natgillin/translations-raw huggingface dataset:
Cardiac failure
Zatajivanje srca
In patients with severe renal impairment, vildagliptin significantly decreased HbA1c compared with placebo (difference of -0.56%) from a mean baseline of 7.7%.
U bolesnika s teškim oštećenjem bubrega, vildagliptin je značajno smanjio HbA1c u usporedbi s placebom (razlika od -0,56%) u odnosu na srednju početnu vrijednost od 7,7%.
There is limited experience in patients with ESRD on haemodialysis.
Postoji ograničeno iskustvo u bolesnika u završnoj fazi bubrežne bolesti na hemodijalizi.
• Common: Dizziness
• Često: omaglica
• Common: Trembling, headache, dizziness, weakness, low blood glucose
• Često: drhtanje, glavobolja, omaglica, slabost, niska razina glukoze u krvi
Other side effects Some patients have had the following side effects while taking Jalra and metformin:
Neki su bolesnici imali sljedeće nuspojave kada su uzimali Jalru i metformin:
Skin lesions, including blistering and ulceration have been reported in extremities of monkeys in nonclinical toxicology studies (see section 5.3).
U nekliničkim toksikološkim ispitivanjima (vidjeti dio 5.3) zabilježene su kožne lezije, uključujući pojavu mjehurića i ulceracija na ekstremitetima majmuna.
Table 2 Adverse reactions reported in patients who received Jalra 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
Tablica 2 Nuspojave zabilježene u bolesnika koji su primali 50 mg Jalre u kombinaciji sa sulfonilurejom u dvostruko slijepim ispitivanjima (N=170)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
11.NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
More than 1,900 patients receiving vildagliptin 50 mg once daily or 100 mg daily were ≥ 65 years.
Broj bolesnika koji su primali vildagliptin u dozi od 50 mg jedanput na dan ili 100 mg na dan, a koji su bili u dobi ≥65 godina, iznosio je više od 1900.
Table 1 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with metformin in double-blind studies (N=208)
Tablica 1 Nuspojave zabilježene u bolesnika koji su primali 100 mg Jalre na dan u kombinaciji s metforminom u dvostruko slijepim ispitivanjima (N=208)
In the pioglitazone add-on study, the absolute weight increases with placebo, Jalra 100 mg daily were 1.4 and 2.7 kg, respectively.
U kliničkom ispitivanju kao dodatne terapije uz pioglitazon, apsolutno povećanje tjelesne težine s placebom bilo je 1,4 kg, odnosno 2,7 kg sa 100 mg Jalre na dan.
Nasopharyngitis Metabolism and nutrition disorders Common
Nazofaringitis Poremećaji metabolizma i prehrane Često
As triple oral therapy in combination with - a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Kao trojna oralna terapija u kombinaciji sa - sulfonilurejom i metforminom u bolesnika u kojih je kontrola glikemije nedostatna usprkos dijeti i tjelovježbi uz dvojnu terapiju ovim lijekovima.
In controlled clinical trials with the combination of vildagliptin 100 mg daily + metformin, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily + metformin or the placebo + metformin treatment groups.
U kontroliranim kliničkim ispitivanjima kombinacije 100 mg vildagliptina na dan uz metformin, nije zabilježeno povlačenje iz ispitivanja zbog nuspojava niti u skupini liječenoj sa 100 mg vildagliptina na dan uz metformin, niti u skupini na placebu uz metformin.
In controlled clinical trials with the combination of vildagliptin 100 mg daily+ a thiazolidinedione, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily + thiazolidinedione or the placebo + thiazolidinedione treatment groups.
U kontroliranim kliničkim ispitivanjima kombinacije 100 mg vildagliptina na dan i tiazolidindiona, nije zabilježeno povlačenje iz ispitivanja zbog nuspojava niti u skupini liječenoj sa 100 mg vildagliptina na dan uz tiazolidindion, niti u skupini koja je primala placebo uz tiazolidindion.
• Uncommon: Headache, weakness, low blood glucose
• Manje često: glavobolja, slabost, niska razina glukoze u krvi
In clinical trials, weight did not change from baseline when vildagliptin 50 mg daily was added to glimepiride (-0.1 kg and -0.4 kg for vildagliptin and placebo, respectively).
U kliničkim se ispitivanjima tjelesna težina nije mijenjala od početne vrijednosti kada je 50 mg vildagliptina na dan dodano glimepiridu (-0,1 kg za vildagliptin odnosno -0,4 kg za placebo).
Table 3 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
Tablica 3 Nuspojave zabilježene u bolesnika koji su primali 100 mg Jalre na dan u kombinaciji s tiazolidindionom u dvostruko slijepim ispitivanjima (N=158)
More than 5,000 male and more than 4,000 female patients received vildagliptin 50 mg once daily or 100 mg daily.
Broj muškaraca i žena koji su dobivali vildagliptin u dozi od 50 mg jedanput na dan ili 100 mg na dan iznosio je više od 5000, odnosno više od 4000.
• Common: Headache, chills, nausea (feeling sick), low blood glucose, heartburn
• Često: glavobolja, zimica, mučnina, niska razina glukoze u krvi, žgaravica
Table 4 Adverse reactions reported in patients who received Jalra 100 mg daily as monotherapy in double-blind studies (N=1,855)
Tablica 4 Nuspojave zabilježene u bolesnika koji su primali 100 mg Jalre na dan kao monoterapiju u dvostruko slijepim ispitivanjima (N=1855)
Nervous system disorders Uncommon
Poremećaj probavnog sustava Nepoznato
• Uncommon : Diarrhoea, flatulence
• Manje često: proljev, nadutost
No severe hypoglycaemic events were reported in the vildagliptin arms.
U skupini bolesnika koji su primali vildagliptin nisu zabilježeni teški hipoglikemijski događaji.
• Uncommon: Headache, constipation, swollen hands, ankle or feet (oedema), joint pain, low blood glucose
• Manje često: glavobolja, zatvor, otečene šake, gležnjevi ili stopala (edem), bol u zglobovima,
Vildagliptin in combination with metformin and glimepiride significantly decreased HbA1c compared with placebo.The placebo-adjusted mean reduction from a mean baseline HbA1c of 8.8% was -0.76%.
Srednja vrijednost sniženja, prilagođena s obzirom na placebo, od početne srednje vrijednosti HbA1c od 8,8% bilo je -0,76%.
• Uncommon: Constipation
• Manje često: zatvor
In case of such reactions, appropriate treatment is recommended.
U slučaju pojave ovakvih reakcija, preporuča se odgovarajuće liječenje.
White homogenous emulsion.
Bijela homogena emulzija.
Zoetis WHC 2 LLC 2000 Rockford Road, Charles City IA 50616 USA
Zoetis WHC 2 LLC 2000 Rockford Road, Charles City IA 50616 SAD
ATCvet code: QI09AA07
ATCvet kod: QI09AL
Upon shaking, the black deposit disappears and the emulsion becomes homogenous again.
Nakon protresanja, crni talog nestaje, a emulzija ponovno postaje homogena.
The use of a multi-dosing syringe is recommended.
Preporučuje se korištenje štrcaljke s više doza.
Vaccination schedule: One injection from 3 weeks of age.
Raspored cijepljenja: Jedna injekcija u dobi od 3 tjedna.
Use vaccination devices according to the manufacturer's instructions.
Koristite uređaj za cijepljenje u skladu s uputama proizvođača.
CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES 25 doses
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA
Shelf life of the veterinary medicinal product as package for sale: 18 months.
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 18 mjeseci.
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.
Ako zamijetite bilo koju nuspojavu,uključujući one koje nisu opisane u ovoj uputi o VMP, ili smatrate da VMP nije djelovao, molimo obavijestite svog veterinara.
Major incompatibilities: Do not mix with any other vaccine or immunological product.
Glavne inkompatibilnosti: Ne miješati s bilo kojim drugim cjepivom ili imunološkim proizvodom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 07/02/2018.
Datum prvog odobrenja: 07/02/2018.
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.
Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
These clinical signs normally resolve without treatment.
Ovi klinički znakovi se obično povuku bez liječenja.
The vaccine is to be administered aseptically.
Cjepivo treba primijeniti aseptično.
0.2 mg *Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
0,2 mg *Jedinica relativne potencije određena pomoću ELISA kvantifikacije antigena (in vitro ispitivanje potencije) uspoređena s referentnim cjepivom.
It is intended to stimulate active immunity against PCV2 in pigs.
Namjenjen je za poticanje aktivnog imuniteta protiv PCV2 u svinja.
MARKETING AUTHORISATION NUMBERS EU/2/17/223/001-006
EU/2/17/223/001-006
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta ili laktacije.
This resolves spontaneously within 48 hours without treatment.
Ono se spontano povlači unutar 48 sati bez liječenja.
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.
Djelatna tvar koja se sastoji od tvari biološkog podrijetla, namijenjenih za stvaranje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) br 470/2009.
During storage, a slight black deposit may appear and the emulsion may separate into two distinct phases.
Tijekom čuvanja može nastati malo crnog taloga, a emulzija se može razdvojiti na dvije zasebne faze.
In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2 °C.
U pojedinih svinja povećanje temperature u odnosu na onu prije tretmana obično može prijeći 2°C.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici poslije EXP.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
Svi neupotrijebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
Administer one dose of 2 ml to pigs in the neck behind the ear.
Svinjama primijenite jednu dozu od 2 ml u vrat iza uha.
This resolved spontaneously within 24 hours without treatment.
Ono se spontano povlači unutar 24 sati bez liječenja.
The area of local tissue reactions is in general below 2 cm in diameter.
Područje lokalne tkivne reakcije je općenito promjera manjeg od 2 cm.
In a laboratory study, a postmortem examination of the injection site, performed 4 weeks after the administration of a single dose of the vaccine, revealed a mild inflammatory response, as evidenced by the absence of tissue necrosis and little fibrosis.
U laboratorijskim ispitivanjima, postmortalni pregled mjesta injekcije, proveden 4 tjedna nakon primjene jedne doze cjepiva, otkrio je blagi upalni odgovor, što je dokazano izostankom nekroze tkiva i malom fibrozom.
Anaphylaxis may occur in very rare cases.
U vrlo rijetkim slučajevima može se javiti anafilaksija.
Do not use during pregnancy and lactation.
Ne primjenjivati tijekom graviditeta i laktacije.
Once broached use immediately.
Jednom otvoreno odmah upotrijebiti.
Local tissue reactions in the form of swelling at the injection site, which may be associated with local heat, redness and pain at palpation, are very common and may last for up to 2 days (based on laboratory safety studies).
Lokalne tkivne reakcije u obliku oteklina na mjestu injekcije, koje mogu biti povezane s lokalnom toplinom, crvenilom i bolovima na dodir, vrlo su česte i mogu trajati do 2 dana (temeljem laboratorijskog istraživanja neškodljivosti).
EXPIRY DATE EXP {month/year} Once broached use immediately.
EXP {mjesec/godina} Jednom otvoren odmah upotrijebiti.
50 doses
125 doza
Pharmacotherapeutic group: immunologicals for Suidae, inactivated viral vaccines for pigs.
Farmakoterapijska grupa: imunološki pripravci za suidae, inaktivirano virusno i inaktivirano bakterijsko cjepivo za svinje.
Zero days.
Nula dana
Do not use in breeding boars.
Ne primjenjivati u rasplodnih nerasta.
Squalane Poloxamer 401 Polysorbate 80
Poloksamer 401 Polisorbat 80
Local tissue reaction in the form of swelling (below 2 cm in diameter) at the injection site was commonly observed and resolved within 2 days.
Lokalne tkivne reakcije u obliku otekline (promjera manjeg od 2 cm) na mjestu injekcije često se zamjećuju i povlače unutar 2 dana.
Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting, diarrhea or depression.
Nakon cijepljenja rijetko se mogu javiti neposredne blage reakcije slične preosjetljivosti, koje rezultiraju prolaznim kliničkim znakovima kao što su povraćanje, proljev ili depresija.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains:
Svaka doza (2 ml) sadrži:
Pigs (for fattening)
Svinje (za tov).
Potassium chloride
Natrijev klorid Kalij klorid
A transient increase in body temperature (on average 1 °C) is very common during the first 24 hours after vaccination.
Prolazno povećanje tjelesne temperature (za prosječno 1°C) vrlo je često tijekom prvih 24 sata nakon cijepljenja.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS HDPE vials (25 or 50 doses)
OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA HDPE bočice (25 ili 50 doza)
Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 3 weeks of age.
Jedna intramuskularna injekcija, jedne doze (2 ml), u vrat iza uha, svinjama u dobi od 3 tjedna.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products, if appropriate
6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda, ako je prikladno
Shake well before administration and intermittently during the process of vaccination.
Dobro protresite prije primjene te povremeno tijekom cijepljenja.
Fertility No information is available on the safety of this vaccine in breeding boars.
Nema dostupnih informacija o neškodljivosti primjene ovog cjepiva u rasplodnih nerasta.
High density polyethylene vials of 50 ml, of 100 ml and of 250 ml (25, 50 and 125 doses), with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Bočica od polietilena visoke gustoće, od 50 ml, 100 ml i 250 ml (25, 50 i 125 doza), s klorbutilnim elastomernim čepom i brtvom s aluminijskim poklopcem.
25 doses (50 ml) 50 doses (100 ml) 125 doses (250 ml)
25 doza (50 ml) 50 doza (100 ml) 125 doza (250 ml)
PACKAGE LEAFLET: Suvaxyn Circo emulsion for injection for pigs
Suvaxyn Circo emulzija za injekciju za svinje
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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).
- česte (više od 1, ali manje od 10 na 100 tretiranih životinja) - manje česte (više od 1, ali manje od 10 na 1000 tretiranih životinja) - rijetke (više od 1, ali manje od 10 na 10000 tretiranih životinja)
10 vial pack: 10 x 25 doses (50 ml) 10 vial pack: 10 x 50 doses (100 ml) 4 vial pack: 4 x 125 doses (250 ml)
Pakovanje od 10 bočica: 10 x 25 doza (50 ml) Pakovanje od 10 bočica: 10 x 50 doza (100 ml) Pakovanje od 4 bočice: 4 x 125 doza (250 ml)
For active immunisation of pigs from 3 weeks of age against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
Za aktivnu imunizaciju svinja u dobi od 3 tjedna protiv cirkovirusa svinja tipa 2 (PCV2) kako bi se smanjila količina virusa u krvi i limfoidnim tkivima te izlučivanje virusa izmetom uzrokovano infekcijom virusom
Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable.
Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Intramuscular use.
DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE HDPE vials (125 doses)
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU HDPE bočice (125 doza)
Disodium phosphate anhydrous Sodium phosphate dibasic heptahydrate Disodium tetraborate decahydrate EDTA tetrasodium
Dinatrijev tetraborat dekahidrat EDTA tetranatrij Voda za injekcije
Special precautions to be taken by the person administering the veterinary medicinal product to animals: Not applicable.
Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:
Cardboard box of 10 vials of 50 ml (25 doses ) or 100ml (50 doses).
Kartonska kutija s 10 bočica od 50 ml (25 doza) ili 100ml (50 doza).
Cardboard box of 4 vials of 250 ml (125 doses)
Kartonska kutija s 4 bočice od 250 ml (125 doza)
Cardboard box of 1 vial of 50 ml (25 doses), 100ml (50 doses) or 250 ml (125 doses).
Kartonska kutija s 1 bočicom od 50 ml (25 doza), 100ml (50 doza) ili 250 ml (125 doza).
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKI DJELATNE TVAR I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2fold overdose.
Predoziranje (simptomi, hitni postupci, antidoti): Prolazno povećanje tjelesne temperature (za prosječno 0,8°C) uočeno je 4 sata nakon primjene dvostruko veće doze.
Monobasic potassium phosphate anhydrous Sodium chloride
Monobazični kalijev fosfat, bezvodni
Duration of immunity: 23 weeks after vaccination
Trajanje imuniteta:
Duration of immunity: 23weeks after vaccination
23 tjedna nakon cijepljenja.
Onset of immunity: from 3 weeks after vaccination.
3 tjedna nakon cijepljenja.
Special precautions for use in animals None
4.5 Posebne mjere opreza prilikom primjene Posebne mjere opreza prilikom primjene na životinjama
BELGIUM
KARENCIJA
The vaccine contains an inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein.
Cjepivo sadrži inaktivirani rekombinirani himerni cirkovirus svinja tip 1, koji sadrži ORF2 protein cirkovirusa svinja tipa
Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Inaktivirani rekombinirani himerni cirkovirus svinja tip 1, koji sadrži ORF2 protein cirkovirusa svinja tipa 2
WITHDRAWAL PERIOD(S) Withdrawal period: Zero days
Karencija: nula dana.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Pročitati uputu o VMP prije primjene.
Active substance:
Djelatne tvari:
STATEMENT OF ACTIVE SUBSTANCES Each dose (2 ml) contains: Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
KOLIČINA DJELATNE(IH) TVARI Inaktivirani rekombinirani himerni cirkovirus svinja tip 1, koji sadrži ORF2 protein cirkovirusa svinja tipa 2
Marketing authorization holder and manufacturer responsible for batch release: Zoetis Belgium SA
Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet:
SPECIAL WARNING(S)
DODATAK II
The frequency of possible adverse effects is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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)
- rijetke (više od 1, ali manje od 10 na 10000 tretiranih životinja)
Call your doctor immediately.
Odmah nazovite liječnika.
Your injection could take about 10 seconds.
Injiciranje može potrajati oko 10 sekundi.
CI 95% for HRa
95% CI za HRa
Single use only.
Samo za jednokratnu upotrebu.
1) including spontaneous reporting data
1) uključujući podatke iz spontanog prijavljivanja
“Click”
“klik”
Double-Blind Response at Week 68
Dvostruko slijepi odgovor u 68. tjednu
Always take the outer carton of this medicine with you, even if it is empty.
Vanjsko pakiranje lijeka uvijek ponesite sa sobom, čak i ako je prazno.
You can use:
Možete odabrati:
This is part of the syringe.
To je dio štrcaljke.
You may also wish to make a note of these details in case you are asked for this information in the future.
I vi također možete zabilježiti te podatke u slučaju da Vas se zatraže te informacije u budućnosti.
Tell your healthcare provider if you are allergic to latex.
Obavijestite zdravstvenog radnika ako ste alergični na lateks.
Dun Laoghaire, Co Dublin Ireland
Dun Laoghaire, Co Dublin Irska
- if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
• Ako ste alergični na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies
* detaljnije informacije mogu se pronaći u dijelovima 4.3, 4.4 i 4.8 ** uključujući otvorene produžetke ispitivanja
ASDAS Inactive Disease hs-CRPd,f,g
ASDAS neaktivna bolest hs-CRPd,f,g
Other medicines and AMGEVITA
Drugi lijekovi i AMGEVITA
The Patient Reminder Cards (adult and paediatric) contain the following key elements
Kartica s podsjetnikom za bolesnika (odrasle i djecu) sadrži sljedeće ključne elemente
What AMGEVITA is and what it is used for
Što je AMGEVITA i za što se koristi
Note: After you remove the pre-filled pen from your skin, the needle will be automatically covered.
Napomena: Kada uklonite napunjenu brizgalicu s kože, igla će biti automatski pokrivena.
The window turns yellow When the injection is done
Prozorčić postaje žut kada je injiciranje završeno
Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose.
Važno: Kada uklonite napunjenu brizgalicu, ako prozorčić nije postao žut, ili ako izgleda da injiciranje lijeka još traje, to znači da niste primili punu dozu.
- Any part appears cracked or broken.
- Bilo koji dio napunjene štrcaljke izgleda napuknuto ili oštećeno.
ASAS partial remission BASDAIb 50
ASAS djelomična remisija BASDAIb 50
You and your doctor should pay special attention to signs of infection while you are being treated with AMGEVITA.
I Vi i Vaš liječnik morate obratite posebnu pažnju na znakove infekcije dok se liječite lijekom AMGEVITA.
There may be local guidelines for disposal.
Možda postoje lokalni propisi o odlaganju.
Dry natural rubber
Suha prirodna guma
You will also need these additional items, as they are not included in the carton:
Također ćete trebati ostali pribor koji nije dio pakiranja:
Disease flares at the end of 32 weeksa (n/N)
Reaktivacija bolesti pri kraju razdoblja od 32 tjednaa (n/N)