natgillin/translations-raw huggingface dataset:
The excipients 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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Pomožne snovi, ki so navedene v poglavju 6.1 Povzetka glavnih značilnosti zdravila, so bodisi dovoljene učinkovine, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 navaja, da se MRL ne zahtevajo, ali pa velja, da niso zajete v Uredbo (ES) št. 470/2009, kadar se uporabljajo tako kot v tem zdravilu za uporabo v veterinarski medicini.
Vaccinate only healthy rabbits.
Cepite samo zdrave kunce.
Any person intending to manufacture, import, possess, sell, supply and/or use Nobivac Myxo-RHD must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati Nobivac Myxo-RHD, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ali uporabo.
The scabs usually disappear within 2 weeks after the small swellings have been observed.
Kraste navadno izginejo v dveh tednih po tem, ko smo opazili male otekline.
Duration of immunity: 1 year.
Trajanje imunosti: 1 leto
These scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
Te kraste opazimo samo pri živalih z aktivno imunostjo in ne vplivajo na splošno zdravje, tek ali obnašanje kunca.
Studies involving the use of the vaccine during early pregnancy were inconclusive, therefore vaccination is not recommended during the first 14 days of pregnancy.
Študije uporabe cepiva med zgodnjo brejostjo so bile pomanjkljive, zato cepljenja ne priporočamo v prvih 14 dneh brejosti.
Use the vaccine suspension within 4 hours of reconstitution.
Uporabite suspenzijo cepiva v 4 urah po rekonstituciji.
Therefore, the vaccination of breeding bucks is not recommended.
Zato cepljenja plemenskih samcev ne priporočamo.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the vaccine.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini razen z vehiklom, ki je priložen za uporabo s tem cepivom.
Ensure that the lyophilisate is completely reconstituted before use.
Liofilizat se mora pred uporabo popolnoma rekonstituirati.
The vector technology used to develop the vaccine strain allows the RHD virus component to be produced in vitro instead of using live rabbits for cultivation.
Vektorska tehnologija, ki se uporablja za pripravo seva cepiva, omogoča, da se RHD virusna komponenta proizvaja in vitro, namesto da bi uporabili žive kunce.
STORAGE CONDITIONS Store in a refrigerator.
Shranjujte v hladilniku.
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.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina, ki je biološkega izvora in je namenjena za vzbujanje aktivne imunosti, ni zajeta v Uredbi (ES) št. 470/2009.
The swelling will resolve completely by 3 weeks after vaccination.
Oteklina popolnoma izgine v treh tednih po cepljenju.
Number of vials of freeze-dried vaccine to be added
Število vial liofiliziranega cepiva, ki jih moramo dodati
The manufacture, import, possession, sale, supply and/or use of Nobivac Myxo-RHD may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Uvoz, prodaja, oskrba in/ali uporaba Nobivac Myxo-RHD je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent.
Zdi se, da imajo pri tem do določene mere vlogo nedavne ali latentne infekcije z miksoma virusom.
4.7 Use during pregnancy and lactation
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti
Total number of rabbits that can be vaccinated
Število kuncev, ki jih lahko cepimo
Onset of immunity: 3 weeks.
Začetek imunosti: 3 tedni
In very rare cases the appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination.
V zelo redkih primerih se v treh tednih po cepljenju lahko pojavijo blagi klinični znaki miksomatoze.
Pharmacotherapeutic group: Immunologicals for leporidae, live viral vaccine, ATCvet code: QI08AD
IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: živo virusno cepivo, oznaka ATCvet: QI08AD
In very rare cases serious hypersensitivity reactions, which may be fatal, may occur after vaccination.
V zelo redkih primerih se lahko pojavijo hude preobčutljivostne reakcije, ki so lahko smrtne.
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na steklenički.
In pet rabbits, in very rare cases, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur.
Pri hišnih kuncih v zelo redkih primerih lahko pride do lokalnih reakcij, kot so nekroza, kraste ali izpadanje dlake.
After infection with virulent myxoma virus some vaccinated animals may develop a few very small swellings, especially on hairless places of the body, which quickly form scabs.
Po okužbi z miksoma virusom se pri nekaterih cepljenih živalih lahko pojavi nekaj zelo majhnih oteklin, posebno na neporaščenih delih telesa, ki se hitro spremenijo v kraste.
After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.
Po rekonstituciji injicirajte 1 odmerek cepiva subkutano kuncem od 5 tednov starosti dalje.
SPECIAL STORAGE CONDITIONS No special storage conditions.
Za shranjevanje ni posebnih navodil.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains:
Vsak odmerek rekonstituiranega cepiva vsebuje:
Solvent: - Glass vial (1 ml or 10 ml): No special precautions for storage.
- viale (1 ml ali 10 ml): Za shranjevanje ni posebnih navodil.
4.2 Indications for use, specifying the target species For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease (RHD) caused by classical RHD virus strains.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za aktivno imunizacijo kuncev od 5 tednov starosti dalje za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in za preprečevanje smrtnosti zaradi hemoragične bolezni kuncev, ki jo povzroča klasični RHD sev virusa.
In addition to the signs observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after overdose vaccination.
Poleg znakov, ki jih opazimo po cepljenju z enkratnim odmerkom, lahko v prvih 3 dneh po cepljenju s prevelikim odmerkom opazimo rahlo oteklino lokalnih limfnih vozlov.
Shelf-life of the lyophilisate as packaged for sale: 2 years.
Rok uporabnosti liofilizata v pakiranju za prodajo: 2 leti Rok uporabnosti vehikla v pakiranju za prodajo:
Ensure that the resulting vaccine suspension in the Nobivac Myxo-RHD solvent vial is properly mixed.
Poskrbite, da je nastala suspenzija cepiva v viali z Nobivac Myxo-RHD vehiklom dobro premešana.
Name and address of the manufacturer responsible for batch release Intervet International B.V.
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije Intervet International BV
1 ml and 10 ml vial
1 ml in 10 ml viale
EXPIRY DATE EXP {month/year}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP { mesec/leto }
Rabbits that have been vaccinated previously with another myxomatosis vaccine, or that have experienced natural myxomatosis infection in the field, may not develop a proper immune response against rabbit haemorrhagic disease following vaccination.
Pri kuncih, ki so bili predhodno cepljeni s kakšnim drugim cepivom proti miksomatozi ali ki so preboleli miksomatozo, po cepljenju ne bo prišlo do pravega imunskega odgovora na hemoragično bolezen kuncev.
For active immunisation of rabbits to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease (RHD) caused by classical RHD virus strains.
Za aktivno imunizacijo kuncev za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in za preprečevanje smrtnosti zaradi hemoragične bolezni kuncev, ki jo povzroča klasični RHD sev virusa.
TARGET SPECIES Rabbits
CILJNE ŽIVALSKE VRSTE
Glass vial of 1 ml or 10 ml, or polyethylene terephthalate (PET) vial of 50 ml closed with a halogenobutyl rubber stopper and aluminium cap.
Viala z 1 ml ali 10 ml, ali plastenka iz polietilen tereftalata (PET) s 50 ml z zamaškom iz halogenbutilne gume in aluminijasto zaporko.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
Add 1 - 2 ml of Nobivac Myxo-RHD solvent to the 50-dose vaccine vial(s) and ensure that the lyophilisate is fully dissolved.
Dodajte 1-2 ml Nobivac Myxo-RHD vehikla v plastenko/e s 50 odmerki cepiva in poskrbite, da se liofilizat popolnoma raztopi.
Vaccine: Store in a refrigerator (2 °C - 8 °C).
Cepivo: shranjujte v hladilniku (2 °C - 8 °C).
Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo-RHD solvent and inject the total contents of the vial.
Rekonstituirajte vialo z enkratnim odmerkom cepiva z 1 ml Nobivac Myxo-RHD vehikla in injicirajte vso vsebino viale.
- PET vial (50 ml): Store in a refrigerator (2 °C - 8 °C).
Vehikel (50 ml plastenak iz PET): Shranjujte v hladilniku (2 °C - 8 °C).
PACKAGE LEAFLET Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
Nobivac Myxo-RHD liofilizat in vehikel za suspenzijo za injiciranje za kunce
The vaccine strain is a myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus.
Sev cepiva je miksoma virus, ki ima v kapsidi proteinski gen virusa hemoragične bolezni kuncev.
No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Na samcih ni bila opravljena nobena študija v zvezi z reprodukcijo.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
• Pogoji ali omejitve glede varne in učinkovite uporabe zdravila za uporabo v veterinarski medicini
Lyophilisate: Glass vial of 1 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Viala z 1 ali 50 odmerki z zamaškom iz halogenbutilne gume in aluminijasto zaporko.
PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection
Liofilizat in vehikel za suspenzijo za injiciranje
Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial.
Izvlecite rekonstituirani koncentrat cepiva iz vial/e in ga injicirajte nazaj v vialo z Nobivac MyxoRHD vehiklom.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Live myxoma vectored RHD virus strain 009: ≥103.0 FFU/dose.
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Miksoma virus, živi vektorski RHD sev 009: ≥10
Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi hidrolizirana želatina pankreasni presnovek kazeina sorbitol dinatrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
− very rare (less than 1 animal in 10,000 animals, including isolated reports).
- občasni (pojavijo se pri 1 od 10 živali od 1.000 živali) - redki (pojavijo se pri 1 od 10 živali od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Myxo-RHD
IME VEHIKLA Nobivac Myxo-RHD vehikel
- 1 ml and 10 ml glass vials: 4 years.
• 1 ml in 10 ml steklene viale: 4 leta • 50 ml plastenke iz PET: 2 leti
QUANTITY OF THE ACTIVE SUBSTANCE(S) Live myxoma vectored RHD virus.
KOLIČINA ZDRAVILNE UČINKOVINE Miksoma virus, živi, vektorski RHD
For proper reconstitution of the multi-dose vial, use the following procedure:
Za pravilno rekonstitucijo večodmerne plastenke ravnajte, kot sledi: 1.
A small, non-painful swelling (max. 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination.
Lahko pride do prehodnega povišanja temperature za 1-2° C. V prvih dveh tednih po cepljenju običajno opazimo na mestu injiciranja majhno, nebolečo oteklino (največ 2 cm premera).
To stimulate immunity against myxoma virus and rabbit haemorrhagic disease virus.
Za stimulacijo imunosti proti virusu miksomatoze in proti virusu hemoragične bolezni kuncev.
As a consequence rabbits are immunised against both myxoma virus and rabbit haemorrhagic disease virus.
Tako so kunci imunizirani proti miksoma virusu in proti virusu hemoragične bolezni kuncev.
Solvent (50 ml PET vial):
Vehikel (1 ml and 10 ml viala):
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Multi-dose vial
Večodmerne plastenke Količina vehikla
− very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali v teku enega zdravljenja) - pogosti (pojavijo se pri 1 od 10 živali od 100 živali)
Solvent
Odmerek
Single dose vial
Viale z enkratnim odmerkom
Name and address of the manufacturers of the biological active substance Intervet International B.V., site De Bilt Ambachtstraat 4
Intervet International BV, site De Bilt
PHARMACEUTICAL PARTICULARS
Sistem farmakovigilance
Fertility:
Vehikel:
- Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.
Zloženka s 25 x vialo z 1 odmerkom cepiva in 25x vialo z 1 ml vehikla.
- Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Zloženka s 5 x vialo z 1 odmerkom cepiva in 5 x vialo z 1 ml vehikla.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Injection volume
Več odmerkov
5 x 1 dose of vaccine including solvent 25 x 1 dose of vaccine including solvent 10 x 50 doses of vaccine + 10 x 10 ml glass solvent vials 10 x 50 doses of vaccine + 2 x 50 ml PET solvent vials
5 x 1 odmerek cepiva z vehiklom 25 x 1 odmerek cepiva z vehiklom 10 x 50 odmerkov cepiva - 10 ml viale z vehiklom
Pregnancy:
Pakiranja:
Plastic box with 5 x 1 dose of vaccine including 5 x 1 ml solvent vials (glass) Plastic box with 25 x 1 dose of vaccine including 25 x 1 ml solvent vials (glass) Cardboard box with 10 x 50 doses of vaccine
Zloženka s 5 x vialo z 1 odmerkom cepiva in 5x vialo z 1 ml vehikla Zloženka s 25 x vialo z 1 odmerkom cepiva in 25x vialo z 1 ml vehikla
Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Miksoma virus, živi vektorski RHD sev 009: ≥10
PACKAGE SIZE 10 x 10 ml
Zloženka z 10 x vialo z 10 ml vehikla.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VACCINE VIAL LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNI OVOJNINI (OZNAKA)
ml vial of solvent.
RHD vehiklom.
Subcutaneous use.
NAVODILO ZA UPORABO
− rare (more than 1 but less than 10 animals in 10,000 animals)
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali v teku enega zdravljenja) - pogosti (pojavijo se pri 1 od 10 živali od 100 živali) - občasni (pojavijo se pri 1 od 10 živali od 1.000 živali) - redki (pojavijo se pri 1 od 10 živali od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
- Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50
Zloženka z 10 x vialo s 50 odmerki cepiva 2 zloženki z 1 x vialo s 50 ml vehikla Zloženka z 10 x vialo z 10 ml vehikla
PACKAGE SIZE 1 x 50 ml
2 zloženki z 1 x vialo s 50 ml vehikla.
Date of first authorisation: 18 July 2014 Date of latest renewal:
Datum prve odobritve: 18. julij 2014 Datum zadnjega podaljšanja:
These effects are more frequent if you also drink alcohol.
Ti učinki so pogostejši, če skupaj pijete tudi alkohol.
The recommended initial doses presented below are intended to act solely as a guideline.
Spodaj navedeni priporočeni začetni odmerki so namenjeni le kot smernice.
Most patients completely recover after appropriate measures are taken.
Večina bolnikov po uvedbi ustreznih ukrepov povsem okreva.
However, cases of spontaneous abortion have been reported.
Vendar pa so poročali o primerih spontanega splava.
• Educational material for Healthcare Professionals
• Izobraževalno gradivo za zdravstvene delavce
Infection including opportunistic infections
Okužba vključno z oportunističnimi okužbami
The educational pack should contain the following:
Paket izobraževalnih gradiv bo vseboval naslednje:
Prevention and management should be in accordance with appropriate clinical guidance.
Preventiva in obvladovanje morajo biti v skladu z ustreznimi kliničnimi smernicami.
The course of pre-existing infections may be aggravated.
Potek obstoječih okužb se lahko poslabša.
- if you have an alteration of the electrical activity of your heart called “QT prolongation”.
- če imate spremembo električnega delovanja srca, imenovano »podaljšanje QT intervala«.
To date, no other relevant epidemiological data are available.
Drugi pomembni epidemiološki podatki za sedaj niso na voljo.
Gonzagagasse 16/16 1010 Wien Austria
Gonzagagasse 16/16 1010 Wien Avstrija
Other interactions leading to clinically detrimental effects
Druge interakcije, ki so povzročile klinično škodljive učinke
When treating rejection, the same doses may be used.
Pri zdravljenju zavrnitve se lahko uporabijo enaki odmerki.
Pure red cell aplasia
(PRCA, pure red cell aplasia).
You should keep in regular contact with your doctor.
Bodite v stalnem stiku z zdravnikom.
- if you are taking any medicines mentioned below under “Other medicines and Envarsus”.
- če jemljete katera koli zdravila, omenjena spodaj v »Druga zdravila in zdravilo Envarsus«,
Your dose depends on your general condition and on which other immunosuppressive medicines you are taking.
Vaš odmerek je odvisen od vašega splošnega stanja in od tega, katera druga imunosupresivna zdravila jemljete.
The use of Envarsus is not recommended in children and adolescents under 18 years.
Uporaba zdravila Envarsus se ne priporoča pri otrocih in mladostnikih, starih manj kot 18 let.
Stevens Johnson syndrome
StevensJohnsonov sindrom
Hypersensitivity to other macrolides.
Preobčutljivost na druge makrolide.
This medicine should be taken once a day.
To zdravilo jemljite enkrat na dan.
If overdose occurs, general supportive measures and symptomatic treatment should be conducted.
Če pride do prevelikega odmerjanja, je treba uporabiti splošne podporne ukrepe in simptomatsko zdravljenje.
Dose adjustments should be made to ensure that similar systemic exposure is maintained after the switch.
Odmerek je treba prilagoditi, da se zagotovi vzdrževanje podobne sistemske izpostavljenosti po prehodu.
A forgotten dose should be taken as soon as possible on the same day.
Pozabljeni odmerek je treba nadomestiti še isti dan takoj, ko je možno.
Corresponding data based on whole blood averaged 47.6 L.
Ustrezni podatek na podlagi polne krvi je povprečno 47,6 l.
Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
Nositi morate primerna zaščitna oblačila in uporabljati sredstva za sončenje z visokim zaščitnim faktorjem.
If the appearance of this medicine is not the same as usual, or if doe instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Če izgled tega zdravila ni tak, kot vedno, ali če so se navodila za odmerek spremenila, se posvetujte z zdravnikom ali farmacevtom takoj, ko je možno, in se prepričajte, ali imate pravo zdravilo.
In practice, tacrolimus-based therapy has been initiated 12 to 24 hours after discontinuation of ciclosporin.
V praksi so zdravljenje na osnovi takrolimusa začenjali od 12 do 24 ur po prekinitvi ciklosporina.
The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to
Pogostnost neželenih učinkov je opredeljena kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do
The tablets should be swallowed whole with a glass of water.
Tablete zaužijte cele s kozarcem vode.
Administration should commence within 24 hours after the completion of surgery.
Dajanje se mora začeti v roku 24 ur po koncu operacije.
Positive EBV-PCR may persist for months and is per se not indicative of lymphoproliferative disease or lymphoma.
Pozitiven EBV-PCR lahko traja mesece in sam po sebi ni kazalec limfoproliferativne bolezni ali limfoma.
Envarsus with food and drink
Zdravilo Envarsus skupaj s hrano in pijačo
In healthy subjects, the mean half-life in whole blood is approximately 30 hours.
Pri zdravih prostovoljcih je povprečni razpolovni čas v polni krvi približno 30 ur.
Following your kidney or liver transplant, your body's immune system will try to reject the new organ.
Po presaditvi ledvice ali jeter bo imunski sistem telesa poskusil zavrniti novi organ.
Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Spremljanje najnižjih ravni v polni krvi je zato dobra ocena sistemske izpostavljenosti.
Envarsus is used in adults.
Zdravilo Envarsus se uporablja pri odraslih.
This medicine should only be prescribed for you by a doctor with experience in the treatment of transplant patients.
To zdravilo vam lahko predpiše le zdravnik, izkušen z zdravljenjem bolnikov po presaditvi.
Envarsus doses are usually reduced in the post-transplant period.
Odmerki zdravila Envarsus se med obdobjem po presaditvi običajno zmanjšajo.
Effect on hepatic clearance is less pronounced.
Učinek na jetrni očistek je manj izrazit.
- if you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na takrolimus ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
- The clinical risks associated with over- and under-dosing.
- Klinična tveganja, povezana s premajhnim in prevelikim odmerjanjem.
No specific antidote to tacrolimus therapy is available.
Specifičnega antidota za takrolimus ni na voljo.
A double dose should not be taken on the next day.
Naslednji dan bolnik ne sme vzeti dvojnega odmerka.
Therapeutic drug monitoring
Terapevtsko nadziranje zdravila
Tacrolimus treatment can be considered in pregnant women when there is no safer alternative, and when the perceived benefit justifies the potential risk to the foetus.
Zdravljenje s takrolimusom pride v poštev tudi pri nosečnicah, če ni varnejše alternative in če pričakovana korist opravičuje možno tveganje za plod.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal preparations.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili brez recepta ali zdravili rastlinskega izvora.
Available tacrolimus is generally rapidly absorbed.
Absorpcija razpoložljivega takrolimusa je običajno hitra.
It should be noted however, that there has been no direct experience with Envarsus in overdose.
Vendar je treba opozoriti, da ni neposrednih izkušenj s prevelikim odmerjanjem zdravila Envarsus.
Severe effects may occur, including allergic and anaphylactic reactions.
Pojavijo se lahko hudi neželeni učinki, vključno z alergijskimi in anafilaktičnimi reakcijami.