FrancophonIA/ELRC3.0 huggingface dataset:
English: These recommendations are based on a review of all available data on the risk of thromboembolism as well as the benefits of Diane 35 and its generics:
Slovenian: Ta priporočila temeljijo na presoji vseh razpoložljivih podatkov v zvezi s tveganjem za tromboembolijo ter koristmi zdravila Diane 35 in njegovih generičnih zdravil:
English: As the CMDh position was adopted by majority vote and not by consensus, the CMDh position will now be sent to the European Commission, which will take a legally binding decision throughout the EU.
Slovenian: Ker je bilo stališče CMDh sprejeto z večino glasov, ne pa soglasno, je bilo stališče CMDh posredovano Evropski komisiji, ki ga je potrdila in dne 25. julija 2013 sprejela pravno zavezujočo odločbo, ki velja za celotno EU.
English: This review highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only.
Slovenian: V presoji so izpostavili pojave resne tromboembolije in obsežno uporabo teh zdravil izključno kot kontracepcijskega sredstva, kar ni v skladu z odobrenimi indikacijami.
English: • Doctors should discuss with their patients the risk of thromboembolism and risk factors such as increasing age, smoking, obesity and prolonged immobility.
Slovenian: • Zdravniki naj se s svojimi bolnicami pogovorijo o tveganju za tromboembolijo in dejavnikih tveganja, kot so višja starost, kajenje, debelost in dolgotrajna gibalna nedejavnost.
English: Because the CMDh took this position by majority it will now be sent to the European Commission, which will adopt a legally binding decision.
Slovenian: Ker je CMDh to stališče sprejel z večino, je bilo poslano Evropski komisiji, ki ga je potrdila in dne 25. julija 2013 sprejela pravno zavezujočo odločbo.
English: You should immediately report any relevant symptoms to your doctor, such as pain and swelling in the legs, or breathlessness and a sharp pain in the chest.
Slovenian: O vseh zadevnih simptomih, kot so na primer bolečine in otekanje nog, zasoplost in ostra bolečina v prsih, nemudoma obvestite svojega zdravnika.
English: • The review also showed that the excess risk of VTE is highest during the first year of use of Diane 35 and its generics or when restarting or switching from an oral hormonal contraceptive to Diane 35 and its generics after a pill-free interval of at least one month.
Slovenian: • Presoja je prav tako pokazala, da je povečano tveganje za venozno tromboembolijo višje v prvem letu uporabe zdravila Diane 35 in njegovih generičnih zdravil oz. pri ponovnem začetku jemanja ali prehodu s peroralnega hormonskega kontracepcijskega sredstva na zdravilo Diane 35 in njegova generična zdravila po najmanj enomesečnem intervalu neuporabe kontracepcijskih tabletk.
English: The risk of blood clots in the veins with these medicines is 1.5 to 2 times higher than for combined oral contraceptives (COCs) containing levonorgestrel and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone.
Slovenian: Tveganje za nastanek krvnih strdkov v venah pri teh zdravilih je 1,5- do 2-krat večje kot pri kombiniranih peroralnih kontracepcijskih sredstvih, ki vsebujejo levonorgestrel, in je lahko podobno tveganju pri kontracepcijskih sredstvih, ki vsebujejo gestoden, dezogestrel ali drospirenon.
English: • For the treatment of acne, these medicines should only be used after topical therapy or systemic antibiotic treatment has failed.
Slovenian: • Za zdravljenje aken se lahko ta zdravila uporabljajo samo, kadar je bilo lokalno zdravljenje ali zdravljenje s sistemskimi antibiotiki neuspešno.
English: • Doctors should review patients on Diane 35 and generics in line with these recommendations at their next scheduled appointment.
Slovenian: • Zdravniki naj bolnice, ki jemljejo zdravilo Diane 35 in njegova generična zdravila, ob naslednjem obisku pregledajo skladno s tem priporočili.
English: • The review confirmed the rare and known risk of thromboembolism with Diane 35 and its generics.
Slovenian: • Pri presoji so potrdili redko in znano tveganje za tromboembolijo pri zdravilu Diane 35 in njegovih generičnih zdravilih.
English: Data on the risk of arterial thromboembolism (ATE) with Diane and its generics are sparse and indicate that this risk is lower than for VTE.
Slovenian: Podatki o tveganju za arterijsko tromboembolijo pri zdravilu Diane in njegovih generičnih zdravilih so obširni in kažejo, da je to tveganje nižje kot tveganje za venozno tromboembolijo.
English: Observational studies have shown that the risk of venous thromboembolism (VTE) with these medicines is 1.5 to 2 times higher than for COCs containing levonorgestrel and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone.
Slovenian: Opazovalne študije so pokazale, da je tveganje za venozno trombembolijo pri teh zdravilih 1,5- do 2-krat večje kot pri kombiniranih peroralnih kontracepcijskih sredstvih, ki vsebujejo levonorgestrel, in je lahko podobno tveganju pri kontracepcijskih sredstvih, ki vsebujejo gestoden, dezogestrel ali drospirenon.
English: However, when used for acne, they should only be used if other treatments, such as those applied to the skin and antibiotics, have failed.
Slovenian: Za zdravljenje aken se lahko uporabljajo samo, če so bila druga zdravljenja, na primer z zdravili, nanesenimi na kožo, in antibiotiki, neuspešna.
English: These medicines should be used solely in the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age.
Slovenian: Ta zdravila se lahko uporabljajo izključno za zdravljenje zmernih do hudih aken, povezanih z občutljivostjo na androgen, in/ali hirzutizma (prekomerne rasti neželenih dlak pri ženskah) pri ženskah v rodni dobi.
English: Concomitant use of Diane 35 and its generics with another hormonal contraceptive will expose women to a higher dose of oestrogen and increase the risk of thromboembolism.
Slovenian: Sočasna uporaba zdravila Diane 35 ali njegovih generičnih zdravil z drugim hormonskim kontracepcijskim sredstvom žensko izpostavi višjemu odmerku estrogena ter tako poveča tveganje za tromboembolijo.
English: • In terms of effectiveness, the available data support the use of Diane 35 and its generics in the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism, in women of reproductive age.
Slovenian: • V zvezi z učinkovitostjo razpoložljivi podatki podpirajo uporabo zdravila Diane 35 in njegovih generičnih zdravil pri zdravljenju zmernih do hudih aken, povezanih z občutljivostjo na androgen, in/ali hirzutizma pri ženskah v rodni dobi.
English: Diane 35 and its generics act also as hormonal contraceptives and stopping them means that you will have to use another form of contraception to prevent unwanted pregnancies.
Slovenian: Zdravilo Diane 35 in njegova generična zdravila delujejo tudi kot hormonska kontracepcijska sredstva, zato boste morali ob prekinitvi njihovega jemanja vzeti drugo obliko kontracepcije, da preprečite neželeno nosečnost.
English: • Since Diane 35 and its generics act also as hormonal contraceptives, they should not be used in combination with other hormonal contraceptives.
Slovenian: • Ker zdravilo Diane 35 in njegova generična zdravila delujejo tudi kot hormonska kontracepcijska sredstva, jih ni dovoljeno jemati v kombinaciji z drugimi hormonskimi kontracepcijskimi sredstvi.
English: Furthermore, Diane 35 and generics should only be used for the treatment of acne when alternative treatments, such as topical therapy and antibiotic treatment, have failed.
Slovenian: Zdravilo Diane 35 in njegova generična zdravila se lahko uporabljajo za zdravljenje aken samo, kadar so bile druge oblike zdravljenja, kot sta denimo lokalno zdravljenje ali zdravljenje z antibiotiki, neuspešne.
English: Once the European Commission has adopted its decision, all EU Member States where Diane 35 and its generics are authorised must follow it and ensure that all agreed risk minimisation measures, including changes to the information to prescribers and patients, are implemented.
Slovenian: Vendar pa bo v vseh državah članicah EU obveljala poznejša odločitev Evropske komisije za ohranitev dovoljenja za promet z zdravili z dogovorjenimi ukrepi za zmanjšanje tveganja, vključno s spremembami informacij za predpisovalce in bolnice.
English: Since Diane 35 and its generics act as hormonal contraceptives, women should not take these medicines in combination with other hormonal contraceptives.
Slovenian: Ker zdravilo Diane 35 in njegova generična zdravila delujejo kot hormonska kontracepcijska sredstva, jih ženske ne smejo jemati v kombinaciji z drugimi hormonskimi kontracepcijskimi sredstvi.
English: • Diane 35 and its generics should only be used to treat moderate to severe acne (related to sensitivity to hormones called androgens) and/or hirsutism in women of child-bearing age.
Slovenian: • Zdravilo Diane 35 in njegova generična zdravila se lahko uporabljajo samo za zdravljenje zmernih do hudih aken (povezanih z občutljivostjo na hormone, imenovane androgeni) in/ali hirzutizma pri ženskah v rodni dobi.
English: • Diane 35 and its generics should only be used for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age.
Slovenian: • Zdravilo Diane 35 in njegova generična zdravila se lahko uporabljajo samo za zdravljenje zmernih do hudih aken, povezanih z občutljivostjo na androgen (s seborejo ali brez je), in/ali hirzutizma pri ženskah v rodni dobi.
English: 10 x 1 dose 50 x 1 dose
Slovenian: 10 x 1 odmerek 50 x 1 odmerek
English: Massachusetts 01702, USA
Slovenian: Massachusetts 01702, ZDA
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu/).
English: ATCvet code: QI06AH07.
Slovenian: Oznaka ATC vet: QI06AH07.
English: This resolves without any treatment.
Slovenian: Ti preidejo brez zdravljenja.
English: It has been demonstrated that this spread did not cause adverse reactions on non-vaccinated cats.
Slovenian: Dokazano je bilo, da to širjenje ni povzročilo neželenih učinkov pri necepljenih mačkah.
English: Subcutaneous use (under the skin).
Slovenian: Subkutana uporaba (pod kožo).
English: Interaction with other medicinal products and other forms of interaction:
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:
English: In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
Slovenian: V primeru anafilaktičnega šoka je potrebno ustrezno simptomatsko zdravljenje.
English: After the second injection, and subsequent administrations, this reaction is markedly reduced.
Slovenian: Po drugem injiciranju in nadaljnjih dajanjih je ta reakcija opazno blažja.
English: Do not use in pregnant cats.
Slovenian: Ne uporabite pri brejih mačkah.
English: Store and transport refrigerated (2 C - 8 C).
Slovenian: Shranjujte in prevažajte v hladilniku (2ºC - 8ºC).
English: 4.6 Adverse reactions (frequency and seriousness)
Slovenian: Neželeni učinki (pogostost in resnost)
English: This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 3 to 4 weeks at the most.
Slovenian: Ta lokalna reakcija je lahko oteklina, edem ali vozliček in spontano izgine v največ od 3 do 4 tednih.
English: In such cases where maternally derived antibodies are expected, a third injection may be appropriate from 15 weeks of age.
Slovenian: V primerih, kjer lahko pričakujemo maternalna protitelesa, je morebiti potrebno še tretje injiciranje od starosti 15 tednov.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli stranske učinke, tudi tiste, ki so navedeni v tem navodilu za uporabo ali mislite da zdravilo ni delovalo obvestite svojega veterinarja.
English: Suspension:
Slovenian: Suspenzija:
English: Date of last renewal: 06/06/2014.
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 06/06/2014
English: Sodium chloride
Slovenian: Natrijev klorid
English: Date of first authorisation: 25/06/2009.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 25/06/2009
English: Pregnancy and lactation: Do not use in pregnant cats.
Slovenian: Brejosti in laktacija: Ne uporabite pri brejih mačkah.
English: The use is not recommended during lactation.
Slovenian: Uporaba v obdobju laktacije ni priporočljiva.
English: In this case, since annual revaccination is required for calicivirus, rhinotracheitis virus and panleucopenia virus components, a single dose of FELIGEN RCP can be used annually.
Slovenian: V tem primeru, ker je potrebno vsakoletno ponovno cepljenje za komponente kalcivirus, virus rinotraheitisa in virus panklevkopenije, lahko uporabite en sam odmerek FELIGEN RCP letno.
English: Anaphylactic reactions have been reported in very rare cases.
Slovenian: V zelo redkih primerih so poročali o anafilaktičnih reakcijah.
English: * Cell culture infectious dose 50%.
Slovenian: * Infektivni odmerek za celične kulture 50%.
English: Special warnings for each target species: Vaccinate healthy animals only.
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto Cepite samo zdrave živali.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Slovenian: Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila za uporabo v veterinarski medicini odločamo od primera od primera.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno)
English: Name and address of the manufacturers of the biological active substances
Slovenian: Ime in naslov proizvajalcev bioloških učinkovin
English: For active immunisation of cats from eight weeks of age against:
Slovenian: Za aktivno imunizacijo mačk, starih osem tednov in več, proti:
English: Suspension: Opalescent liquid.
Slovenian: Suspenzija: opalescentna tekočina.
English: - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: Pain at palpation, sneezing or conjunctivitis may be noted in rare cases.
Slovenian: Bolečina na otip, kihanje ali konjunktivitis se pojavijo v redkih primerih.
English: Primary vaccination: - first injection in kittens from 8 weeks of age - second injection 3 or 4 weeks later.
Slovenian: Prvo cepljenje: - prvo injiciranje mačjih mladičev, starih nad 8 tednov - drugo injiciranje 3 ali 4 tedne kasneje.
English: Vaccinate healthy animals only.
Slovenian: Cepite samo zdrave živali.
English: De-worming at least 10 days prior to vaccination is recommended.
Slovenian: Priporočljivo je odstranjevanje glist vsaj 10 dni pred cepljenjem.
English: Store and transport refrigerated.
Slovenian: Shranjujte in prevažajte v hladilniku.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Slovenian: Za vse nadaljnje informacije o tem zdravilu za uporabo v veterinarski medicini se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.
English: Febrile limping syndrome reactions may occur very rarely in kittens, as reported in the literature after the use of any vaccine containing a Feline Calicivirus component.
Slovenian: Pri mačjih mladičih se zelo redko lahko pojavi sindrom febrilne šepavosti, kot literatura poroča po uporabi katerega koli cepiva, ki vsebuje komponento mačjega Kalicivirusa.
English: EXP {month/year} Once reconstituted use immediately.
Slovenian: EXP {mesec/leto} Rekonstruirano zdravilo uporabite takoj.
English: Incompatibilities:
Slovenian: Inkompatibilnost:
English: Pharmacotherapeutic group: immunologicals for Felidae, live and inactivated viral vaccines for cats.
Slovenian: Farmakoterapevtska skupina: imunološka sredstva za felidae, živa in inaktivirana virusna cepiva za mačke.
English: Adjuvants: 3% aluminium hydroxide gel expressed as mg Al
Slovenian: Dodatki: 3% gel aluminijevega hidroksida, izražen kot mg Al
English: The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed.
Slovenian: Prehodni znaki po cepljenju, kot so hipertermija (ki traja od 1 do 4 dni), apatija in prebavne motnje so prav tako pogosto opaženi.
English: Overdose (symptoms, emergency procedures, antidotes):
Slovenian: Preveliko odmerjanje (simptomi, nujniukrepi, protistrupi):
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: Ni podatkov o varnosti ter učinkovitosti o uporabi tega cepiva skupaj s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: MANUFACTURER'S BATCH NUMBER
Slovenian: PROIZVAJALČEVA ŠTEVILKA SERIJE
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: The vaccine contains the purified p45 FeLV-envelope antigen, obtained by genetic recombination of the E. coli strain.
Slovenian: Cepivo vsebuje prečiščen antigen ovojnice p45 FeLV, pridobljen z genetsko rekombinacijo seva E. coli.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Slovenian: BESEDILO “SAMO ZA ŽIVALI”
English: The onset of immunity has been demonstrated from: - 3 weeks after the primary vaccination for the panleucopenia and leukaemia components - 4 weeks after the primary vaccination for the calicivirus and rhinotracheitis virus components.
Slovenian: Nastop imunosti je bil dokazan od: - 3 tedne po prvem cepljenju za komponenti panlevkopenija in levkemija - 4 tedne po prvem cepljenju za komponenti kalicivirus in virusni rinotraheitis.
English: SUSPENSION VIAL
Slovenian: VIALE SUSPENZIJE
English: Re-vaccinations:
Slovenian: Revakcinacija:
English: For the leukaemia component, protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.
Slovenian: Za komponento levkemije se je zaščita pred trajno viremijo pojavila pri 73 odstotkih mačk tri tedne po prejemu prve injekcije cepiva.
English: Lyophilisate and suspension for suspension for injection.
Slovenian: Liofilizat in suspenzija za suspenzijo za injiciranje.
English: The vaccine can be used as a booster for kittens or cats previously vaccinated with FELIGEN RCP and LEUCOGEN separately.
Slovenian: Cepivo se lahko uporabi kot poživilni odmerek za mačje mladiče in mačke, ki so bile predhodno cepljene posebej z zdraviloma FELIGEN CRP in LEUCOGEN.
English: Excipient: Stabilizing buffer containing gelatin: to
Slovenian: Pufer za stabilizacijo, ki vsebuje želatino: do
English: The antigenic suspension is adjuvanted with an aluminium hydroxide gel and with a purified extract of Quillaja saponaria.
Slovenian: Antigenski suspenziji je dodan gel aluminijevega hidroksida ter prečiščen izvleček Quillaja saponaria.
English: Therefore, a test for presence of FeLV before vaccination is recommended.
Slovenian: Zato pred cepljenjem priporočamo test za prisotnost virusa FeLV.
English: No adverse reactions were observed after an overdose administration (10 doses of lyophilisate and 2 doses of suspension) of the veterinary medicinal product other than those mentioned in section 4.6 except local reactions that can last longer (from 5 to 6 weeks at the most).
Slovenian: Po dajanju prevelikega odmerka (10 odmerkov liofilizata in 2 odmerka suspenzije) zdravila za uporabo v veterinarski medicini ni bilo opaziti neželenih učinkov, razen tistih, ki so omenjeni v poglavju 4.6, z izjemo lokalnih reakcij, ki lahko trajajo dlje časa (od 5 do 6 tednov največ).
English: Lyophilisate: White pellet.
Slovenian: Liofilizat: bela peleta.
English: Purified extract of Quillaja saponaria
Slovenian: Prečiščen izvleček Quillaja saponaria
English: 1.3 ml before freeze-drying
Slovenian: 1,3 ml pred liofilizacijo
English: 4.7 Use during pregnancy, lactation or lay
Slovenian: Uporaba v obdobju brejosti, laktacije ali nesnosti
English: A moderate and transient local reaction (<2 cm) is commonly observed after the first injection.
Slovenian: Po prvem injiciranju je pogosto opažena zmerna in prehodna lokalna reakcija (<2 cm).
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: NAČIN IN POT(I) UPORABE
English: After the primary vaccination course, the duration of immunity lasts for one year for all components.
Slovenian: Po prvem krogu cepljenja je trajanje imunosti eno leto za vse komponente.
English: Excipient: Stabilizing buffer containing gelatin to 1.3 ml before freeze-drying
Slovenian: Pufer za stabilizacijo, ki vsebuje želatino do 1,3 ml pred liofilizacijo
English: 1 dose
Slovenian: 1 odmerek
English: Maternally derived antibodies, especially those against feline panleucopenia virus, can negatively influence the immune response to vaccination.
Slovenian: Maternalna protitelesa, še posebej tista proti virusu mačje panleukopenije, lahko negativno vplivajo na imunski odziv na cepivo.
English: Gelatin
Slovenian: Želatina
English: Box of 10 or 50 lyophilisate vials and 10 or 50 suspension vials
Slovenian: Škatla z 10 ali 50 vialami liofilizata in 10 ali 50 vialami suspenzije.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: Pogostnost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali), - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali), - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali), - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali), -zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: Shelf life after reconstitution: use immediately.
Slovenian: Rok uporabnosti po rekonstituciji: uporabite takoj.
English: Per dose of 1 ml:
Slovenian: Na odmerek 1 ml:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated)
Slovenian: Pogostnost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali), - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali), - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali), - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali),
English: Reconstitute one dose of lyophilisate with one dose of suspension, shake gently and administer immediately.
Slovenian: En odmerek liofilizata rekonstituirajte z enim odmerkom suspenzije, rahlo pretresite in takoj aplicirajte.
English: Plastic or cardboard box of 50 lyophilisate vials and 50 suspension vials.
Slovenian: Plastična ali kartonska škatla s 50 vialami liofilizata in 50 vialami suspenzije.
English: Plastic or cardboard box of 10 lyophilisate vials and 10 suspension vials.
Slovenian: Plastična ali kartonska škatla z 10 vialami liofilizata in 10 vialami suspenzije.