natgillin/translations-raw huggingface dataset:
In the first study, the average time from surgery to wound closure was 17.1 days for the wounds treated with standard wound dressing only and 15.5 days for the wounds also treated with Episalvan.
V prvi študiji je bil pri ranah, zdravljenih samo s standardnim povojem, povprečni čas od kirurškega posega do zaprtja rane 17,1 dneva, pri ranah, zdravljenih tudi z zdravilom Episalvan, pa 15,5 dneva.
How is Episalvan used?
Kako se zdravilo Episalvan uporablja?
How does Episalvan work?
Kako zdravilo Episalvan deluje?
Episalvan contains a dry extract from birch bark.
Zdravilo Episalvan vsebuje suh ekstrakt skorje breze.
Withdrawal of the marketing authorisation application for Fulphila (pegfilgrastim) EMA/577551/2017
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fulphila (pegfilgrastim) EMA/577551/2017
In addition, one study in 194 patients receiving cancer medicines compared the safety, effectiveness and immunogenicity, meaning the medicine's ability to trigger the production of antibodies, of Fulphila and Neulasta.
Poleg tega so s študijo pri 194 bolnikih, ki so prejemali zdravila proti raku, primerjali varnost, učinkovitost in imunogenost, tj. zmožnost zdravila, da sproži nastajanje protiteles, zdravil Fulphila in Neulasta.
Neutropenia is a side effect of certain cancer treatments and can lead to development of serious infections.
Nevtropenija je neželeni učinek določenih zdravil za zdravljenje raka in lahko vodi do razvoja resnih okužb.
This means that Fulphila was intended to be highly similar to a biological medicine already authorised in the European Union (the ‘reference medicine') called Neulasta.
To pomeni, da naj bi bilo zelo podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji, in sicer zdravilu Neulasta.
Other concerns related to the description of the manufacturing process, the control of impurities in the active substance and the sterilisation of the final product.
Drugi pomisleki so se nanašali na opis proizvodnega postopka, nadzor nečistot v zdravilni učinkovini in sterilizacijo končnega zdravila.
It encourages the bone marrow to produce more neutrophils and improves the patient's ability to fight off infections.
mozeg spodbuja k proizvodnji večjega števila nevtrofilcev in izboljša bolnikovo sposobnost boja proti okužbam.
Withdrawal of the marketing authorisation application for Fulphila (pegfilgrastim)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fulphila (pegfilgrastim)
Fulphila was to be used in cancer patients to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and the occurrence of febrile neutropenia (neutropenia with fever).
Zdravilo Fulphila naj bi se uporabljalo pri bolnikih z rakom za skrajšanje trajanja nevtropenije (nizkih vrednosti nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam) in zmanjšanje pogostnosti pojavljanja febrilne nevtropenije (nevtropenije z zvišano telesno temperaturo).
Fulphila is a medicine that contains the active substance pegfilgrastim.
Fulphila je zdravilo, ki vsebuje zdravilno učinkovino pegfilgrastim.
The company presented results of studies designed to show that Fulphila is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Družba je predstavila rezultate študij, ki naj bi pokazale, da je zdravilo Fulphila po kemijski sestavi, čistosti, načinu delovanja in tem, kako ga telo presnavlja, zelo podobno referenčnemu zdravilu Neulasta.
The active substance in Fulphila and Neulasta, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Zdravilna učinkovina v zdravilih Fulphila in Neulasta, pegfilgrastim, je sestavljena iz filgrastima, ki je bil pegiliran (nanj je bila pritrjena kemična snov, imenovana polietilenglikol).
Fulphila was developed as a ‘biosimilar' medicine.
Zdravilo Fulphila je bilo razvito kot „podobno biološko zdravilo“.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the quality of Fulphila had not been demonstrated.
Zato je odbor CHMP ob umiku vloge menil, da kakovost zdravila Fulphila ni bila dokazana.
protein called granulocyte-colony-stimulating factor (G-CSF).
Filgrastim je zelo podoben človeški beljakovini, imenovani granulocitne kolonije stimulirajoči faktor (G-CSF).
One of the CHMP's main concerns was the lack of a certificate of Good Manufacturing Practice (GMP) for the manufacturing site of the product.
Eden od glavnih pomislekov odbora CMHP je bil odsotnost potrdila o dobri proizvodni praksi za proizvodni obrat, v katerem proizvajajo zdravilo.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Fulphila could not have been approved to reduce neutropenia in patients taking cancer treatments.
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Fulphila ni mogoče odobriti za zmanjšanje nevtropenije pri bolnikih, ki jemljejo zdravila proti raku.
The company informed the CHMP that the withdrawal does not impact ongoing clinical trials with Fulphila.
Družba je odbor CHMP obvestila, da zavrnitev nima vpliva na klinična preskušanja, ki trenutno potekajo z zdravilom Fulphila.
officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fulphila, for reducing neutropenia in patients taking cancer treatments.
je 3. avgusta 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Fulphila, namenjenim zmanjševanju nevtropenije pri bolnikih, ki jemljejo zdravila proti raku.
What is Fulphila?
Kaj je zdravilo Fulphila?
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because a GMP certificate for the manufacturing site of Fulphila could not be obtained in the time available.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da umika vlogo, ker potrdila o dobri proizvodni praksi za proizvodni obrat, v katerem proizvajajo zdravilo Fulphila, ne more pridobiti v razpoložljivem času.
What was Fulphila expected to be used for?
Za kaj naj bi se zdravilo Fulphila uporabljalo?
The CHMP was assessing the company's responses to the questions at the time of the withdrawal.
Ob umiku vloge je odbor CHMP ocenjeval odgovore družbe na zastavljena vprašanja.
1 vial +1 infusion bag +1 syringe +1 vial adaptor
1 viala + 1 infuzijska vrečka + 1 brizga + 1 nastavek za vialo
Powder : 200mg Solvent: 20 ml (10 mg/ml)
200 mg prašek in vehikel za raztopino za infundiranje prašek: viala (steklo) vehikel: infuzijska vrečka prašek: 200 mg vehikel: 20 ml (10 mg/ml)
Powder for oral suspension
1 viala prašek za peroralno suspenzijo plastenka (HDPE) 45 g
Intravenous use vial (glass)
200 mg prašek za raztopino za infundiranje viala (steklo)
They should be taken within one hour after morning and evening meals.
Jemati jih je treba v eni uri po jutranjem in večernem obroku.
The Agency considered that the measures put in place are adequate to manage these risks.
Agencija je menila, da so uvedeni ukrepi ustrezni za obvladovanje teh tveganj.
The tablets are taken twice a day on certain days of each treatment cycle.
Tablete se jemljejo dvakrat na dan na določene dneve vsakega cikla zdravljenja.
Further information on Lonsurf can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lonsurf.
Nadaljnje informacije za zdravilo Lonsurf so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/lonsurf.
What measures are being taken to ensure the safe and effective use of Lonsurf?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lonsurf?
Lonsurf received a marketing authorisation valid throughout the European Union on 25 April 2016.
Za zdravilo Lonsurf je bilo 25. aprila 2016 izdano dovoljenje za promet, veljavno po vsej EU.
Lonsurf is available as tablets (15 mg trifluridine and 6.14 mg tipiracil; 20 mg trifluridine and 8.19 mg tipiracil) and is given in treatment cycles of 28 days.
Zdravilo Lonsurf je na voljo v obliki tablet (15 mg trifluridina in 6,14 mg tipiracila; 20 mg trifluridina in 8,19 mg tipiracila), daje pa se v 28-dnevnih ciklih.
The European Medicines Agency decided that Lonsurf's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Lonsurf večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
All patients received supportive care.
Vsi bolniki v študiji so prejemali podporno zdravljenje.
Other information about Lonsurf
Druge informacije o zdravilu Lonsurf
This therefore boosts trifluridine's effect.
To okrepi učinek trifluridina.
As for all medicines, data on the use of Lonsurf are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Lonsurf stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lonsurf have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lonsurf upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Why is Lonsurf authorised in the EU?
Zakaj je bilo zdravilo Lonsurf odobreno v EU?
What benefits of Lonsurf have been shown in studies?
Kakšne koristi zdravila Lonsurf so se pokazale v študijah?
In the body, trifluridine is converted into an active form that is incorporated into DNA, the genetic material of cells.
Trifluridin se v telesu pretvori v aktivno obliko, ki se vgradi neposredno v DNK, genetski material celic.
Tipiracil increases the level of trifluridine in the blood by slowing its breakdown.
Tipiracil poviša raven trifluridina v telesu tako, da upočasni njegovo razgradnjo.
It is used when the cancer is metastatic (has spread to other parts of the body) in patients who have already been treated with, or who cannot be given, other treatments for their cancer.
Uporablja se, kadar je rak metastatski (se je razširil na druge dele telesa), pri bolnikih, ki so že prejemali druge razpoložljive oblike zdravljenja ali pa teh ne morejo prejemati.
Treatment with Lonsurf should be prescribed by a doctor who is experienced in the use of cancer medicines.
Zdravljenje z zdravilom Lonsurf mora predpisati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
Side effects reported with Lonsurf are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Lonsurf, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The conversion of trifluridine into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Pretvorba trifluridina v aktivno obliko lažje poteka v rakavih celicah kot v normalnih celicah, kar privede do večje koncentracije aktivne oblike zdravila in njegovega daljšega učinkovanja v rakavih celicah.
For more information about using Lonsurf, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Lonsurf glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Lonsurf?
Kakšna tveganja so povezana z zdravilom Lonsurf?
This reduces the growth of cancer cells, while normal cells are only slightly affected.
To upočasni rast rakavih celic, medtem ko je vpliv na normalne celice zelo majhen.
Gastric cancer
Rak želodca
Treatment with Lonsurf should continue for as long as benefits can be seen and the side effects are tolerable.
Zdravljenje z zdravilom Lonsurf je treba nadaljevati, dokler so vidne koristi in dokler je neželene učinke mogoče prenašati.
All patients had previously received other treatments.
Vsi bolniki so prejeli vsaj dve predhodni zdravljenji.
The most common side effects with Lonsurf (which may affect more than 3 in 10 people) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), feeling sick, tiredness and anaemia (low red blood cell counts).
Najpogostejši neželeni učinki zdravila Lonsurf (ki se lahko pojavijo pri več kot 3 bolnikih od 10) so nevtropenija (nizke vrednosti nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam), slabost, utrujenost in anemija (nizka raven rdečih krvnih celic).
What is Lonsurf and what is it used for?
Kaj je zdravilo Lonsurf in za kaj se uporablja?
It contains two active substances: trifluridine and tipiracil.
Vsebuje dve učinkovini: trifluridin in tipiracil.
In one main study involving 800 patients, those treated with Lonsurf lived on average for 7.1 months compared with 5.3 months for patients who were treated with placebo (a dummy treatment).
V glavni študiji, ki je vključevala 800 bolnikov, so tisti, ki so prejemali zdravilo Lonsurf, živeli povprečno 7,1 meseca, v primerjavi s 5,3 meseca pri bolnikih, zdravljenih s placebom (zdravilom brez učinkovine).
Regarding its safety, although Lonsurf's side effects can be serious they are in line with what can be expected for this type of medicine.
Z vidika varnosti so neželeni učinki zdravila Lonsurf sicer lahko resni, vendar so v skladu s pričakovanji za citotoksično zdravilo.
Lonsurf is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells).
Zdravilo Lonsurf je citotoksično zdravilo (zdravilo, ki uniči celice, ki se delijo, kot so rakave celice).
The most serious side effects are bone marrow suppression (when the bone marrow produces fewer blood cells than normal) and effects on the gut (diarrhoea and feeling sick).
Najpogostejši resni neželeni učinki so supresija kostnega mozga (kadar kostni mozeg proizvaja manj krvnih celic kot običajno) in neželeni učinki na prebavila (driska in slabost).
In a study involving 507 adults with metastatic gastric cancer, patients treated with Lonsurf lived on average for 5.7 months compared with 3.6 months for patients who received placebo.
V študiji, ki je vključevala 570 odraslih z metastatskim rakom želodca, so bolniki, ki so prejemali zdravilo Lonsurf, živeli povprečno 5,7 meseca v primerjavi s 3,6 meseca pri bolnikih, ki so prejemali placebo.
Lonsurf is a medicine used to treat adults with colorectal cancer (cancer of the large bowel) and gastric (stomach) cancer.
Lonsurf je zdravilo, ki se uporablja za zdravljenje odraslih s kolorektalnim rakom (rakom debelega črevesa) in rakom želodca.
An overview of Lonsurf and why it is authorised
Pregled zdravila Lonsurf in zakaj je odobreno v EU
For the full list of side effects and restrictions of Lonsurf, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Lonsurf glejte navodilo za uporabo.
How does Lonsurf work?
Kako zdravilo Lonsurf deluje?
As a result, trifluridine interferes with DNA function and prevents the cells from dividing to make more cells.
Tako moti delovanje DNK ter prepreči delitev in razmnoževanje celic.
The doctor may reduce the dose or interrupt treatment if certain side effects develop.
V primeru določenih neželenih učinkov bo zdravnik morda zmanjšal odmerek ali začasno prekinil zdravljenje.
The Agency considered that the benefit of Lonsurf in prolonging survival in patients with metastatic colorectal and metastatic gastric cancer who have received previous treatment was important.
Menila je, da so koristi zdravila Lonsurf pri podaljšanju preživetja bolnikov z metastatskim kolorektalnim rakom in metastatskim rakom želodca, ki so se predhodno že zdravili, klinično pomembne.
Lonsurf contains the active substances trifluridine and tipiracil.
Zdravilo Lonsurf vsebuje učinkovini trifluridin in tipiracil.
How is Lonsurf used?
Kako se zdravilo Lonsurf uporablja?
Lonsurf prolonged overall survival of patients with metastatic colorectal cancer and in patients with metastatic gastric cancer.
Zdravilo Lonsurf je podaljšalo celokupno preživetje bolnikov z metastatskim kolorektalnim rakom, ki so predhodno prejemali druga zdravila.
Date of first authorisation: 19 May 2006 Date of latest renewal: 11 February 2016
Datum prve odobritve: 19. maj 2006 Datum zadnjega podaljšanja: 11. februar 2016
Average VE§
Povprečna VE§
VE over study period‡
VE v obdobju študije‡
North Carolina 27712 U.S.A
North Carolina 27712 ZDA
• if you have or have had any medical problems or any allergies
• če imate ali ste kdaj imeli kakršne koli zdravstvene težave ali alergije,
d. Special populations
d. Posebne populacije
Some of these reactions may be serious and may include difficulty in breathing or swallowing.
Nekatere od teh reakcij so lahko hude in lahko vključujejo težave z dihanjem ali požiranjem.
e. Other studies
e. Druge študije
VZV-seronegative adults
VZV-seronegativni odrasli
It may lead to severe and long-lasting pain and scarring.
Lahko povzroči hudo in dolgotrajno bolečino in brazgotinjenje.
VE % (95% CI)
VE % (95 % IZ)
• if you have HIV infection
• če imate okužbo z virusom HIV.
286 subjects received two doses and 9 subjects received only one dose.
286 oseb je prejelo dva odmerka, 9 oseb pa le en odmerek.
See sections 4.3 and 4.4.
Glejte poglavji 4.3 in 4.4.
Sometimes, after many years, the virus becomes active again and causes shingles.
Včasih po več letih virus postane znova aktiven in povzroči pasovec.
Inject the vaccine.
Cepivo injicirajte.
The safety and efficacy of ZOSTAVAX in children and adolescents have not been established.
Varnost in učinkovitost cepiva ZOSTAVAX pri otrocih in mladostnikih nista bili dokazani.
Read all of this leaflet carefully before you are vaccinated because it contains important information for you.
Pred cepljenjem natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this vaccine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega cepiva.
The requirements for submission of periodic safety update reports for this medicinal products 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 predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The adverse reactions are assigned frequency categories using the following convention: Very Common (≥1/10);
Kategorije pogostnosti neželenih učinkov so opredeljene po naslednjem dogovoru: Zelo pogosti (≥ 1/10)
If you have an allergic reaction, call your doctor right away.
Če imate alergijsko reakcijo, se takoj posvetujte z zdravnikom.
After the shingles blisters heal, pain can last for months or years and may be severe.
Ko se pasovec (izpuščaj) zaceli, lahko bolečina traja še mesece ali leta in je lahko huda.
Vaccine efficacy (95% CI)
Učinkovitost cepiva (95 % IZ)
The other ingredients are:
Druge sestavine cepiva so:
As these events are reported voluntarily from a population of uncertain size, it is not possible to reliably calculate their frequency or establish a causal relationship to vaccine exposure.
Ker gre za dogodke, o katerih so poročali prostovoljno iz populacije neznane velikosti, ni mogoče zanesljivo izračunati njihove pogostnosti ali ugotoviti vzročne povezave z izpostavljenostjo cepivu.
• if you have a blood disorder or any type of cancer that weakens your immune system
• če imate krvno bolezen ali katero koli vrsto raka, ki je oslabil vaš imunski sistem,
This vaccine may contain traces of neomycin.
To cepivo lahko v sledeh vsebuje neomicin.
In clinical trials, general safety has been evaluated in more than 57,000 adults vaccinated with ZOSTAVAX.
V kliničnih preskušanjih so splošno varnost ocenili pri več kot 57.000 odraslih, cepljenih s cepivom ZOSTAVAX.
• Active untreated tuberculosis.
• Aktivna, nezdravljena tuberkuloza.
Reconstitution instructions intended for healthcare professionals are included at the end of the leaflet.
Navodila za pripravo cepiva, namenjena zdravstvenemu osebju, se nahajajo na koncu navodila.
However, data collected in a large observational study did not indicate increased risk for developing herpes zoster after concomitant administration of the two vaccines.
Toda podatki, zbrani v obsežni opazovalni študiji, niso pokazali večjega tveganja za pojav herpesa zostra po sočasni uporabi obeh cepiv.
Rarely (may affect up to 1 in 1,000 people), allergic reactions may occur.
Redko (pojavijo se lahko pri največ 1 od 1.000 oseb) se lahko pojavijo alergijske reakcije.
Neomycin allergy generally manifests as a contact dermatitis.
Alergija na neomicin se običajno pokaže kot kontaktni dermatitis.
Less commonly, bacterial skin infections, weakness, muscle paralysis, loss of hearing or vision can occur.
Manj pogosto se lahko pojavijo še bakterijske okužbe kože, oslabelost, mišična paraliza in izguba sluha ali vida.
Produced in human diploid (MRC-5) cells
Pridobljen na humanih diploidnih (MRC-5) celicah.
Adverse events were followed up to Day 42 post vaccination and serious adverse events throughout the entire study period (i.e. through Day 180).
Neželene učinke so spremljali do 42. dne po cepljenju, resne neželene učinke pa med celotnim obdobjem študije (tj. do 180. dne).
What ZOSTAVAX is and what it is used for
Kaj je cepivo ZOSTAVAX in za kaj ga uporabljamo
Shingles Prevention Study (SPS)
Študija preprečevanja pasovca (SPS)
Pharmacotherapeutic group: Vaccines, Viral Vaccine; ATC code: J07BK02
Farmakoterapevtska skupina: Cepiva, virusna cepiva, oznaka ATC: J07BK02
Data from a clinical trial (n=368) demonstrated that the current refrigerated formulation has a safety profile comparable to that of the frozen formulation.
Podatki iz kliničnega preskušanja (n = 368) kažejo, da ima sedanja oblika, ki se shranjuje v hladilniku, varnostni profil, primerljiv s tistim za zamrznjeno obliko.
Avoid contact with disinfectants as they may inactivate the vaccine virus.
Preprečite stik z razkužili, ker lahko inaktivirajo virus v cepivu.
Most of the reporting rashes that were VZV positive by PCR analysis were associated with wild-type VZV.
Večina poročanih izpuščajev, ki je bila VZV pozitivna po PCR analizi, je bila povezana z divjim tipom VZV.
The European Medicines Agency has waived the obligation to submit the results of studies with ZOSTAVAX in all the subsets of paediatric population (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s cepivom ZOSTAVAX za vse podskupine pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalcev bioloških učinkovin
Abbreviations: VE denotes vaccine effectiveness; CI confidence interval; DxCG diagnostic cost group; HCUP healthcare cost and utilization project
Okrajšave: VE - učinkovitost cepiva; IZ - interval zaupanja; DxCG - skupina diagnostičnih stroškov; HCUP - stroški zdravstvenega varstva in projekt utilizacije
• if you are pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see
• če ste noseči (poleg tega ne smete zanositi 1 mesec po cepljenju, glejte Nosečnost in dojenje).