natgillin/translations-raw huggingface dataset:
- The other ingredients are hydroxypropylmethylcellulose, glycerol (see section 2), polysorbate 80, sodium benzoate (E211) (see section 2), citric acid monohydrate, sodium citrate (see section 2), strawberry aroma (artificial) and purified water.
80, natrijev benzoat (E211) (glejte poglavje 2), citronska kislina monohidrat, natrijev citrat
In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP3A4-mediated metabolism.
Študije in vitro, pri katerih so uporabili človeške mikrosome jeter in s cDNA izražene encime P450,
Nitisinone treatment may therefore result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9.
zato lahko zdravljenje z nitizinonom povzroči zvišane plazemske koncentracije sočasno dajanih zdravil, ki se presnavljajo predvsem preko encima CYP 2C9 (glejte poglavje 4.4).
No formal food interactions studies have been performed with Orfadin hard capsules.
Formalnih študij interakcij zdravila Orfadin trde kapsule s hrano niso opravili, vendar so med zbiranjem podatkov o učinkovitosti in varnosti nitizinon dajali skupaj s hrano.
After first opening, the medicine can be stored for a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Po prvem odprtju lahko zdravilo shranjujete največ 2 meseca pri temperaturi do 25 °C, potem ga je treba zavreči.
The bottle should be kept in an upright position and the oral syringe inserted firmly into the hole of the adaptor, at the top of the bottle (Figure E).
Steklenico je treba držati v pokončnem položaju in brizgo za peroralno dajanje čvrsto vstaviti v odprtino na nastavku na vrhu steklenice (slika E).
The oral syringes are graduated in 0.01 ml, 0.1 ml and 0.2 ml steps respectively.
Brizge za peroralno dajanje so graduirane v stopnjah po 0,01 ml, 0,1 ml in 0,2 ml. Spodnja preglednica prikazuje pretvorbo odmerka (mg/ml) za tri velikosti brizg za peroralno dajanje.
Talk to your doctor or pharmacist before taking Orfadin.
Pred začetkom jemanja zdravila Orfadin se posvetujte z zdravnikom ali farmacevtom.
1-ml oral syringe (0.01 ml graduation)
1-ml brizga za peroralno dajanje (graduira na po 0,01 ml)
Your liver will be checked at regular intervals because the disease affects the liver.
Ker bolezen prizadene jetra, vam bodo v intervalih opravili redne preglede jeter.
Orfadin 5 mg: Each capsule contains 5 mg nitisinone.
Orfadin 5 mg: Ena kapsula vsebuje 5 mg nitizinona.
Therefore, it is recommended that if nitisinone treatment with Orfadin hard capsules is initiated with food, this should be maintained on a routine basis, see section 4.2.
Če se zdravljenje z nitizinonom z zdravilom Orfadin trde kapsule začne ob hrani, se priporoča, da se to vzdržuje rutinsko,
Orfadin 20 mg: Each capsule contains 20 mg nitisinone.
Orfadin 20 mg: Ena kapsula vsebuje 20 mg nitizinona.
Figure C.
Slika C
Capsule shell: gelatine titanium dioxide (E 171).
- Druge sestavine zdravila so: Vsebina kapsule: predgeliran (koruzni) škrob Ovojnica kapsule: želatina titanov dioksid (E 171)
1 ml contains 4 mg nitisinone.
1 ml vsebuje 4 mg nitizinona.
After first opening, the in-use stability is a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
2 leti Po prvem odprtju je zdravilo fizikalno stabilno 2 meseca pri temperaturi do 25 °C, potem ga je treba zavreči.
3-ml oral syringe (0.1 ml graduation)
3-ml brizga za peroraln o dajanje (graduir ana po 0,1 ml)
Figure D.
Slika D
The bottle should be turned carefully upside down with the oral syringe in place (Figure F).
Steklenico je treba z nameščeno brizgo za peroralno dajanje obrniti navzdol (slika F).
Orfadin 2 mg: Each capsule contains 2 mg nitisinone.
Orfadin 2 mg: Ena kapsula vsebuje 2 mg nitizinona.
Package leaflet: Information for the user Orfadin 4 mg/ml oral suspension nitisinone
Navodilo za uporabo Orfadin 4 mg/ml peroralna suspenzija nitizinon
Orfadin 10 mg: Each capsule contains 10 mg nitisinone.
Orfadin 10 mg: Ena kapsula vsebuje 10 mg nitizinona.
If you have the impression that the medicine is not working properly, talk to your doctor.
Če ste prenehali jemati zdravilo Orfadin Če menite, da je učinek zdravila premočan ali prešibak, se posvetujte z zdravnikom.
Figure E.
Slika E
The product can be stored for a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Zdravilo lahko shranjujete 2 meseca pri temperaturi do 25 °C, potem ga je treba zavreči.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNIH OVOJNINAH
Each ml contains 4 mg nitisinone.
En ml vsebuje 4 mg nitizinona.
Each capsule contains 20 mg nitisinone.
Ena kapsula vsebuje 20 mg nitizinona.
The hard capsules are white, opaque, imprinted with “NTBC” and the strength “2 mg”, “5 mg”, “10 mg” or “20 mg”, in black.
Kapsule so trde želatinske kapsule motno bele barve, vtisnjen imajo napis »NTBC« in jakost »2 mg«,
Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone is a moderate inhibitor of CYP2C9 (2.3-fold increase in tolbutamide AUC), therefore nitisinone treatment may result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9 (see section 4.4).
Klinična študija medsebojnega delovanja z nitizinonom 80 mg v stanju dinamičnega ravnovesja je pokazala, da je nitizinon zmerni zaviralec encima CYP 2C9 (2,3−kratno zvišanje AUC tolbutamida),
Figure A.
Slika A
A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/l.
500 mikromolov/l, je treba z dieto še bolj zmanjšati vnos tirozina in fenilalanina.
Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules nitisinone
Orfadin 2 mg trde kapsule Orfadin 5 mg trde kapsule Orfadin 10 mg trde kapsule Orfadin 20 mg trde kapsule nitizinon peroralna uporaba
Replace the child resistant screw cap directly after use.
Takoj po uporabi znova namestite za otroke varno navojno zaporko.
White, opaque capsules (6x16 mm) imprinted “NTBC 5mg” in black on the body of the capsule.
Kapsule (6 x 16 mm) motno bele barve s črnim vtisom »NTBC 5mg« na telesu kapsule.
The child-resistant screw cap should be replaced directly after use.
Takoj po uporabi je treba znova namestiti za otroke varno navojno zaporko.
PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS BOTTLE LABEL
PODATKI NA PRIMARNI OVOJNINI NALEPKA NA VSEBNIKU
The plunger inside the oral syringe should be pushed fully down.
Bat je treba do konca pritisniti navzdol v brizgo za peroralno dajanje.
Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules
Orfadin 2 mg trde kapsule Orfadin 5 mg trde kapsule Orfadin 10 mg trde kapsule Orfadin 20 mg trde kapsule
White, opaque capsules (6x16 mm) imprinted “NTBC 20mg” in black on the body of the capsule.
Kapsule (6 x 16 mm) motno bele barve s črnim vtisom »NTBC 20mg« na telesu kapsule.
White, opaque capsules (6x16 mm) imprinted “NTBC 2mg” in black on the body of the capsule.
Kapsule (6 x 16 mm) motno bele barve s črnim vtisom »NTBC 2mg« na telesu kapsule.
White, opaque capsules (6x16 mm) imprinted “NTBC 10mg” in black on the body of the capsule.
Kapsule (6 x 16 mm) motno bele barve s črnim vtisom »NTBC 10mg« na telesu kapsule.
All patients Start age months Start age months
Začetna starost ≤ 24 mesecev
Three oral syringes (1 ml, 3 ml and 5 ml) are provided for accurate measurement of the prescribed dose.
Za natančno merjenje predpisanega omerka so priložene tri brizge za peroralno dajanje (1 ml,
- Keep this leaflet.
Shranjujte v pokončnem položaju.
4 x 1 capsules (unit dose)
4 x 1 kapsula (za enkraten odmerek)
Further information on Lumark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Lumark so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Lumark received a marketing authorisation valid throughout the EU on 19 June 2015.
Za zdravilo Lumark je bilo 19. junija 2015 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Lumark?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lumark?
Lumark is never given to a patient on its own.
Zdravilo Lumark se bolniku nikoli ne daje samostojno.
However, the quantity of Lumark to be used is very small and therefore these risks are considered low.
Vendar pa je količina zdravila Lumark, ki jo je treba uporabiti, zelo majhna, zato je tudi to tveganje majhno.
Other information about Lumark
Druge informacije o zdravilu Lumark
The most common side effects with Lumark (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and mild and temporary hair loss.
Najpogostejši neželeni učinki zdravila Lumark (ki se lahko pojavijo pri več kot 1 bolniku od 10) so anemija (nizko število rdečih krvnih celic), trombocitopenija (nizko število trombocitov), levkopenija (nizko število belih krvnih celic), limfopenija (nizko število limfocitov, posebne vrste belih krvnih celic), navzeja (slabost), bruhanje in blago, začasno izpadanje las.
These tumours affect hormone-secreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs.
Ti tumorji prizadenejo celice, ki izločajo hormone, v številnih delih telesa, vključno s trebušno slinavko, črevesjem, želodcem in pljuči.
The doctor will ensure that the expected benefit to the patients of using Lumark outweigh the risks linked to the radioactivity.
Zdravnik bo zagotovil, da bodo pričakovane koristi uporabe zdravila Lumark za bolnike večje od tveganj, povezanih z radioaktivnostjo.
Why is Lumark authorised in the EU?
Zakaj je bilo zdravilo Lumark odobreno v EU?
The Agency concluded that the benefits of Lumark outweigh the risks and it can be authorised for use in the EU.
Agencija je zaključila, da so koristi zdravila Lumark večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What benefits of Lumark have been shown in studies?
Kakšne koristi zdravila Lumark so se pokazale v študijah?
What is Lumark and what is it used for?
Kaj je zdravilo Lumark in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lumark 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 Lumark upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Lumark are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Lumark, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Radiolabelling with Lumark takes place in a laboratory.
Radiooznačevanje z zdravilom Lumark poteka v laboratoriju.
An overview of Lumark and why it is authorised in the EU
Pregled zdravila Lumark in zakaj je odobreno v EU
When a medicine is radiolabelled with Lumark, the medicine carries the radiation to where it is needed in the body, either to kill cancer cells (when used for treatment) or to obtain images on a screen (when used for diagnosis).
Ko je zdravilo radiooznačeno z zdravilom Lumark, prenese sevanje v tiste dele telesa, v katerih je potrebno, da uniči rakave celice (kadar se uporablja za zdravljenje) ali da se pridobijo slike na zaslonu (kadar se uporablja za diagnostične namene).
Lumark is only used by specialists who have experience in radiolabelling.
Zdravilo Lumark smejo uporabljati samo specialisti, ki imajo izkušnje z radiooznačevanjem.
As for all medicines, data on the use of Lumark are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Lumark stalno spremljajo.
Information on how to minimise the risks is included in the product information for Lumark.
Informacije o tem, kako zmanjšati tveganja, so vključene v informacije o zdravilu Lumark.
The radiolabelled medicine is then given to the patient according to the instructions in that medicine's product information.
Nato bolnik prejme radiooznačeno zdravilo v skladu z navodili iz informacij o označenem zdravilu.
Radiolabelling is a technique for tagging (or labelling) medicines with radioactive compounds so they can carry radioactivity to where it is needed in the body, for example, the site of a tumour.
Radiooznačevanje je tehnika za označevanje zdravil z radioaktivnimi spojinami, tako da lahko prenesejo radioaktivnost v tiste dele telesa, kjer je potrebna, na primer na mesto tumorja.
Medicines radiolabelled with Lumark must not be used in women unless pregnancy has been ruled out.
Zdravila, radiooznačena z zdravilom Lumark, se ne smejo uporabljati pri nosečnicah ali ženskah, ki bi lahko bile noseče.
What are the risks associated with Lumark?
Kakšna tveganja so povezana z zdravilom Lumark?
The active substance in Lumark, lutetium (177Lu) chloride, is a radioactive compound that mainly releases beta radiation, with small amounts of gamma radiation.
Učinkovina v zdravilu Lumark, lutecijev (177Lu) klorid, je radioaktivna spojina, ki v glavnem oddaja sevanje beta, skupaj z majhnimi količinami sevanja gama.
Because the use of lutetium (177Lu) to radiolabel medicines is well established, the company presented data from the scientific literature.
Ker je uporaba lutecija (177Lu) za radiooznačevanje zdravil dobro uveljavljena, je podjetje predložilo podatke iz znanstvene literature.
Lumark itself is radioactive, and as with any other radioactive product, its use may carry a risk of developing cancer and hereditary defects.
Zdravilo Lumark je radioaktivno, zato pri njegovi uporabi enako kot pri uporabi katerega koli drugega radioaktivnega proizvoda obstaja tveganje za nastanek raka in dednih okvar.
Information on restrictions that apply specifically to medicines radiolabelled with Lumark can be found in the package leaflets of those medicines.
Informacije o omejitvah, ki veljajo posebej za zdravila, radiooznačena z zdravilom Lumark, bodo na voljo v navodilih za uporabo teh zdravil.
The European Medicines Agency considered that the use of lutetium (177Lu) for radiolabelling medicines was well established and well documented in the scientific literature.
Evropska agencija za zdravila je menila, da je uporaba lutecija (177Lu) za radiooznačevanje zdravil dobro uveljavljena in dobro dokumentirana v znanstveni literaturi.
For the list of all side effects and restrictions with Lumark, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Lumark glejte navodilo za uporabo.
Lumark contains the radioactive compound lutetium (177Lu) chloride and is used for radiolabelling other medicines.
Zdravilo Lumark vsebuje radioaktivno spojino lutecijev (177Lu) klorid in se uporablja za radiooznačevanje drugih zdravil.
Several published studies have established the usefulness of lutetium (177Lu) in radiolabelling medicines for diagnosing and treating neuroendocrine tumours.
V več objavljenih študijah so potrdili uporabnost lutecija (177Lu) pri radiooznačevanju zdravil za diagnostične namene in zdravljenje nevroendokrinih tumorjev.
The side effects with Lumark depend largely on the medicine it is used with and are described in that medicine's package leaflet.
Neželeni učinki pri uporabi zdravila Lumark so odvisni predvsem od zdravila, s katerim se uporablja, in so opisani v navodilu za uporabo tega zdravila.
As with all radiolabelling materials for medicines, there are risks linked to radiation exposure from Lumark.
Tako kot pri uporabi drugih snovi za radiooznačevanje zdravil tudi pri uporabi zdravila Lumark obstajajo tveganja, povezana z izpostavljenostjo njegovemu sevanju.
Lumark is to be used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.
Zdravilo Lumark je namenjeno radioaktivnemu označevanju tistih zdravil, ki so bila razvita posebej za uporabo z lutecijevim (177Lu) kloridom.
How does Lumark work?
Kako zdravilo Lumark deluje?
How is Lumark used?
Kako se zdravilo Lumark uporablja?
How well Lumark works will largely depend on the medicine that it is used to radiolabel.
Učinkovitost delovanja zdravila Lumark je predvsem odvisna od zdravila, za radiooznačevanje katerega se uporabi.
Lu) chloride)
Lumark (lutecijev [177Lu] klorid)
The vaccine was generally well tolerated and shown to be safe.
Živali so cepivo na splošno dobro prenašale in izkazalo se je kot varno.
They may also have a swelling at the injection site lasting no more than seven days or a hardening under the skin (nodules), which could last more than six or seven weeks.
Lahko se pojavi tudi oteklina na mestu injiciranja, ki ne traja več kot sedem dni, ali zatrdline pod kožo, ki lahko trajajo več kot šest ali sedem tednov.
Following vaccination sheep may have a slightly raised body temperature.
Po cepljenju se lahko pri ovcah pojavi rahlo povišana telesna temperatura.
The studies showed that the vaccine prevents viraemia in sheep and offered protection for one year.
Študije so pokazale, da cepivo preprečuje viremijo pri ovcah in da traja zaščita eno leto.
The safety of the vaccine was studied in two main laboratory safety studies carried out in sheep and two studies carried out in pregnant ewes.
Varnost zdravila je bila raziskana v dveh glavnih laboratorijskih študijah varnosti, ki sta bili opravljeni pri ovcah, in dveh študijah, opravljenih pri brejih ovcah.
Protection starts three weeks after the last injection and lasts for a year.
Zaščita je učinkovita od tretjega tedna po zadnji injekciji in traja eno leto.
The effectiveness of the vaccine was studied in three main laboratory studies in lambs from 1 months of age.
Učinkovitost cepiva je bila proučena v treh glavnih laboratorijskih študijah pri jagnjetih, starejših od enega meseca.
In 2012 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1 Ovis to convert to normal.
Leta 2012 je CVMP menil, da predloženi podatki zadostujejo, da se dovoljenje za promet z zdravilom Zulvac 1 Ovis spremeni v običajno.
Zulvac 1 Ovis was initially authorised under ‘exceptional circumstances'.
Zdravilo Zulvac 1 Ovis je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
The vaccine is safe for sheep from one and a half months of age onwards and in pregnant ewes.
Cepivo je varno za uporabo pri ovcah, starejših od enega meseca in pol ter pri brejih ovcah.
When it is given to sheep, the immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Ko ovca prejme cepivo, imunski sistem virus prepozna kot „tujek“ in proti njemu razvije protitelesa.
In the future, if the animals are exposed to the bluetongue virus, the immune system will be able to produce antibodies more quickly.
Ob ponovni izpostavitvi virusu bolezni modrega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
The studies goal was to establish the smallest dose of vaccine that prevented viraemia as well as the duration of protection for Zulvac 1 Ovis.
Cilja študij sta bila določiti najmanjši odmerek, ki preprečuje viremijo, in ugotoviti trajanje zaščite po cepljenju s cepivom Zulvac 1 Ovis.
The European Commission granted a marketing authorisation valid throughout the European Union, for Zulvac 1 Ovis on 05/08/2011.
Evropska komisija je dovoljenje za promet z zdravilom Zulvac 1 Ovis, veljavno po vsej Evropski uniji, odobrila dne 5. avgusta 2011.
Zulvac 1 Ovis is a vaccine that is available as a suspension for injection.
Zdravilo Zulvac 1 Ovis je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
The animals were challenged with bluetongue virus serotype 1, after receiving Zulvac 1 Bovis vaccine containing different amounts of virus.
Živali so izpostavili serotipu 1 virusa bolezni modrega jezika po tem, ko so bile cepljene s cepivom Zulvac 1 Ovis, ki je vsebovalo različne količine virusa.
Other information about Zulvac 1 Ovis:
Druge informacije o zdravilu Zulvac 1 Ovis:
Zulvac 1 Ovis is a vaccine.
Zdravilo Zulvac 1 Ovis je cepivo.
What benefit has Zulvac 1 Ovis shown during the studies?
Kakšne koristi je zdravilo Zulvac 1 Ovis izkazalo med študijami?
The withdrawal period for Zulvac 1 Ovis for meat and milk is zero days.
Karenca za cepivo Zulvac 1 Ovis za meso in mleko je nič dni.
Zulvac 1 Bovis contains bluetongue virus of one serotype (serotype 1).
Cepivo Zulvac 1 Ovis vsebuje virus bolezni modrega jezika enega tipa (serotip 1).
Zulvac 1 Ovis is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Zdravilo Zulvac 1 Ovis se uporablja pri ovcah za zaščito pred boleznijo modrega jezika, tj. okužbo, ki jo povzroča virus modrega jezika, prenašajo pa jo trzače.
This means that it was not possible to obtain complete information about Zulvac 1 Ovis at the time of the initial authorisation.
To pomeni, da ob prvotni izdaji dovoljenja za promet ni bilo mogoče pridobiti vseh podatkov o cepivu Zulvac 1
What is the risk associated with Zulvac 1 Ovis?
Kakšna tveganja so povezana z zdravilom Zulvac 1 Ovis?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zulvac 1 Ovis exceed the risks in the prevention of viraemia caused by Bluetongue Virus, serotype 1 in sheep from one and a half months of age.
CVMP je zaključil, da so pri ovcah, starejših od enega meseca in pol, koristi cepiva Zulvac 1 Ovis pri preprečevanju viremije, ki jo povzroča serotip 1 virusa bolezni modrega jezika, večje od z njim povezanih tveganj.
Why has Zulvac 1 Ovis been approved?
Zakaj je bilo zdravilo Zulvac 1 Ovis odobreno?
Zulvac 1 Ovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Cepivo Zulvac 1 Ovis vsebuje inaktiviran virus bolezni modrega jezika, ki ne povzroča bolezni.
The vaccine is used to prevent viraemia (the presence of the viruses in the blood) in sheep from one and a half months of age.
Cepivo se uporablja za preprečevanje viremije (prisotnosti virusov v krvi) pri ovcah, starejših od enega meseca in pol. Cepivo se mladičem injicira pod kožo v dveh odmerkih.
Inactivated vaccine against Bluetongue disease virus, serotype 1
Zulvac 1 Ovis inaktivirano cepivo proti virusu modrega jezika, serotip 1
What is Zulvac 1 Ovis?
Kaj je zdravilo Zulvac 1 Ovis?
How has Zulvac 1 Ovis been studied?
Kako je bilo zdravilo Zulvac 1 Ovis raziskano?
What is ZULVAC 1 Ovis used for?
Za kaj se zdravilo Zulvac 1 Ovis uporablja?
How does Zulvac 1 Ovis work?
Kako zdravilo Zulvac 1 Ovis deluje?
Animals should be re-examined every 6 months during treatment.
Živali je treba med zdravljenjem vsakih 6 mesecev pregledati.
Dogs (bitches).
Psi (psice)
See also 4.3 Contraindications.
Glejte tudi 4.3 Kontraindikacije.
The incidence is about 59 %.
Pogostnost teh pojavov je približno 5 do 9 %.
Pharmacotherapeutic group: estrogens, ATCvet code: QG03CA04.
Farmakoterapevtska skupina: estrogeni, oznaka ATCvet: QG03CA04.
SPECIAL WARNINGS, IF NECESSARY Not applicable.
POSEBNA OPOZORILA, ČE SO POTREBNA Ni smiselno.
11 PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno.
Nearly the whole Estriol is bound to Albumin in Plasma.
Skoraj ves estriol se veže na albumin v plazmi.
MARKETING AUTHORISATION NUMBER(S) EU/2/00/018/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/00/018/001
Date of last renewal: March 2010
Datum podaljšanja: marec 2010
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Če opazite kakršne koli resne neželene učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
B.V. Kloosterstraat 6 5349 AB Oss The Netherlands
Kloosterstraat 6 5349 AB Oss Nizozemska