natgillin/translations-raw huggingface dataset:
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
SPC so bodisi dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
Thaw the ampoules in clean water at 25-27 °C. 
Ampule odmrzujte v čisti vodi pri 25-27 °C.
Special warnings for each target species: Vaccinate healthy animals only. 
Posebna opozorila za vsako ciljno živalsko vrsto: Cepite samo zdrave živali.
If frozen suspension is situated in the tip of the ampoule this indicates that the suspension has been thawed and must not be used. 
Če je v konici ampule zmrznjena suspenzija, to pomeni, da je bila suspenzija odmrznjena, in je ne smete uporabiti.
Dry the ampoule, then break the ampoule at its neck and immediately proceed as described below. 
Ampulo osušite, nato jo na vratu odlomite in takoj postopajte, kot je opisano spodaj.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009. 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina, ki je v osnovi biološkega izvora, namenjema vzbujanju aktivne imunosti, ne spade v področje uprabe Uredbe (EC) No 470/2009.
Intervet International B.V. Ambachtstraat 2, 4, 5a 3732 CN De Bilt THE NETHERLANDS 
Ambachtstraat 2, 4, 5a 3732 CN De Bilt
As this is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys. 
Ker je cepivo živo, se vakcinalni sev izloči iz cepljenih živali in se lahko razširi na purane.
CAUTION: The ampoules have been known to explode on exposure to sudden temperature changes. 
PREVIDNOST: Znano je, da ampule eksplodirajo ob nenadnih spremembah temperature.
Pancreatic digest of casein Phenolsulfonphthalein (Phenol red) Potassium dihydrogen phosphate Water for injections 
saharoza pankreasni presnovek kazeina fenolsulfonftalein (rdeči fenol) kalijev dihidrogenfosfat voda za injekcije
The bag of vaccine should be gently swirled frequently during vaccination to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titre is administered (e.g. during long vaccination sessions). 
Vrečko s cepivom je treba med cepljenjem večkrat narahlo obračati, da je zagotovljeno, da suspenzija za injiciranje ostane homogena in da je apliciran pravilni titer vakcinalnega virusa (npr. med dolgimi postopki cepljenja).
Subcutaneous use and in ovo use. 
Subkutana uporaba in in ovo uporaba.
After adding the contents of the ampoule to the solvent, the ready to use product is a clear, red coloured suspension for injection. 
Ko ste vsebino ampule dodali vehiklu, je pripravek za uporabo bistra, rdeče obarvana suspenzija za injiciranje.
In ovo: One single injection of 0.05 ml per chicken egg. 
In ovo: Ena injekcija 0,05 ml na kokošje jajce.
Number of vaccine ampoules for subcutaneous use 
Število ampul s cepivom za subkutano uporabo
Gently swirl the ampoule(s) to disperse the contents. 
Ampulo(e) narahlo vrtite, da se vsebina dispergira.
To allow a check on correct storage and transport the ampoules are placed upside down in the liquid nitrogen containers. 
Da bi lahko kontrolirali pravilno shranjevanje in prevažanje, so ampule postavljene z gornjim delom navzdol v posode s tekočim dušikom.
Ampoules are stored on a cane and attached to the cane is a coloured clip displaying the dose (2,000 doses: salmon-pink coloured clip, and 4,000 doses: yellow coloured clip). 
Ampule so shranjene na nizu in na nizu je barvna priponka, ki kaže odmerek (2.000 odmerkov: lososovo rožnata priponka, 4.000 odmerkov: rumena priponka).
Innovax-ND-IBD is a virus suspension packed in glass ampoules and stored in liquid nitrogen. 
Innovax-ND-IBD je virusna suspenzija, pakirana v steklenih ampulah in hranjena v tekočem dušiku.
There is no information available on the number of doses on the ampoules once they are removed from the cane, so special care has to be taken to ensure that the mix-ups of ampoules with different number of doses is avoided and the correct solvent is used. 
Na voljo ni podatkov o številu odmerkov na ampulah, ko jih vzamete iz niza, zato je treba posebej paziti, da ne pride do mešanja ampul z različnim številom odmerkov in da je uporabljen pravi vehikel.
Control of correct storage: 
Kontrola pravilnega shranjevanja
Gently swirl and invert the bag to mix the vaccine. 
Pazljivo vrtite in obračajte vrečko, da se cepivo premeša.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 
NAVEDBA UČINKOVIN(E) IN DRUGIH SESTAVIN
Suspension: Store and transport frozen in liquid nitrogen (below -140 °C). 
Suspenzija: Shranjujte in prevažajte zmrznjeno v tekočem dušiku (pod -140°C).
Store below 25 °C. 
Shranjujte pod 25 °C.
Pharmacotherapeutic group: Immunologicals for aves, live viral vaccines for domestic fowls. 
IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: Imunološka sredstva za perutnino, živa virusna cepiva za domačo perutnino.
Bovine serum Veggie medium Dimethyl sulfoxide 
Suspenzija: goveji serum bazalni medij dimetil-sulfoksid
For active immunisation of one-day-old chicks or 18-19 day-old embryonated chicken eggs: - to reduce mortality and clinical signs caused by Newcastle disease (ND) virus, - to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease 
Za aktivno imunizacijo enodnevnih piščancev ali 18-19 dni starih embrioniranih kokošjih jajc: - za zmanjšanje smrtnosti in kliničnih znakov, ki jih povzroči virus atipične kokošje kuge
Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product. 
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini razen z vehiklom, ki je dobavljen skupaj z zdravilom.
Suspension: - One Type I glass ampoule of 2 ml containing 2,000 or 4,000 doses. 
Suspenzija: - Ena steklena ampula, steklo tipa I, po 2 ml, ki vsebuje 2.000 ali 4.000 odmerkov.
Official control authority batch release is required for this product. 
Za to zdravilo se zahteva, da sprosti serijo uraden organ za kontrolo.
For such associated use, an onset of immunity of 3 weeks (when used with Nobilis ND Clone 30) and 2 weeks (when used with Nobilis ND C2), has been demonstrated for ND. 
Za kot združeno uporabo je bil ugotovljen nastop imunosti za ND v 3 tednih (kadar se uporablja z Nobilis ND Clone 30) in v 2 tednih ( kadar se uporablja z Nobilis ND C2).
The handling of liquid nitrogen should take place in a well-ventilated area. 
Delo s tekočim dušikom mora potekati v dobro prezračevanem prostoru.
Gently withdraw the contents of the ampoule into a sterile syringe fitted with an 18 gauge needle. 
Narahlo potegnite vsebino ampule v sterilno brizgo z 18 gauge iglo.
For subcutaneous use reconstitute the vaccine according to the table below: 
Za subkutano uporabo pripravite cepivo v skladu s spodnjo tabelo:
A 3-fold overdose was tested in ovo, which was regarded as safe. 
Preverjali smo 3-kratno preveliko odmerjanje in ovo, ki je veljalo za varno.
Solvent bag 
Vrečka za vehikel
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
No symptoms were observed after the administration of a 10-fold dose of vaccine when applied subcutaneously. 
Po aplikaciji 10-kratnega odmerka cepiva simptomov niso opazili ko se uporablja subkutano.
Lay: The safety of the veterinary medicinal product has not been established during lay. 
Nesnost: Varnost zdravila za uporabo v veterinarski medicini v obdobju nesnosti ni bila ugotovljena.
Shelf life of the cell suspension as packaged for sale: 2 years. 
Rok uporabnosti suspenzije celic v pakiranju za prodajo: 2 leti.
Solvent: clear, red solution. 
Vehikel: bistra, rdeča raztopina.
The vaccine induces active immunity against Newcastle disease, infectious bursal disease (Gumboro disease) and Marek's disease in chickens. 
Cepivo spodbudi aktivno imunost proti atipični kokošji kugi, Gumborski bolezni in Marekovi bolezni pri piščancih.
Solvent for cell associated poultry vaccines. 
Vehikel za na celice vezana cepiva za perutnino.
After removing the ampoule(s), the remaining ampoules should be put back immediately into the canister in the liquid nitrogen container. 
Ko vzamete ampule ven, je treba preostale takoj dati nazaj v kanister v posodo s tekočim dušikom.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC(PROIZVAJALCI) BIOLOŠKE(BIOLOŠKIH) UČINKOVINE(UČINKOVIN) IN PROIZVAJALEC(PROIZVAJALCI) ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJ
No information is available on the safety or possible adverse reactions following a 10-fold overdose applied in ovo. 
Ni podatkov o varnosti ali možnih neželenih učinkih po 10-kratnem prevelikem odmerjanju in ovo.
Suspension and solvent for suspension for injection. 
Suspenzija in vehikel za suspenzijo za injiciranje
Duration of immunity: ND: 8 weeks, IBD: 8 weeks, 
ND: 8 tednov, IBD: 8 tednov,
Subcutaneous: One single injection of 0.2 ml per chick. 
Subkutano: Ena injekcija 0,2 ml na piščanca.
Name and address of the manufacturers of the biological active substance 
Ime in naslov proizvajalca(proizvajalcev) biološke(bioloških) učinkovine(učinkovin)
Insert the needle through the stopper of the solvent bag, and then slowly and gently add the contents of the syringe to the solvent. 
Iglo zabodite skozi zamašek vrečke z vehiklom in vsebino brizge počasi in narahlo dodajte vehiklu.
Withdraw a small quantity from the solvent bag into the syringe and rinse the ampoule. 
Potegnite majhno količino vehikla v brizgo, da sperete ampulo.
1 ampoule containing 4000 doses For in ovo use reconstitute the vaccine according to the table below: Solvent bag 
1 ampula, ki vsebuje 4000 odmerkov Za in ovo uporabo pripravite cepivo v skladu s spodnjo tabelo:
Container: Store liquid nitrogen container securely in an upright position in a clean, dry and wellventilated room separated from the hatching/chicken room. 
Vsebnik: Vsebnik s tekočim dušikom shranjujte varno v pokončnem položaju v čistem, suhem in dobro prezračevanem prostoru, ločeno od prostora, kjer se valijo piščanci.
When withdrawing a cane of ampoules from the canister in the liquid nitrogen container, expose only the ampoule(s) to be used immediately. 
Ko jemljete niz ampul iz kanistra v posodi s tekočim dušikom, vzemite le toliko ampul, kot jih boste takoj porabili.
Shelf life of the solvent (multilayer plastic bags) as packaged for sale: 2 years. 
Rok uporabnosti vehikla (večslojne plastične vrečke) v pakiranju za prodajo: 2 leti.
- One 800 ml polyethylene or multilayer plastic bag. 
- Ena 800 ml polietilenska ali večslojna plastična vrečka.
Thaw the content of the ampoule(s) rapidly by immersing the ampoule in clean water at 2527 °C. 
Vsebina ampul(e) se hitro otopi, ko potopite ampule(o) v čisto vodo pri temperaturi 25-27 °C.
Posology: 
Vsebnik:
Store liquid nitrogen container securely in an upright position in a clean, dry and well-ventilated room separated from the hatching/chicken room. 
Vsebnik s tekočim dušikom shranjujte varno v pokončnem položaju v čistem, suhem in dobro prezračevanem prostoru, ločeno od prostora, kjer se valijo piščanci v valilnici.
- One 400 ml polyethylene or multilayer plastic bag. 
- Ena 400 ml polietilenska ali večslojna plastična vrečka.
Innovax-ND-IBD suspension and solvent for suspension for injection for chickens 
NAVODILO ZA UPORABO Innovax-ND-IBD suspenzija in vehikel za suspenzijo za injiciranje za piščance
(IBD) virus, - to reduce mortality, clinical signs and lesions caused by Marek's disease (MD) virus. 
- za zmanjšanje smrtnosti, kliničnih znakov in poškodb, ki jih povzroči virus Marekove bolezni (MD)
Inject the remaining contents of the ampoule gently into the solvent bag. 
Injicirajte preostalo vsebino ampule pazljivo v vrečko z vehiklom.
Preparation of the vaccine shall be planned before the ampoules are taken from the liquid nitrogen and the exact amount of vaccine ampoules and amount of solvent needed shall be calculated first. 
Najprej je treba izračunati točno količino ampul cepiva in količino potrebnega vehikla.
Safety and efficacy data are available which demonstrate that Nobilis IB Ma5 or Nobilis IB 4-91 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with the vaccine. 
Podatki o varnosti in učinkovitosti so pokazali, da se Nobilis IB Ma5 ali Nobilis IB 4-91 lahko dajemo na enodnevno piščancev ki so cepljeni s subkutano ali in ovo dajanje cepiva.
ND: 4 weeks of age, IBD: 3 weeks of age, MD: 9 days. 
ND: 4 tedni starosti, IBD: 3 tedni starosti,
Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 103.3 - 104.6 PFU1. 
Učinkovina: Na celico vezan živ rekombinantni puranji herpesvirus (sev HVP360) z izraženim fuzijskim proteinom virusa newcastelske bolezni (atipične kokošje kuge - ND) in proteinom VP2 Gumborske bolezni: 103,3 - 104,6 PFU1.
Solvent: Store below 25 °C. 
Vehikel: Shranjujte pod 25°C.
Shelf life of the solvent (polyethylene bags) as packaged for sale: 3 years. 
Rok uporabnosti vehikla (polietilenske vrečke) v pakiranju za prodajo: 3 leta.
Use solvent for cell associated poultry vaccines for reconstitution. 
Za rekonstitucijo uporabite vehikel za na celico vezana cepiva za perutnino.
Number of vaccine ampoules for in ovo use 
Število ampul s cepivom za in ovo uporabo
In order to prevent serious wounds, by either the liquid nitrogen or the ampoules when removing an ampoule from the canister, hold the palm of the (gloved) hand holding the ampoule away from the body and face. 
Da bi preprečili hude rane bodisi s tekočim dušikom ali pa z ampulami, med jemanjem ampule iz posode držite dlan orokavičene roke ki drže ampule stran od telesa in obraza.
Interaction with other medicinal products and other forms of interaction: Safety and efficacy data are available which demonstrate that Nobilis ND Clone 30 or Nobilis ND C2 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with Innovax-ND-IBD. 
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Podatki o varnosti in učinkovitosti so pokazali, da se Nobilis ND Clone 30 ali Nobilis ND C2 lahko dajeta enodnevnim piščancem, ki so cepljeni subkutano ali in ovo z Innovax -ND-IBD.
After dilution, administer 1 dose of 0.2 ml vaccine per chicken by subcutaneous injection in the neck or 1 dose of 0.05 ml per egg by in ovo injection. 
Po redčenju dajte 1 odmerek 0,2 ml cepiva na piščanca s subkutano injekcijo v vrat.
Before withdrawing ampoules from the liquid nitrogen canister, protective equipment consisting of gloves, long sleeves and a facemask or goggles should be worn. 
Preden vzamete ampule iz posode s tekočim dušikom, si je treba nadeti zaščitno opremo, tj. rokavice, dolge rokave in obrazno masko ali zaščitna očala.
The vaccine is administered by subcutaneous injection in the neck or by in ovo injection. 
Cepivo damo subkutano v vrat ali in ovo injiciramo.
PACKAGE LEAFLET: Innovax-ND-IBD suspension and solvent for suspension for injection for chickens 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Innovax-ND-IBD suspenzija in vehikel za suspenzijo za injiciranje za piščance
STORAGE CONDITIONS 
NAVODILA ZA SHRANJEVANJE
Suspension: off-red to red suspension. 
Suspenzija: rdečkasta do rdeča suspenzija Vehikel: bistra, rdeča raztopina
The vaccine is a cell-associated live recombinant turkey herpesvirus (HVT) expressing the F protein of Newcastle disease virus and the VP2 protein of Infectious bursal disease virus. 
Cepivo je na celico vezan živ rekombinantni puranji virus herpesa (HVT), ki izraža F protein virusa atipične kokošje kuge in VP2 protein virusa Gumborske bolezni.
Bag of 400 ml solvent or bag of 800 ml solvent. 
Vrečka s 400 ml vehikla ali vrečka z 800 ml vehikla.
Before withdrawing the ampoules from the liquid nitrogen container, protect hands with gloves, wear long sleeves and use a facemask or goggles. 
Preden vzamete ampule iz posode s tekočim dušikom, zaščitite roke z rokavicami, nosite dolge rokave in si nadenite obrazno masko ali zaščitna očala.
The solvent must be clear, red coloured, without sediment and at room temperature (15-25 °C) at the time of mixing. 
Ob mešanju mora biti vehikel bister, rdeče obarvan, brez sedimenta in pri sobni temperature
In order to protect the cells, it is important that the suspension is mixed, immediately after thawing, with the solvent. 
Pomembno je, da supenzijo takoj, ko se otopi, zmešate v vehikel, da zaščitite celice.
Zero days. 
MD: 9 dni.
1 ampoule, containing 2,000 or 4,000 doses. 
Velikosti pakiranj: 1 ampula, ki vsebuje 2.000 ali 4.000 odmerkov.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENA NA MANJŠIH NA STIČNIH OVOJNINAH
Name and address of the manufacturer responsible for batch release 
ZDRUŽENE DRŽAVE AMERIKE Ime in naslov proizvajalca(proizvajalcev) zdravila, odgovornega(odgovornih) za sproščanje serij
EXP 
AMPULA
(gloved) hand holding the ampoule away from the body and face. 
Ko jemljete ampulo iz posode, jo držite v dlani orokavičene roke proč od telesa in obraza.
Bag of 400 ml solvent 
Vrečka po 400 ml vehikel
Bag of 800 ml solvent 
Vrečka po 800 ml vehikel
4 ampoules containing 4000 doses 
4 ampule, ki vsebujejo 4000 odmerkov
8 ampoules containing 2000 doses 
8 ampul ki vsebuje 2000 odmerkov
2 ampoules containing 4000 doses 
2 ampuli ki vsebujeta 4000 odmerkov
1 ampoule containing 2000 doses 
1 ampula ki vsebuje 2000 odmerkov
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE SOLVENT BAG 
PODATKI NA STIČNI OVOJNINI VREČKA Z VEHIKLOM
4 ampoules containing 2000 doses 
4 ampule, ki vsebujejo 2000 odmerkov
Excipients: 
PREVIDNOST:
2 ampoules containing 2000 doses 
2 ampuli, ki vsebujeta 2000 odmerkov
Active substance: 
Nastop imunosti:
Content (concentration) Package size 
Vsebina Velikost pakiranja
EU-number 
Vsebnik
Blister (PA/Al/PVC//Al) 336 (3x112) tablets 
336 (3x112) tablet
In such case, treatment must be stopped immediately. 
V takih primerih je treba z zdravljenjem takoj prenehati.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC. 
Informacije o zdravilu bodo pristojni organi držav članic v sodelovanju z referenčno državo članico kasneje posodobili za zdravilo(a) odobrena v skladu s poglavjem 4 naslova III Direktive 2001/83/ES.
Section 4.1 “Therapeutic indications” 
Poglavje 4.1 - »Terapevtske indikacije«
Section 4.4 “Special Warnings and Precautions for Use” 
Poglavje 4.4 - »Posebna opozorila in previdnostni ukrepi«
There is limited experience on the safety and efficacy of the use of <name of product>in patients over 65 years of age. 
Podatkov o varnosti in učinkovitosti zdravila <ime zdravila> pri bolnikih, starih več kot 65 let, je malo.
Tell your doctor if you have high blood pressure or if you are treated for high blood pressure, as testosterone may cause a rise in blood pressure. 
Obvestite zdravnika, če imate visok krvni tlak ali se zdravite zaradi visokega krvnega tlaka, saj lahko testosteron zviša krvni tlak.
[the wording below should be inserted in the relevant sections] 
[besedilo, kot je navedeno spodaj je treba vstaviti v ustrezna poglavja] Povzetek glavnih značilnosti zdravila
However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age. 
Kljub temu je treba upoštevati, da se fiziološke vrednosti testosterona v serumu s starostjo manjšajo.
In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, liver function tests and lipid profile. 
Pri bolnikih na dolgotrajnem androgenskem zdravljenju, je treba redno spremljati tudi naslednje laboratorijske parametre: hemoglobin in hematokrit, jetrne teste in lipidni profil.
What <name of product> is and what it is used for <name of product> is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). 
Kaj je zdravilo <ime zdravila> in za kaj ga uporabljamo Zdravilo <ime zdravila> se pri odraslih moških uporablja za nadomeščanje testosterona in za zdravljenje težav, ki jih povzroči pomanjkanje testosterona (hipogonadizem pri moških).
Testosterone may cause a rise in blood pressure and <name of product> should be used with caution in men with hypertension. 
Testosteron lahko povzroči zvišanje krvnega tlaka, zato je treba zdravilo <ime zdravila> pri moških s hipertenzijo uporabljati previdno.
Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. 
Nadomestno zdravljenje s testosteronom pri moških s hipogonadizmom, kadar je bilo pomanjkanje testosterona potrjeno s kliničnimi znaki in biokemijskimi preiskavami.
Frequency common: Increase in red blood cell count, haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests. 
Pogostnost - pogosti: povečano število rdečih krvnih celic, zvišane vrednosti hematokrita (odstotek rdečih krvnih celic v krvi) in povečane vrednosti hemoglobina (sestavina rdečih krvnih celic, ki prenaša kisik), kar se ugotavlja s krvnimi preiskavami v rednih časovnih intervalih.
In patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. 
Pri bolnikih s hudim srčnim popuščanjem, jetrno ali ledvično okvaro ali ishemično boleznijo srca lahko zdravljenje s testosteronom povzroči hude zaplete, za katere je značilen edem z ali brez kongestivne srčne odpovedi.
Testosterone level should be monitored at baseline and at regular intervals during treatment. 
Vrednosti testosterona je treba spremljati na začetku zdravljenja, nato pa v rednih presledkih med zdravljenjem.
Currently, there is no consensus about age specific testosterone reference values. 
Soglasja glede referenčnih vrednosti testosterona, specifičnih za starost, ni.
The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count. 
Pred in med zdravljenjem mora zdravnik opraviti naslednje krvne preiskave: določiti vrednost testosterona v krvi, narediti celotno krvno sliko.
Package Leaflet 
Priloga III
Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels. 
Zdravniki morajo odmerke prilagoditi posameznikom, da zagotovijo vzdrževanje ravni testosterona v okviru normalnih vrednosti.
If you are suffering from severe heart, liver or kidney disease, treatment with <name of product> may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure. 
Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila> Če imate hudo bolezen srca, jeter ali ledvic, lahko zdravljenje z <ime zdravila> povzroči hude zaplete kot so zastajanje vode v telesu, ki ga včasih spremlja (kongestivna) srčna odpoved.
These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure. 
Ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo so bila dogovorjena v postopku napotitve.