natgillin/translations-raw huggingface dataset:
Micotil 300 Injectie is a solution for injection containing tilmicosin with a strength of 300 mg per ml. 
Zdravilo Micotil 300 Injectie je raztopina za injiciranje, ki vsebuje tilmikozin, v jakosti 300 mg na ml. Tilmikozin je makrolidni antibiotik, sintetiziran iz tilozina.
Micotil 300 mg/ml 
tilmikozin 300 mg/ml
Further to the serious concerns expressed by the CVMP about the proposed indication “as an aid in the in the control of outbreaks of enzootic abortion in ewes caused by Chlamydia psittaci” the MAHs agreed to remove all reference to this indication from the product information. 
Glede na resne zadržke, ki jih je CVMP izrazil glede predlagane indikacije „kot pomoč pri obvladovanju izbruhov enzootskega zvrgavanja ovac, ki ga povzroča bakterija Chlamydia psittaci”, so se imetniki dovoljenj za promet z zdravilom strinjali z umikom vseh referenc na to indikacijo iz informacij o zdravilu.
The clinical trials did not demonstrate a bacteriological cure in sheep with acute mastitis caused by Staphyloccocus aureus and Mycoplasma agalactiae. 
Klinična preskušanja niso pokazala bakteriološke ozdravitve pri ovcah z akutnim mastitisom, ki ga povzročata bakteriji Staphyloccocus aureus in Mycoplasma agalactiae.
Further to the serious concerns expressed by the CVMP regarding the use of the product in the target species rabbits and as “aid in the control of outbreaks of enzootic abortion in ewes caused by Chlamydia psittaci” the MAHs agreed to remove all references to rabbits and enzootic abortion in ewes from the product information. 
Glede na resne zadržke, ki jih je CVMP izrazil glede uporabe zdravila pri ciljnih vrstah kuncev in kot „pomoč pri obvladovanju izbruhov enzootskega zvrgavanja ovac, ki ga povzroča bakterija Chlamydia psittaci”, so se imetniki dovoljenj za promet z zdravilom strinjali z umikom vseh referenc na kunce in enzootsko zvrgavanje ovac iz informacij o zdravilu.
Thus, based on the available data the Committee considered the indication “treatment of foot rot in sheep associated with Dichelobacter nodosus and Fusobacterium necrophorum” was acceptable at the recommended dose of 10 mg/kg body weight. 
Na osnovi razpoložljivih podatkov je Odbor zato menil, da je indikacija „zdravljenja nalezljive šepavosti ovac, povezane z bakterijama Dichelobacter nodosus in Fusobacterium necrophorum“ sprejemljiva pri priporočenem odmerku 10 mg/kg telesne mase.
Restrain the animal and insert separate needle subcutaneously at the injection site, preferably in a skinfold over the rib cage behind the shoulder. 
Žival imobilizirajte in novo iglo subkutano vstavite v mesto injiciranja, najbolje v kožno gubo nad rebri za plečetom.
Special precautions to be taken by the person administering the veterinary medicinal product to animals 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Varnostna opozorila za uporabnika
Therefore the following warning sentences should be added in SPC section 4.11 Withdrawal period(s): (i) “If the product is administered to cows during the dry period (in accordance with section 4.7 of the SPC), milk should not be used for human consumption until 36 days after calving” and (ii) “If the product is administered to ewes during the dry period (in accordance with section 4.7 of the SPC), milk should not be used for human consumption until 18 days after lambing”. 
V poglavje 4.11 Karenca v povzetku glavnih značilnosti zdravila je zato treba dodati naslednje opozorilne stavke: (i) „če se zdravilo daje kravam v presušitvi (v skladu s poglavjem 4.7 povzetka glavnih značilnosti zdravila), mleka ni dovoljeno uporabiti za prehrano ljudi do 36 dni po otelitvi“ in (ii) „če se zdravilo daje ovcam v presušitvi (v skladu s poglavjem 4.7 povzetka glavnih značilnosti zdravila), mleka ni dovoljeno uporabiti za prehrano ljudi do 18 dni po jagnjitvi“.
4.8 Interaction with other medicinal products and other forms of interaction 
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pri nekaterih vrstah so opazili interakcije med makrolidi in ionofori.
NAME OF THE VETERINARY MEDICINAL PRODUCT To be completed nationally 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Attach the syringe to the needle and inject into the base of the skinfold. 
Na iglo pritrdite injekcijsko brizgo in injicirajte v središče kožne gube.
PHARMACEUTICAL FORM Solution for injection. 
FARMACEVTSKA OBLIKA Raztopina za injiciranje Bistra raztopina
Do not administer intravenously. 
Ne uporabljajte intravensko.
Treatment of bovine respiratory disease associated with Mannheimia haemolytica and Pasteurella multocida. 
Zdravljenje respiratorne bolezni goveda, povezane z bakterijama Mannheimia haemolytica in Pasteurella multocida.
Sheep have died following a single intravenous injection of 7.5 mg/kg body weight. 
Pri ovcah je nastopila smrt po enkratnem intravenskem injiciranju 7,5 mg/kg telesne mase.
Regarding the cattle and sheep withdrawal periods there may be a concern that if the product is administered to an animal during the dry period, residues may continue to be present in milk for days after parturition. 
V zvezi s karencami pri govedu in ovcah morda obstaja zadržek, da so lahko pri dajanju zdravila živali v presušitvi ostanki v mleku prisotni še več dni po porodu.
Treatment of acute ovine mastitis caused by Staphylococcus aureus and Mycoplasma agalactiae. 
Zdravljenje akutnega mastitisa pri ovcah, ki ga povzročata bakteriji Staphylococcus aureus in Mycoplasma agalactiae.
In pigs, tilmicosin-induced lethality is potentiated by adrenalin. 
Pri prašičih adrenalin poveča smrtnost, ki jo povzroča tilmikozin.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf a single subcutaneous injection with tilmicosin at a dose of 10 mg/kg body weight. 
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf okužbe z bakterijo M. haemolytica so zabeležili jasno znižanje telesne temperatur in stopnje dispneje ter izboljšanje rezultatov glede vedenja živali na 3. dan po enkratnem subkutanem injiciranju tilmikozina pri odmerku 10 mg/kg telesne mase.
the CVMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in annex III for Micotil 300 Injectie and associated names (see annex I). 
• CVMP je pregledal povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih predlagajo imetniki dovoljenj za promet, in upošteval vse predložene podatke; je odbor CHMP priporočil spremembo dovoljenj za promet z zdravilom, za katero so v Prilogi III za zdravilo Micotil 300 Injectie in povezana imena določeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo (glejte Prilogo I).
Neonatal calves Feedlot cattle 
Novorojena teleta Pitano govedo
Tilmicosin is a macrolide antibiotic synthesized from tylosin which has an antibacterial spectrum similar to tylosin with enhanced activity against Pasteurella multocida and Mannheimia haemolytica. 
Protibakterijski spekter tilmikozina je podoben tilozinu, vendar ima povečano aktivnost proti bakterijama Pasteurella multocida in Mannheimia haemolytica.
Germany 
NEMČIJA
Portugal 
Portugalska PORTUGALSKA
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tilmicosin 300 mg/ml PHARMACEUTICAL FORM Solution for injection PACKAGE SIZE 
tilmikozin 300 mg/ml FARMACEVTSKA OBLIKA raztopina za injiciranje VELIKOST PAKIRANJA
Keep the syringe and needle separate at all other times. 
Preostali čas morata biti injekcijska brizga in igla ločeni.
If the product is administered to cows during the dry period or to pregnant dairy heifers (in accordance with section 4.7 above), milk should not be used for human consumption until 36 days after calving. 
Če se zdravilo uporablja pri kravah med obdobji presušitve ali brejih telicah molznicah (skladno z zgornjim poglavjem 4.7), se mleko ne sme uporabljati za prehrano ljudi do 36 dni po otelitvi.
If the product is administered to ewes during the dry period or to pregnant ewes (in accordance with section 4.7 above), milk should not be used for human consumption until 18 days after lambing. 
Če se zdravilo uporablja pri ovcah med obdobji presušitve ali brejih ovcah (skladno z zgornjim poglavjem 4.7), se mleko ne sme uporabljati za prehrano ljudi do 18 dni po jagnjitvi.
INJECTION OF TILMICOSIN IN HUMANS HAS BEEN ASSOCIATED WITH FATALITIES. 
OPOMBA ZA ZDRAVNIKA PRI LJUDEH JE BILO INJICIRANJE TILMIKOZINA POVEZANO S SMRTJO.
Treatment of respiratory tract infections caused by Mannheimia haemolytica and Pasteurella multocida. 
Zdravljenje okužb dihal, ki jih povzročata bakteriji Mannheimia haemolytica in Pasteurella multocida.
Do not administer to goats. 
Ne uporabljajte pri kozah.
In dogs, CaCl2 treatment showed a positive effect on the left ventricular inotrophic state after tilmicosin administration and some changes in vascular blood pressure and heart rate. 
Pri psih je zdravljenje s CaCl2 po uporabi tilmikozina pokazalo pozitiven učinek na inotropno stanje levega prekata ter nekatere spremembe žilnega krvnega tlaka in srčnega utripa.
If the product is administered to cows during the dry period or to pregnant dairy heifers, milk should not be used for human consumption until 36 days after calving. 
Če se zdravilo uporablja pri kravah med obdobji presušitve ali brejih telicah molznicah, se mleko ne sme uporabljati za prehrano ljudi do 36 dni po otelitvi.
4.7 Use during pregnancy, lactation or lay 
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Varnost zdravila v obdobju brejosti ni bila ugotovljena.
If the product is administered to ewes during the dry period or to pregnant ewes, milk should not be used for human consumption until 18 days after lambing. 
Če se zdravilo uporablja pri ovcah med obdobji presušitve ali brejih ovcah, se mleko ne sme uporabljati za prehrano ljudi do 18 dni po jagnjitvi.
• Posology; 
• odmerjanje;
Deaths occurred after one single intravenous injection of 5 mg/kg body weight in cattle and 7.5 mg/kg in sheep body weight. 
Smrt pri govedu se je pojavila po enkratnem intravenskem injiciranju odmerka 5 mg/kg telesne mase, pri ovcah pa po enkratnem intravenskem injiciranju 7,5 mg/kg telesne mase.
The vial should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. 
Vialo preglejte in se prepričajte, da v njej ni tujkov in/ali da ni spremembe v fizikalnem videzu vsebine.
10 DATE OF REVISION OF THE TEXT To be completed nationally. 
10 DATUM REVIZIJE BESEDILA
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally. 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic Group: antibacterials for systemic use, macrolides. 
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, makrolidni antibiotiki, oznaka ATC vet: QJ01FA91
Restrain the sheep whilst leaning over the animal and insert a separate needle subcutaneously into the injection site, which should be in a skinfold over the rib cage behind the shoulder. 
Žival imobilizirajte in novo iglo subkutano vstavite v mesto injiciranja, tj. v kožno gubo nad rebri, za plečetom.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the sight and reach of children. 
BESEDILO »ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM« Zdravilo shranjujte nedosegljivo otrokom.
Therefore, the Committee considered that the following warning sentence should be added in SPC section 4.11 Withdrawal period(s): “If the product is administered to cows during the dry period (in accordance with section 4.7 of the SPC), milk should not be used for human consumption until 36 days after calving”. 
Odbor je zato menil, da je treba v poglavje 4.11 Karenca v povzetku glavnih značilnosti zdravila dodati naslednji opozorilni stavek: „Če se zdravilo daje kravam v presušitvi (v skladu s poglavjem 4.7 povzetka glavnih značilnosti zdravila), mleka ni dovoljeno uporabiti za prehrano ljudi do 36 dni po otelitvi“.
There may be a concern that if the product is administered to an animal during the dry period, residues may continue to be present in milk for several days after parturition. 
Morda obstaja zadržek, da so lahko pri dajanju zdravila živali v presušitvi ostanki v mleku prisotni še nekaj dni po kotitvi.
Therefore, the Committee considered that the following warning sentence should be added in SPC section 4.11 Withdrawal period(s): “If the product is administered to ewes during the dry period (in accordance with section 4.7 of the SPC), milk should not be used for human consumption until 18 days after lambing”. 
Odbor je zato menil, da je treba v poglavje 4.11 Karenca v povzetku glavnih značilnosti zdravila dodati naslednji opozorilni stavek: „Če se zdravilo daje ovcam v presušitvi (v skladu s poglavjem 4.7 povzetka glavnih značilnosti zdravila), mleka ni dovoljeno uporabiti za prehrano ljudi do 18 dni po jagnjitvi“.
Intravenous injection of 4.5 to 5.6 mg tilmicosin/kg body weight followed by intravenous injection of 1 ml epinephrine (1/1000) 2 to 6 times resulted in death of all 6 injected pigs. 
5,6 mg tilmikozina/kg telesne mase, ki mu je sledilo od 2- do 6-kratno intravensko injiciranje
Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening of the immediate packaging: 28 days 
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti
The CLSI at the present time have no interpretive criteria for P. multocida of bovine origin, however they have interpretive criteria for P. multocida of swine origin, specifically swine respiratory disease, as ≤16 µg/ml = susceptible and ≥ 32 µg/ml = resistant. 
P. multocida prašičjega izvora, predvsem pri respiratorni bolezni prašičev, in sicer ≤ 16 µg/ml =
ELANCO VALQUÍMICA S.A, 
Mycoplasma agalactiae.
Residue depletion data was made available and supported a sheep milk withdrawal period of 18 days following a subcutaneous injection at the recommended dose of 10 mg/kg body weight. 
Podatki o izločanju ostankov so bili na voljo in so podpirali 18 dnevno karenco za ovčje mleko po subkutanem injiciranju v priporočenem odmerku 10 mg/kg telesne mase.
Hampshire 
KARENCA
Regarding treatment of foot rot in sheep associated with Dichelobacter nodosus and Fusobacterium necrophorum, the in vitro studies demonstrated that the MIC values (MIC50 <0.25-0.5 µg/ml) of several bacteria, causing foot rot in sheep, indicate sensitivity for tilmicosin, however some strains were resistant. 
Na osnovi razpoložljivih podatkov je Odbor zato menil, da bi bila sprejemljiva indikacija za dihala pri ovcah pri priporočenem odmerku 10 mg/kg telesne mase naslednja: „Zdravljenje okužb dihalnih poti, ki jih povzročata bakteriji Mannheimia haemolytica in Pasteurella multocida.“ V zvezi z zdravljenjem nalezljive šepavosti ovac, povezane z bakterijama Dichelobacter nodosus in Fusobacterium necrophorum, so in vitro študije pokazale, da vrednosti MIK (MIK50 < 0,25−0,5 µg/ml) pri več bakterijah, ki povzročajo nalezljivo šepavost ovac, nakazujejo občutljivost na tilmikozin, vendar so bili nekateri sevi odporni.
Residue depletion data were made available and supported a cattle milk withdrawal period of 36 days following a subcutaneous injection at the recommended of dose of 10 mg/kg body weight. 
Podatki o izločanju ostankov so bili na voljo in so podpirali 36 dnevno karenco za kravje mleko po subkutanem injiciranju pri priporočenem odmerku 10 mg/kg telesne mase.
Pregnancy: 
Brejost:
Clear solution. 
rezistentno.
Subcutaneous injection 
raztopina za injiciranje govedo subkutano injiciranje
Residue depletion data was made available and supported a sheep meat and offal withdrawal period of 42 days following a subcutaneous injection at the recommended dose of 10 mg/kg body weight. 
Podatki o izločanju ostankov so bili na voljo in so podpirali 42 dnevno karenco za ovčje meso in organe po subkutanem injiciranju v priporočenem odmerku 10 mg/kg telesne mase.
Residue depletion data were made available and supported a cattle meat and offal withdrawal period of 70 days following a subcutaneous injection at the recommended dose of 10 mg/kg body weight. 
Podatki o izločanju ostankov so bili na voljo in so podpirali 70-dnevno karenco za goveje meso in organe po subkutanem injiciranju pri priporočenem odmerku 10 mg/kg telesne mase.
1030 Wien 
4.11 Karenca
Special warnings for each target species: 
POSEBNO(A) OPOZORILO(A) Posebna opozorila za vsako živalsko vrsto Ovce
Priestley Road Basingstoke RG24 9NL 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI
INN 
Serija
(EMA/CVMP/SAGAM/741087/2009)1 and not in line with the CVMP guideline on the SPC for antimicrobials (EMEA/CVMP/SAGAM/383441/2005)2. 
Nadalje besedilo v predlagani indikaciji „… in drugi mikroorganizmi, občutljivi na tilmikozin“ ni v skladu s presojo CVMP glede makrolidov, linkozamidov in streptograminov (EMA/CVMP/SAGAM/741087/2009)1 in z navodili CVMP v povzetku glavnih značilnosti zdravila za protimikrobna sredstva (EMEA/CVMP/SAGAM/383441/2005)2.
4600 Wels AUSTRIA 
6.3 Rok uporabnosti
CMC Harmonisation 
Uskladitev CMC
The same applies for the lactation period. 
Enako velja za obdobje dojenja.
Pantoprazole is not registered in Iceland and Malta. 
Pantoprazol ni registriran na Islandiji in Malti.
Intravenous (i.v.) 
Intravenski (i.v.)
However, as it can be overcome, a contraindication is inappropriate. 
Ker pa je to možno premagati, kontraindikacija ni primerna.
In conclusion, the provided information was in general adequate; however, a number of unresolved minor concerns were identified. 
Predloženi podatki so bili torej na splošno zadostni, vendar so bili ugotovljeni številni manjši nerešeni zadržki.
If affected, patients should not drive or operate machines.” 
Če jih bolniki opazijo, ne smejo voziti ali upravljati s stroji.“
Therefore, pantoprazole should only be used when the benefit exceeds the potential risk. 
Zato se lahko pantoprazol uporablja le, ko so koristi večje od možnega tveganja.
In order to reduce the risk in this population, the statement was moved to Section 4.2. 
Zaradi zmanjšanja tveganja v tej populaciji je bila izjava premaknjena v poglavje 4.2.
Similarly, the most effective length of treatment is debated as European guidelines contradict recent studies, which may reflect varying resistance rates within the populations studied. 
Podobno se razpravlja o najučinkovitejšem trajanju zdravljenja, saj so evropske smernice v nasprotju z nedavnimi študijami, kar lahko odraža različne stopnje odpornosti v proučevanih populacijah.
Currently, triple therapy for seven days is still a valid and cost effective duration of treatment. 
Trenutno je tritirno zdravljenje v obdobju sedmih dni še vedno veljavno in stroškovno učinkovito trajanje zdravljenja.
It works by decreasing the amount of acid made in the stomach. 
Deluje tako, da zmanjša količino kisline, ki nastaja v želodcu.
The text referring to “official local guidance” is agreed as it allows the inclusion of alternative antibiotics without stating all the alternatives used nationally. 
Strinjal se je glede besedila, ki se sklicuje na „uradna lokalna priporočila“, saj omogoča vključitev alternativnih antibiotikov brez navedb vseh alternativ, ki se uporabljajo na nacionalni ravni.
In agreement with the EMEA, Module 3 was also harmonised during this procedure. 
Med postopkom je bil v dogovoru z agencijo EMEA usklajen tudi modul 3.
The CHMP considered that the optimal duration is one week, and that another course of seven days might be recommended in individual cases. 
CHMP je menil, da je optimalno trajanje en teden in da se lahko v posameznih primerih priporoči še eno zdravljenje v trajanju sedmih dni.
at doses of 80 mg up to 120 mg every 8 to 12 hours was able to control acid output. 
z odmerki od 80 mg do 120 mg vsakih 8 do 12 ur lahko obvlada izločanje želodčne kisline.
Section 4.7 - Effects on ability to drive and use machines 
Poglavje 4.7 - Vpliv na sposobnost vožnje in upravljanja s stroji
The CHMP therefore decided that a statement regarding this interaction was unwarranted. 
CHMP se je zato odločil, da je izjava o tej interakciji neutemeljena.
Section 5 - Pharmacological properties 
Poglavje 5 - Farmakološke lastnosti
The CHMP requested the input of the cardiovascular subgroup of the Efficacy Working Party (EWP-CVS) on this issue. 
CHMP je glede te težave prosil za mnenje kardiovaskularne podskupine pri delovni skupini za učinkovitost (EWP-CVS).
It is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome. 
Uporablja se tudi za zdravljenje stanj, pri katerih želodec tvori preveč kisline, kot je Zollinger-Ellisonov sindrom.
The inclusion of substances for which an involvement of CYP 3A4 or CYP 2C19 is known (such as carbamazepine, diazepam, glibenclamide, and nifedipine) is justified. 
Utemeljena je vključitev snovi, pri katerih je vpletenost CYP 3A4 ali CYP 2C19 znana (kot so karbamazepin, diazepam, glibenklamid in nifedipin).
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PROTIUM AND ASSOCIATED NAMES (SEE ANNEX I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA PROTIUM IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
The separate inclusion of caffeine and ethanol is justified by their widespread use. 
Ločena vključitev kofeina in etanola je utemeljena zaradi njune razširjene rabe.
In addition the indication for H. Pylori eradication was simplified. 
Poleg tega je poenostavil indikacijo za eradikacijo H. pylori.
The EWP-CVS concluded that there was no evidence supporting an interaction between pantoprazole and clopidogrel. 
Podskupina EWP-CVS je menila, da ni dokazov v podporo interakciji med pantoprazolom in klopidogrelom.
Pantoprazole treatment in these studies was well tolerated and had a favourable benefit-risk ratio. 
Zdravljenje s pantoprazolom so bolniki v teh študijah dobro prenašali in je imelo ugodno razmerje med koristmi in tveganji.
Section 4.6 now states that “a decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Protium should be made taking into account the benefit of breast-feeding to the child and the benefit of Protium therapy to the woman.” 
V poglavju 4.6 je sedaj navedeno: „odločitev o nadaljevanju/prekinitvi dojenja ali nadaljevanju/prekinitvi zdravljenja z zdravilom Protium je treba sprejeti ob upoštevanju dejavnikov prednosti dojenja za otroka in prednosti zdravljenja z zdravilom Protium za bolnico“.
In conclusion, the CHMP adopted a harmonised text for section 4.4. 
Na koncu je CHMP sprejel usklajeno besedilo za poglavje 4.4.
In particular, the interaction between atazanavir and others PPIs has been moved to Sections 4.4 and 4.5. 
Medsebojno delovanje med atazanavirjem in drugimi zaviralci protonske črpalke je bilo premaknjeno v poglavji 4.4 in 4.5.
Dose recommendations in special populations were inserted in section 4.2. 
Priporočila o odmerjanju pri posebnih populacijah so bila vstavljena v poglavje 4.2.
In particular, gynaecomastia was added to the list of undesirable effects. 
Na seznam neželenih učinkov je bila dodana ginekomastija.
Section 4.1: Therapeutic indications 
Razdelek 4.1: Terapevtske indikacije
For Module 1, the submitted current manufacturing authorisations for all manufacturers of the drug products in EU countries and GMP certificates of EU inspectorates for manufacturers of the drug products in non-EU countries, together with the declaration of the QP of the manufacturer for drug product release in the EU were considered acceptable. 
V modulu 1 so se predložena trenutna dovoljenja za izdelavo za vse izdelovalce zdravil v državah EU in certifikati GMP s strani inšpektoratov EU za izdelovalce zdravil zunaj držav EU ter izjava izdelovalca za sproščanje zdravila EU glede usposobljenosti za proizvodnjo šteli za sprejemljive.
Regarding use in adolescents and the safety and efficacy in children, Protium is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group. 
Kar zadeva uporabo pri mladostnikih in varnost ter učinkovitost pri otrocih, zdravilo Protium ni priporočljivo pri otrocih, mlajših od 12 let, ker je podatkov o varnosti in učinkovitosti v tej starostni skupini malo.