natgillin/translations-raw huggingface dataset:
On 26 April 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Cabazitaxel Teva, intended for the treatment of prostate cancer.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 26. aprila 2019 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Cabazitaxel Teva, namenjenim zdravljenju raka prostate.
The company informed the CHMP that there are no ongoing clinical trials with Cabazitaxel Teva in the EU.
Podjetje je odbor CHMP obvestilo, da v EU trenutno ne poteka nobeno klinično preskušanje z zdravilom Cabazitaxel Teva.
The company made reference to two medicines, Jevtana (containing cabazitaxel) and Taxotere (containing docetaxel, see below for more details).
Podjetje se je sklicevalo na dve zdravili, in sicer zdravilo Jevtana (ki vsebuje kabazitaksel) in zdravilo Taxotere (ki vsebuje docetaksel; za več podrobnosti glejte spodaj).
Based on these findings, the CHMP was of the opinion that it cannot be concluded that cabazitaxel and docetaxel do not differ significantly with regard to safety and effectiveness.
Odbor CHMP je na podlagi teh ugotovitev menil, da ni mogoče zaključiti, da se kabazitaksel in docetaksel glede varnosti in učinkovitosti ne razlikujeta bistveno.
Because Cabazitaxel Teva was developed as a hybrid medicine, the company presented data from the published literature to demonstrate that it is similar to Jevtana.
Ker je bilo zdravilo Cabazitaxel Teva razvito kot hibridno zdravilo, je podjetje predložilo podatke iz objavljene literature kot dokaz, da je podobno zdravilu Jevtana.
The applicant also made reference to another medicine, Taxotere, which contains docetaxel.
Predlagatelj se je skliceval še na zdravilo Taxotere, ki vsebuje docetaksel.
The CHMP did not agree that the data presented by the company were sufficient to support the claim that cabazitaxel and docetaxel should be considered the same active substance.
Odbor CHMP se ni strinjal, da podatki, ki jih je predložilo podjetje, zadoščajo kot podpora trditvi, da je treba kabazitaksel in docetaksel obravnavati kot enaki učinkovini.
This means that Cabazitaxel Teva was intended to be similar to a ‘reference medicine' containing the same active substance and already authorised in the European Union.
To pomeni, da naj bi bilo podobno „referenčnemu zdravilu“, ki vsebuje enako učinkovino in je že odobreno v Evropski uniji.
Cabazitaxel works by blocking the ability of cancer cells to break down their internal ‘skeleton' that allows them to divide and multiply.
Deluje tako, da zavira sposobnost rakavih celic za razgradnjo njihovega notranjega „ogrodja“, ki jim omogoča, da se delijo in množijo.
Cabazitaxel also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.
Kabazitaksel učinkuje tudi na nerakave celice, kot so krvne ali živčne celice, kar lahko povzroči neželene učinke.
The company claimed that cabazitaxel is a derivative of docetaxel, and that the active substances do not differ significantly in their safety and effectiveness.
Podjetje je trdilo, da je kabazitaksel derivat docetaksela in da se učinkovini glede varnosti in učinkovitosti ne razlikujeta bistveno.
Cabazitaxel Teva was developed as a ‘hybrid medicine'.
Zdravilo Cabazitaxel Teva je bilo razvito kot „hibridno zdravilo“.
Cabazitaxel Teva was to be used when the cancer had spread to other parts of the body (metastatic) despite treatments to prevent the production of testosterone or after surgical removal of the testes (castration).
Zdravilo Cabazitaxel Teva naj bi se uporabljalo, kadar se je rak razširil na druge dele telesa (metastaziral) kljub zdravljenjem za zaviranje tvorjenja testosterona ali po kirurški odstranitvi mod (kastraciji).
Refusal of the marketing authorisation for Cabazitaxel Teva (cabazitaxel)
Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Cabazitaxel Teva (kabazitaksel)
Cabazitaxel Teva was expected to be used to treat men with prostate cancer, a cancer that affects the prostate gland (which produces the liquid in semen).
Zdravilo Cabazitaxel Teva naj bi se uporabljalo za zdravljenje moških z rakom prostate, tj. rakom, ki prizadene žlezo prostato (ki proizvaja tekočino v spermi).
There was no need for ‘bioequivalence' studies to investigate whether Cabazitaxel Teva is absorbed similarly to Jevtana to produce the same level of the active substance in the blood.
Izvedba študije „bioekvivalence“, s katero bi raziskali, ali se zdravilo Cabazitaxel Teva absorbira podobno kot zdravilo Jevtana in tako doseže enako raven učinkovine v krvi, ni bila potrebna.
This is because Cabazitaxel Teva is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Zdravilo Cabazitaxel Teva se namreč daje z infundiranjem v veno, tako da učinkovina vstopa neposredno v krvni obtok.
Cabazitaxel belongs to the group of cancer medicines known as ‘taxanes'.
Kabazitaksel spada v skupino zdravil za zdravljenje raka, imenovanih „taksani“.
Cabazitaxel Teva is a cancer medicine that contains the active substance cabazitaxel.
Cabazitaxel Teva je zdravilo za zdravljenje raka, ki vsebuje učinkovino kabazitaksel.
Cabazitaxel Teva was to be used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine).
Uporabljalo naj bi se v kombinaciji s prednizonom ali prednizolonom (protivnetnima zdraviloma) pri bolnikih, ki so se že zdravili z docetakselom (drugim zdravilom za zdravljenje raka).
Cabazitaxel Teva is expected to work in the same way as the reference medicine, Jevtana.
Zdravilo Cabazitaxel Teva naj bi delovalo na enak način kot referenčno zdravilo Jevtana.
What is Cabazitaxel Teva?
Kaj je zdravilo Cabazitaxel Teva?
What was Cabazitaxel Teva expected to be used for?
Za kaj naj bi se zdravilo Cabazitaxel Teva uporabljalo?
How does Cabazitaxel Teva work?
Kako zdravilo Cabazitaxel Teva deluje?
Thus Taxotere cannot be used to support the application for Cabazitaxel Teva and the CHMP recommended that Cabazitaxel Teva be refused marketing authorisation.
Zato zdravila Taxotere ni mogoče uporabiti v podporo vlogi za zdravilo Cabazitaxel Teva.
Although cabazitaxel is a derivative of docetaxel, laboratory studies have shown that cabazitaxel and docetaxel have different properties, for example cabazitaxel can cross the blood-brain barrier while docetaxel cannot.
Čeprav je kabazitaksel derivat docetaksela, so laboratorijske študije pokazale, da imata kabazitaksel in docetaksel drugačne lastnosti.
Egg production may also be affected.
Prizadeta je lahko tudi proizvodnja jajc.
If another course of treatment is required, the interval between the two courses of treatment should be at least 3 months.
Če je potreben še en cikel zdravljenja, mora interval med obema zdravljenjema znašati vsaj tri mesece.
The duration of effectiveness was between 6 weeks and 8 months, depending on the length of the production cycle and how effectively the farms prevented re-introduction of new mites into their houses.
Učinkovitost je trajala od 6 tednov do 8 mesecev, odvisno od dolžine proizvodnega ciklusa in tega, kako učinkovito so farme preprečevale ponovni vnos pršic v svoje hleve.
While handling the product people must not eat, drink or smoke.
Pri ravnanju z zdravilom se ne sme jesti, piti ali kaditi.
The full EPAR for Exzolt can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Exzolt je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
It is not intended to provide practical advice on how to use Exzolt.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Sufficient Exzolt is added to ensure the required dose is present in the volume of water that the chickens will consume in one day.
Doda se dovolj zdravila Exzolt, da se zagotovi potreben odmerek v količini vode, ki jo bodo piščanci zaužili v enem dnevu.
This means it kills parasites such as mites that feed on the skin of animals.
To pomeni, da ubija parazite, kot so pršice, ki se hranijo na koži živali.
Exzolt reduced the number of mites by more than 99% in pullets and breeders and more than 98% in layers.
Zdravilo Exzolt je število pršic zmanjšalo za več kot 99 % pri jarkicah in matičnih jatah ter za več kot 98 % pri nesnicah.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Exzolt's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Exzolt večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Exzolt.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Exzolt.
Exzolt has been studied in a field study involving 9 farms with poultry red mite infestation, each with two similar houses with 550 to 100,000 chickens per house.
Zdravilo Exzolt so raziskovali v terenski raziskavi, v katero je bilo vključenih devet farm, na katerih je prišlo do infestacije z rdečimi pršicami perutnine, vsaka pa je imela dva podobna hleva s 550 do 100 000 piščanci na hlev.
What are the risks associated with Exzolt?
Kakšna tveganja so povezana z zdravilom Exzolt?
Fluralaner kills mites by acting on their nervous system after they have ingested the chicken's blood.
Fluralaner ubija pršice tako, da deluje na njihov živčni sistem, potem ko so zaužile kri piščanca.
It works by interfering with the way that signals are passed between nerve cells (neurotransmission) in the nervous system of parasites, resulting in paralysis and death of the mites.
Deluje tako, da ovira pot, po kateri potujejo signali med živčnimi celicami v živčnem sistemu zajedavcev, kar povzroči paralizo in pogin pršic.
What benefits of Exzolt have been shown in studies?
Kakšne koristi je zdravilo Exzolt izkazalo v študijah?
Why is Exzolt approved?
Zakaj je bilo zdravilo Exzolt odobreno?
Since the veterinary medicine may be slightly irritating to skin and/or eyes, contact with skin, eyes and mucous membranes (moist body surfaces, such as the lining of the mouth) should be avoided.
Ker je zdravilo za uporabo v veterinarski medicini lahko rahlo dražilno za kožo in/ali oči, se je treba izogibati stiku s kožo, očmi in sluznicami (vlažnimi telesnimi površinami, kot je ustna sluznica).
Exzolt is a veterinary medicine used to treat poultry red mite (Dermanyssus gallinae) infestation in pullets (young female chickens), breeders and layer hens.
Exzolt je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zdravljenje infestacij z rdečimi pršicami perutnine (Dermanyssus gallinae) pri jarkicah (mladih piščancih ženskega spola), matičnih jatah in kokoših nesnicah.
Poultry red mite is a parasite that feeds on the blood of hens.
Rdeča pršica perutnine je parazit, ki se hrani s krvjo kokoši.
Red mite infestations can cause irritation and restlessness of the bird, feather pecking and anaemia (low red blood cell counts).
Infestacije z rdečimi pršicami lahko povzročijo razdraženost in nemir ptičev, kljuvanje perja in anemijo (nizko število rdečih krvnih celic).
Exzolt is added to drinking water on two occasions, seven days apart.
Zdravilo Exzolt se v pitno vodo doda dvakrat v razmiku sedmih dni.
What is Exzolt and what is it used for?
Kaj je zdravilo Exzolt in za kaj se uporablja?
The withdrawal period for eggs from chickens treated with Exzolt is ‘zero' days, which means there is no mandatory waiting time.
Karenca za jajca piščancev, zdravljenih z zdravilom Exzolt, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
Hands and contacted skin should be washed after use of the medicine.
Roke in kožo, ki je prišla v stik z zdravilom, je treba po uporabi zdravila sprati.
The withdrawal period for meat from chickens treated with Exzolt is 14 days.
Karenca za meso piščancev, zdravljenih z zdravilom Exzolt, je 14 dni.
One of the houses on each of the farms was treated with Exzolt, the other house was left untreated.
V enem od hlevov na vsaki farmi so bile živali zdravljene z zdravilom Exzolt, v drugem hlevu pa niso bile zdravljene.
The active substance in Exzolt, fluralaner, acts as an ‘ectoparasiticide'.
Zdravilna učinkovina v zdravilu Exzolt, fluralaner, deluje kot ektoparaziticid.
Other information about Exzolt?
Druge informacije o zdravilu Exzolt
Exzolt is available as a solution for use in drinking water and can only be obtained with a prescription.
Zdravilo Exzolt je na voljo v obliki raztopine za dajanje v vodo za pitje, njegovo predpisovanje in izdaja pa je le na recept.
Exzolt contains the active substance fluralaner.
Zdravilo Exzolt vsebuje zdravilno učinkovino fluralaner.
Safety information has been included in the summary of product characteristics and the package leaflet for Exzolt, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila Exzolt in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
For more information about treatment with Exzolt, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Exzolt naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
The European Commission granted a marketing authorisation valid throughout the EU for Exzolt on 18 August 2017.
Evropska komisija je izdala dovoljenje za promet z zdravilom Exzolt, veljavno po vsej Evropski uniji
For practical information about using Exzolt, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Exzolt naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
How is Exzolt used?
Kako se zdravilo Exzolt uporablja?
How does Exzolt work?
Kako zdravilo Exzolt deluje?
This usually disappears within one to four weeks.
Ta navadno izgine v enem do štirih tednih.
This summary was last updated on 24 October 2007.
Povzetek je bil nazadnje posodobljen 24. oktobra 2007.
The marketing authorisation was renewed on 18 April 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 18. aprila 2005.
Immunisation against FeLV sub-group A provides full protection against all three sub-groups of the virus: A, B and C.
Cepljenje proti virusu FeLV podskupine A nudi celovito zaščito proti vsem trem podskupinam virusa: A, B in C.
Immunity starts at the latest two weeks after the second injection and lasts for a year.
Imunost se razvije najkasneje dva tedna po drugi injekciji in traja eno leto.
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax FeLV to MERIAL on 13 April 2000.
Evropska komisija je dovoljenje za promet z zdravilom Purevax FeLV, veljavno po vsej Evropski uniji, odobrila družbi MERIAL dne 13. aprila 2000.
The cats should be revaccinated every year.
Mačke je treba po enem letu znova cepiti.
Temporary lethargy (listlessness) and hyperthermia (increased body temperature) may occur for one day, exceptionally for two days.
Lahko se pojavita začasna letargičnost (ravnodušnost) in hipertermija (povišana telesna temperatura), ki trajata en dan ter le izjemoma dva dni.
The first injection should be given in cats aged at least eight weeks, with a second injection three to five weeks later.
Prvo injekcijo je treba dati mačkam, ki so stare vsaj osem tednov, druga injekcija pa ji mora slediti tri do pet tednov kasneje.
Information on the prescription status of this product may be found on the label/outer package.
Podatki o statusu predpisovanja tega zdravila so na nalepki/zunanji ovojnini.
Vaccines work by priming the immune system (the body's natural defences) how to defend itself against diseases.
Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) pripravijo na obrambo proti bolezni.
In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor.
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite Navodilo za uporabo ali nalepko na škatli zdravila.
The antibodies will help to protect against the disease caused by the virus.
Protitelesa bodo pomagala ščititi mačke proti bolezni, ki jo povzroča ta virus.
The vaccine is used to prevent the symptoms of the disease and to prevent FeLV from remaining in the blood.
Cepivo se uporablja za preprečevanje simptomov bolezni in preprečevanje zadrževanja virusa FeLV v krvi.
The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Poxvirusi kanarčkov se v mački ne širijo in ne množijo, tvorijo pa proteine iz genov virusa FeLV.
When a cat is given the vaccine, the immune system recognises the FeLV proteins as ‘foreign' and makes antibodies against them.
Kadar mačka prejme cepivo, imunski sistem prepozna beljakovine virusa FeLV kot „tuje“ in začne proti njim tvoriti protitelesa.
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to the FeLV.
V prihodnosti lahko imunski sistem ob izpostavitvi virusu FeLV hitreje ustvarja protitelesa.
The effectiveness of Purevax FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with FeLV.
Učinkovitost zdravila Purevax FeLV so raziskali v več preizkušanjih v laboratorijskih pogojih, pri katerih so mačke cepili in okužili z virusom FeLV.
The benefit-risk balance may be found in module 6 of this EPAR.
Razmerje med koristmi in tveganji je v modulu 6 tega Evropskega javnega poročila o oceni zdravila (EPAR).
A 1 ml dose of Purevax FeLV is injected under the skin.
Odmerek 1 ml zdravila Purevax FeLV se vbrizga pod kožo.
A temporary small nodule (hard lump) may appear at the site of injection.
Na mestu vbrizganja se lahko začasno pojavi manjši vozlič (trda bula).
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREVAX FELV EPAR summary for the public
EMEA/V/C/056 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PUREVAX FELV Povzetek EPAR za javnost
Other information about Purevax FeLV:
Druge informacije o zdravilu Purevax FeLV:
In all trials, the main measure of effectiveness was the presence of antibodies against the virus and infectious FeLV in the vaccinated kittens' blood.
V vseh preizkušanjih je bilo glavno merilo učinkovitosti prisotnost protiteles proti virusu in kužnemu virusu FeLV v krvi cepljenih muck.
The first evidence of FeLV infection occurred after six weeks in only a few of the kittens vaccinated with Purevax FeLV.
Prvi dokazi o okužbi z virusom FeLV so se pojavili po šestih tednih pri samo majhnem številu muck, ki so jih cepili z zdravilom Purevax FeLV.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax FeLV exceed the risks for active immunisation of cats eight weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease, and recommended that Purevax FeLV be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Purevax FeLV pri aktivni imunizaciji mačk, starih osem tednov ali več, proti mačji levkemiji za preprečevanje perzistentne viremije in kliničnih znakov z njo povezane bolezni, večje od z njim povezanih tveganj, ter je priporočil odobritev dovoljenja za promet z zdravilom Purevax FeLV.
Purevax FeLV should not be used in pregnant cats.
Zdravila Purevax FeLV ne bi smeli uporabljati pri brejih mačkah.
Infection was seen from four weeks in non-vaccinated animals.
Okužbo pri živalih, ki jih niso cepili, so opazili od četrtega tedna dalje.
What benefit has Purevax FeLV shown during the studies?
Kakšne koristi je zdravilo Purevax FeLV izkazalo med študijami?
The vaccinated kittens were housed for up to 28 weeks with a group of kittens who were infected with FeLV.
Cepljene mucke so za največ 28 tednov nastanili s skupino muck, ki so bile okužene z virusom FeLV.
In the field, efficacy has been studied in one main study of kittens aged eight weeks or older, in which the effects of Purevax FeLV were compared with those of another vaccine against FeLV.
Na terenu so izvedli eno glavno študijo na muckah, ki so bile stare osem tednov ali več, pri katerih so učinke zdravila Purevax FeLV primerjali z učinki drugega cepiva proti virusu FeLV.
For a full list of all side effects reported with Purevax FeLV, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Purevax FeLV, glejte Navodilo za uporabo.
Purevax FeLV contains genes from the FeLV sub-group A called env and gag which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology'.
Zdravilo Purevax FeLV vsebuje gene virusa FeLV podskupine A, imenovane env in gag, ki so jih s pomočjo „tehnologije rekombinantne DNA“ vstavili v drug vektorski (prenašalni) virus, imenovan poxvirus kanarčkov.
Purevax FeLV is used to vaccinate cats from the age of eight weeks against feline leukaemia, an illness affecting the immune system caused by a type of virus known as a retrovirus.
Zdravilo Purevax FeLV se uporablja za cepljenje mačk, starih osem tednov ali več, proti mačji levkemiji, bolezni, ki prizadene imunski sistem in jo povzroča tip virusa, znan tudi kot retrovirus.
Purevax FeLV vaccine provided protection against FeLV infection.
Cepivo Purevax FeLV je ustvarilo zaščito proti okužbi z virusom FeLV.
What is the risk associated with Purevax FeLV?
Kakšna tveganja so povezana z zdravilom Purevax FeLV?
Purevax FeLV is a vaccine containing feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
Zdravilo Purevax FeLV je cepivo z rekombinantnim poxvirusom kanarčkov (vCP97), ki vsebuje antigen virusa mačje levkemije (FeLV).
Purevax FeLV is presented as a suspension for injection.
Zdravilo Purevax FeLV je suspenzija za injiciranje.
Purevax FeLV is a vaccine.
Zdravilo Purevax FeLV je cepivo.
Why has Purevax FeLV been approved?
Zakaj je bilo zdravilo Purevax FeLV odobreno?
What is Purevax FeLV?
Kaj je zdravilo Purevax FeLV?
How has Purevax FeLV been studied?
Kako je bilo zdravilo Purevax FeLV raziskano?
What is Purevax FeLV used for?
Za kaj se zdravilo Purevax FeLV uporablja?
How does Purevax FeLV work?
Kako zdravilo Purevax FeLV deluje?
to you and your child.
za vas in vašega otroka.
Date of first authorisation: 28 April 2017
Datum prve odobritve: 28. april 2017
- Risk management plan (RMP)
- Načrt za obvladovanje tveganj (RMP)
with food and drink
skupaj s hrano in pijačo
should not be given to adolescents with existing kidney problems.
se ne sme dajati mladostnikom z obstoječimi ledvičnimi težavami.
may be considered during pregnancy, if necessary.
med nosečnostjo, če je potrebno.
(see sections 4.2, 4.4 and 5.2).
(glejte poglavja 4.2, 4.4 in 5.2).
less frequently.
uporabljate manj pogosto.
contains lactose later in this section).
vsebuje laktozo v nadaljevanju tega poglavja).
has not been studied in patients over 65 years of age.
niso proučevali pri bolnikih, starejših od 65 let.
is not for use in children under 12 years of age.
ne smejo uporabljati otroci, mlajši od 12 let.
This is because the active substances in this medicine pass into human breast milk.
To je zato, ker zdravilni učinkovini tega zdravila prehajata v materino mleko.
you may still develop infections or other illnesses associated with HIV infection.
lahko še vedno pride do okužbe ali drugih bolezni, povezanih z okužbo s HIV.