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Dobro došli na stranicu AstraZeneca Medical

Ovu stranicu možete koristiti za prijavljivanje neželjenih događaja ili žalbi na kvalitet proizvoda kompanija AstraZeneca, Alexion (AstraZeneca kompanija za retke bolesti) i drugih kompanija AstraZeneca u skladu sa obaveštenjem o privatnosti koje se nalazi na njihovim veb stranicama. Takođe možete zatražiti medicinske informacije za gore pomenute proizvode.

Ako prijavljujete neželjeni događaj/žalbu na kvalitet proizvoda, izaberite zemlju u kojoj se neželjeni događaj/žalba na kvalitet proizvoda dogodila, bez obzira na vašu lokaciju.

Kako možemo da Vam pomognemo?

Izaberite sve što je primenjivo

Neželjene događaje nekad nazivaju i neželjenim dejstvima i to su neželjeni ili nečekivani događaji ili reakcije na lek ili medicinsko sredstvo.

Upiti o medicinskim informacijama su medicinska ili naučna pitanja koja se odnose na naše lekove i uređaje.

Prijava žalbe na kvalitet proizvoda se odnose na fizičkom problemu sa lekom ili uređajem i/ili njegovom pakovanju.

Molimo izaberite opciju

Prijava neželjenog događaja

Neželjeni događaji ponekad nazivaju i: neželjena dejstva, neželjeni ili neočekivani događaji ili reakcije na lek.

Zahtev za medicinskim informacijama

Upiti o medicinskim informacijama su medicinska ili naučna pitanja koja se odnose na naše lekove i uređaje.

Prijava žalbe na kvalitet proizvoda

Prijava žalbe na kvalitet proizvoda se odnose na fizičkom problemu sa lekom ili uređajem i/ili njegovom pakovanju.

Šta Vas od navedenog najbolje opisuje?

Ja sam...

If you are a healthcare professional, you can access further information about AstraZeneca medicines and devices via https://azmedical.com.

(Odaberite ovu opciju samo ako ste sigurni da se neželjeni događaj pojavio u okviru AstraZeneca programa ranog pristupa (EAP), pojedinačnog saosećajnog korišćenja leka (SiPCU), pristupa leku nakon kliničkog ispitivanja (PTA) ili globalnog pristupa leku (GATM)).

AstraZeneca Medical

Informacije o pacijentu

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Identifikacijski broj programa kojeg dodjeljuje AstraZeneca. Za EAP-ove i PTA-ove to može biti D-kod (ili drugi kod kojeg daje AstraZeneca); za pojedinačnog saosećajnog korišćenja leka molimo unesite "SiPCU" (Single Patient Early Access), za GATM molimo unesite"GATM" (Global Access to Medicine). Ako niste sigurni, obratite se svom kontaktu iz kompanije AstraZeneca.

Identifikacijski kod za pacijenta kome se desio neželjeni događaj. Ako niste sigurni, obratite se svom kontaktu iz kompanije AstraZeneca.

Kontakt informacije

Demografija

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

visina

težina

visina

težina

datum poslednje menstruacije
termin porođaja

Podaci o reporteru

Izgleda da nas kontaktirate u ime zdravstvenog radnika. Molimo Vas da navedete informacije o Vama.

Zdravstveni radnik

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Kontakt informacije

Negovalatelj

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Kontakt informacije

Informacije o Vama

Šta najbliže opisuje Vašu ulogu u vezi sa kompanijom AstraZeneca?

Ja sam...

Please enter your Patient Support Program or Market Research Program number here. For all other programs, please tick ‘Not applicable’

datum kada je AZ zaposleni prvi put dobio informaciju *

Od pružaoca usluga za programe organizovanog prikupljanja podataka (ODCP) traži se da u ovom delu unese ID pacijenta ili referentni ID samog pružaoca usluga. Jasno navedite koju informaciju ste uneli, ID pacijenta ili Referentni ID pružaoca usluga, na sledeći način: “Pat ID: [xxx]” ili “Ref ID: [yyy]”; pri čemu je potrebno obezbediti da podatak ne prelazi 20 karaktera. Dodatne informacije možete uneti u sekciju „Veza između leka i događaja“, uz obavezno poštovanje da tamo ne budu sadržani podaci ličnog identiteta (PII).

Suppliers of Organized Data Collection Programs, such as Patient Support Programs, Market Research, Non-Interventional Studies, etc., are requested to fill in this field with either the Vendor Local Reference ID or Patient ID, and to clearly specify which data is being included. Use one of the following formats:

To enter only the Vendor Reference ID, write: "Ref ID: [yyy]"

To enter only the Patient ID, write: "Pat ID: [xxx]"

Warning: Make sure that the data entered does not exceed the 20-character limit.

If it is necessary to provide both identifiers, include them exclusively in the free text field located in the "Relationship between Medication and Event" section as follows:

"Pat ID: [xxx]; Ref ID: [yyy]"

Informacije o pacijentu

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Identifikacijski broj programa kojeg dodjeljuje AstraZeneca. Za EAP-ove i PTA-ove to može biti D-kod (ili drugi kod kojeg daje AstraZeneca); za pojedinačnog saosećajnog korišćenja leka molimo unesite "SiPCU" (Single Patient Early Access), za GATM molimo unesite"GATM" (Global Access to Medicine). Ako niste sigurni, obratite se svom kontaktu iz kompanije AstraZeneca.

Identifikacijski kod za pacijenta kome se desio neželjeni događaj. Ako niste sigurni, obratite se svom kontaktu iz kompanije AstraZeneca.

Kontakt informacije

Demografija

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

visina

težina

visina

težina

datum poslednje menstruacije
termin porođaja

Negovalatelj

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Kontakt informacije

Podaci o reporteru

Izgleda da nas kontaktirate u ime zdravstvenog radnika. Molimo Vas da navedete informacije o Vama.

Zdravstveni radnik

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Kontakt informacije

Informacije o pacijentu

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Identifikacijski broj programa kojeg dodjeljuje AstraZeneca. Za EAP-ove i PTA-ove to može biti D-kod (ili drugi kod kojeg daje AstraZeneca); za pojedinačnog saosećajnog korišćenja leka molimo unesite "SiPCU" (Single Patient Early Access), za GATM molimo unesite"GATM" (Global Access to Medicine). Ako niste sigurni, obratite se svom kontaktu iz kompanije AstraZeneca.

Identifikacijski kod za pacijenta kome se desio neželjeni događaj. Ako niste sigurni, obratite se svom kontaktu iz kompanije AstraZeneca.

Kontakt informacije

Demografija

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

visina

težina

visina

težina

datum poslednje menstruacije
termin porođaja

Zdravstveni radnik

Detalji o zdravstvenom radniku

Kontakt podaci zdravstvenog radnika

Molimo Vas da navedete barem jedan način kontakta

Neželjeni događaj za lek / medicinsko sredstvo

Molimo Vas da dodate svaki lek / medicinsko sredstvo, koristeći dugme Dodaj lek / medicinsko sredstvo

rok upotrebe

Please refer to the indications and usage described in the Japanese product information when entering the reason for taking the medication.

Datumi primene lekova

datum početka

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

datum završetka

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

Detalji o vakcinisanju

Doza 1

Rok upotrebe

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

Datum primene

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

Doza 1

Doza 2

Vaccination Facility

Additional Patient Information

Complete only for U.S military / Department of Defense (DoD) related reports

Doza 1

Doza 2

Informacije o događaju

Molimo vas da navedete pojedinačne neželjene događaje koristeći dugme "Dodaj događaj".

Ako informacije o prijavljenom neželjenom događaju prelaze predviđeni broj karaktera, molimo Vas da preostale informacije unesete u polje za slobodan tekst (Veza između leka i događaja) u nastavku.

datum kada se ovaj događaj desio

datum početka

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

datum završetka

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

trajanje događaja
Ovo polje je obavezno

Izaberite primenjive kriterijume za ovaj događaj

Izaberite sve što je primenjivo, ostavite prazno ako ništa nije primenjivo

Pour les Collaborateurs AstraZeneca / Prestataires AstraZeneca:

sélectionner si applicable le ou les critère(s) de gravité tel que rapporté par le notificateur, sans interprétation de votre part.

Sélectionner tous les critères applicables (laisser vide si non applicable)

može zahtevati medicinsku/hiruršku intervenciju kako bi se sprečila smrt, invaliditet, urođena anomalija ili porođajni defekt

detalji smrti

datum smrti

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

hospitalizacija

datum prijema

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

datum otpusta

ako je tačan datum nepoznat, unesite mesec i godinu ili godinu.

Odnos lekova i događaja

Molimo Vas unesite detalje ukoliko smatrate da je neki lek / medicinsko sredstvo u povezani sa neželjenim događajem.

Please change on the Product page if this is incorrect

Molimo izaberite opciju

Molimo izaberite opciju

Koji neželjeni događaj smatrate povezanim saovim lekom / medicinskim sredstvom?*

Vaše medicinsko pitanje

Rok za odgovor ka klijentu

Žalba na kvalitet proizvoda

rok upotrebe

Fast Track investigations are reserved for extremely serious PQCs that have the potential to cause risk to patients and / or required rapid notification to regulatory authorities.

Datum nastanka defekta

- Opišite prirodu i detalje pritužbe i okolnosti koje dovode do otkrića.

- Kada i koliko dugo ste iskusili problem s proizvodom?

- Je li se problem s kvalitetom dogodio prije, tijekom ili nakon uporabe proizvoda?

Ako je uzorak dostupan, molimo vas da ga zadržite 21 dana od danas. AstraZeneca može tražiti uzorak tokom naše istrage.

Molimo navedite kontakt podatke kako možemo da Vas kontaktiramo za povrat uzoraka

Molimo Vas da nam pomognete oko detalja Vaše reklamacije, tako što ćete odgovoriti na sledeća pitanja*

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Device Appearance, Cosmetic damage

Device Appearance, Foreign Matter

Device Appearance, Plunger Rod, Stopper, Needle Guard, Syringe, Finger Flange, Needle Cover

Attachment/Detachment Issue Plunger Rod/Stopper

Attachment/Detachment Issue Syringe Plunger Rod back out

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Finger Flange

Attachment/Detachment Issue Needle Guard

B/M/D Plunger Rod

B/M/D Finger Flange

B/M/D Needle Guard

B/M/D Needle Cover

B/M/D Stopper

B/M/D Syringe

Device doesn’t function

Incorrect Dosing administered: Incorrect Dose

Incorrect Dosing administered: Incomplete dose

Device Label Missing/Damaged: Missing Label

Device Label Missing/Damaged: Unreadable Label

Device Label Missing/Damaged: Flawed Label

Device Label Missing/Damaged: Damaged Label

Fluid present after use

Fluid present during set up

Fluid present from a component: Needle Cover

Fluid present from a component: Syringe

Fluid present from a component: Stopper

Fluid present from a component: Unspecified

Device Missing Item/Needle Cover

Device Missing Item/Plunger Rod

Device Missing Item/Needle Guard

Device Missing Item/Finger Flange

Device Missing Item/Syringe

Needle Cover Damage

Needle Cover Difficult to Remove

Needle Clogged

Damaged Needle/Unspecified

Damaged Needle/Dull

Damaged Needle/Bent

Damaged Needle/Tip flat or not beveled

Damaged Needle/Needle detached/broke off

Damaged Needle/Needle missing

Needle Guard deployed early/ during carton opening

Needle Guard deployed early/ upon arrival

Needle Guard deployed early/removal from package

Needle Guard deployed early/removal of Needle Cover

Needle Guard deployed late

Needle Guard undeployed

Unable to administer/No dose

Unable to administer/No drug coming out

Pack Broken/Malformed/Damaged- Carton

Pack Broken/Malformed/Damaged- TES

Broken/Malformed/Damaged- Tray

Pack Broken/Malformed/Damaged- Carton Dirty

Foreign Matter in the packaging

Instructions Difficult to Understand

Literature Missing/Damaged: Missing Literature

Literature Missing/Damaged: Damaged Literature

Missing Text/IFU

Incorrect text/IFU

Missing Text/PI

Incorrect text/PI

Pack Artwork:Missing Text/Carton

Pack Artwork:Incorrect text/Carton

Missing Pack Item/APFS

Missing Pack Item/Tray

Pack Mix Up/Lot numbers

Pack Mix Up/Lliterature

Pack Printing/Flawed text

Pack Printing/missing text

Pack Printing/unreadable text

Product Appearance/Air Bubbles

Product Appearance/Cloudiness

Product Appearance/Discoloration

Consistency/Solubility

Foreign matter inside the syringe

Different/wrong looking APFS

Incorrect color of Plunger Rod

Incorrect color of Needle Guard

Incorrect color of Finger Flange

Different/wrong looking APFS

Different/wrong looking APFS

Different/wrong looking APFS

Odor/Taste/Drug

Odor/Taste/Package Components

Pack/Other

Medical/Adverse Event

Medical/Product Tag Alert

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Device Appearance, Cosmetic damage

Device Appearance, Foreign Matter

Device Appearance, Plunger Rod, Stopper, Needle Guard, Syringe, Finger Flange, Needle Cover

Attachment/Detachment Issue Plunger Rod/Stopper

Attachment/Detachment Issue Syringe Plunger Rod back out

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Finger Flange

Attachment/Detachment Issue Needle Guard

B/M/D Plunger Rod

B/M/D Finger Flange

B/M/D Needle Guard

B/M/D Needle Cover

B/M/D Stopper

B/M/D Syringe

Device doesn’t function

Incorrect Dosing administered: Incorrect Dose

Incorrect Dosing administered: Incomplete dose

Device Label Missing/Damaged: Missing Label

Device Label Missing/Damaged: Unreadable Label

Device Label Missing/Damaged: Flawed Label

Device Label Missing/Damaged: Damaged Label

Fluid present after use

Fluid present during set up

Fluid present from a component: Needle Cover

Fluid present from a component: Syringe

Fluid present from a component: Stopper

Fluid present from a component: Unspecified

Device Missing Item/Needle Cover

Device Missing Item/Plunger Rod

Device Missing Item/Needle Guard

Device Missing Item/Finger Flange

Device Missing Item/Syringe

Needle Cover Damage

Needle Cover Difficult to Remove

Needle Clogged

Damaged Needle/Unspecified

Damaged Needle/Dull

Damaged Needle/Bent

Damaged Needle/Tip flat or not beveled

Damaged Needle/Needle detached/broke off

Damaged Needle/Needle missing

Needle Guard deployed early/ during carton opening

Needle Guard deployed early/ upon arrival

Needle Guard deployed early/removal from package

Needle Guard deployed early/removal of Needle Cover

Needle Guard deployed late

Needle Guard undeployed

Unable to administer/No dose

Unable to administer/No drug coming out

Pack Broken/Malformed/Damaged- Carton

Pack Broken/Malformed/Damaged- TES

Broken/Malformed/Damaged- Tray

Pack Broken/Malformed/Damaged- Carton Dirty

Foreign Matter in the packaging

Instructions Difficult to Understand

Literature Missing/Damaged: Missing Literature

Literature Missing/Damaged: Damaged Literature

Missing Text/IFU

Incorrect text/IFU

Missing Text/PI

Incorrect text/PI

Pack Artwork:Missing Text/Carton

Pack Artwork:Incorrect text/Carton

Missing Pack Item/APFS

Missing Pack Item/Tray

Pack Mix Up/Lot numbers

Pack Mix Up/Lliterature

Pack Printing/Flawed text

Pack Printing/missing text

Pack Printing/unreadable text

Product Appearance/Air Bubbles

Product Appearance/Cloudiness

Product Appearance/Discoloration

Consistency/Solubility

Foreign matter inside the syringe

Different/wrong looking APFS

Incorrect color of Plunger Rod

Incorrect color of Needle Guard

Incorrect color of Finger Flange

Different/wrong looking APFS

Different/wrong looking APFS

Different/wrong looking APFS

Odor/Taste/Drug

Odor/Taste/Package Components

Pack/Other

Medical/Adverse Event

Medical/Product Tag Alert

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Hvala Vam što ste nam pomogli da bolje razumemo pojedinosti.

Molimo Vas da uneste podatke o nedostatku u odeljku 'informacije o žalbi'

What address can the PQC acknowledgement letter be sent to?

Ukoliko je izveštač dao pristanak za kontakt, kompanija AstraZeneca se može obratiti izveštaču u cilju traženja dodatnih informacija putem zaštićempg e-maila poslate putem Proofpoint sistema.