia prejemati vsaj 24 mesecev po doseženi remisiji (odsotnost kliničnih znakov in simptomov).
This will be administered 1 year and 18 months after the initial treatment and then every 6 months as needed or your doctor may change this, depending on how you respond to the medicine.
Tega boste dobili 1 leto in 18 mesecev po začetnem zdravljenju in nato vsakih 6 mesecev, če bo treba, a zdravnik vam lahko ta razpored spremeni, odvisno od tega, kako se odzovete na zdravilo.
Post-hoc retrospective laboratory evaluation
Post-hoc retrospektivna laboratorijska ocena
Tell your doctor immediately if you have any of these symptoms.
Nemudoma povejte svojemu zdravniku, če se pri vas pojavi kateri od teh simptomov.
p-value (Wald test, not adjusted)
p-vrednost (test Wald, ni prilagojen)
The alert card contains important safety information for patients regarding potential increased risk of infections, including PML.
Opozorilna kartica vsebuje za bolnika pomembne podatke o varnosti glede možnega povečanega tveganja za okužbe, vključno s PML.
The gender-related pharmacokinetic differences are not considered to be clinically relevant and dose adjustment is not required.
S spolom povezane razlike v farmakokinetiki ne štejemo za klinično pomembne in prilagajanje odmerkov ni potrebno.
4 Includes observations collected as part of routine laboratory monitoring.
4Vključujejo opažanja zbrana v okviru rutinskega laboratorijskega spremljanja.
7 includes fatal cases
7 Vključujejo smrtne primere.
B cell counts returned to normal in these animals within 6 months of birth and did not compromise the reaction to immunisation.
Število celic B se je pri teh živalih vrnilo na normalno raven v 6 mesecih po rojstvu in ni ogrožalo reakcije na imunizacijo.
CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.
CD20 ne kroži v plazmi kot prosti antigen in zato ne tekmuje za vezavo na protitelo.
Block 7, City North Business Campus, Stamullen, Co. Meath K32 YD60, Ireland
Block 7, City North Business Campus, Stamullen, Co. Meath K32 YD60, Irska
If you can get pregnant, you and your partner must use an effective method of contraception while using Ritemvia.
Če bi lahko zanosili, morate vi in vaš partner med uporabo zdravila Ritemvia uporabljati učinkovito kontracepcijsko zaščito.
You may require additional treatment such as an antihistamine or paracetamol.
Morda boste potrebovali dodatno zdravljenje z zdravili, kot so antihistaminiki ali paracetamol.
Your doctor may decide to stop your Ritemvia treatment if these reactions are serious.
Zdravnik se lahko odloči za prenehanje zdravljenja z zdravilom Ritemvia, če so te reakcije resne.
9.32 years
9,32 let
The safety and efficacy of Ritemvia in children below 18 years has not been established.
Varnost in učinkovitost zdravila Ritemvia pri otrocih do 18 leta starosti nista dokazani.
• The need for close supervision during administration in an environment where full resuscitation facilities are immediately available
• informacije o nujnosti skrbnega nadzora med aplikacijo v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo,
Your doctor may decide to treat you longer with Ritemvia (up to 5 years), depending on how you respond to the medicine.
Zdravnik se lahko odloči, da vas bo z zdravilom Ritemvia zdravil dlje (do 5 let), odvisno od tega, kako se odzovete na zdravilo.
• Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Ritemvia.
• Pokažite jo vsem zdravnikom, medicinskim sestram in zobozdravnikom, ki jih obiščete - ne samo specialistu, ki vam predpiše zdravilo Ritemvia.
Since the medicinal product does not contain any anti-microbial preservative or bacteriostatic agents, aseptic technique must be observed.
Ker zdravilo ne vsebuje antimikrobnih ali bakteriostatičnih zaščitnih sredstev, je treba upoštevati aseptično tehniko.
• if you have ever taken medicines which affect your immune system - such as chemotherapy or immune-suppressive medicines.
• če ste kdaj jemali zdravila, ki vplivajo na imunski sistem - na primer kemoterapijo ali imunosupresivna zdravila.