natgillin/translations-raw huggingface dataset:
• Extremely rarely, thrombosis has been reported to occur in other blood vessels, e.g. hepatic, mesenteric, renal, cerebral or retinal veins and arteries, in hormonal contraceptive users. 
• Izredno redko so pri uporabnicah hormonskih kontraceptivov, poročali o trombozi v drugih žilah, npr. jetrnih, mezenteričnih, ledvičnih, možganskih ali mrežničnih venah in arterijah.
For the treatment of acne, <invented name> should only be used after topical therapy or systemic antibiotic treatments have failed. 
Zdravilo <ime zdravila> se lahko uporablja za zdravljenje aken le takrat, ko lokalno zdravljenje ali sistemsko zdravljenje z antibiotiki, nista bili uspešni.
Your doctor will also tell you when you can start using <invented name> again after you are back on your feet. 
Vaš zdravnik vam bo tudi svetoval, kdaj po okrevanju lahko spet začnete uporabljati zdravilo <ime zdravila>.
Summary of Product Characteristics (SmPC) 
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
• Presence or history of cerebrovascular accident 
• cerebrovaskularni dogodek, prisoten ali v anamnezi
• There is an increased risk of thromboembolism for all women who use <invented name> (see section 4.4). 
• Pri vseh ženskah, ki uporabljajo zdravilo <ime zdravila>, je tveganje za trombembolijo povečano (glejte poglavje 4.4).
• Venous thromboembolic disorders 
• venska trombembolija
Section 4.4 Special warnings and precautions for use [The wording below should be inserted in this section] <invented name> is composed of the progestogen cyproterone acetate and the oestrogen ethinylestradiol and is administered for 21 days of a monthly cycle. 
Zdravilo <ime zdravila> vsebuje progestagen ciproteronacetat in estrogen etinilestradiol in se ga jemlje 21 dni v mesečnem ciklusu.
Your doctor may tell you to stop using <invented name> several weeks before surgery or while you are less mobile. 
Vaš zdravnik vam bo morda svetoval, da nekaj tednov pred operacijo ali ko ste manj pokretni prenehate uporabljati zdravilo <ime zdravila>.
• if you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism) 
• če imate (ali ste kdaj imeli) krvni strdek v nogah (tromboza), pljučih (pljučna embolija) ali drugih delih telesa
• The use of <invented name> carries an increased risk of venous thromboembolism (VTE) compared with no use. 
• Pri ženskah, ki uporabljajo zdravilo <ime zdravila>, je tveganje za pojav venske trombembolije (VTE) večje kot pri ženskah, ki ga ne uporabljajo.
an unusual sudden cough; severe pain in the chest which may reach the left arm; breathlessness; any unusual, severe, or long-lasting headache or worsening of migraine; partial or complete loss of vision, or double vision; slurring or speech disability; sudden changes to your hearing, sense of smell, or taste; dizziness or fainting; weakness or numbness in any part of your body; severe pain in your abdomen; severe pain or swelling in either of your legs. 
Takoj nehajte jemati tablete in se posvetujte s svojim zdravnikom, če opazite kakršne koli znake, ki spremljajo nastanek krvnih strdkov, npr.: neobičajen, nenaden kašelj huda bolečina v prsnem košu, ki se lahko širi v levo roko težko dihanje vsak nenavaden, hud ali dolgotrajen glavobol ali poslabšanje migrene delna ali popolna izguba vida ali dvojni vid nerazločno govorjenje ali nezmožnost govorjenja nenadne spremembe sluha, spremenjen vonj ali okus omotica ali omedlevica šibkost ali omrtvelost katerega koli dela telesa hude bolečine v trebuhu hude bolečine ali oteklost ene noge
Blood clots in an artery 
Krvni strdki v arteriji
Section 4.1 Therapeutic indications [The currently approved indications should be deleted and replaced by the following:] Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. 
Zdravljenje zmernih do hudih aken, povezanih z občutljivostjo za androgene (z ali brez seboreje) in/ali hirzutizmom, pri ženskah v rodni dobi.
Blood clots in a vein 
Krvni strdki v venah
- hypertension; - migraine; - valvular heart disease; - atrial fibrillation; - a positive family history (arterial thrombosis ever in a sibling or parent at a relatively early age). 
če želijo jemati zdravilo <ime zdravila>) - dislipoproteinemijo - debelostjo (indeks telesne mase več kot 30 kg/m²) - hipertenzijo - migreno - boleznijo srčnih zaklopk - atrijsko fibrilacijo - pozitivno družinsko anamnezo (tj. z arterijsko trombozo pri sorojencu ali katerem od staršev v sorazmerno zgodnji starosti).
[The wording below should be inserted in this section] When should you contact your doctor 
Opozorila in previdnostni ukrepi [Spodnje besedilo je treba vstaviti v to poglavje] Kdaj se morate posvetovati z zdravnikom
Adequate contraception should be initiated because of the teratogenicity of anti-coagulant therapy (coumarins). 
Zaradi teratogenosti antikoagulantnega zdravljenja (kumarinov) je treba uporabljati drugo ustrezno kontracepcijsko metodo.
• if you have (or have ever had) a heart attack or stroke 
• če imate (ali ste kdaj v preteklosti imeli) srčni infarkt ali možgansko kap
Antithrombotic treatment should be considered if the use of <invented name> has not been discontinued in advance. 
Če jemanje zdravila <ime zdravila> ni prekinjeno vnaprej, je treba razmisliti o antitrombotičnem zdravljenju.
Circulatory disorders 
KLINIČNI PODATKI
The following serious adverse events have been reported in women using <invented name>, which are discussed in section 4.4 Special warning and precautions for use: 
• Žilne bolezni, redke (≥ 1/10.000 do < 1/1.000): trombembolija [Naslednje besedilo je treba vključiti pod preglednico o neželenih učinkih] Pri ženskah, ki uporabljajo zdravilo <ime zdravila>, so poročali o naslednjih resnih neželenih učinkih, ki so podrobneje navedeni v poglavju 4.4 Posebna opozorila in previdnostni ukrepi:
Stop taking tablets and contact your doctor immediately if you notice possible signs of a blood clot. 
Če opazite kakršne koli znake, ki spremljajo nastanek krvnih strdkov, takoj prenehajte jemati tablete in se posvetujte s svojim zdravnikom.
Women over 35 years of age should be strongly advised not to smoke if they wish to use <invented name>); - dyslipoproteinemia; - obesity (body mass index over 30 kg/m2); 
Ženskam po 35. letu je treba strogo odsvetovati kajenje, če želijo jemati zdravilo <ime zdravila>).
The risk of arterial thromboembolic complications or of a cerebrovascular accident increases with: - increasing age; - smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age. 
Tveganje za nastanek arterijskih trombemboličnih zapletov ali cerebrovaskularnega dogodka se povečuje s: - starostjo
Tell your doctor if any of the following conditions applies to you before starting to use <invented name>. 
Preden boste začeli jemati zdravilo <ime zdravila>, obvestite zdravnika, če kar koli od naštetega velja za vas.
(e.g angina pectoris which cases severe pain in the chest) or ‘mini-stroke' (transient ischaemic attack) 
• če imate (ali ste kdaj imeli) bolezen, ki lahko napoveduje srčni napad (npr angina pektoris, ki povzroča hudo bolečino v prsnem košu) ali rahlo možgansko kap" (prehodni ishemični napad)
What you need to know before you use < invented name > [The wording below should be inserted in the relevant sections] 
Kaj morate vedeti, preden boste uporabili zdravilo <ime zdravila>
If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any hormonal contraceptive use; - prolonged immobilisation, major surgery, any surgery to the legs, or major trauma. 
- dolgotrajno imobilizacijo, večjo operacijo, vsako operacijo nog ali večjo poškodbo.
The main measure of effectiveness was the average change in the blood pressure. 
Glavno merilo učinkovitosti je bila povprečna sprememba v krvnem tlaku.
In addition, one main study was carried out in around 1,200 patients with essential hypertension. 
Izvedena je bila tudi ena glavna študija, v katero je bilo vključenih okoli 1 200 bolnikov z esencialno hipertenzijo.
The application was withdrawn at ‘day 180'. 
Vloga je bila umaknjena na 180. dan postopka.
It was to be available as film-coated tablets. 
Na voljo naj bi bilo v obliki filmsko obloženih tablet.
This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions. 
To pomeni, da je CHMP ovrednotil dokumentacijo, ki jo je družba predložila, in pripravil seznam vprašanj.
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'. 
Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo pod zavihkom „Vsi dokumenti“.
The two active substances in Rasival are anti-hypertensive medicines that are already in use in the European Union (EU). 
Obe zdravilni učinkovini v zdravilu Rasival sta antihipertenzivni zdravili, ki se v Evropski uniji (EU) že uporabljata.
The effects of Rasival were first tested in experimental models before being studied in humans. 
Učinki zdravila Rasival so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The company presented results of studies designed to show that the tablet containing the two substances is absorbed in the body in the same way as the separate tablets. 
Družba je predstavila rezultate študij, s katerimi je želela dokazati, da tablete, ki vsebujejo obe zdravilni učinkovini, telo absorbira na enak način kot dve posamezni tableti.
Withdrawal of the marketing authorisation application for Rasival (aliskiren / valsartan) EMA/584655/2010 
Umik vloge za dovoljenje za promet z zdravilom Rasival (aliskiren/valsartan) EMA/584655/2010
Aliskiren reduces the production of the angiotensin II (a hormone that narrows blood vessels), while valsartan blocks the receptors to which angiotensin II normally attaches. 
Aliskiren znižuje proizvajanje angiotenzina II (hormon, ki zožuje krvne žile), medtem ko valsartan zavira receptorje, na katere se angiotenzin II običajno veže.
The CHMP wanted further studies to be carried out on how Rasival behaved in the body, specifically after a patient has eaten food. 
CHMP je želel, da se izvedejo še nadaljnje študije o delovanju zdravila Rasival v telesu, zlasti po zaužiti hrani.
The company had not yet responded to the last round of questions at the time of the withdrawal. 
Ob umiku vloge družba na zadnji sklop vprašanj še ni odgovorila.
In addition, the CHMP was not convinced that the company had demonstrated that the combination of aliskiren and valsartan is widely used in clinical practice. 
CHMP prav tako ni bil prepričan, da je družba ustrezno dokazala, da se zdravljenje s kombinacijo aliskirena in valsartana v klinični praksi pogosto uporablja.
On 15 September 2010, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Rasival, for the treatment of essential hypertension in adults whose blood pressure is already adequately controlled with a combination of aliskiren and valsartan taken separately. 
Družba Novartis Europharm Limited je dne 15. septembra 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Rasival, namenjenemu zdravljenju esencialne hipertenzije pri odraslih bolnikih, pri katerih se krvni tlak ustrezno uravnava s kombinacijo aliskirena in valsartana, ki se jemljeta ločeno.
The company informed the CHMP that there are no consequences for patients in clinical trials or compassionate use programmes, as there are no ongoing trials with Rasival. 
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki sodelujejo v kliničnih preskušanjih ali v programih sočutne uporabe, saj z zdravilom Rasival trenutno ne potekajo nobena preskušanja.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Rasival could not have been approved for the treatment of essential hypertension. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Rasival za zdravljenje esencialne hipertenzije ni mogoče odobriti.
What was Rasival expected to be used for? 
Za kaj naj bi se zdravilo Rasival uporabljalo?
How is Rasival expected to work? 
Kako naj bi zdravilo Rasival delovalo?
Rasival was expected to be used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of aliskiren and valsartan taken separately. 
Zdravilo Rasival naj bi se uporabljalo za zdravljenje esencialne hipertenzije (visok krvni tlak) pri odraslih, pri katerih se krvni tlak že ustrezno uravnava s kombinacijo aliskirena in valsartana, ki se jemljeta ločeno.
By blocking the activity of angiotensin II, Rasival acts to widen blood vessels and so lower blood pressure. 
Z zaviranjem delovanja angiotenzina II zdravilo Rasival vpliva na razširjanje krvnih žil in tako znižuje krvni tlak.
Withdrawal of the marketing authorisation application for Rasival (aliskiren / valsartan) 
Umik vloge za dovoljenje za promet z zdravilom Rasival (aliskiren/valsartan)
Patients received either Rasival or a medicine containing only one of the active substances, aliskiren or valsartan, for eight weeks. 
Bolniki so osem tednov prejemali zdravilo Rasival ali zdravilo, ki vsebuje le eno izmed dveh zdravilnih učinkovin, aliskiren ali valsartan.
Therefore, at the time of the withdrawal, the CHMP was of the opinion the company had not provided enough scientific data to support the application for Rasival. 
Tako je CHMP v času umika vloge menil, da družba v podporo vlogi za dovoljenje za promet z zdravilom Rasival ni predložila zadostnih znanstvenih podatkov.
Rasival is a medicine that contains the active substances aliskiren and valsartan. 
Rasival je zdravilo, ki vsebuje zdravilni učinkovini aliskiren in valsartan.
What is Rasival? 
Kaj je zdravilo Rasival?
Date of first authorisation: 28 February 2011 Date of latest renewal: 24 April 2015 
Datum prve odobritve: 28. februar 2011 Datum zadnjega podaljšanja: 24.
Children and adolescents Daliresp should not be used by children and adolescents under 18 years of age. 
Otroci in mladostniki Zdravilo Daliresp se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
You may need to take Daliresp for several weeks to achieve its beneficial effect. 
Morda boste morali jemati zdravilo Daliresp več tednov, da doseže svoj ugoden učinek.
If on one day you have forgotten to take a tablet of Daliresp, just carry on the next day with the next tablet as usual. 
Če ste na določen dan pozabili vzeti tableto zdravila Daliresp, potem naslednji dan samo nadaljujte z naslednjo tableto kot običajno.
In case of an allergic reaction, stop taking Daliresp and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital. 
V primeru pojava alergijske reakcije nemudoma prenehajte jemati zdravilo Daliresp in se nemudoma posvetujte z zdravnikom ali poiščite nujno zdravniško pomoč na urgentnem oddelku najbližje bolnišnice.
Daliresp may need to be taken for several weeks to achieve its effect (see section 5.1). 
Zdravilo Daliresp je treba jemati nekaj tednov, preden doseže svoj učinek (glejte poglavje 5.1).
Do not take Daliresp - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section 
Ne jemljite zdravila Daliresp - če ste alergični na roflumilast ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
•Obligation to conduct post-authorisation measures 
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
Before starting treatment with Daliresp, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects. 
Pred začetkom zdravljenja z zdravilom Daliresp obvestite zdravnika, če imate kakršne koli simptome te vrste ali, če morebiti jemljete še dodatna zdravila, ker lahko katero od teh poveča verjetnost teh neželenih učinkov.
• Copies of the patient card to be given to patients or caregivers before they receive Daliresp 
• Kopije opozorilne kartice za bolnika, ki naj bi jih bolniki ali skrbniki prejeli pred začetkom jemanja zdravila Daliresp
The educational pack should contain the following: • Summary of Product Characteristics and Patient Information Leaflet for Daliresp 
Izobraževalno gradivo mora vsebovati naslednje: • Povzetek glavnih značilnosti zdravila in navodilo za uporabo zdravila Daliresp
The need to inform patients about the risks of Daliresp and the precautions for safe use including: 
Obveznost informiranja bolnikov o tveganjih zdravila Daliresp in previdnostnih ukrepih za varno uporabo vključujoč:
Daliresp is to be used in addition to bronchodilators. 
Zdravilo Daliresp se uporablja poleg bronhodilatatorjev.
Thus Daliresp eases breathing problems. 
Tako zdravilo Daliresp olajša težave z dihanjem.
Daliresp has been studied in clinical trials for up to one year. 
Klinične študije z zdravilom Daliresp so trajale do enega leta.
Other medicines and Daliresp 
Druga zdravila in zdravilo Daliresp
The fact that Daliresp is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency. 
Dejstvo, da zdravilo Daliresp ni indicirano za zdravljenje bolnikov s KOPB izven odobrene indikacije, niti ni primerno za uporabo pri bolnikih z astmo ali pomanjkanjem alfa-1-antitripsina.
Daliresp should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma). 
Zdravila Daliresp se ne sme uvesti oz. ga je treba ukiniti pri bolnikih z rakom (z izjemo bazalnoceličnega karcinoma).
Hypromellose Macrogol 4000 Titanium dioxide (E171) Iron oxide yellow (E172) 
Obloga hipromeloza makrogol 4000 titanov dioksid (E171) rumeni železov oksid (E172)
The potential risk of infections: Dalirespshould not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases. 
Potencialno tveganje za okužbe: zdravila Dalirespse ne sme uvajati oz. zdravljenje je treba prekiniti pri bolnikih z resnimi oblikami akutnih infekcijskih bolezni.
All patients should be informed about the risks of Daliresp and the precautions for safe use and should be given a patient card before starting Daliresp. 
Vse bolnike je treba obvestiti o tveganjih zdravila Daliresp in previdnostnih ukrepih za varno uporabo in jim je treba dati kartico za bolnike pred začetkom jemanja zdravila.
In two confirmative replicate one-year studies (M2-124 and M2-125) and two supplementary six-month studies (M2-127 and M2-128), a total number of 4,768 patients were randomized and treated of whom 2,374 were treated with roflumilast. 
V dve potrditveni ponovljeni enoletni študiji (M2-124 in M2-125) in dve dodatni šestmesečni študiji (M2-127 in M2-128) je bilo randomiziranih skupno 4.768 bolnikov, od tega jih je bilo 2.374 zdravljenih z roflumilasom.
Daliresp is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms). 
Zdravilo Daliresp ni namenjeno zdravljenju nenadnih napadov težkega dihanja (akutni bronhospazmi).
The effect of Daliresp may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy). 
Učinek zdravila Daliresp se lahko zmanjša, če istočasno jemljete rifampicin (antibiotik) ali fenobarbital, karbamazepin ali fenitoin (zdravila, ki so običajno predpisana za zdravljenje epilepsije).
1 What Daliresp is and what it is used for 
Kaj je zdravilo Daliresp in za kaj ga uporabljamo
The potential cardiac risk: Daliresphas not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population. 
Potencialno tveganje za srce: zdravilo Daliresp ni bilo raziskano pri bolnikih s kongestivnim srčnim popuščanjem (NYHA stopnje 3 in 4); za to populacijo ni priporočljiv.
The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daliresp and the potential risk of suicide. 
Tveganje za psihiatrične motnje, npr. nespečnost, tesnobo, depresijo, pri bolnikih, ki jemljejo zdravilo Daliresp in potencialno tveganje za samomor.
The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Daliresp are provided with an updated Educational pack. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo imeli vsi zdravniki, ki bodo predpisovali zdravilo Daliresp, na razpolago posodobljeno izobraževalno gradivo.
2 What you need to know before you take Daliresp 
Kaj morate vedeti, preden boste vzeli zdravilo Daliresp
There is no relevant use of Daliresp in the paediatric population (under 18 years) in the indication COPD. 
Uporaba zdravila Daliresp za indikacijo KOPB pri pediatrični populaciji (mlajših od 18 let) ni primerna.
If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low blood pressure. 
Če ste vzeli večji odmerek zdravila Daliresp, kot bi smeli Če ste vzeli več tablet kot bi smeli, se lahko pojavijo naslednji simptomi: glavobol, slabost, driska, omotica, udarjanje srca, vrtoglavica, vlažna in hladna koža ter nizek krvni tlak.
If you forget to take Daliresp 
Če ste pozabili vzeti zdravilo Daliresp
You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Daliresp may be harmful for the unborn baby. 
Ves čas zdravljenja morate uporabljati učinkovito kontracepcijo, saj lahko zdravilo Daliresp škodljivo vpliva na nerojenega otroka.
The clinical data with Daliresp in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daliresp should be used with caution in these patients. 
Klinični podatki o uporabi zdravila Daliresp pri bolnikih z blago okvaro jeter stopnje Child-Pugh A ne zadostujejo, da bi lahko priporočili prilagoditev odmerka (glejte poglavje 5.2), zato je pri teh bolnikih treba zdravilo Daliresp uporabljati previdno.
Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. 
Zdravilo Daliresp je indicirano za vzdrževalno zdravljenje hude oblike kronične obstruktivne pljučne bolezni (KOPB) (FEV1 po bronhodilatatorju manjši od 50 % pričakovane vrednosti), povezane s kroničnim bronhitisom, pri odraslih bolnikih z anamnezo pogostih poslabšanj bolezni kot dopolnilo zdravljenju z bronhodilatatorji.
If you stop taking Daliresp 
Če ste prenehali jemati zdravilo Daliresp
There is a lack of relevant experience with Daliresp under these conditions. 
V takšnih primerih ni ustreznih izkušenj z uporabo zdravila Daliresp.
Daliresp has no influence on the ability to drive and use machines. 
Zdravilo Daliresp nima vpliva na sposobnost vožnje in upravljanja s stroji.
Daliresp is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis. 
Zdravilo Daliresp uporabljamo za vzdrževalno zdravljenje KOPB pri odraslih, ki so v preteklosti imeli pogosta poslabšanja simptomov KOPB in imajo kronični bronhitis.
Driving and using machines Daliresp has no influence on the ability to drive and use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Daliresp nima vpliva na sposobnost vožnje in upravljanja s stroji.
Daliresp tablets contain lactose. 
Zdravilo Daliresp vsebuje laktozo.