natgillin/translations-raw huggingface dataset:
− excessive sweating (including night sweats), rash
− čezmerno potenje (z nočnim znojenjem vred), izpuščaj
Anti-degarelix antibodies
Protitelesa proti degareliksu
Monitoring of liver function in patients with known or suspected hepatic disorder is advised during treatment.
Pri bolnikih z dokazano ali možno boleznijo jeter je med zdravljenjem priporočljivo spremljati delovanja jeter.
Elderly, hepatically or renally impaired patients:
Starejši,bolniki z okvarami jeter ali ledvic:
FIRMAGON is a powder and solvent for solution for injection.
Zdravilo FIRMAGON je prašek in vehikel za raztopino za injiciranje.
• for the leuprorelin 7.5 mg treatment group 17.4 ng/ml (interquartile range: P25 8.4 ng/ml, P75
• pri skupini, zdravljeni z levprorelinom v odmerku 7,5 mg, 17,4 ng/ml (interkvartilni razpon: P25 8,4 ng/ml, P75 56,5 ng/ml).
From baseline to end of study the median change for FIRMAGON was 12.0 msec and for leuprorelin it was 16.7 msec.
Od izhodišča do konca študije je bila mediana sprememba pri zdravilu FIRMAGON 12,0 msek, pri levprorelinu pa 16,7 msek.
− trouble sleeping, tiredness, dizziness, headache
− nespečnost, utrujenost, omotica, glavobol
No target organ toxicity was observed from acute, subacute and chronic toxicity studies in rats and monkeys following subcutaneous administration of degarelix.
V študijah akutne, subakutne in kronične toksičnosti na podganah in opicah po subkutanem dajanju degareliksa niso ugotovili nikakršne toksičnosti za tarčne organe.
Each vial contains 80 mg degarelix (as acetate).
Ena viala vsebuje 80 mg degareliksa (v obliki acetata).
Seek medical advice straight away if you develop a severe rash, itching or shortness of breath or difficulty breathing.
Če se pri vas pojavijo hudi izpuščaji, srbenje ali zadihanost ali oteženo dihanje takoj poiščite zdravniško pomoč.
In 4 of the 8 cases, the causal relationship between degarelix and the event could not be ruled out; the cases were well documented, without evident alternative aetiology or confounding factors, with compatible time-to-onset and positive dechallenge and increased blood CPK.
Primeri so bili dobro dokumentirani, brez očitne alterntivne etiologije ali drugih možnih vzročnih dejavnikov, združljivimi s časom pojava in prenehanjem ter povečanim krvnim CK. Degareliks je bil ukinjen v vseh primerih.
1 plunger rod, 1 vial adapter and 1 injection needle.
1 bat brizge, 1 adapter viale in 1 injekcijsko iglo.
Renal impairment Degarelix has not been studied in patients with severe renal impairment and caution is therefore warranted.
Pri bolnikih s težkimi okvarami ledvic degareliksa niso proučevali, zato je potrebna previdnost.
2 plunger rods, 2 vial adapters and 2 injection needles.
2 bata brizge, 2 adapterja viale in 2 injekcijski igli.
Pack-size of 1 tray containing:
Pakiranje z 1 podstavkom vsebuje:
Bilirubin increased, alkaline phosphatase increased
žolčnika in žolčevodov zvišane jetrne transaminaze zvišan bilirubin, zvišana alkalna fosfataza
The prostate volume reduction was similar to that attained with goserelin plus anti-androgen protection.
Velikost prostate se je zmanjšala v podobni meri kot pri zdravljenju z goserelinom v kombinaciji z antiandrogensko zaščito proti nihanju ravni testosterona.
Glass (type I) vial with bromobutyl rubber stopper and aluminium flip-off seal containing 80 mg powder for solution for injection
Steklena (tip I) viala z bromobutilnim gumijastim zamaškom in aluminijasto zaščitno zaporko, ki vsebuje 80 mg praška za raztopino za injiciranje
Three (<1%) out of 409 patients in the degarelix group and four (2%) out of 201 patients in the leuprorelin 7.5 mg group, had a QTcF ≥ 500 msec. From baseline to end of study the median change in QTcF for degarelix was 12.0 msec and for leuprorelin was 16.7 msec.
Trije (<1 %) od 409 bolnikov v skupini z degareliksom in štirje (2 %) od 201 bolnikov v skupini, zdravljeni z levprorelinom v odmerku 7,5 mg, so imeli QTcF ≥ 500 msek.
night sweats)*, rash
(vključno z nočnim znojenjem)*,
− skin redness, loss of hair, skin nodule, numbness
− pordelost kože, izpadanje las, vozlič v koži, odrevenelost
8 cases of rhabdomyolysis have cumulativly been reported with degarelix.
Pri zdravljenju z degareliksom so poročali o 8 primerih rabdomiolize.
− Any cardiovascular conditions or heart rhythm problems (arrythmia), or are being treated with medicines for this condition.
Povejte svojemu zdravniku, če imate kaj od naslednjega: − kakršnekoli srčnožilne težave ali težave s srčnim ritmom (aritmija) ali se zdravite z zdravili, ki se uporabljajo za zdravljenje takih težav.
− loss of sexual desire, testicular pain, pelvic pain, ejaculation failure, genital irritation, breast pain
− izguba spolnega poželenja, bolečina v modih, bolečina v medenici, nezmožnost ejakulacije, draženje spolovil, bolečina v dojkah
Pre-filled glass (type I) syringe with elastomer plunger stopper, tip cap and line-marking at 4 ml containing 4.2 ml solvent
Napolnjena steklena (tip I) injekcijska brizga z batno zaporko iz elastomera, kapico in črtno oznako pri 4 ml, ki vsebuje 4,2 ml vehikla
The lack of intrinsic effect of degarelix on cardiac repolarisation (QTcF), heart rate, AV conduction, cardiac depolarisation, or T or U wave morphology was confirmed in a thorough QT study in healthy subjects (N=80) receiving an i.v.
Odsotnost intrinzičnega učinka degareliksa na repolarizacijo srčnih prekatov (QTcF), srčni utrip, prevodnost AV-vozla, depolarizacijo srčnih prekatov ali morfologije vala T ali U je bila potrjena v temeljiti študiji intervala QT pri zdravih osebah (N = 80), ki so prejemale intravensko infuzijo učinkovine degareliks več kot 60 minut in so dosegle povprečno Cmax 222 ng/mL, kar predstavlja približno 3- do 4-kratno vrednost Cmax, prejeto med zdravljenjem raka na prostati.
Dose adjustment is not necessary in patients with mild or moderate hepatic impairment.
Pri bolnikih z blago ali zmerno okvaro jeter prilagajanje odmerka ni potrebno.
− reduced size of testicles, breast swelling, impotence
− zmanjšanje mod, otekanje dojk, impotenca.
Perform a deep subcutaneous injection.
Vsebino brizge injicirajte globoko subkutano.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE FOR SOLVENT 3 ml water for injections
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NAPOLNJENA INJEKCIJSKA BRIZGA ZA VEHIKEL 3 ml voda za injekcije
Urticaria, skin nodule, alopecia, pruritus, erythema
izpuščaj koprivnica, vozlič v koži, plešavost, pruritus, eritem
Turn the vial upside down and draw up to the line mark on the syringe for injection.
Zasukajte vialo na glavo in povlecite iz nje količino do črtne oznake na brizgi za injiciranje.
Hot flush*
Žilne bolezni vročinski valovi*
Hyperglycemia/Diabetes mellitus, cholesterol increased, weight decreased, appetite decreased, changes in blood calcium
hiperglikemija /diabetes mellitus, zvišan holesterol, zmanjšana telesna masa, zmanjšan tek, spremembe kalcija v krvi
Avoid shaking to prevent foam formation.
Viale ne stresajte, da ne bo nastala pena.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE FOR SOLVENT 4.2 ml water for injections
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NAPOLNJENA INJEKCIJSKA BRIZGA ZA VEHIKEL 4,2 ml voda za injekcije
Glass (type I) vials with bromobutyl stopper and aluminium flip-off seal containing 120 mg powder for solution for injection
Stekleni (tip I) viali z bromobutilnim gumijastim zamaškom in aluminijasto zaščitnoodtržno zaporko, ki vsebujeta po 120 mg praška za raztopino za injiciranje
FIRMAGON might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e.g. methadone (used for pain relief and as part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics).
kinidina, prokainamida, amiodarona in solatola), ali drugih zdravil, ki lahko vplivajo na srčni ritem (npr. metadona (uporablja se za lajšanje bolečine in pri odvajanju od zasvojenosti z zdavili),
No signs of increased exposure in the hepatically impaired subjects were observed compared to healthy subjects.
primerjavi z zdravimi osebami niso pri osebah z okvaro jeter ugotovili nikakršnih znakov zvečane izpostavljenosti.
− muscular weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, pain in the joint
− šibkost mišic, mišični spazmi, otekanje/otrdelost sklepov, osteoporoza/osteopenija, bolečine v sklepih
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA • Načrt za obvladovanje tveganja (RMP)
If you get any of the side effects, talk to your doctor.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
The pack contains two vials of powder and two pre-filled syringes with solvent that must be prepared for subcutaneous injection.
Zloženka vsebuje dve viali s praškom in dve napolnjeni injekcijski brizgi z vehiklom, ki ju je treba pripraviti za subkutano injekcijo.
1 vial adapter
1 adapter viale
2 vial adapters
2 adapterja viale
− Keep this leaflet.
izpuščaj koprivnica,
− If you get any of the side effects, talk to your doctor.
− Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
Gynaecomastia*, testicular atrophy*, erectile dysfunction*
Motnje reprodukcije in dojk ginekomastija*, atrofija mod*, erektilna disfunkcija*
− allergic reactions, hives, itching
− alergijske reakcije, koprivnica, srbenje
Pack-size of 1 tray containing: 1 powder vial, 1 solvent pre-filled syringe, 1 plunger rod, 1 vial adapter and 1 needle.
Pakiranje z 1 podstavkom vsebuje: 1 vialo s praškom, 1 napolnjeno injekcijsko brizgo z vehiklom, 1 bat brizge,1 adapter viale in 1 iglo.
3 vial adapter
3 adapterje viale
SC use only
Samo za s.c. uporabo.
A reduction in glucose tolerance has been observed in men who have had orchiectomy or who have been treated with a GnRH agonist.
Pri moških, ki so imeli orhiektomijo ali so jih zdravili s kakim agonistom GnRH, so opazili zmanjšano toleranco za glukozo.
Pack sizes
Bat brizge
1 injection needle
1 injekcijska igla
− Liver disease.
− bolezni ledvic.
Inject 4 ml of FIRMAGON 80 mg slowly,
Počasi injicirajte 4 ml zdravila FIRMAGON 80 mg takoj po rekonstituciji.
Remove the cap of the pre-filled syringe.
Snemite kapico z napolnjene injekcijske brizge.
How to store FIRMAGON
Shranjevanje zdravila FIRMAGON
Marked decrease in haematological values, hematocrit (≤0.37) and hemoglobin (≤115 g/l) were seen in 40% and 13-15%,
Znatno zmanjšanje hematoloških vrednosti, hematokrita (≤0,37) pri 40 % bolnikov in hemoglobina (≤115 g/l) pri 13-15 % bolnikov, so ugotovili po zdravljenju z obema zdraviloma pri bolnikih, ki so imeli pred zdravljenjem normalne vrednosti.
Prepare the pre-filled syringe by attaching the plunger rod.
Pripravite napolnjeno injekcijsko brizgo, tako da pritrdite bat brizge.
Pack-size of 2 trays containing 2 powder vials, 2 solvent pre-filled syringes, 2 plunger rods, 2 vial adapters and 2 needles
Pakiranje z 2 podstavkoma vsebuje 2 viali s praškom, 2 napolnjeni injekcijski brizgi z vehiklom, 2 bata brizge, 2 adapterja viale in 2 igli.
The pack contains one vial of powder and one pre-filled syringe with solvent that must be prepared for subcutaneous injection.
Zloženka vsebuje eno vialo praška in eno napolnjeno injekcijsko brizgo z vehiklom, ki ga je treba pripraviti za subkutano injekcijo.
Pack-size of 3 trays containing: 3 powder vials, 3 solvent pre-filled syringes, 3 plunger rods, 3 vial adapters and 3 needles.
Pakiranje s 3 podstavki vsebuje: 3 viale s praškom, 3 napolnjene injekcijske brizge z vehiklom, 3 bate brizge, 3 adapterje viale in 3 igle.
FIRMAGON is administered as a subcutaneous injection in the abdominal region.
Zdravilo FIRMAGON se daje s subkutano injekcijo v predel trebuha.
Hyperglycemia/Diabe tes mellitus, cholesterol increased, weight decreased, appetite decreased, changes in blood calcium
hiperglikemija/diab etes mellitus, zvišan holesterol, zmanjšana telesna masa, zmanjšan tek, spremembe kalcija v krvi
Uncommon (may affect up to 1 in 100 people)
Občasni (pojavijo se pri največ 1 od 100 bolnikov)
Hypertension, vasovagal reaction (incl.
hipertenzija, vazovagalna reakcija (vključno s hipotenzijo)
Bone density has not been measured during treatment with degarelix.
Med zdravljenjem z degareliksom kostne gostote niso merili.
Mental impairment, hypoaesthesia
Bolezni živčevja omotica, glavobol duševne motnje, hipestezija
Common (may affect up to 1 in 10 people)
Pogosti (pojavijo se pri največ 1 od 10 bolnikov)
No testosterone microsurges were observed after re-injection during degarelix treatment.
Po ponovnem injiciranju med zdravljenjem z degareliksom ni prišlo do porasta testosterona.
Pregnancy and breast-feeding There is no relevant indication for use of FIRMAGON in women.
Ustreznih indikacij za uporabo zdravila FIRMAGON pri ženskah ni. Plodnost
methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics ).
moksifloksacina (antibiotik), antipsihotikov).
2 vials with powder containing 120 mg of degarelix and 2 pre-filled syringes with 3 ml of solvent.
2 viali s praškom, ki vsebujeta po 120 mg degareliksa, in 2 napolnjeni injekcijski brizgi s 3 ml vehikla.
FIRMAGON 120 mg powder for injection degarelix
FIRMAGON 120 mg prašek za injekcijo degareliks
1 vial with powder containing 80 mg of degarelix and 1 pre-filled syringe with 4.2 ml of solvent.
1 vialo s praškom, ki vsebuje 80 mg degareliksa, in 1 napolnjeno injekcijsko brizgo s 4,2 ml vehikla.
FIRMAGON 80 mg powder for injection degarelix
FIRMAGON 80 mg prašek za injekcijo degareliks
Malaise, peripheral oedema
periferni edemi
Pack-size of 2 trays containing: 2 vials with 120 mg degarelix (powder) 2 pre-filled syringes with 3 ml solvent 2 plunger rods
Pakiranje z 2 podstavkoma vsebuje 2 viali s 120 mg degareliksa (prašek) 2 napolnjeni injekcijski brizgi s 3 ml vehikla 2 bata brizge
3 injection needle
3 injekcijske igle
Name and address of the manufacturer responsible for batch release Ferring GmbH
Ime in naslov izdelovalca, odgovornega za sproščanje serij
Constipation, vomiting, abdominal pain, abdominal discomfort, dry mouth
bolečine v trebuhu, nelagodje v trebuhu, suha usta
Since androgen deprivation treatment may prolong the QTc interval, the concomitant use of degarelix with medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).
Ker zdravljenje z deprivacijo androgenov lahko podaljša interval QTc, moramo skrbno ovrednotiti sočasno uporabo degareliksa z zdravili, za katere je znano, da podaljšujejo interval QTc, ali zdravili, ki lahko sprožijo torsades de pointes, n.pr.
− Diabetes mellitus.
− sladkorno bolezen.
Anaphylactic reactions
hipertenzija, vazovagalna reakcija
Pre-filled glass (type I) syringes with elastomer plunger stopper, tip cap and line-marking at 3 ml containing 3 ml solvent
Napolnjeni stekleni (tip I) injekcijski brizgi z batno zaporko iz elastomera, kapico in črtno oznako pri 3 ml,
− frequent urination, urinary urgency (must hurry to pass urine), difficult or painful urination, urination at night, impaired renal function, incontinence
oteženo odvajanje vode ali bolečine pri odvajanju vode, odvajanje vode ponoči, zmanjšano delovanje ledvic, inkontinenca − zameglen vid
Vial adapter
Adapter viale
Pack-size of 3 trays containing 3 vials with 80 mg degarelix (powder) 3 pre-filled syringe with 4.2 ml solvent 3 plunger rod
Pakiranje s 3 podstavki vsebuje 3 viale z 80 mg degareliksa (prašek) 3 napolnjene injekcijske brizge s 4,2 ml vehikla 3 bate brizge
Pack-size of 1 tray containing 1 vial with 80 mg degarelix (powder) 1 pre-filled syringe with 4.2 ml solvent 1 plunger rod
Pakiranje z 1 podstavkom vsebuje 1 viala z 80 mg degareliksa (prašek) 1 napolnjena injekcijska brizga s 4,2 ml vehikla 1 bat brizge
− musculoskeletal pain and discomfort
− bolečine in nelagodje v mišicah in kosteh
Testicular pain, breast pain, pelvic pain, genital irritation, ejaculation failure
bolečina v modih, bolečina v dojkah, bolečina v medenici, draženje spolovil, nezmožnost ejakulacije
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR FIRMAGON 80 mg powder and solvent for solution for injection
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA FIRMAGON 80 mg prašek in vehikel za raztopino za injiciranje
Successful response in the study was defined as attainment of medical castration at day 28 and maintenance through day 364 where no single testosterone concentration was greater than 0.5 ng/ml.
364. dne, če v tem obdobju nobena izmerjena koncentracija testosterona ni bila višja od 0,5 ng/ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR FIRMAGON 120 mg powder and solvent for solution for injection
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA FIRMAGON 120 mg prašek in vehikel za raztopino za injiciranje
Maintenance dose - monthly administration
Vzdrževalni odmerek - vsakomesečno dajanje
Drug-related local irritation was noted in animals when degarelix was administered subcutaneously in high doses.
Kadar so dajali degareliks subkutano v velikih odmerkih, so pri živalih opazili z zdravilom povezano lokalno draženje.
Ferring Arzneimittel GmbH Tel: +49 431 5852 0 info-service@ferring.de
Ferring Arzneimittel GmbH Tel: +49 431 5852 0
immediately after reconstitution.
120 mg takoj po rekonstituciji.
Dizziness, headache
plešavost, pruritus, eritem
Inject 3 ml of FIRMAGON 120 mg slowly,
Počasi injicirajte 3 ml zdravila FIRMAGON
Vial adapters
Adapterja viale
Day 1 Day 3 Day 7
7. dan
No pharmacokinetic studies in renally impaired patients have been conducted.
Pri bolnikih z okvaro ledvic farmakokinetičnih študij niso opravili.
After reconstitution, each ml solution contains 40 mg of degarelix.
Po rekonstituciji en ml raztopine vsebuje 40 mg degareliksa.
Dyspnoea
Levprorelin
After reconstitution, each ml of solution contains 20 mg of degarelix.
Po rekonstituciji en ml raztopine vsebuje 20 mg degareliksa.
1 ml of the reconstituted solution contains 20 mg degarelix.
Po rekonstituciji vsebuje 1 ml rekonstituirane raztopine 20 mg degareliksa.
hypotension)
(vključno s hipotenzijo)
Cardiac disorders
Elektrokardiografske spremembe
FIRMAGON 120 mg powder and solvent for solution for injection
FIRMAGON 120 mg prašek in vehikel za raztopino za injiciranje
1 ml of the reconstituted solution contains 40 mg degarelix.
Po rekonstituciji vsebuje 1 ml rekonstituirane raztopine 40 mg degareliksa.
Three months therapy with degarelix (240/80 mg dose regimen) resulted in a 37% reduction in prostate volume as measured by trans-rectal ultrasound scan (TRUS) in patients requiring hormonal therapy prior to radiotherapy and in patients who were candidates for medical castration.
izmerjeno s transrektalnim ultrazvokom (TRUZ), pri bolnikih, ki so pred radioterapijo potrebovali hormonsko zdravljenje, in bolnikih, ki so bili primerni za medicinsko kastracijo.
FIRMAGON might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e.g.
Zdravilo FIRMAGON lahko ovira delovanje nekaterih zdravil, ki se uporabljajo za zdravljenje težav s srčnim ritmom (n.pr.
FIRMAGON 80 mg powder and solvent for solution for injection
FIRMAGON 80 mg prašek in vehikel za raztopino za injiciranje
The site of injection is likely to vary within the abdominal region.
Zdravilo se navadno injicira v različnih točkah v predelu trebuha.
In each case degarelix was discontinued.
V 4 od 8 primerov vzročne povezave med degareliksom in d ni bilo mogoče izključiti.
FIRMAGON 120 mg powder and solvent for solution for injection degarelix
FIRMAGON 120 mg prašek in vehikel za raztopino za injiciranje degareliks
Osteoporosis/osteopenia, arthralgia muscular weakness, muscle spasms, joint swelling/stiffness
Bolezni mišično skeletnega sistema, vezivnega tkiva in kosti bolečine in nelagodje v mišicah in kosteh osteoporoza/osteop enija, artralgija, šibkost mišic,
FIRMAGON 80 mg powder and solvent for solution for injection degarelix
FIRMAGON 80 mg prašek in vehikel za raztopino za injiciranje degareliks
Nervous system disorders
Organski sistemi po
The pigs should be re-vaccinated every 6 months.
Cepljenje prašičev je treba ponavljati vsakih 6 mesecev.
If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Če bolečina traja več kot 12 ur po zdravniškem pregledu, se je treba znova zglasiti pri zdravniku.
Any person intending to import, sell, supply and/or use the veterinary medicinal product must be authorised by the competent authority of the Member State.
Vsakdo, ki želi uvažati, prodajati, dobavljati in/ali uporabljati zdravilo za uporabo v veterinarski medicini, mora dobiti dovoljenje pristojnega organa države članice.
The import, sale, supply and/or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended).
Uvoz, prodaja, dobava in/ali uporaba zdravila Porcilis Pesti so dovoljeni samo pod posebnimi pogoji, določenimi z zakonodajo Evropske skupnosti o nadzoru KPK (Direktiva Sveta 80/217/EGS, z vsemi spremembami).
This first dose is followed by a second injection 4 weeks later.
Prvemu odmerku sledi druga injekcija 4 tedne kasneje.
Maternally derived antibodies did not interfere with vaccination.
Maternalno pridobljena protitelesa niso vplivala na rezultate cepljenja.
If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected.
Če pride do nehotenega injiciranja tega izdelka, mora ta oseba nemudoma poiskati zdravniško pomoč, tudi če je bila injicirana le zelo majhna količina.
The piglets were also tested for viraemia (presence of virus in their blood).
Pujski so bili testirani tudi za viremijo (prisotnost virusa v krvi).
It is recommended that the second vaccination is given at a different site than the first vaccination.
Priporočljivo je, da se drugo cepljenje ne izvede na istem mestu kot prvo.
When this antigen is injected, this small exposure helps the pig's immune system to recognise and attack CSF.
Po injiciranju tega antigena, ta majhna izpostavitev pripomore k temu, da imunski sistem prašiča prepozna in napade KPK.
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - rarely causing the loss of a finger.
Nenamerno injiciranje lahko povzroči hudo bolečino in otekanje, še posebej če je bilo injiciranje izvedeno v sklep ali prst, kar lahko v redkih primerih privede do izgube prsta.
When exposed to CSF later in life, the pig will either not become infected or have a much less serious infection.
Če bo prašič bolezni KPK izpostavljen pozneje v življenju, se ne bo okužil ali pa bo imel bistveno manj resno okužbo.
Protection from CSF starts after 2 weeks and lasts for 6 months.
Zaščita pred KPK začne učinkovati po 2 tednih in traja 6 mesecev.
The field trials confirm the results obtained in the laboratory safety experiments and show that the product is safe for the target animal (piglets from 5 weeks of age onwards) and in the most sensitive category of animals (pregnant sows).
Terenske študije potrjujejo rezultate laboratorijskih preizkusov varnosti in kažejo, da je izdelek varen za ciljne živali (pujski od 5 meseca dalje) in najobčutljivejšo kategorijo živali (breje svinje).
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PORCILIS PESTI EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PORCILIS PESTI Povzetek EPAR za javnost
It is also used to reduce infection with CSF and excretion of CSF virus into the environment.
Uporablja se tudi za zmanjševanje okuženosti s KPK in izločanja virusa KPK v okolico.
Porcilis Pesti is an emulsion for injection.
Zdravilo Porcilis Pesti je emulzija za injiciranje.
Other information about Porcilis Pesti:
Druge informacije o zdravilu Porcilis Pesti: