natgillin/translations-raw huggingface dataset:
The full EPAR for Gardasil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Gardasil je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.Za več informacij o zdravljenju z zdravilom Gardasil preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Another study in around 800 girls and women compared the effect of two doses of Gardasil in girls aged nine to 13 years with the effect of three doses in girls and young women aged 16 to 24 years. 
V drugi študiji, v katero je bilo vključenih okoli 800 deklic in žensk, so primerjali učinek dveh odmerkov zdravila Gardasil pri deklicah, starih od devet do trinajst let, in učinek treh odmerkov pri deklicah in mlajših ženskah, starih od 16 do 24 let.
• precancerous lesions (growths) in the cervix, vulva or vagina and anus; 
• predrakavimi lezijami (nenormalno rastjo celic) na materničnem vratu, ženskih zunanjih ali notranjih spolovilih in zadnjiku);
HPV types 16 and 18 cause approximately 70% of cervical cancers and between 75 and 80% of anal cancers. 
Tipa 16 in 18 humanega papilomavirusa sta povzročitelja približno 70 % vseh primerov raka materničnega vratu in 80 % raka zadnjika.
It is recommended that individuals who receive the first dose of Gardasil should complete the dosing regimen with Gardasil. 
Priporočeno je, da osebe, ki prejmejo prvi odmerek, prejmejo vse tri odmerke zdravila Gardasil.
Three studies of Gardasil given as three doses looked at the ability of Gardasil to prevent infection with HPV types 6, 11, 16 and 18 and genital warts caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years. 
V treh študijah so proučevali sposobnost zdravila Gardasil, danega v treh odmerkih, za preprečevanje okužbe s tipi 6, 11, 16 in 18 humanega papilomavirusa ter bradavic na spolovilih, ki jih povzročijo ti tipi humanega papilomavirusa, pri skoraj 4 000 ženskah, starih od 24 do 45 let, in nastanek protiteles proti omenjenim tipom virusa pri okoli 1 700 deklicah in dečkih, starih od devet do 15 let.
Finally, a main study in around 4,000 boys and men from 16 years of age compared the vaccine with placebo to test the vaccine's effect in preventing genital warts, precancerous anal lesions and anal cancer. 
V glavni študiji, v katero je bilo vključenih okoli 4 000 dečkov in moških, starejših od 16 let, so nazadnje cepivo primerjali s placebom, da bi preizkusili učinek cepiva pri preprečevanju nastanka bradavic na spolovilih, predrakavih lezij na zadnjiku in raka zadnjika.
If the second dose is given earlier than six months after the first dose, a third dose should always be given. 
Če se drugi odmerek da pred pretekom šestih mesecev po prvem odmerku,
In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group. 
Za razliko od tega so med skoraj 8 000 ženskami iz skupine, ki je prejemala placebo, zabeležili 189 primerov lezij na zunanjih spolovilih.
For people aged nine to thirteen years, Gardasil can be given as two doses six months apart. 
Zdravilo Gardasil se lahko daje osebam, starim od devet do trinajst let, v dveh odmerkih s šestmesečnim razmikom.
In addition, these studies confirmed the ability of Gardasil to protect against lesions and HPV infection in 24- to 45-year-old women. 
Poleg tega so te študije potrdile, da zdravilo Gardasil ščiti ženske, stare od 24 do 45 let, pred lezijami in okužbo s humanim papilomavirusom.
In four main studies of Gardasil given as three dose, Gardasil was compared with placebo (a dummy vaccine) in almost 21,000 women aged between 16 and 26 years. 
Zdravilo Gardasil, ki so ga dajali v treh odmerkih, so s placebom primerjali v štirih glavnih študijah, v katerih je sodelovalo skoraj 21 000 žensk, starih od 16 do 26 let.
In the four studies in 21,000 women, out of the more than 8,000 women vaccinated with Gardasil who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18. 
V štirih študijah, v katere je bilo vključenih 21 000 žensk, je bilo dokazano, da so se v skupini žensk, ki predhodno niso bile okužene s tipi 6, 11, 16 ali 18 humanega papilomavirusa, pri eni bolnici od več kot 8 000 žensk, cepljenih z zdravilom Gardasil, pojavile predrakave lezije na materničnem vratu, ki bi lahko bile povezane s tipom 16 ali 18 humanega papilomavirusa.
HPV types 6 and 11 cause approximately 90% of genital warts. 
Tipa 16 in 11 humanega papilomavirusa sta povzročitelja približno 90 % bradavic na spolovilih.
How has Gardasil been studied? 
Kako je bilo zdravilo Gardasil raziskano?
What is Gardasil used for? 
Za kaj se zdravilo Gardasil uporablja?
What is Gardasil? 
Kaj je zdravilo Gardasil?
In the three studies on genital warts, 2 women out of almost 8,000 in the Gardasil group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina. 
V treh študijah, v katerih so proučevali bradavice na spolovilih, so se bradavice na spolovilih pojavile pri dveh bolnicah od skoraj 8 000 žensk v skupini, ki je prejemala zdravilo Gardasil, primerov predrakavih lezij na zunanjem ali notranjem spolovilu pa ni bilo.
How does Gardasil work? 
Kako zdravilo Gardasil deluje?
Vaccination should be postponed in patients who are ill with a high fever. 
Pri osebah, ki so bolne in imajo povišano telesno temperaturo, je treba cepljenje odložiti.
For people aged fourteen or above, Gardasil is normally given according to a three-dose schedule with the second dose given two months after the first and the third given four months after the second. 
Zdravilo Gardasil se osebam, starejšim od štirinajst let, običajno daje v treh odmerkih, pri čemer drugi odmerek sledi dva meseca po prvem, tretji pa štiri mesece po drugem.Enake tri odmerke lahko prejmejo tudi osebe, stare od devet do trinajst let.
• cervical and anal cancers; 
• rakom materničnega vratu ali zadnjika;
How is Gardasil used? 
Kako se zdravilo Gardasil uporablja?
In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types. 
Nasprotno pa so se lezije, ki jih je povzročila okužba s tema dvema tipoma humanega papilomavirusa, pojavile pri 85 bolnicah od več kot 8 000 žensk, ki so bile cepljene s placebom.
Filgrastim has been available in other medicines in the EU for a number of years. 
Filgrastim je v Evropski uniji kot sestavina v drugih zdravilih na voljo že več let.
Further information on Pegfilgrastim Mundipharma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma. 
Nadaljnje informacije za zdravilo Pegfilgrastim Mundipharma so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma.
The most common side effect with Pegfilgrastim Mundipharma (which may affect more than 1 in 10 people) is pain in the bones. 
Najpogostejši neželeni učinek zdravila Pegfilgrastim Mundipharma (ki se lahko pojavi pri več kot 1od 10 bolnikov) je bolečina v kosteh.
This means that Pegfilgrastim Mundipharma is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever due to an infection). 
Zdravilo se daje zlasti za skrajševanje trajanja nevtropenije in preprečevanje febrilne nevtropenije (nevtropenije, ki jo spremlja povišana telesna temperatura zaradi okužbe).
Side effects reported with Pegfilgrastim Mundipharma are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Pegfilgrastim Mundipharma, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Pegfilgrastim Mundipharma is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy. 
Zdravilo Pegfilgrastim Mundipharma se daje v obliki enkratnega 6-miligramskega odmerka, ki se injicira pod kožo vsaj 24 ur po koncu vsakega cikla kemoterapije.
What measures are being taken to ensure the safe and effective use of Pegfilgrastim Mundipharma? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pegfilgrastim Mundipharma?
For more information about using Pegfilgrastim Mundipharma, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Pegfilgrastim Mundipharma glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pegfilgrastim Mundipharma 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 Pegfilgrastim Mundipharma upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Pegfilgrastim Mundipharma and why it is authorised in the EU 
Pregled zdravila Pegfilgrastim Mundipharma in zakaj je odobreno v EU
Pegfilgrastim Mundipharma can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders. 
Predpisovanje in izdaja zdravila Pegfilgrastim Mundipharma je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem rakavih obolenj ali krvnih bolezni.
As for all medicines, data on the use of Pegfilgrastim Mundipharma are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Pegfilgrastim Mundipharma stalno spremljajo.
All these data were considered sufficient to conclude that Pegfilgrastim Mundipharma will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses. 
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Pegfilgrastim Mundipharma pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Neulasta.
The safety of Pegfilgrastim Mundipharma has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta. 
Varnost zdravila Pegfilgrastim Mundipharma je bila ocenjena in na podlagi vseh izvedenih študij so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Neulasta.
The active substance in Pegfilgrastim Mundipharma, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF). 
Učinkovina v zdravilu Pegfilgrastim Mundipharma, pegfilgrastim, je ena od oblik filgrastima, ki je zelo podoben človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF).
Because Pegfilgrastim Mundipharma is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pegfilgrastim Mundipharma. 
Zdravilo Pegfilgrastim Mundipharma je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti pegfilgrastima, izvedenih z zdravilom Neulasta, z zdravilom Pegfilgrastim Mundipharma ni treba ponavljati.
Pegfilgrastim Mundipharma is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia). 
Zdravilo Pegfilgrastim Mundipharma ni namenjeno uporabi pri bolnikih s krvnim rakom, tj. kronično mieloično levkemijo ali mielodisplastičnimi sindromi (boleznimi, pri katerih nastajajo velike količine nenormalnih krvnih celic, ki se lahko razvijejo v levkemijo).
Why is Pegfilgrastim Mundipharma authorised in the EU? 
Zakaj je bilo zdravilo Pegfilgrastim Mundipharma odobreno v EU?
What benefits of Pegfilgrastim Mundipharma have been shown in studies? 
Kakšne koristi zdravila Pegfilgrastim Mundipharma so se pokazale v študijah?
The reference medicine for Pegfilgrastim Mundipharma is Neulasta. 
Referenčno zdravilo za zdravilo Pegfilgrastim Mundipharma je zdravilo Neulasta.
Pegfilgrastim Mundipharma is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer chemotherapy and can leave patients vulnerable to infections. 
Pegfilgrastim Mundipharma je zdravilo, ki se uporablja pri bolnikih z rakom za pomoč pri nevtropeniji (zmanjšanem številu nevtrofilcev, vrste belih krvnih celic), ki je pogost neželeni učinek pri zdravljenju raka s kemoterapijo, zaradi katerega pa so bolniki dovzetnejši za okužbe.
What are the risks associated with Pegfilgrastim Mundipharma? 
Kakšna tveganja so povezana z zdravilom Pegfilgrastim Mundipharma?
Other information about Pegfilgrastim Mundipharma 
Druge informacije o zdravilu Pegfilgrastim Mundipharma
For the full list of side effects and restrictions with Pegfilgrastim Mundipharma, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Pegfilgrastim Mundipharma glejte navodilo za uporabo.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pegfilgrastim Mundipharma has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Pegfilgrastim Mundipharma po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Neulasta in da se po telesu enako prenaša.
What is Pegfilgrastim Mundipharma and what is it used for? 
Kaj je zdravilo Pegfilgrastim Mundipharma in za kaj se uporablja?
Studies have also shown that giving Pegfilgrastim Mundipharma produces similar levels of the active substance in the body to giving Neulasta. 
Študije so pokazale tudi, da zdravilo Pegfilgrastim Mundipharma vzpostavi podobne ravni učinkovine v telesu kot zdravilo Neulasta.
Therefore, the Agency's view was that, as for Neulasta, the benefits of Pegfilgrastim Mundipharma outweigh the identified risks and it can be authorised for use in the EU. 
Zato je agencija menila, da koristi zdravila Pegfilgrastim Mundipharma enako kot pri zdravilu Neulasta odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
Laboratory studies comparing Pegfilgrastim Mundipharma with Neulasta have shown that the active substance in Pegfilgrastim Mundipharma is highly similar to that in Neulasta in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Pegfilgrastim Mundipharma primerjali z zdravilom Neulasta, so pokazale, da je učinkovina v zdravilu Pegfilgrastim Mundipharma po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Neulasta.
How does Pegfilgrastim Mundipharma work? 
Kako Pegfilgrastim Mundipharma deluje?
Mundipharma, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol). 
V zdravilu Pegfilgrastim Mundipharma je filgrastim „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
Pegfilgrastim Mundipharma is a ‘biosimilar medicine'. 
Zdravilo Pegfilgrastim Mundipharma je „podobno biološko zdravilo“.
How is Pegfilgrastim Mundipharma used? 
Kako se zdravilo Pegfilgrastim Mundipharma uporablja?
Pegfilgrastim Mundipharma contains the active substance pegfilgrastim. 
Zdravilo Pegfilgrastim Mundipharma vsebuje učinkovino pegfilgrastim.
{Name and Address} {tel} {fax} {e-mail} 
{Ime in naslov} {tel.} {fax} {e-mail}
Long-term carcinogenicity studies have not been performed. 
Dolgoročnih študij kancerogenosti niso opravili.
0.8 (sublingual) 
0,8 (sublingualno)
As a general rule in EU, if such a study would have to be conducted, the 50 µg/h strength would be recommended. 
Kot splošno pravilo v EU velja, da če je treba izvesti tako študijo, je priporočljiva jakost 50 µg/h.
The experience in children under 12 years of age is limited. 
Izkušnje uporabe pri otrocih starih manj kot 12 let so omejene.
In most cases this is after 72 hours (3 days), in some patients after 48 hours (2 days). 
Običajno po 72 urah (3 dneh), pri nekaterih bolnikih pa po 48 urah (2 dneh).
based on the documentation submitted by the Marketing Authorisation Holder and the scientific discussion within the Committee, 
je, na podlagi dokumentacije, ki jo je posredoval imetnik dovoljenja za promet z zdravilom, in znanstvene razprave v okviru Odbora,
This may affect serum concentrations. 
To lahko vpliva na koncentracije v serumu.
Your doctor will base his judgement on: the severity of your pain, your general condition and the type of pain treatment that you have received so far. 
Svojo odločitev bo utemeljil z: jakostjo bolečine, vašo splošno kondicijo in načinom zdravljenja bolečine, ki ste ga do sedaj prejemali.
10 (rectal) 
10 (rektalno)
Usually the patch does not come off by itself. 
Ponavadi se obliž sam ne odlepi.
Its principal therapeutic effects are analgesia and sedation. 
Njegova glavna terapevtska učinka sta analgezija in sedacija.
You should change your patch at the same time of day every three days (every 72 hours), unless directed otherwise by your doctor. 
Obliž zamenjajte ob istem času vsake tri dni (vsakih 72 ur), če vaš zdravnik ne določi drugače.
This may help you remember when to change your patch. 
To vam lahko pomaga, da si zapomnite, kdaj je potrebno obliž zamenjati.
Non-epileptic (myo)clonic reactions can occur. 
Lahko se pojavijo neepileptične (mio)klonične reakcije.
Teratogenic effects have, however, not been demonstrated. 
Teratogenih učinkov ni bilo.
If you do stop using the patches you may feel unwell. 
Če prenehate uporabljati obliže, se lahko neprijetno počutite.
painful flatulence, ileus. 
boleči vetrovi, ileus
Therefore, due to ethical and safety reasons, it would be questionable to conduct studies with the highest strength when all necessary information could be derived from studies with lower patch strengths. 
Posledično je iz etičnih in varnostnih razlogov vprašljivo izvajanje študij z najvišjimi jakostmi, če je vse potrebne informacije mogoče pridobiti iz študij z obliži z manjšimi jakostmi.
It may harm them, even if their symptoms are the same as yours. 
Slednjim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
Spain ratiopharm España, S.A. 
Spanija ratiopharm España, S.A.
For a full list of excipients, see section 6.1. 
Za celoten seznam pomožne snovi glejte poglavje 6.1.
skin reactions on the application site. 
kožne reakcije na mestu uporabe
Increased intracranial pressure 
Povišan intrakranialni pritisk
Long-term treatment during pregnancy may cause withdrawal symptoms in the infant. 
Dolgotrajno zdravljenje med nosečnostjo lahko povzroči odtegnitvene simptome pri novorojencih.
This is also the case with used transdermal patches. 
To velja tudi za transdermalne obliže.
Albert-SchweitzerGasse 3, 1140 WIEN, Austria 
Albert-SchweitzerGasse 3, 1140 WIEN, Avstrija
- Apply a new patch as described above but on another part of the skin. 
- Nov obliž namestite kot je opisano zgoraj, vendar na drugo izbrano mesto.
The tendency to develop tolerance varies considerably between individuals. 
Hitrost razvoja tolerance je pri posameznih bolnikih precej različna.
The quantity of analgesics required over the last 24 hours should be determined. 
Določite potrebno količino analgetikov v zadnjih 24 urah.
The CHMP considered also that bioequivalence between test and reference medicinal product has been sufficiently characterised in 2 studies (single and multiple dose) performed with a reduced patch size (7.5 cm²). 
CHMP je nadalje menil, da je bila bioekvivalenca med testnim in referenčnim zdravilom v zadostni meri opredeljena v 2 študijah (z enkratnimi in večkratnimi odmerki), izvedenih z zmanjšano velikostjo obliža (7,5 cm²).
Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spain 
Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spanija
Furthermore, a study at the highest dose (100 µg/h) would be possible only in intensive care units and under concomitant treatment with opioid antagonists (naltrexone) in order to avoid life threatening side effects. 
Nadalje bi bila študija z največjimi odmerki (100 µg/h) možna le v oddelkih za intenzivno nego in pri sočasnem zdravljenju z opioidnimi antagonisti (naltreksonom), da bi tako preprečili življenjsko nevarne stranske učinke.
The most serious undesirable effect of fentanyl is respiratory depression. 
Najresnejši neželeni učinek fentanila je respiratorna depresija.
WARNING: 
OPOZORILO:
Not known (cannot be estimated from the available data): Long-term use of fentanyl can lead to development of tolerance and physical and psychological dependence. 
Neznano (iz obstoječih podatkov ni mogoče ovrednotiti): Pri dolgotrajni uporabi fentanila se lahko razvijejo toleranca, telesna in psihična odvisnost.
- A fentanyl transdermal patch is usually used for 72 hours (3 days). 
- Transdermalni obliž se ponavadi uporablja 72 ur (tri dni).
If analgesia is insufficient at the end of the initial application period, the dose may be increased after 3 days, until the desired effect is obtained for each patient. 
Če je analgetični učinek ob koncu začetnega obdobja uporabe neustrezen, lahko odmerek povečujete v tridnevnih presledkih, dokler ne dosežete želenega učinka.
The major metabolite, norfentanyl, is inactive. 
Glavni presnovek, norfentanil, je neaktiven.
Physical dependence may develop as well and you might experience withdrawal symptoms, if you do suddenly stop using the patches. 
Lahko se pojavi tudi fizična odvisnost in odtegnitveni simptomi, če nenadoma prenehate uporabljati obliže.
Inform your doctor if you develop a fever during the treatment, as the increased body temperature may cause too much medicine to pass through the skin. 
Svojega zdravnika obvestite, če se med zdravljenjem pri vas pojavi vročina, ker lahko zvišana telesna temperatura povzroči pospešeno prehajanje zdravila skozi kožo.
The following frequencies are used for the description of the occurrence of adverse reactions: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10,000, <1/1000), Very rare (<1/10,000) 
Opis neželenih učinkov temelji na naslednjih podatkih o pogostosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000).
It is allowed to stay outside in the sun, but you must protect the patch with some piece of clothing during hot summer days. 
Dovoljeno je, da ste izpostavljeni soncu, vendar je potrebno v vročih poletnih dneh obliž pred soncem zavarovati s kosom obleke.
Because of the importance of an adequate pain management for the mother, the CHMP agrees, in accordance with the “guideline on summary of product characteristics”, that the proposed text stays in section 4.6 and should not be included as a contra-indication. 
Z ozirom na pomembnost ustreznega obvladovanja bolečin pri materah se CHMP strinja, v skladu s „smernico o povzetku glavnih značilnosti zdravila“, da predlagano besedilo ostane v poglavju 4.6 in se ne vključi kot kontraindikacija.
Austria ratiopharm 
Avstrija ratiopharm
In such cases increased care and observation of the patient should be undertaken. 
V teh primerih je potrebna večja skrb in natančno spremljanje bolnika.
- In children, the upper back is the preferred location to apply the patch, to minimize the potential of the child removing the patch. 
- Pri otrocih je zgornji del hrbta najprimernejše mesto namestitve, da zmanjšamo možnost, da ga otroci odstranijo sami.