natgillin/translations-raw huggingface dataset:
Pharmacotherapeutic group: immunologicals for bovidae, live viral vaccines.
Farmakoterapevtska skupina: Imunološka zdravila za votloroge (bovidae), živa virusna cepiva.
Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 USA
Ime in naslov proizvajalca bioloških učinkovin Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 ZDA
Cattle
Govedo.
Reconstitute the lyophilisate by adding the full content of the solvent at room temperature.
Rekonstituirajte liofilizat z dodatkom vse vsebine vehikla pri sobni temperaturi.
50 doses (100 ml)
50 odmerkov (100 ml)
The vaccine is designed to stimulate the development of an active immune response against BVDV-1 and BVDV-2 in cattle.
Cepivo je oblikovano za spodbujanje razvoja aktivnega imunskega odziva na BVDV-1 in BVDV-2 pri govedu.
For active immunisation of cattle from 3 months of age to reduce hyperthermia and to minimise the reduction of leukocyte count caused by bovine viral diarrhoea virus (BVDV-1 and BVDV-2), and to reduce virus shedding and viraemia caused by BVDV-2.
Za aktivno imunizacijo od 3 mesecev starosti za zmanjšanje hipertermije in kar največje zmanjšanje števila levkocitov, ki ju povzroča virus bovine virusne driske (BVDV-1 in BVDV-2), in za zmanjšanje razsoja virusa in viremije, ki ju povzroča BVDV-2.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen za uporabo s tem zdravilom.
It is recommended to vaccinate before pregnancy to ensure protection against persistent infection of the foetus.
Priporočajo cepljenje pred brejostjo, da se zagotovi zaščita pred trajno okužbo ploda.
The cornerstone of bovine viral diarrhoea (BVD)-eradication is identification and culling of persistently infected animals.
Temelj izkoreninjenja bovine virusne driske (BVD) je prepoznavanje in izločanje trajno okuženih živali.
3 weeks after immunisation.
Nastop imunosti: 3 tedne po imunizaciji.
After reconstitution, administer one dose (2 ml) of the vaccine by intramuscular (IM) injection.
Po rekonstituciji dajte en odmerek (2 ml) cepiva z intramuskularno (i.m.)
Lyophilisate and solvent for suspension for injection Lyophilisate: Off-white colour without foreign matter.
Liofilizat in vehikel za suspenzijo za injiciranje Liofilizat: sivo bele barve brez tujih snovi.
It is recommended to vaccinate cattle at least 3 weeks before insemination/mating to provide foetal protection from the first day of conception.
Priporočljivo je cepiti govedo vsaj 3 tedne pred osemenitvijo/parjenjem, s čimer zagotovimo zaščito ploda od prvega dne spočetja.
For active immunisation of cattle against BVDV-1 and BVDV-2, to prevent the birth of persistently infected calves caused by transplacental infection.
Za aktivno imunizacijo goveda proti BVDV-1 in BVDV-2, da preprečimo kotitev telet s trajno okužbo, ki jo povzroča transplacentalna okužba.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKIH UČINKOVIN IN PROIZVAJALEC, ODGOVOREN ZA SPROSTITEV SERIJ
Each dose (2 ml) contains: Lyophilisate:
En odmerek (2 ml) vsebuje: Liofilizat:
This may result in transplacental transmission on the vaccine virus, but no adverse effects on foetus or pregnancy was observed in studies.
To lahko povzroči transplacentalen prenos virusa cepiva, vendar v študijah niso opazili nikakršnih neželenih učinkov na plod ali brejost.
EXP {month/year} Once reconstituted use within 8 hours.
EXP {mesec/leto} Rekonstituirano zdravilo uporabite v 8 urah.
The vaccine strains are able to infect sheep and swine when administered intranasally, but no adverse reactions or spreading to in-contact animals has been demonstrated.
Sevi cepiva lahko okužijo ovce in svinje, kadar jih damo intranazalno, vendar niso dokazali neželenih učinkov ali kontaktnega širjenja na živali.
In some limited cases with newborn calves, positive ear notches for BVDV vaccine strain were reported by molecular diagnostic tests.
V nekaterih omejenih primerih so z molekularnimi diagnostičnimi metodami poročali o pozitivnih testih zareze uhlja novorojenih telet na prisotnost cepitvenega seva za BVDV.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after the abbreviation EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in plastenki po Uporabno do:.
Mild swellings or nodules up to 3 cm diameter were observed at the injection site and disappeared within 4 days post vaccination (clinical studies).
Na mestu injiciranja so opazili blage otekline ali vozliče, ki so imeli do 3 cm v premeru in so izginili v 4 dneh po cepljenju (klinične študije).
Bovine viral diarrhoea virus type 1: 104.0-106.0 TCID50, Bovine viral diarrhoea virus type 2: 104.0-106.0 TCID50.
virus bovine virusne driske tip 1: 104,0-106,0 TCID50, virus bovine virusne driske tip 2: 104,0-106,0 TCID50.
Longlasting viremia has been observed after vaccination, in particular in pregnant seronegative heifers (10 days in a study).
Po cepljenju so opazili dolgotrajno viremijo, posebno pri brejih seronegativnih telicah (10 dni v študiji).
Each dose (2 ml) contains: BVDV-1: 104.0-106.0 TCID50, BVDV-2: 104.0-106.0 TCID50.
En odmerek (2 ml) vsebuje: BVDV-1: 104,0-106,0 TCID50, BVDV-2: 104,0-106,0 TCID50.
5 doses (10 ml) 10 doses (20 ml) 25 doses (50 ml)
5 odmerkov (10 ml) 10 odmerkov (20 ml) 25 odmerkov (50 ml)
5 doses (10 ml) 10 doses (20 ml) 25 doses (50 ml) 50 doses (100 ml) 4 x 5 doses (10 ml) 4 x 10 doses (20 ml) 4 x 25 doses (50 ml) 4 x 50 doses (100 ml) 6 x 5 doses (10 ml) 6 x 10 doses (20 ml) 6 x 25 doses (50 ml) 6 x 50 doses (100 ml) 10 x 5 doses (10 ml) 10 x 10 doses (20 ml) 10 x 25 doses (50 ml) 10 x 50 doses (100 ml)
5 odmerkov (10 ml) 10 odmerkov (20 ml) 25 odmerkov (50 ml) 50 odmerkov (100 ml) 4 x 5 odmerkov (10 ml) 4 x 10 odmerkov (20 ml) 4 x 25 odmerkov (50 ml) 4 x 50 odmerkov (100 ml) 6 x 5 odmerkov (10 ml) 6 x 10 odmerkov (20 ml) 6 x 25 odmerkov (50 ml) 6 x 50 odmerkov (100 ml) 10 x 5 odmerkov (10 ml) 10 x 10 odmerkov (20 ml) 10 x 25 odmerkov (50 ml) 10 x 50 odmerkov (100 ml)
Additional laboratory tests to differentiate vaccine strain virus from field strain are available upon request from the marketing authorisation holder.
Na zahtevo imetnika dovoljenja za promet so na voljo dodatni laboratorijski testi za razlikovanje seva virusa cepiva od divjega seva.
Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections
Vehikel: natrijev klorid kalijev klorid kalijev dihidrogenfosfat dinatrijev hidrogenfosfat voda za injekcije
Potassium hydroxide L-Glutamine acid Potassium dihydrogen phosphate Dipotassium phosphate Sodium chloride Water for injections
Liofilizat: saharoza želatina kalijev hidroksid L-glutaminska kislina kalijev dihidrogenfosfat dikalijev fosfat natrijev klorid voda za injekcije
High density polyethylene (HDPE) bottles sof solvent, closed with a siliconised chlorobutyl rubber stopper with lacquered aluminium seal.
Plastenke vehikla iz polietilena velike gostote (HDPE), zaprte z zamaški iz silikonizirane bromobutilne gume z lakiranimi aluminijastimi zaporkami.
An increase in body temperature within the physiological range is common within 4 hours of vaccination and spontaneously resolves within 24 hours (clinical studies).
Pogost je porast telesne temperature znotraj fiziološkega razpona v 4 urah po cepljenju, ki v 24 urah spontano izzveni (klinične študije).
For the full list of excipients, see section 6.1.
Pomožne snovi (vključno z dodatki), navedene v poglavju 6.1.
EU/2/14/176/013 50 doses EU/2/14/176/014 4 x 50 doses EU/2/14/176/015 6 x 50 doses EU/2/14/176/016 10 x 50 doses
EU/2/14/176/013 50 odmerkov EU/2/14/176/014 4 x 50 odmerkov EU/2/14/176/015 6 x 50 odmerkov EU/2/14/176/016 10 x 50 odmerkov
While persistent infection of the foetus caused by the vaccine was not observed, transmission of vaccine virus to the foetus may occur.
Čeprav niso opazili trajne okužbe ploda, povzročene s cepivom, lahko pride do prenosa na plod.
Type I amber glass vials closed with siliconised bromobutyl rubber stopper with lacquered aluminium seal.
Viale iz rumenkasto rjavega stekla tipa I, zaprte z zamaški iz silikonizirane bromobutilne gume z lakiranimi aluminijastimi zaporkami.
Bovela lyophilisate for suspension for injection for cattle
Bovela liofilizat za suspenzijo za injiciranje za govedo
EU/2/14/176/005 10 doses and 20 ml EU/2/14/176/006 10 doses and 20 ml (4 x) EU/2/14/176/007 10 doses and 20 ml (6 x) EU/2/14/176/008 10 doses and 20 ml (10 x) EU/2/14/176/009 25 doses and 50 ml EU/2/14/176/010 25 doses and 50 ml (4 x) EU/2/14/176/011 25 doses and 50 ml (6 x) EU/2/14/176/012 25 doses and 50 ml (10 x) EU/2/14/176/013 50 doses and 100 ml EU/2/14/176/014 50 doses and 100 ml (4 x) EU/2/14/176/015 50 doses and 100 ml (6 x) EU/2/14/176/016 50 doses and 100 ml (10 x)
EU/2/14/176/004 5 odmerkov in 10 ml (10 x) EU/2/14/176/005 10 odmerkov in 20 ml EU/2/14/176/006 10 odmerkov in 20 ml (4 x) EU/2/14/176/007 10 odmerkov in 20 ml (6 x) EU/2/14/176/008 10 odmerkov in 20 ml (10 x) EU/2/14/176/009 25 odmerkov in 50 ml EU/2/14/176/010 25 odmerkov in 50 ml (4 x) EU/2/14/176/011 25 odmerkov in 50 ml (6 x) EU/2/14/176/012 25 odmerkov in 50 ml (10 x) EU/2/14/176/013 50 odmerkov in 100 ml EU/2/14/176/014 50 odmerkov in 100 ml (4 x) EU/2/14/176/015 50 odmerkov in 100 ml (6 x) EU/2/14/176/016 50 odmerkov in 100 ml (10 x)
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Liofilizat: Rok uporabnosti zdravila v pakiranju za prodajo:
Modified live BVDV*-1, non-cytopathic parent strain KE-9: 104.0-106.0 TCID50**, Modified live BVDV*-2, non-cytopathic parent strain NY-93: 104.0-106.0 TCID50**.
Modificirani živi BVDV*-1, necitopatični, matični sev KE-9: 104,0-106,0 TCID50** Modificirani živi BVDV*-2, necitopatični, matični sev NY-93: 104,0 -106,0 TCID50**
Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Ime in naslov proizvajalca zdravila, odgovornega za sprostitev serij Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Solvent: Clear, colourless solution.
Vehikel: bistra, brezbarvna raztopina.
Gelatine
OVOJNINAH
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju desetkrat prevelikega odmerka so na mestu injiciranja opazili blage otekline ali vozliče do
Furthermore, an increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see section 4.6).
Nadalje je bil znotraj 4 ur po cepljenju pogost porast rektalne telesne temperature, ki v 24 urah spontano izzveni (glejte poglavje 4.6).
The vaccine has not been tested in breeding bulls and should therefore not be used in breeding bulls.
Cepiva niso preskusili pri bikih v času parjenja.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
NAVODILO ZA UPORABO Bovela liofilizat in vehikel za suspenzijo za injiciranje za govedo IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA
Keep the vials in the outer carton.
Viale shranjujte v zunanji ovojnini.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Keep the lyophilisate and the solvent vials in the outer carton.
Shranjujte viali z liofilizatom in vehiklom v zunanji ovojnini.
Furthermore, a increase of the rectal body temperature was common within 4 hours following administration and spontaneously resolves within 24 hours (see section “Adverse reactions”).
Nadalje je bil znotraj 4 ur po cepljenju pogost porast rektalne telesne temperature, ki v 24 urah spontano izzveni (glejte poglavje “Neželeni učinki”).
Lyophilisate: Off-white colour without foreign matter.
Liofilizat: sivo bele barve brez tujih snovi Vehikel: bistra, brezbarvna raztopina
Solvent for Bovela
Vehikel za cepivo Bovela
EU/2/14/176/001 5 doses and 10 ml EU/2/14/176/002 5 doses and 10 ml (4 x) EU/2/14/176/003 5 doses and 10 ml (6 x) EU/2/14/176/004 5 doses and 10 ml (10 x)
EU/2/14/176/002 5 odmerkov in 10 ml (4 x) EU/2/14/176/003 5 odmerkov in 10 ml (6 x)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box: 5 doses, 10 doses, 25 doses, 50 doses lyophilisate and 10 ml, 20 ml, 50 ml, 100 ml solvent
Kartonska škatla: 5 odmerkov, 10 odmerkov, 25 odmerkov, 50 odmerkov liofilizata in 10 ml, 20 ml, 50 ml, 100 ml vehikla
EXP {month/year} Once reconstituted use within: 8 hours.
Rok uporabnosti rekonstituiranega zdravila: 8 ur.
Shelf life after reconstitution: 8 hours.
Rok uporabnosti zdravila po rekonstituciji v skladu z navodili: 8 ur.
Therefore, use during pregnancy should only be on a case-by-case basis decided by the responsible veterinarian, taking into consideration e.g. the BVD immunological status of the animal, the time-span between vaccination and mating/insemination, the stage of pregnancy and the risk of infection.
imunološko stanje živali, kar se tiče BVD, časovni razmik med cepljenjem in parjenjem/oploditvijo,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vials: 5 doses, 10 doses and 25 doses
Viale z liofilizatom: 5 odmerkov, 10 odmerkov in 25 odmerkov
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC BIOLOŠKIH UČINKOVIN IN PROIZVAJALEC,
Bovela lyophilisate and solvent for suspension for injection for cattle
Bovela liofilizat in vehikel za suspenzijo za injiciranje za govedo
Keep the bottle in the outer carton.
Plastenko shranjujte v zunanji ovojnini.
Mild swellings or nodules up to 3 cm diameter were observed at the injection site after administration of a 10-fold overdose and disappeared within 4 days post vaccination.
3 cm v premeru, ki so izginili v 4 dneh po cepljenju.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent bottles: 10 ml, 20 ml, 50 ml, 100 ml
Plastenke z vehiklom: 10 ml, 20 ml, 50 ml, 100 ml
Marketing authorisation holder and manufacturer responsible for batch release: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Imetnik dovoljenja za promet z zdravilom in proizvajalec, odgovoren za sproščanje serij: Boehringer Ingelheim Vetmedica GmbH
1 lyophilisate vial of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 1 solvent bottle of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
1 viala, ki vsebuje 10 ml (5 odmerkov), 20 ml (10 odmerkov), 50 ml (25 odmerkov) ali 100 ml (50 odmerkov) liofilizata in 1 plastenka, ki vsebuje 10 ml, 20 ml, 50 ml ali 100 ml vehikla, pakirani v eni kartonasti škatli.
6 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 6 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
6 vial, ki vsebujejo 10 ml (5 odmerkov), 20 ml (10 odmerkov), 50 ml (25 odmerkov) ali 100 ml (50 odmerkov) liofilizata in 6 plastenk, ki vsebujejo 10 ml, 20 ml, 50 ml ali 100 ml vehikla, pakiranih v eni kartonasti škatli.
4 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 4 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
4 viale, ki vsebujejo 10 ml (5 odmerkov), 20 ml (10 odmerkov), 50 ml (25 odmerkov) ali 100 ml (50 odmerkov) liofilizata in 4 plastenke, ki vsebujejo 10 ml, 20 ml, 50 ml ali 100 ml vehikla, pakirane v eni kartonasti škatli.
10 lyophilisate vials of 10 ml (5 doses), 20 ml (10 doses), 50 ml (25 doses) or 100 ml (50 doses) and 10 solvent bottles of 10 ml, 20 ml, 50 ml or 100 ml packed in one cardboard box.
10 vial, ki vsebujejo 10 ml (5 odmerkov), 20 ml (10 odmerkov), 50 ml (25 odmerkov) ali 100 ml (50 odmerkov) liofilizata in 10 plastenk, ki vsebujejo 10 ml, 20 ml, 50 ml ali 100 ml vehikla, pakiranih v eni kartonasti škatli.
Shelf life of the solvent:
Vehikel: Rok uporabnosti vehikla:
EU number
Eu številka
Content (concentration) Package size
Vsebnost (koncentracija) Velikost pakiranja
Further information on Striascan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/striascan.
Nadaljnje informacije o zdravilu Striascan so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/striascan.
• dementia (loss of intellectual function).
• demence (poslabšanja kognitivnih sposobnosti).
A scan is taken 3 to 6 hours after the injection.
Slikanje se opravi od tri do šest ur po injiciranju.
Why is Striascan authorised in the EU?
Zakaj je bilo zdravilo Striascan odobreno v EU?
The European Medicines Agency concluded that, in accordance with EU requirements, Striascan has been shown to be comparable to DaTSCAN.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Striascan primerljivo z zdravilom DaTSCAN.
Striascan is a diagnostic medicine.
Striascan je diagnostično zdravilo.
What measures are being taken to ensure the safe and effective use of Striascan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Striascan?
An overview of Striascan and why it is authorised in the EU
Pregled zdravila Striascan in zakaj je odobreno v EU
The medicine is used to help in the diagnosis of the following conditions in adults (aged 18 years or over):
Zdravilo se uporablja pri odraslih (starih 18 let ali več) kot pomoč pri diagnosticiranju naslednjih bolezni:
Because Striascan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Striascan generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
As for every medicine, the company provided studies on the quality of Striascan.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Striascan.
Because tremor can also occur in ‘essential tremor' (tremor whose cause is unknown), Striascan can help distinguish between essential tremor and diseases related to Parkinson's disease;
Ker lahko tremor nastopi tudi v obliki „esencialnega tremorja“ (tremorja, katerega vzrok je neznan), lahko zdravilo Striascan pripomore k razločevanju esencialnega tremorja od obolenj, povezanih s Parkinsonovo boleznijo;
Side effects reported with Striascan are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Striascan, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Striascan have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Striascan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Other information about Striascan
Druge informacije o zdravilu Striascan
What are the benefits and risks of Striascan?
Kakšne so koristi in tveganja, povezani z zdravilom Striascan?
If this happens, the amount of Striascan attaching to these nerve cells is greatly reduced, which can be seen on the scan.
Če se to zgodi, je količina zdravila Striascan, ki se veže na te živčne celice, precej manjša, kar je razvidno s slik.
As for all medicines, data on the use of Striascan are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Striascan stalno spremljajo.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, DaTSCAN, and do not need to be repeated for Striascan.
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom DaTSCAN, zato jih ni treba ponoviti za zdravilo Striascan.
Between 1 to 4 hours before receiving Striascan, patients must also take another medicine, such as iodine tablets, to prevent the radioactive iodine in Striascan from getting into the thyroid gland.
Od ene do štiri ure pred injiciranjem zdravila Striascan morajo bolniki prejeti drugo zdravilo, kot so na primer jodove tablete, da se prepreči privzem radioaktivnega joda iz zdravila Striascan v ščitnici.
For more information about using Striascan, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Striascan glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Striascan is given by slow injection lasting at least 15 to 20 seconds into an arm vein.
Zdravilo Striascan se daje v veno na roki s počasnim injiciranjem, ki traja najmanj 15 do 20 sekund.
In patients with Parkinson's disease and related diseases, and in patients with dementia with Lewy bodies, there is typically a loss of the dopamine-containing nerve cells in the striatum.
Pri bolnikih s Parkinsonovo boleznijo in drugimi sorodnimi boleznimi ter pri bolnikih z demenco z Lewyjevimi telesci navadno pride do odmiranja živčnih celic, ki vsebujejo dopamin, v striatumu.
Striascan is used to help distinguish between a type of dementia known as ‘dementia with Lewy bodies' and Alzheimer's disease.
Zdravilo Striascan se uporablja kot pomoč pri razlikovanju vrste demence, poznane kot demenca z Lewyjevimi telesci, od Alzheimerjeve bolezni.
Resuscitation equipment should be available before Striascan is given, in case the patient has an allergic reaction.
Ob dajanju zdravila Striascan mora biti na voljo oprema za oživljanje za primer, kadar pri bolniku pride do alergijske reakcije.
• movement disorders such as those in Parkinson's disease and other related diseases, where a loss of nerve cells leads to tremor (shaking), gait disturbance (problems with the way the patient walks) and stiffness of the muscles.
• motenj gibanja, kot so tiste, ki se pojavijo pri Parkinsonovi bolezni in drugih sorodnih boleznih, pri katerih odmiranje živčnih celic povzroči tremor (tresavico), motnje pri hoji in otrdelost mišic.
There was no need for ‘bioequivalence' studies to investigate whether Striascan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Izvedba študije „bioekvivalence“, s katero bi raziskali, ali se zdravilo Striascan absorbira podobno kot referenčno zdravilo in tako doseže enako raven učinkovine v krvi, ni bila potrebna.
It is used to detect the loss of nerve cells in an area of the brain called the striatum, specifically the cells that release dopamine, a chemical messenger.
Uporablja se za zaznavanje odmiranja živčnih celic na območju možganov, ki se imenuje striatum, zlasti celic, ki sproščajo kemični prenašalec dopamin.