FrancophonIA/ELRC3.0 huggingface dataset:
English: Hold the PecFent bottle with your thumb on the bottom of the bottle and your first and middle fingers on the finger grips (Figure 4).
Croatian: PecFenta tako da je palcem uhvatite s donje strane a kažiprst i srednji prst stavite na mjesta za prste ispod mlaznice (slika 4).
English: You must empty the remaining doses of PecFent from the bottle by aiming the nasal spray away from you (and any other people) and pressing and releasing the grips until the red number “8” appears in the counting window.
Croatian: • Budući da iz bočice morate isprazniti preostale doze lijeka PecFent, usmjerite sprej za nos na stranu suprotnu od sebe (i svih drugih osoba) i naizmjence pritišćite i otpuštajte pritisak sve dok se u prozorčiću brojača ne pojavi broj „8“ crvene boje.
English: After the PecFent bottle has been primed (prepared for use) it delivers 2 full sprays.
Croatian: Aktivirana bočica lijeka PecFent (bočica pripremljena za uporabu) omogućava 2 puna potiska / raspršivanja.
English: 2 spray bottle: o Aim the spray away from themselves (and any other people) and expel remaining spray until the red number “2” appears in the counting window and there are no more full therapeutic sprays obtainable from the bottle.
Croatian: o Sprej usmjerite u stranu suprotnu od sebe (i od drugih osoba) i raspršite preostali lijek sve dok se u prozorčiću brojača ne pojavi broj "2" crvene boje i dok više nije moguće iz bočice dobiti nijednu punu terapijsku dozu lijeka.
English: • Store the PecFent bottle in the child resistant container at all times, even when finished.
Croatian: • Bočicu s PecFentom uvijek čuvati u spremniku sigurnom za djecu, čak i kad je lijek potrošen.
English: • cough, sneezing, catarrh or cold, changes in the fluid produced by your nose
Croatian: • kašalj, kihanje, upala sluznice nosa i ždrijela ili prehlada, promjene u izgledu tekućine koju ispuhujete iz nosa • alergijska reakcija, osip
English: • you take antidepressants or antipsychotics, please refer to the section ‘Other medicines and
Croatian: • ako imate tegobe s jetrom ili bubrezima; to bi moglo utjecati na način na koji se lijek razgrađuje u Vašem tijelu • ako uzimate antidepresive ili antipsihotike, molimo pogledajte odlomak „Drugi lijekovi i
English: EXP After first-use, use within 60 days.
Croatian: Upotrijebiti u roku od 60 dana od prve upotrebe.
English: There are 8 full sprays in each PecFent bottle.
Croatian: U svakoj bočici lijeka PecFent ima 8 punih potisaka / raspršivanja lijeka.
English: It is recommended that you prime the bottle immediately before use rather than in advance (Note: This 2 spray bottle cannot be re-primed.
Croatian: Preporučuje se da aktivirate bočicu neposredno prije upotrebe, radije nego unaprijed.
English: A fentanyl dose reduction or discontinuation of fentanyl treatment or treatment review may be indicated.
Croatian: Može biti indicirano sniziti dozu fentanila, prekinuti terapiju fentanilom ili ponovno procijeniti liječenje.
English: • chest infection
Croatian: • infekcija dišnog sustava
English: Dose readjustment
Croatian: Ponovna prilagodba doze
English: • PecFent nasal spray is only indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain
Croatian: Edukacijski materijal za ljekarnike treba isticati sljedeće: o PecFent sprej za nos indiciran je samo za kontrolu probijajuće boli u odraslih koji već primaju terapiju održavanja opioidnim lijekovima za kroničnu karcinomsku bol.
English: There are 2 full sprays in each PecFent bottle.
Croatian: U svakoj bočici lijeka PecFent ima 2 punih potisaka / raspršivanja lijeka.
English: If this dose is not successful, the patient may be prescribed a bottle of PecFent 400 micrograms/spray and instructed to change to one 400 microgram spray for their next episode of pain.
Croatian: PecFenta od 400 mikrograma/potisak i savjetovati mu da za sljedeću epizodu probijajuće boli prijeđe na jedan potisak od 400 mikrograma.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva artralgija trzanje mišića
English: Warnings and precautions Keeping PecFent safe from children
Croatian: Čuvanje lijeka PecFent podalje od djece
English: Tmax (hours)* 0.33 (0.08
Croatian: Tmax (sati)*
English: The active substance is fentanyl.
Croatian: OTPADNIH MATERIJALA KOJI POTJEČU
English: Typical opioid adverse reactions are to be expected with PecFent.
Croatian: Uz PecFent se moraju očekivati nuspojave karakteristične za primjenu opioida.
English: MANUFACTURERRESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva pruritus hiperhidroza urtikarija
English: • PecFent nasal spray should be prescribed only by physicians experienced in the management of opioid therapy in cancer patients.
Croatian: Edukacijski materijal za liječnike treba isticati sljedeće: 1. PecFent sprej za nos smiju propisivati samo liječnici s iskustvom u opioidnoj terapiji u bolesnika s karcinomom.
English: • feeling or being sick
Croatian: • osjećate mučninu ili povraćate
English: PecFent with food, drink and alcohol
Croatian: PecFent s hranom, pićem i alkoholom • Ne pijte alkoholna pića dok se liječite PecFentom.
English: Store the PecFent bottle in the child resistant container at all times, even when finished.
Croatian: Bočicu s PecFentom uvijek čuvati u spremniku sigurnom za djecu, čak i kad je lijek potrošen.
English: Loss of consciousness Depressed level of consciousness Convulsion Ageusia
Croatian: Poremećaji živčanog sustava disgeuzija omaglica somnolencija glavobolja gubitak svijesti snižena razina svijesti konvulzije ageuzija anosmija oštećenje pamćenja parosmija poremećaj govora sedacija letargija tremor
English: What PecFent is and what it is used for What you need to know before you use PecFent How to use PecFent
Croatian: Što je PecFent i za što se koristi Što je PecFent
English: If switching to PecFent from another fentanyl product for BTP, independent dose titration with PecFent is required as the bioavailability between products differs significantly.
Croatian: PecFent jer se bioraspoloživost među lijekovima značajno razlikuje.
English: E. OTFC 200 µg dose
Croatian: OTFC 200 µg doza
English: Abdominal pain Tongue disorder Mouth ulceration Dyspepsia
Croatian: Poremećaji probavnog sustava povraćanje mučnina konstipacija perforacija crijeva peritonitis oralna hipoestezija oralna parestezija proljev dizanje želuca bol u abdomenu poremećaj jezika ulceracija usta dispepsija suha usta
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije pad namjerna zloupotreba lijeka pogreška u primjeni lijeka
English: The metabolic pathways following nasal administration of PecFent have not been characterised in clinical studies.
Croatian: U kliničkim ispitivanjima nisu detaljno opisani metabolički putevi nakon nazalne primjene PecFenta.
English: Coadministration of fentanyl with a serotoninergic medicinal product, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition.
Croatian: Serotoninergički lijekovi: Istodobna primjena fentanila sa serotoninergičkim lijekom, kao što je selektivni inhibitor ponovne pohrane serotonina (SSRI) ili selektivni inhibitor ponovne pohrane serotonina i noradrenalina (SNRI)
English: PecFent 100 micrograms/spray nasal spray, solution PecFent 400 micrograms/spray nasal spray, solution
Croatian: PecFent 100 mikrograma/potisak sprej za nos, otopina PecFent 400 mikrograma/potisak sprej za nos, otopina
English: In a fertility and early embryonic development study in rats, a male-mediated effect was observed at high doses (300 mcg/kg/day, s.c.) and is consistent with the sedative effects of fentanyl in animal studies.
Croatian: (300 mikrograma/kg na dan, s.c.) opažen je učinak posredovan mužjacima koji je u skladu sa sedativnim učincima fentanila u ispitivanjima na životinjama.
English: 1 spray (100 microlitres) contains 400 micrograms fentanyl (as citrate).
Croatian: Jedan potisak (100 mikrolitara) sadrži 400 mikrograma fentanila (u obliku fentanilcitrata).
English: D. PecFent 800 µg dose
Croatian: PecFent 800 µg dose E.
English: • Do not use PecFent more than 4 times daily • Wait at least 4 hours to take the next dose of PecFent.
Croatian: • Pričekajte barem 4 sata prije nego što primijenite sljedeću dozu PecFenta.
English: 1 spray (100 microlitres) contains 100 micrograms fentanyl (as citrate).
Croatian: Jedan potisak (100 mikrolitara) sadrži 100 mikrograma fentanila (u obliku fentanilcitrata).
English: Stay sitting for at least 1 minute after using the nasal spray.
Croatian: Nakon primjene spreja za nos, ostanite sjediti barem još 1 minutu.
English: AUC (pg.hour/ml) 2460.5 (17.9 4359.9 (29.8) 7513.4 (26.7) 17272 (48.9) 3735.0 (32.8) t1/2 (hour) *Data for Tmax presented as median (range).
Croatian: AUC (pg.sat/ml) t1/2 (sat) *Podaci za Tmax prikazani su kao medijan (raspon).
English: • vertigo, falling over, malaise
Croatian: • plava boja kože • vrtoglavica, padanje, malaksalost
English: Store the bottle in the child resistant container at all times, even when finished.
Croatian: Bočicu uvijek čuvajte u spremniku sigurnom za djecu, čak i kad je lijek potrošen.
English: • you experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure.
Croatian: • ako Vam se pojavi kombinacija sljedećih simptoma: mučnina, povraćanje, gubitak teka, umor,
English: • feel very dizzy or faint
Croatian: • osjetite jaku omaglicu ili nesvjesticu
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki vaginalna hemoragija
English: Nasal spray, solution (nasal spray).
Croatian: nalbufina, pentazocina).
English: A. PecFent 100 µg dose
Croatian: PecFent 100 µg dose B.
English: C. PecFent 400 µg dose
Croatian: PecFent 400 µg dose D.
English: Even if there is little or no medicine left in the bottle, PecFent must be disposed of properly, according to the following steps: o Patients and caregivers must be instructed to properly dispose of all unused, partially used and used PecFent bottles.
Croatian: Čak i kad je u bočici preostalo malo lijeka ili ga uopće nije preostalo, PecFent se mora odgovarajuće zbrinuti prema sljedećim koracima:
English: • difficulty in or inability to pass water
Croatian: • otežano ili onemogućeno mokrenje
English: Cardiac disorders
Croatian: Srčani poremećaji cijanoza
English: Hypersensitivity
Croatian: • osjećaj omaglice
English: • PecFent 400 micrograms/spray nasal spray, solution Each ml of solution contains 4,000 micrograms fentanyl (as citrate).
Croatian: • PecFent 400 mikrograma/potisak sprej za nos, otopina Jedan ml otopine sadrži 4000 mikrograma fentanila (u obliku fentanilcitrata).
English: A review of the dose of the background opioid therapy may be required if patients consistently present with more than four BTP episodes per 24 hours.
Croatian: Ako bolesnik redovito ima više od četiri epizode probijajuće boli u 24 sata, može biti potrebno provjeriti dozu osnovne opioidne terapije.
English: B. PecFent 200 µg dose
Croatian: PecFent 200 µg dose C.
English: Dry mouth
Croatian: pročišćena voda
English: After first-use, use within 60 days Date of first use: ……….
Croatian: Rok valjanosti Upotrijebiti u roku od 60 dana od prve upotrebe.
English: • PecFent 100 micrograms/spray nasal spray, solution Each ml of solution contains 1,000 micrograms fentanyl (as citrate).
Croatian: • PecFent 100 mikrograma/potisak sprej za nos, otopina Jedan ml otopine sadrži 1000 mikrograma fentanila (u obliku fentanilcitrata).
English: Lethargy
Croatian: • proljev
English: PecFent 400 micrograms/spray nasal spray Fentanyl
Croatian: PecFent 400 mikrograma/potisak sprej za nos fentanil
English: PecFent 100 micrograms/spray nasal spray Fentanyl
Croatian: PecFent 100 mikrograma/potisak sprej za nos fentanil
English: • If you use more PecFent than you should, you may feel sleepy, sick, dizzy or have slow or shallow breathing.
Croatian: mučninu, omaglicu ili će Vam disanje biti sporo ili plitko.
English: PecFent 400 micrograms/spray nasal spray, solution Each ml of solution contains 4,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 400 micrograms fentanyl (as citrate)
Croatian: PecFent 400 mikrograma/potisak sprej za nos, otopina Jedan ml otopine sadrži 4000 mikrograma fentanila (u obliku fentanilcitrata).
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using PecFent.
Croatian: Ako se nešto od gore navedenog odnosi na Vas (ili niste sigurni), obratite se liječniku ili ljekarniku prije nego što počnete primjenjivati PecFent.
English: PecFent 100 micrograms/spray nasal spray, solution Each ml of solution contains 1,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 100 micrograms fentanyl (as citrate)
Croatian: PecFent 100 mikrograma/potisak sprej za nos, otopina Jedan ml otopine sadrži 1000 mikrograma fentanila (u obliku fentanilcitrata).
English: Put the bottle back in the child-resistant container after each use.
Croatian: Poslije svake upotrebe, bočicu vratite u spremnik siguran za djecu.
English: Intentional drug misuse Medication error
Croatian: Pomoćne tvari lijeka PecFent
English: PARTICULARS TO APPEAR ON THE CHILD RESISTANT CONTAINER (CRC)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA SPREMNIKU SIGURNOM ZA DJECU
English: Nasal conditions
Croatian: Prijavljivanje nuspojava
English: Pectin (E440)
Croatian: PecFenta (ispitivanje CP043).
English: • blockage in the wind-pipe
Croatian: • zapriječen dušnik
English: Vaginal haemorrhage
Croatian: • navale crvenila
English: Each spray contains 100 micrograms of fentanyl (as citrate)
Croatian: Jedan potisak sadrži 100 mikrograma fentanila (u obliku fentanilcitrata)
English: Method of administration PecFent is for nasal use only.
Croatian: PecFent je samo za primjenu za nos.
English: Each spray contains 400 micrograms of fentanyl (as citrate)
Croatian: Jedan potisak sadrži 400 mikrograma fentanila (u obliku fentanilcitrata).
English: Anosmia
Croatian: OBLIK
English: Opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating have been observed with transmucosal fentanyl.
Croatian: Uz transmukozni fentanil opaženi su simptomi ustezanja od opijata kao što su mučnina, povraćanje,
English: One spray administered into each nostril
Croatian: Količina jedan potisak u jednu nosnicu po jedan potisak u svaku nosnicu jedan potisak u jednu nosnicu po jedan potisak u svaku nosnicu
English: Sneezing
Croatian: nuspojava.
English: PecFent 400 micrograms/spray nasal spray solution Fentanyl
Croatian: PecFent 400 mikrograma/potisak sprej za nos, otopina fentanil
English: Neutropenia
Croatian: Plodnost
English: You can do this by holding them in your hands until they feel as warm as your hands.
Croatian: To možete postići tako da ih držite u šaci dok ne osjetite da su jednako topli kao vaši dlanovi.
English: Allow the alcohol to dry.
Croatian: Pustite da se alkohol osuši.
English: (pre- and postoperative)
Croatian: (preoperativno i postoperativno)
English: The required dose is determined using the following formula:
Croatian: Potrebna doza određuje se uporabom sljedeće formule:
English: The regimen may be adjusted based on patient response.
Croatian: Režim se može prilagoditi na temelju odgovora bolesnika.
English: Adult and adolescent population 12 - 65 years of age
Croatian: Populacija odraslih i adolescenata u dobi od 12 - 65 godina
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Croatian: To je naročito važno pri mijenjanju laboratorija i/ili reagensa primijenjenih u testu.
English: Of these patients, 34 (85%) were treated twice weekly or less.
Croatian: Od tih bolesnika, njih 34 (85%) bilo je liječeno dvaput tjedno ili rjeđe.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene su odgovornost korisnika.
English: You must contact your doctor immediately if you notice any of the following symptoms:
Croatian: Odmah se obratite svom liječniku ako primijetite bilo koji od navedenih simptoma:
English: Adult population
Croatian: Populacija odraslih
English: If you are unsure about this, ask your doctor.
Croatian: Ako niste sigurni u vezi toga, pitajte svog liječnika.
English: The sample was tested by the central laboratory at eight dilutions.
Croatian: Uzorak je testiran u središnjem laboratoriju s osam razrjeđenja.
English: Therefore, Vihuma should be used during pregnancy and breast-feeding only if clearly indicated.
Croatian: Stoga se Vihuma treba koristiti tijekom trudnoće i dojenja samo ako je to jasno indicirano.
English: Taken out of refrigerator: _____________
Croatian: Datum vađenja iz hladnjaka: _____________
English: The result was positive only at dilution factor 1 and the antibody titre was very low.
Croatian: Rezultat je bio pozitivan samo pri faktoru razrjeđenja 1, a titar antitijela bio je vrlo nizak.
English: Non-neutralising antibody positive (in PTPs)
Croatian: Stvaranje neneutralizirajućih antitijela (u PTPs)
English: If you use more than one vial of powder for one treatment, you may use the same injection needle again.
Croatian: Ako koristite više od jedne bočice s praškom za jednu primjenu, možete ponovno koristiti istu iglu za injekciju.
English: The way Vihuma is used in children does not differ from the way it is used in adults.
Croatian: Način na koji se lijek Vihuma koristi u djece ne razlikuje se od načina na koji se koristi u odraslih.
English: 33 (82.5%) patients did not experience any bleeds and 36 (90.0%) patients had no spontaneous bleeds.
Croatian: 33 (82,5%) bolesnika nije doživjelo nikakva krvarenja, a 36 (90,0%) bolesnika nije imalo spontana krvarenja.
English: This is particularly important if you are having major surgery.
Croatian: To je posebno važno u slučaju podvrgavanja većem kirurškom zahvatu.
English: No blood must flow into the syringe due to the risk of formation of fibrin clots.
Croatian: Krv ne smije ući u štrcaljku zbog rizika od stvaranja fibrinskih ugrušaka.
English: Frequency of doses (hours)/ Duration of therapy (days)
Croatian: Učestalost doza (sati)/ Trajanje liječenja (dani)
English: Do not use Vihuma:
Croatian: Nemojte primjenjivati Vihuma:
English: Proceed with the next dose immediately and continue as advised by your doctor or pharmacist.
Croatian: Odmah primijenite sljedeću dozu i nastavite s primjenom kao što Vam je savjetovao liječnik ili ljekarnik.
English: After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours when stored at room temperature.
Croatian: Nakon rekonstitucije dokazana je kemijska i fizikalna stabilnost u trajanju od 24 sata, ako se lijek čuva na sobnoj temperaturi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 February 2017
Croatian: Datum prvog odobrenja: 13. veljača 2017.
English: What Vihuma is and what it is used for
Croatian: Što je Vihuma i za što se koristi
English: All (n=20)
Croatian: Svi (n=20)
English: Wait until all the powder dissolves completely.
Croatian: Pričekajte da se otopi sav prašak.
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels.
Croatian: Liječnik će provesti laboratorijske testove kako bi provjerio imate li odgovarajuću razinu faktora VIII.
English: • if you are allergic to the active substance simoctocog alfa or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na djelatnu tvar simoktokog alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: It is recommended that not more than 4 ml per minute be administered.
Croatian: Preporuča se da primjena ne premašuje 4 ml po minuti.
English: Every 24 hours, at least 1 day, until healing is achieved.
Croatian: Svaka 24 sata, najmanje 1 dan, dok se ne postigne zacjeljivanje.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Croatian: Trombin tada pretvara fibrinogen u fibrin i omogućuje stvaranje ugruška.
English: You should be aware of the early signs of allergic reactions.
Croatian: Morate biti svjesni ranih znakova alergijskih reakcija.
English: This should be taken into consideration if you are on a controlled sodium diet.
Croatian: Ovo je potrebno uzeti u obzir ako ste na dijeti s kontroliranim unosom natrija.
English: In another clinical study, 22 adult patients were treated on demand.
Croatian: U drugom kliničkom ispitivanju 22 su odrasla bolesnika liječena prema potrebi.
English: Data have been obtained in 29 previously treated children between 2 and 5 years of age, 31 children between 6 and 12 years of age and one adolescent of 14 years.
Croatian: Podaci su dobiveni za 29 prethodno liječene djece između 2 i 5 godina, 31 dijete između 6 i 12 godina te jednog adolescenta u dobi od 14 godina.
English: If severe, sudden allergic reactions (anaphylactic) occur (very rare, up to 1 in 10,000), the injection must be stopped immediately.
Croatian: Ako doživite jaku i iznenadnu alergijsku reakciju (anafilaksiju) (vrlo rijetko, u do 1 na 10 000 osoba), odmah prekinite s ubrizgavanjem lijeka.
English: Do not remove the gray stopper or metal ring around the top of the vial.
Croatian: Nemojte uklanjati sivi čep ili metalni prsten na vrhu bočice.
English: Uncommon* Uncommon (PTPs) # Very common (PUPs)#
Croatian: Manje često* Manje često (PTPs)# Vrlo često (PUPs)#
English: Solvent: a clear, colourless liquid.
Croatian: Otapalo: bistra, bezbojna tekućina.
English: The reconstituted medicinal product is a clear, colourless solution, free from foreign particles and has a pH of 6.5 to 7.5.
Croatian: Rekonstituirani lijek je bistra, bezbojna otopina bez vidljivih čestica, s pH vrijednosti od 6,5 do 7,5.
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Croatian: Potrebno je napomenuti da anualizirana stopa krvarenja (engl. annualised bleeding rate, ABR) nije usporediva između različitih koncentrata faktora i između različitih kliničkih ispitivanja.
English: If this happens, you should contact your doctor immediately.
Croatian: Ako se to dogodi,odmah se obratite liječniku.
English: Once the product has been taken out of the refrigerator the product must not be returned to the refrigerator.
Croatian: Kada se jednom izvadi iz hladnjaka, lijek se ne smije vraćati u hladnjak.
English: The specific activity of Vihuma is approximately 9500 IU/mg protein.
Croatian: Specifična aktivnost lijeka Vihuma je približno 9500 IU/mg proteina.
English: Vihuma can be used for all age groups.
Croatian: Vihuma se može primjenjivati kod svih dobnih skupina.
English: As known from the literature, recovery and half-life was lower in young children than in adults and clearance higher, which may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Croatian: Kao što je poznato iz literature, povrat i poluvijek bili su manji u mlađe djece nego u odraslih, a klirens je bio veći, što bi djelomično moglo biti uzrokovano utvrđenim većim volumenom plazme po kilogramu tjelesne težine u mlađih bolesnika.
English: Normal weight (n=14)
Croatian: Normalna težina (n=14)
English: What you need to know before you use Vihuma
Croatian: Što morate znati prije nego počnete primjenjivati Vihuma
English: Specific studies with long-term repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with Vihuma due to the immune response to heterologous proteins in all non-human mammalian species.
Croatian: Posebna ispitivanja s dugoročnom ponovljenom primjenom kao što su reproduktivna toksičnost, kronična toksičnost i karcinogenost nisu provedena za lijek Vihuma zbog imunološkog odgovora na heterologne proteine u svih neljudskih vrsti sisavaca.