FrancophonIA/ELRC3.0 huggingface dataset:
English: Local allergic reactions at the injection site (itching, hives) have also been reported.
Croatian: Također su prijavljene i lokalne alergijske reakcije na mjestu ubrizgavanja (svrbež, koprivnjača).
English: Adverse reaction data was taken from a total of 413 clinical trial patients with severe Primary IGFD.
Croatian: Podaci o nuspojavama dobiveni su od ukupno 413 bolesnika s teškom primarnom deficijencijom IGF uključenih u kliničko ispitivanje.
English: Do not recap the syringe.
Croatian: Ne stavljajte ponovno kapicu na štrcaljku.
English: Pharmacodynamic effects The following actions have been demonstrated for endogenous human IGF-1:
Croatian: Iskazana su sljedeća djelovanja za endogeni ljudski IGF-1:
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: U svakoj grupi učestalosti, nuspojave su poredane od ozbiljnijih prema manje ozbiljnima.
English: A negative pregnancy test and adequate contraception is required in all pre-menopausal women receiving INCRELEX.
Croatian: Negativan test na trudnoću i odgovarajuća kontracepcija potrebni su u svih žena prije perioda menopauze koje primaju INCRELEX.
English: Infections Infections of the middle ear have been observed in children with mecasermin treatment.
Croatian: Infekcije Infekcije srednjeg uha primijećene su kod djece liječene mekaserminom.
English: Tissue Growth
Croatian: Rast tkiva
English: Increased pressure in the brain (intracranial hypertension) INCRELEX can sometimes cause a temporary increase in pressure within the brain.
Croatian: INCRELEX ponekad može izazvati privremeno povećanje tlaka u mozgu.
English: Enlarged tonsils/adenoids
Croatian: Povećani krajnici (tonzile/adenoidi)
English: 65, quai Georges Gorse 92100 Boulogne-Billancourt France
Croatian: 65, quai Georges Gorse 92100 Boulogne-Billancourt Francuska
English: Seventy-four (91%) of the subjects were prepubertal at baseline.
Croatian: Sedamdeset i četiri (91%) ispitanika bilo je na početku ispitivanja u predpubertetskom razdoblju.
English: Clinical Trial
Croatian: Kliničko ispitivanje
English: Treatment of acute overdose of mecasermin should be directed at alleviating any hypoglycaemic effects.
Croatian: Liječenje akutnog predoziranja mekaserminom treba biti usmjereno na ublažavanje svih hipoglikemijskih učinaka.
English: See the package leaflet for further information.
Croatian: Pogledajte uputu o lijeku za daljnje informacije.
English: Stop INCRELEX immediately and seek urgent medical advice if you develop seizures/fits or become unconscious.
Croatian: Prekinite odmah uzimanje INCRELEXA i zatražite hitni medicinski savjet ako dobijete napadaje ili izgubite svijest.
English: Mecasermin may lower blood sugar levels.
Croatian: Mekasermin može sniziti razine šećera u krvi.
English: The height velocities for years 2 through 8 remained statistically greater than baseline.
Croatian: Brzine rasta od 2 do 8 godine ostale su statistički veće nego u početku.
English: Figure 2: Inject air into vial
Croatian: Slika 2: Ubrizgajte zrak u bočicu
English: Excipients INCRELEX contains 9 mg/ml benzyl alcohol as a preservative.
Croatian: Pomoćne tvari INCRELEX sadrži 9 mg/ml benzilnog alkohola koji služi kao konzervans.
English: Common: Sleep apnoea syndrome, adenoidal hypertrophy, tonsillar hypertrophy, snoring
Croatian: Često: apneja u snu, adenoidna hipertrofija, tonzilarna hipertrofija, hrkanje
English: Only use INCRELEX that is clear and colourless.
Croatian: Primjenjujte samo INCRELEX koji je bistar i bezbojan.
English: Generalised hives, difficulty in breathing, dizziness, swelling of the face and/or throat have been reported following mecasermin use.
Croatian: Generalizirana koprivnjača, otežano disanje, omaglica, oticanje lica i/ili grla prijavljeni su nakon primjene mekasermina.
English: The mean terminal t1/2 of total IGF-1 after single subcutaneous administration of 0.12 mg/kg in three paediatric subjects with severe Primary IGFD is estimated to be 5.8 hours.
Croatian: Procjenjuje se da srednja vrijednost t1/2 od ukupnog IGF-1 nakon jednokratne supkutane primjene od 0,12 mg/kg u tri pedijatrijska ispitanika s teškom primarnom deficijencijom IGF iznosi 5,8 sati.
English: • Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth.
Croatian: • Iskliznuće epifize glave femura i napredovanje skolioze mogu se javiti kod bolesnika koji iskuse brzi rast.
English: Hypoglycaemia is a very common adverse reaction.
Croatian: Hipoglikemija je vrlo česta nuspojava.
English: After first use, the vial may be stored for up to 30 days at 2C to 8ºC.
Croatian: Nakon prve uporabe, bočica se može čuvati najviše 30 dana na 2 ºC do 8ºC.
English: Children The pharmacokinetics of INCRELEX have not been studied in subjects younger than 12 years of age.
Croatian: Farmakokinetika INCRELEXA nije ispitivana u ispitanika dobi mlađe od 12 godina.
English: Ipsen Farmaceutica B.V. Taurusavenue 33 B NL-2132 LS Hoofddorp Tel: + 31 23 55 41 600
Croatian: Taurusavenue 33 B NL-2132 LS Hoofddorp Tel: + 31 23 55 41 600
English: Severe hypoglycaemia may cause unconsciousness, seizures/fits or death.
Croatian: Teška hipoglikemija može dovesti do gubitka svijesti, napadaja ili smrti.
English: Common (may affect up to 1 in 10 people) Seizures
Croatian: Česte (mogu se javiti kod do 1 na 10 osoba) Napadaji
English: Aqueous, clear and colourless solution.
Croatian: Vodena, bistra i bezbojna otopina.
English: Serious allergic reactions have also been reported with INCRELEX.
Croatian: S INCRELEXOM su prijavljene i ozbiljne alergijske reakcije.
English: Data was also collected from post-marketing sources.
Croatian: Podaci su također prikupljeni i iz prijava nakon stavljanja lijeka u promet.
English: Put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see Figure 2).
Croatian: Stavite iglu kroz gumeni vrh bočice i gurnite klip kako biste ubrizgali zrak u bočicu (pogledajte Sliku 2).
English: The total IGF-1 volume of distribution (mean ± SD) after subcutaneous administration of INCRELEX in 12 subjects with severe Primary IGFD is estimated to be 0.257 (± 0.073) l/kg at a mecasermin dose of 0.045 mg/kg, and is estimated to increase as the dose of mecasermin increases.
Croatian: Procjenjuje se da ukupan volumen distribucije IGF-1 (srednja vrijednost ± SD) nakon supkutane primjene INCRELEXA kod 12 ispitanika s teškom primarnom deficijencijom IGF iznosi 0,257 (± 0,073) l/kg pri dozi mekasermina od 0,045 mg/kg, te da se povećava s povećanjem doze mekasermina.
English: PharmaSwiss d.o.o.
Croatian: PharmaSwiss d.o.o. Brodišče 32
English: Eighty-three (83) out of 92 patients were naïve to INCRELEX at baseline and 81 completed at least one year of INCRELEX treatment.
Croatian: Na početku ispitivanja osamdeset i tri (83) od ukupno 92 ispitanika nisu bili prethodno liječeni INCRELEXOM, a 81 je ispitanik primao terapiju INCRELEXOM najmanje jednu godinu.
English: Hypoacusis (hearing loss), ear pain and fluid in the middle ear have been observed with mecasermin treatment.
Croatian: Hipoakuzija (gubitak sluha), bol u uhu i tekućina u srednjem uhu uočeni su kod liječenja mekaserminom.
English: If you stop using INCRELEX
Croatian: Ako prestanete primjenjivati INCRELEX
English: - INCRELEX is a liquid that contains mecasermin which is a man-made insulin-like growth factor-1 (IGF-1), which is similar to the IGF-1 made by your body.
Croatian: - INCRELEX je tekućina koja sadrži mekasermin koji je umjetni inzulinu slični faktor rasta-1 (IGF-1), koji je sličan IGF-1 kojeg stvara vaše tijelo.
English: Acute overdose could lead to hypoglycaemia.
Croatian: Akutno predoziranje može dovesti do hipoglikemije.
English: Insulin-like growth factor-1 (IGF-1) is the principal hormonal mediator of statural growth.
Croatian: Inzulinu sličan faktor rasta-1 (IGF-1) osnovni je hormonalni medijator staturalnog rasta.
English: If you forget to use INCRELEX
Croatian: Ako ste zaboravili primijeniti INCRELEX
English: Mecasermin should be administered shortly before or after a meal or snack, because it may have insulin-like hypoglycaemic effects.
Croatian: Mekasermin treba primjenjivati neposredno prije ili nakon obroka ili užine, jer može imati hipoglikemijski učinak slično inzulinu.
English: Other ingredients: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate and water for injections.
Croatian: Drugi sastojci: benzilni alkohol, natrijev klorid, polisorbat 20, ledena acetatna kiselina, natrijev acetat i voda za injekcije.
English: Al. Jana Pawła II 29
Croatian: Ipsen Poland Sp. z o.o. Al. Jana Pawła II 29
English: Change the injection site for each injection.
Croatian: Promijenite mjesto ubrizgavanja za svako davanje.
English: Height Velocity (cm/yr)
Croatian: Brzina rasta (cm/god.)
English: Other adverse reactions have been identified during post approval use of INCRELEX.
Croatian: Druge nuspojave identificirane su tijekom uporabe INCRELEXA nakon odobrenja lijeka.
English: Mecasermin has been tested in a rat teratology study with no effects on fœtus up to 16 mg/kg (20 fold the maximum recommended human dose (MRHD) based on body surface area) and in a rabbit teratology with no effects on foetus at dose of 0.5 mg/kg (2 fold the MRHD based on body surface area).
Croatian: Mekasermin je ispitan u teratogenom ispitivanju kod štakora i nije imao učinaka na fetus do doze od 16 mg/kg (20 puta veća od maksimalne dozvoljene doze kod ljudi na temelju površine tijela) i u teratogenom ispitivanju kod kunića, bez učinaka na fetus u dozi od 0,5 mg/kg (2 puta većoj od maksimalne dozvoljene doze kod ljudi temeljeno na površini tijela).
English: Pull the plunger to withdraw the correct dose into the syringe (see Figure 5).
Croatian: Povucite klip kako biste povukli točnu dozu u štrcaljku (pogledajte Sliku 5).
English: Common: Papilloedema
Croatian: Često: papiloedem
English: INCRELEX should not be given to pregnant or nursing women.
Croatian: INCRELEX se ne smije davati trudnicama ili dojiljama.
English: Very common: Otitis media Common: Hypoacusis, ear pain, middle ear effusion
Croatian: Vrlo često: otitis media Često: hipoakuzija, bol u uhu, tekućina u srednjem uhu
English: Mecasermin may enlarge your tonsils/adenoids.
Croatian: Mekasermin može povećati Vaše krajnike.
English: The amino acid sequence of the product is identical to that of endogenous human IGF-1.
Croatian: Sekvenca aminokiselina u lijeku identična je onoj u endogenom, ljudskom IGF-1.
English: There are limited data concerning the pharmacokinetics of mecasermin in children with renal impairment, in this specific population of severe primary IGFD patients.
Croatian: Ograničeni su podaci o farmakokinetici mekasermina u djece s oštećenjem bubrega u ovoj specifičnoj populaciji bolesnika s teškom primarnom deficijencijom IGF-a.
English: Glucagon raises the blood sugar when it is injected.
Croatian: Glukagon, kada se ubrizga, podiže razinu šećera u krvi.
English: The typical dose is 0.04 to 0.12 mg/kg of patient weight administered twice a day.
Croatian: Uobičajena doza je 0,04 do 0,12 mg/kg težine bolesnika primijenjena dvaput dnevno.
English: Renal impairment No studies have been conducted in children with renal impairment.
Croatian: Nisu provođene studije kod djece s bubrežnim oštećenjem.
English: The absolute subcutaneous bioavailability of mecasermin in severe Primary IGFD subjects has not been determined.
Croatian: Apsolutna bioraspoloživost supkutanog mekasermina kod ispitanika s teškom primarnom deficijencijom IGF nije utvrđena.
English: Uncommon: Increased weight
Croatian: Manje često: porast tjelesne težine
English: Common: Gynaecomastia
Croatian: Često: ginekomastija
English: There are limited data concerning the pharmacokinetics of mecasermin in children with hepatic impairment, in this specific population of severe primary IGFD patients.
Croatian: Ograničeni su podaci o farmakokinetici mekasermina u djece s oštećenjem jetre u ovoj specifičnoj populaciji bolesnika s teškom primarnom deficijencijom IGF-a.
English: Height SDS
Croatian: SDS visine
English: Skin and hair changes Skin thickening, moles and abnormal hair texture have been seen with mecasermin treatment.
Croatian: Promjene na koži i kosi Zadebljanje kože, madeži i poremećena tekstura kose primijećeni su kod liječenja mekaserminom.
English: What INCRELEX looks like and contents of the pack INCRELEX is a clear and colourless solution for injection (injection) supplied in a glass vial closed with a stopper and a seal.
Croatian: INCRELEX je bistra i bezbojna otopina za injekciju (injekcija) koja se isporučuje u staklenoj bočici zatvorenoj s čepom i zaštitnim poklopcem.
English: Intracranial hypertension (IH) with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in patients treated with mecasermin, as has been reported with therapeutic GH administration.
Croatian: Intrakranijska hipertenzija s papiloedemom, promjenama vida, glavoboljom, mučninom i/ili povraćanjem prijavljena je kod bolesnika liječenih mekaserminom, kako je prijavljeno s terapijskom primjenom hormona rasta.
English: The lowest dose that was associated with substantial growth increases on an individual basis was 0.04 mg/kg twice daily (BID).
Croatian: Najniža doza povezana sa značajnim povećanjem rasta kod pojedinog bolesnika bila je 0,04 mg/kg dva puta dnevno.
English: Funduscopic examination is recommended at the initiation, periodically during the course of mecasermin therapy and at the occurrence of clinical symptoms.
Croatian: Preporučuju se pregledi očne pozadine prije započinjanja i periodički za vrijeme terapije mekaserminom i pri pojavi kliničkih simptoma.
English: Systemic hypersensitivity included symptoms such as anaphylaxis, generalized urticaria, angioedema and dyspnoea.
Croatian: Sistemska preosjetljivost uključivala je simptome kao što su anafilaksija, generalizirana urtikarija, angioedem i dispneja.
English: If you take INCRELEX, you should avoid participating in high risk activities (such as vigorous physical activity) within 2 to 3 hours after INCRELEX injection, especially at the beginning of INCRELEX treatment.
Croatian: Ako uzimate INCRELEX, trebate izbjegavati sudjelovanje u visokorizičnim aktivnostima (kao što je naporna tjelesna aktivnost) unutar 2 do 3 sata nakon INCRELEX injekcije, posebno na početku liječenja INCRELEXOM.
English: Treatment of acute overdose of mecasermin should be directed at reversing hypoglycaemia.
Croatian: Liječenje akutnoga predoziranja mekaserminom treba usmjeriti na ublažavanje hipoglikemije.
English: • That INCRELEX should be administered shortly before or after a meal or snack because it has insulin-like hypoglycaemic effects.
Croatian: • INCRELEX treba primijeniti neposredno prije ili nakon obroka ili užine jer ima hipoglikemijske učinke nalik inzulinu.
English: The dose of INCRELEX should not be doubled to make up for one or more omitted doses.
Croatian: Doza INCRELEXA se ne smije udvostručiti kako bi se nadoknadile jedna ili dvije propuštene doze.
English: • To report the onset of severe headache, blurred vision and associated nausea and vomiting to their physician.
Croatian: • Izvijestiti svog liječnika o početku teške glavobolje, zamagljenom vidu i povezanoj mučnini i povraćanju.
English: You should avoid engaging in any high-risk activities (e.g., driving, etc.) within 2-3 hours after dosing, particularly at the start of INCRELEX treatment, until a dose of INCRELEX has been found which does not cause side effects that make these activities risky.
Croatian: Trebate izbjegavati upuštanje u bilo kakve visokorizične aktivnosti (npr. upravljanje vozilima itd.) unutar 2-3 sata nakon doziranja, naročito na početku liječenja INCRELEXOM, dok se ne pronađe doza INCRELEXA koja ne uzrokuje nuspojave koje ove aktivnosti čine rizičnima.
English: Brodišče 32 SI-1236 Trzin Tel: + 386 1 236 47 00
Croatian: SI-1236 Trzin Tel: + 386 1 236 47 00
English: Pain in muscles has also been seen with mecasermin treatment.
Croatian: Bol u mišićima također je primijećena kod liječenja mekaserminom.
English: Sugarcontaining fluids or food should be consumed.
Croatian: Treba konzumirati tekućinu ili hranu koja sadrži šećer.
English: Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology.
Croatian: Mekasermin je ljudski inzulinu sličan faktor rasta-1 (rhIGF-1) dobiven tehnologijom rekombinantne DNK.
English: Common: Abdominal pain
Croatian: Često: bol u abdomenu
English: Hair loss has also been reported following mecasermin use.
Croatian: Opadanje kose (alopecija) Također je prijavljeno opadanje kose nakon primjene mekasermina.
English: If a vial freezes, dispose appropriately.
Croatian: Ako se bočica zaledi, uklonite je na odgovarajući način.
English: These conditions should be monitored during INCRELEX treatment.
Croatian: Ova stanja trebaju biti praćena za vrijeme liječenja INCRELEXOM.
English: Heart abnormalities A fast heart rate and abnormal heart sounds have been reported with mecasermin treatment.
Croatian: Poremećaji u radu srca Ubrzani puls i nenormalni zvukovi srca prijavljeni su kod liječenja mekaserminom.
English: An increased incidence of adrenal medullary hyperplasia and pheochromocytoma was observed in male rats at doses of 1 mg/kg/day and above ( 1 times the clinical exposure with the maximum recommended human dose [MRHD] based on AUC) and female rats at all dose levels ( 0.3 times the clinical exposure with the MRHD based on AUC).
Croatian: Povećana incidencija hiperplazije srži nadbubrežne žlijezde i feokromocitoma zabilježena je kod mužjaka štakora pri dozama od 1 mg/kg/dan i iznad ( 1 puta klinička izloženost s maksimalno dozvoljenom dozom kod ljudi temeljena na AUC) i ženkama štakora pri svim dozama ( 0,3 puta klinička izloženost s maksimalno dozvoljenom dozom kod ljudi temeljena na AUC).
English: There were also reports of systemic hypersensitivity from post-marketing use, of which some cases were indicative of anaphylaxis.
Croatian: Nakon stavljanja lijeka u promet bilo je i prijava o sistemskoj preosjetljivosti, gdje su neki slučajevi ukazivali na anafilaksiju.
English: The symptoms in the cases indicative of anaphylaxis included hives, angioedema and dyspnoea.
Croatian: Simptomi u slučajevima koji su upućivali na anafilaksiju uključivali su koprivnjaču, angioedem i dispneju.
English: Figure 4: Tip in liquid
Croatian: Slika 4: Vrh u tekućinu
English: Lonza AG Lonzastrasse CH-3930 Visp Switzerland
Croatian: CH-3930 Visp
English: Patients should avoid engaging in any high-risk activities within 2-3 hours after dosing, particularly at the initiation of mecasermin treatment, until a welltolerated dose of INCRELEX has been established.
Croatian: Bolesnici trebaju izbjegavati bilo kakve visokorizične aktivnosti unutar 2-3 sata nakon doziranja, osobito pri započinjanju liječenja mekaserminom, dok se ne utvrdi doza INCRELEXA koja se dobro podnosi.
English: Decide on an injection area - upper arm, thigh, buttock, or abdomen (see below).
Croatian: Odlučite se za područje ubrizgavanja - nadlaktica, bedro, stražnjica ili trbuh (pogledajte ispod).
English: Table 2: Annual Height Results by Number of Years Treated with INCRELEX Pre-Tx Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8
Croatian: Tablica 2: Godišnji rezultati visine po broju godina liječenja INCRELEXOM Pre-Tx Godina
English: Inject INCRELEX just below the skin in your upper arm, upper leg (thigh), stomach area (abdomen), or buttocks.
Croatian: Ubrizgajte INCRELEX pod samu kožu na nadlaktici, natkoljenici (bedru), području trbuha ili stražnjici.
English: Very common: Hypoglycaemia Common: Hypoglycaemic seizure, hyperglycaemia
Croatian: Vrlo često: hipoglikemija Često: hipoglikemijski napadaj, hiperglikemija
English: The injection site should be changed for each injection (rotate the injection site).
Croatian: Mjesto ubrizgavanja treba mijenjati za svaku injekciju (rotirati mjesto ubrizgavanja).
English: Figure 7: Ready to inject
Croatian: Slika 7: Spremni za ubrizgavanje nadlaktica bedro stražnjica trbuh
English: Papilloedema
Croatian: Papiloedem
English: INCRELEX 10 mg/ml solution for injection Mecasermin
Croatian: INCRELEX 10 mg/ml otopina za injekciju mekasermin
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: An increased incidence of mammary gland carcinoma in both male and female rats was observed in animals treated with 10 mg/kg/day (7 times the exposure with the MRHD based on AUC).
Croatian: Povećana incidencija od karcinoma mliječne žlijezde i u mužjaka i ženki štakora zabilježena je u životinja tretiranih s 10 mg/kg/dan (7 puta izloženost s maksimalno dozvoljenom dozom kod ljudi temeljena na AUC).
English: Dizziness and tremor have also been reported with mecasermin treatment.
Croatian: Omaglica i nevoljno drhtanje također su prijavljeni kod liječenja mekaserminom.
English: Race No information is available.
Croatian: Nema dostupnih podataka.
English: Echocardiogram is recommended before initiation of mecasermin treatment in all patients.
Croatian: Kod svih bolesnika preporučuje se učiniti ehokardiogram prije započinjanja liječenja mekaserminom.
English: An increased incidence of keratoacanthoma in the skin was observed in male rats at doses of 4 and 10 mg/kg/day ( 4 times the exposure with the MRHD based on AUC).
Croatian: Povećana incidencija keratoakantoma u koži zabilježena je u mužjaka štakora pri dozama od 4 i 10 mg/kg/dan ( 4 puta izloženost s maksimalno dozvoljenom dozom kod ljudi temeljena na AUC).
English: All 4 subjects recovered from the event without sequelae.
Croatian: Sva su se 4 ispitanika oporavila bez posljedica.
English: Common: Injection site pain, injection site reaction, injection site haematoma, injection site erythema, injection site induration, injection site haemorrhage, injection site irritation
Croatian: Često: bol na mjestu injiciranja, reakcija na mjestu injiciranja, hematom na mjestu injiciranja, eritem na mjestu injiciranja, otvrdnuće na mjestu injiciranja, krvarenje na mjestu injiciranja, iritacija na mjestu injiciranja Manje često: osip na mjestu injiciranja, oticanje na mjestu injiciranja, lipohipertrofija
English: In post-marketing experience in patients treated with INCRELEX, cases of hypersensitivity, urticaria, pruritus and erythema have been reported.
Croatian: U iskustvu nakon stavljanja lijeka u promet kod bolesnika liječenih INCRELEXOM, prijavljeni su slučajevi preosjetljivosti, urtikarije, pruritusa i eritema.
English: • To avoid engaging in any high-risk activities (such as vigorous physical activity) within 2 - 3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a well-tolerated dose of INCRELEX has been established.
Croatian: • Izbjegavati upuštanje u bilo kakve visokorizične aktivnosti (kao što su naporne tjelesne aktivnosti) unutar 2 - 3 sata nakon doziranja, osobito pri započinjanju liječenja INCRELEXOM, dok se ne ustanovi doza INCRELEXA koja se dobro podnosi.
English: What you need to know before you use INCRELEX 3.
Croatian: Što morate znati prije nego počnete primjenjivati INCRELEX 3. Kako primjenjivati INCRELEX 4. Moguće nuspojave
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION INCRELEX 10 mg/ml injection mecasermin
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA INCRELEX 10 mg/ml injekcija mekasermin s.c.
English: - if you have symptoms of increased pressure in the brain (intracranial hypertension), such as visual changes, headache, nausea and/or vomiting, contact the doctor for advice.
Croatian: - ako imate simptome povećanog tlaka u mozgu (intrakranijalna hipertenzija), kao što su promjene vida,
English: Get medical help immediately if you have a generalised allergic reaction (hives, trouble breathing, faintness or collapse and feeling generally unwell).
Croatian: Potražite odmah medicinsku pomoć kao imate generaliziranu alergijsku reakciju (koprivnjaču, otežano disanje,
English: 140 00 Praha 4 Tel: + 420 242 481 821
Croatian: Tel: + 420 242 481 821