natgillin/translations-raw huggingface dataset:
• Treatment of sarcoptic mange (caused by Sarcoptes scabiei) 
• Zatiranje garij vrste Sarcoptes ( Sarcoptes scabiei)
Loose debris should be gently removed from the external ear canal at each treatment. 
Pri vsakem zdravljenju moramo nežno odstraniti odluščeno skorjico iz zunanjega ušesnega kanala.
For complete elimination of the mites, a single dose of the veterinary medicinal product should be administered for two consecutive months. 
Za popolno odpravo garij zadostuje odmerek zdravila za uporabo v veterinarski medicini, ki ga dajemo dva meseca zapored.
Remove the product pipette from its protective package. 
Merilno kapalko z zdravilom vzamemo iz zaščitnega ovoja.
Marketing authorisation holder and manufacturer responsible for batch release: Chanelle Pharmaceuticals Manufacturing Ltd, Loughrea, 
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea,
Selamectin 15 mg 
selamektin 15 mg
Loose debris should be gently removed from the external ear canal at the time of treatment. 
V času zdravljenja moramo nežno odstraniti odluščeno skorjico iz zunanjega ušesnega kanala.
Animals may be bathed 2 hours after treatment without loss of efficacy. 
2 uri po nanosu lahko živali kopamo, brez da bi se učinkovitost zdravila zmanjšala.
• Treatment of adult intestinal hookworms (Ancylostoma tubaeforme). 
• Zatiranje odraslih črevesnih nematodov (Ancylostoma tubaeforme).
3 pipettes, 15 pipettes 
3 merilne kapalke 15 merilnih kapalk
The product should be administered as a single application of a single dose delivering a minimum of 6 mg/kg selamectin. 
Zdravilo dajemo v enkratnem odmerku, ki zagotavlja najmanj 6 mg selamektina na kg telesne mase.
This ensures that fleas infesting the animal are killed, no viable flea eggs are produced by these fleas, and larvae (found only in the environment) are also killed. 
Taka uporaba zagotovi, da poginejo bolhe, ki so na živali, proizvodnja jajčec je ustavljena in ličinke (ki se nahajajo le v okolju) poginejo.
CARTON, 45 mg, 60 mg for cats 
Škatla, 45 mg, 60 mg za mačke
Chanhold 15 mg for cats and dogs 
Chanhold 15 mg za mačke in pse
Following spot on administration selamectin is absorbed from the skin reaching maximum plasma concentrations approximately 1 and 3 days after administration in cats and dogs respectively. 
Po nanosu na kožo se selamektin resorbira in doseže maksimalno plazemsko koncentracijo približno v 1 dnevu po nanosu pri mačkah oziroma 3 dneh po nanosu pri psih.
Selamectin 30 mg Selamectin 60 mg Selamectin 120 mg Selamectin 240 mg Selamectin 360 mg 
selamektin 30 mg selamektin 60 mg selamektin 120 mg selamektin 240 mg selamektin 360 mg
Following absorption from the skin selamectin distributes systemically and is slowly eliminated from plasma as manifested in detectable plasma concentrations in dogs and cats 30 days after administration of a single topical dose at 6 mg/kg. 
Z detekcijo koncentracije selamektina v plazmi so ugotovili, da se selamektin po resorbciji iz kože, sistemsko porazdeli in se nato počasi eliminira iz plazme še 30 dni po nanosu enkratnega odmerka (6 mg/kg) na kožo.
The product can be used in breeding, pregnant and lactating cats and dogs. 
Lahko se uporablja pri vzrejnih, brejih in doječih psicah in mačkah.
This breaks the flea life cycle and prevents flea infestations. 
Razvojni krog bolhe je prekinjen in preprečena je ponovna infestacija z bolhami.
A single dose of the veterinary medicinal product should be administered. 
Za zdravljenje zadostuje enkraten odmerek zdravila za uporabo v veterinarski medicini.
Each single-dose (pipette) delivers: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak enkratni odmerek (merilna kapalka) vsebuje:
Chanhold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg selamectin 
Chanhold 15 mg kožni nanos, raztopina za mačke in pse ≤ 2,5 kg selamektin
The alopecia and irritation are normally self-resolving, but symptomatic therapy may be applicable in some circumstances. 
Izguba dlake in draženje kože običajno prenehata sama od sebe, nekatere živali pa potrebujejo simptomatično zdravljenje.
CARTON, 30 mg, 60 mg, 120 mg, 240 mg, 360 mg for dogs 
Škatla, 30 mg, 60 mg, 120 mg, 240 mg, 360 mg za pse
FOIL LABEL/SACHET FOIL, 15 mg, 30 mg, 45 mg, 60 mg, 120 mg, 240 mg, 360 mg 
Etiketa iz folije/Vrečica iz folije, 15 mg,30 mg, 45 mg, 60 mg, 120 mg, 240mg, 360 mg
12% w/v solution 
12% w/v raztopina selamektin
6% w/v solution 
6% w/v raztopina selamektin
The final dose must be given within one month after the last exposure to mosquitoes. 
Zadnji odmerek je treba dati najkasneje mesec dni po zadnjem stiku živali s komarji.
It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when the product has been administered monthly. 
V okviru preprečevanja dirofilarioze priporočamo periodično testiranje psov na morebitno okužbo z odraslo dirofilarijo, tudi takrat, ko zdravilo uporabljamo mesečno.
• Treatment of biting lice infestations (Trichodectes canis) 
• Zatiranje infestacij z ušmi (Trichodectes canis)
Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestation in the litter up to seven weeks of age. 
Z zmanjševanjem populacije bolh, mesečno zdravljenje brejih in doječih psic omogoča preprečevanje infestacije z bolhami pri mladičih do sedmega tedna starosti.
• Treatment of adult intestinal roundworms (Toxocara canis). 
• Zatiranje odraslih intestinalnih nematodov (Toxocara canis).
Selamectin was administered at 3 times the recommended dose to cats and dogs infected with adult heartworms and no undesirable effects were observed. 
Po uporabi 10-kratnega priporočenega odmerka niso opazili neželenih učinkov.Po trikratnem priporočenem odmerku selamectina, ki so ga dali mačkam in psom, inficiranim z odraslimi filarijami, niso opazili neželenih učinkov.
Treatment of sarcoptic mange (dogs) 
Zatiranje garij vrste Sarcoptes (pri psih)
• Treatment of adult roundworms (Toxocara cati) 
• Zatiranje odraslih nematodov (Toxocara cati)
Lactation: Can be used in lactating cats and dogs. 
Laktacija: Lahko se uporablja pri doječih mačkah in psih.
Fertility: Can be used in breeding cats and dogs. 
Plodnost: Lahko se uporablja pri vzrejnih mačkah in psih.
for one month following a single administration. 
zdravilo deluje en mesec po enkratnem odmerku.
CARTON, 15 mg 
Škatla, 15 mg
For the prevention of flea infestations, the veterinary medicinal product should be administered at monthly intervals throughout the flea season, starting one month before fleas become active. 
V sezoni razmnoževanja bolh je treba za preprečevanje infestacij z njimi zdravilo za uporabo v veterinarski medicini dajati v mesečnih presledkih, in sicer z začetkom mesec dni preden bolhe postanejo aktivne.
The veterinary medicinal product may be administered year-round or at least within one month of the animal's first exposure to mosquitoes and monthly thereafter until the end of the mosquito season. 
Preprečevanje obolenja pri okužbi z Dirofilario immitis (psi in mačke) Zdravilo za uporabo v veterinarski medicini lahko dajemo vse leto ali vsaj v enem mesecu po prvi izpostavitvi živali komarjem, nato pa vsak mesec, dokler traja njihova sezona.
Administered volume (nominal pipette size, ml) 
Volumen merilne kapalke, ml
Do not apply when the hair coat is wet. 
Zdravila za uporabo v veterinarski medicini ne nanašamo na mokro dlako.
Chanhold 45 mg spot-on solution for cats 2.6-7.5 kg Chanhold 60 mg spot-on solution for cats 7.6-10.0 kg selamectin 
Chanhold 45 mg kožni nanos, raztopina za mačke 2,6 - 7,5 kg Chanhold 60 mg kožni nanos, raztopina za mačke 7,6 - 10,0 kg selamektin
This product is highly flammable; keep away from heat, sparks, open flames or other sources of ignition. 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Zdravilo je lahko vnetljivo, zato ga hranite zaščitenega pred vročino, iskrami, odprtim plamenom ali drugimi viri vžiga.
Wash hands after use and wash off any product in contact with the skin immediately with soap and water. 
Po uporabi zdravila si roke temeljito umijte z vodo in milom, še zlasti tiste dele kože, ki so prišli v stik z zdravilom.
≤ 2.5 1 pipette of Chanhold 15 mg for cats and dogs ≤ 2.5 kg 
Mačke in psi, ki tehtajo 2,5 kg ali manj (Chanhold 15 mg kožni nanos, raztopina za mačke in pse ≤ 2,5 kg)
Prevention of heartworm disease (cats and dogs) 
Zatiranje ušesnih garij (mačke)
For use as part of a treatment strategy for flea allergy dermatitis the veterinary medicinal product should be administered at monthly intervals. 
Zdravilo uporabljamo tudi kot del terapije pri zdravljenju alergijskega dermatitisa, ki ga povzročajo bolhe in sicer ga dajemo enkrat mesečno po en odmerek.
Treatment of ear mites (dogs) 
Zdravljenje ušesnih garij (psi)
Activity has also been demonstrated against heartworm larvae. 
Selamektin dokazano uniči tudi razvojne oblike Dirofilarie immitis.
Dogs weighing 2.6-5.0 kg. 
Psi s telesno maso 2,6-5,0 kg.
Dogs weighing 5.1-10.0 kg. 
Psi s telesno maso 5,1-10,0 kg.
Chanhold 360 mg for dogs 
Chanhold 360 mg za n pse
Dogs weighing 10.1-20.0 kg. 
Psi s telesno maso 10,1-20,0 kg.
Flea treatment and prevention (cats and dogs) 
Zdravljenje in preprečevanje infestacije z bolhami (mačke in psi) Živali starejše od 6 tednov:
When replacing another heartworm preventive product in a heartworm disease prevention programme, the first dose of the veterinary medicinal product must be given within a month of the last dose of the former medication. 
Prvi odmerek moramo dati v obdobju enega meseca po zadnjem dajanju prejšnjega zdravila za uporabo v veterinarski medicini.
Selamectin has adulticidal, ovicidal and larvicidal activity against fleas. 
Selamektin učinkuje na jajčeca, ličinke in odrasle bolhe.
Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin 
Chanhold 30 mg kožni nanos, raztopina za pse 2,6-5,0 kg Chanhold 60 mg kožni nanos, raztopina za pse 5,1-10,0 kg Chanhold 120 mg kožni nanos, raztopina za pse 10,1-20,0 kg Chanhold 240 mg kožni nanos, raztopina za pse 20,1-40,0 kg Chanhold 360 mg kožni nanos, raztopina za pse 40,1-60 kg selamektin
Dogs weighing 20.1-40.0 kg. 
Psi s telesno maso 20,1-40,0 kg.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Vsak enkratni odmerek (merilna kapalka) vsebuje:
Dogs weighing 40.1-60.0 kg. 
Psi s telesno maso 40, 1-60,0 kg
Cats and dogs weighing 2.5 kg or less (Chanhold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg) Dogs weighing 2.6 kg-5.0 kg (Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg) Cats weighing 2.6 kg-7.5 kg (Chanhold 45 mg spot-on solution for cats 2.6-7.5 kg) Cats weighing 7.6 kg-10.0 kg (Chanhold 60 mg spot-on solution for cats 7.6-10.0 kg) Dogs weighing 5.1 kg-10.0 kg (Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg) Dogs weighing 10.1 kg-20.0 kg (Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg) Dogs weighing 20.1 kg-40.0kg (Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg) Dogs weighing 40.1 kg-60.0 kg (Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg) 
Psi, ki tehtajo 2,6 kg-5,0 kg (Chanhold 30 mg kožni nanos, raztopina za pse 2,6-5,0 kg) Mačke, ki tehtajo 2,6 kg-7,5 kg (Chanhold 45 mg kožni nanos, raztopina za mačke 2,6-7,5 kg) Mačke, ki tehtajo 7,6 kg-10,0 kg (Chanhold 60 mg kožni nanos, raztopina za mačke 7,6-10,0 kg).
Cats weighing 2.6-7.5 kg. Cats weighing 7.6-10.0 kg. 
Mačke s telesno maso 2,6-7,5 kg.
Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age. 
Zdravljenje brejih in doječih živali kot preventiva infestacij pri mladičkih psov in mačk Z mesečnim tretiranjem brejih in doječih živali močno zmanjšamo populacijo bolh, obenem pa zaščitimo leglo z mladički pred infestacijo z bolhami do njihovega sedmega tedna starosti.
PACKAGE LEAFLET: Chanhold spot-on solution 
NAVODILO ZA UPORABO Chanhold kožni nanos, raztopina
Chanhold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg Chanhold 45 mg spot-on solution for cats 2.6-7.5 kg Chanhold 60 mg spot-on solution for cats 7.6-10.0 kg Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin 
Chanhold 15 mg kožni nanos, raztopina za mačke in pse ≤ 2,5 kg Chanhold 30 mg kožni nanos, raztopina za pse 2,6-5,0 kg Chanhold 45 mg kožni nanos, raztopina za mačke 2,6-7,5 kg Chanhold 60 mg kožni nanos, raztopina za mačke 7,6-10,0 kg Chanhold 30 mg kožni nanos, raztopina za pse 5,1-10,0 kg Chanhold 120 mg kožni nanos, raztopina za pse 10,1-20,0 kg Chanhold 240 mg kožni nanos, raztopina za pse 20,1-40,0 kg Chanhold 360 mg kožni nanos, raztopina za pse 40,1-60 kg selamektin
Chanhold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg Chanhold 45 mg spot-on solution for cats 2.6-7.5 kg Chanhold 60 mg spot-on solution for cats 7.6-10.0 kg Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg 
≤ 2,5 1 merilna kapalka Chanholda 15 mg za mačke in pse ≤ 2,5 kg 2,6 - 5,0 1 merilna kapalka Chanholda 30 mg za pse 2,6-5,0 kg 5,1- 10,0 1 merilna kapalka Chanholda 60 mg za pse 5,1-10,0 kg 10,1 - 20,0 1 merilna kapalka Chanholda 120 mg za pse 10,1-20,0 kg 20,1 - 40,0 1 merilna kapalka Chanholda 240 mg za pse 20,1-40,0 kg 40,1 - 60,0 1 merilna kapalka Chanholda 360 mg za pse 40,1-60,0 kg
EU/2/19/236/001-016 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/19/236/001-016
This stops flea reproduction, breaks the flea lifecycle and may aid in the control of existing environmental flea infestations in areas to which the animal has access. 
Po dajanju zdravila za uporabo v veterinarski medicini odrasle bolhe na živali odmrejo, produkcija jajčec je ustavljena in tudi ličinke (prisotne le v okolju) odmrejo.Na ta način se razmnoževanje ustavi in prekine se razvojni krog bolhe, kar lahko pomaga pri kontroli infestacije okolja z bolhami na področjih, ki so dostopna živalim.
EMEA Number 
Številka postopka EMEA Ime
Name 
DODATEK
Route of Administration 
Pot uporabe ovojnina
The full EPAR for Pioglitazone Teva Pharma 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 Pioglitazone Teva Pharma je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Treatment with Pioglitazone Teva Pharma should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. 
Zdravljenje z zdravilom Pioglitazone Teva Pharma je treba ponovno oceniti po treh do šestih mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, prekiniti.
The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Teva Pharma on 26 March 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Pioglitazone Teva Pharma, veljavno po vsej Evropski uniji, odobrila dne 26. marca 2012.
For more information about treatment with Pioglitazone Teva Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Pioglitazone Teva Pharma preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Pioglitazone Teva Pharma, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. 
Zdravilna učinkovina zdravila Pioglitazone Teva Pharma, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed. 
Priporočeni začetni odmerek zdravila Pioglitazone Teva Pharma je 15 ali 30 mg enkrat na dan. Odmerek bo po enem ali dveh tednih morda treba povečati do 45 mg enkrat na dan, če je potreben boljši nadzor glukoze (sladkorja) v krvi.
This means that Pioglitazone Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Actos.
This is a summary of the European public assessment report (EPAR) for Pioglitazone Teva Pharma. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pioglitazone Teva Pharma.
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva Pharma has been shown to have comparable quality and to be bioequivalent to Actos. 
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pioglitazone Teva Pharma primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
Because Pioglitazone Teva Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Pioglitazone Teva Pharma generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enake kot pri referenčnem zdravilu.
Pioglitazone Teva Pharma is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight. 
Zdravilo Pioglitazone Teva Pharma se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih (starejših od 18 let), zlasti tistih s prekomerno telesno maso.
Pioglitazone Teva Pharma is a ‘generic medicine'. 
Pioglitazone Teva Pharma je „generično zdravilo“.
Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi, tako kot pri zdravilu Actos, odtehtajo znana tveganja.
Because Pioglitazone Teva Pharma is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos. 
Ker je zdravilo Pioglitazone Teva Pharma generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Actos.
Pioglitazone Teva Pharma should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease). 
Zdravilo Pioglitazone Teva Pharma se ne sme uporabljati pri bolnikih na dializi (tehniki čiščenja krvi, ki se uporablja pri bolnikih z obolenjem ledvic).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pioglitazone Teva Pharma. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pioglitazone Teva Pharma, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Pioglitazone Teva Pharma can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin. 
Zdravilo Pioglitazone Teva Pharma se lahko uporablja tudi skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno nadzorovana zgolj z insulinom in za katere metformin ni primeren.
What are the benefits and risks of Pioglitazone Teva Pharma? 
Kakšne so koristi in tveganja, povezani z zdravilom Pioglitazone Teva Pharma?
Pioglitazone Teva Pharma is a medicine that contains the active substance pioglitazone. 
Pioglitazone Teva Pharma je zdravilo, ki vsebuje zdravilno učinkovino pioglitazon.
Pioglitazone Teva Pharma is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable. 
Zdravilo Pioglitazone Teva Phara se uporablja kot samostojno zdravilo pri bolnikih, za katere metformin (drugo zdravilo proti sladkorni bolezni) ni primeren.
Other information about Pioglitazone Teva Pharma 
Druge informacije o zdravilu Pioglitazone Teva Pharma
The Committee recommended that Pioglitazone Teva Pharma be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Pioglitazone Teva Pharma odobri dovoljenje za promet.
Why has Pioglitazone Teva Pharma been approved? 
Zakaj je bilo zdravilo Pioglitazone Teva Pharma odobreno?
How has Pioglitazone Teva Pharma been studied? 
Kako je bilo zdravilo Pioglitazone Teva Pharma raziskano?
How does Pioglitazone Teva Pharma work? 
Kako zdravilo Pioglitazone Teva Pharma deluje?
What is Pioglitazone Teva Pharma used for? 
Za kaj se zdravilo Pioglitazone Teva Pharma uporablja?
What is Pioglitazone Teva Pharma? 
Kaj je zdravilo Pioglitazone Teva Pharma?
How is Pioglitazone Teva Pharma used? 
Kako se zdravilo Pioglitazone Teva Pharma uporablja?
The medicine is currently marketed in the following Member States of the EU: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Malta, Netherlands, Poland, Portugal, Spain, Sweden and United Kingdom, as well as in Iceland and Norway. 
Zdravilo se trenutno trži v naslednjih državah članicah EU: v Avstriji, Belgiji, na Cipru, v Češki republiki, na Danskem, Finskem, v Franciji, Nemčiji, Grčiji, na Irskem, v Italiji, Latviji, Luksemburgu, na Malti, Nizozemskem, Poljskem, Portugalskem, v Španiji, na Švedskem in v Združenem kraljestvu ter na Islandiji in Norveškem.
The company that markets these medicines is Astra Zeneca. 
Družba, ki trži ta zdravila, je Astra Zeneca.
The European Commission issued an EU-wide legally binding decision on 28 November 2014. 
Evropska komisija je 28. novembra 2014 izdala pravno zavezujoč sklep, veljaven v vsej Evropski uniji.
What is EMLA cream? 
Kaj je krema EMLA?
Why was EMLA cream reviewed? 
Zakaj je bila krema EMLA pregledana?
It is used as a local anaesthetic to prevent pain during medical or superficial surgical procedures. 
Uporablja se kot lokalni anestetik za preprečevanje bolečine med zdravniškimi ali površinskimi kirurškimi posegi.
EMLA cream has been nationally authorised in EU Member States since 1984. 
Krema EMLA je odobrena na nacionalni ravni v državah članicah EU od leta 1984.
EMLA cream is authorised in the EU via national procedures. 
Krema EMLA je v EU odobrena z nacionalnimi postopki.
The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warning and precautions for use), 4.6 (fertility, pregnancy and lactation) and 4.8 (side effects). 
CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjem 4.4 (Posebna opozorila in previdnostni ukrepi), 4.6 (Plodnost, nosečnost in dojenje) in 4.8 (Neželeni učinki).
After reviewing the available data supporting the medicine's use, the CHMP agreed that EMLA cream can be used for the following: 
Po pregledu razpoložljivih podatkov v podporo uporabi zdravila se je CHMP strinjal, da se krema EMLA lahko uporablja za:
Having harmonised the indications, the CHMP also harmonised recommendations on the doses and the duration of application of EMLA cream before different medical or surgical procedures in children, adolescents or adults. 
Po uskladitvi indikacij je CHMP uskladil tudi priporočila glede odmerkov in časa nanosa kreme EMLA pred različnimi zdravniškimi ali kirurškimi posegi pri otrocih, mladostnikih ali odraslih.