natgillin/translations-raw huggingface dataset:
Stored pipettes must be kept in the intact foil package.
Merilne kapalke hranite v nepoškodovani originalni ovojnini.
carton box 3 pipettes
1 merilna kapalka 3 merilne kapalke
Amitraz is a monoamine oxidase inhibitor (MAOI); therefore, people taking MAOIcontaining medication should take particular care and avoid direct contact with the product.
Amitraz je inhibitor monoaminoksidaze (MAOI), zato je potrebna posebna previdnost pri ljudeh, ki jemljejo MAOI, in izogibanje direktnemu stiku z zdravilom.
For the 2.14 ml, 4.28 ml or 6.42 ml pipette: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Za 2,14 ml, 4,28 ml ali 6,42 ml merilno kapalko:
The treatment indirectly reduces the risk of transmission of tick-borne diseases (canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis) from infected ticks for 4 weeks.
Zdravljenje posredno 4 tedne zmanjšuje tveganje za prenos s klopi prenosljivih bolezni (babezioza psov, monocitna erlihioza, granulocitna anaplazmoza in borelioza).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Cut off the pipette tip with a pair of scissors.
S škarjami odrežite vrh merilne kapalke.
They may consist of hypersalivation, vomiting, lethargy, hyperglycaemia, bradycardia or bradypnea.
Neželeni učinki so lahko prekomerno slinjenje, bruhanje, letargija, hiperglikemija, bradikardija ali bradipneja.
Safety was demonstrated in breeding, pregnant and lactating animals treated at 28-day intervals with multiple consecutive doses up to 3 times the maximum recommended dose.
Varnost uporabe je bila ugotovljena pri vzrejnih in brejih živalih ter živalih v laktaciji, ki so bile zdravljene v 28-dnevnih intervalih z več zaporednimi odmerki do 3-kratnega največjega priporočenega odmerka.
WITHDRAWAL PERIOD Not applicable
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Avoid direct contact with the application site.
Izogibajte se neposrednemu stiku z mestom nanosa zdravila.
Safety was also demonstrated in breeding, pregnant and lactating animals treated at 28-day intervals with multiple consecutive doses of up to 3 times the maximum recommended dose.
Prav tako je bila varnost ugotovljena pri vzrejnih in brejih živalih ter živalih v laktaciji, ki so bile zdravljene v 28-dnevnih intervalih z več zaporednimi odmerki do 3-kratnega največjega
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
CERTIFECT spot-on solution
CERTIFECT kožni nanos, raztopina
Special precautions to be taken by the person administering the veterinary medicinal product to
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo:
Should this occur, contact your veterinarian promptly for treatment advice and discontinue use of the product.
V primeru pojava omenjenih sprememb na koži, se o zdravljenju posvetujte z veterinarjem in prenehajte z uporabo zdravila.
The risk of developing canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis for 4 weeks is thereby
Tveganje za pojavnost babezioze, monocitne erlihioze, granulocitne anaplazmoze in limske borelioze pri psih je zato posredno zmanjšano za obdobje 4 tednov.
In case of incorrect use, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nepravilne uporabe se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Any unused veterinary medicinal product or waste material derived from it should be disposed of in accordance with local requirements and should not enter water courses as this may be dangerous for fish
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
Fipronil sulfone decreased to concentrations of < 0.6 μg/g by 58 days after topical application.
Glavni metaboliti se porazdelijo po dlaki celotnega telesa psa. Količina fipronil sulfona se je zmanjšala na koncentracije < 0,6 μg/g po 58 dneh po nanosu.
The recommended minimum dose is 6.7 mg/kg bodyweight (b.w.)
Priporočeni najmanjši odmerek je 6,7 mg/kg telesne teže za fipronil, 6 mg/kg za (S)-metopren in
Date of latest renewal:
Datum podaljšanja dovoljenja za promet:
Stored pipettes must be kept in the intact foil
Merilne kapalke hranite v nepoškodovani originalni
For spot-on application only.
Samo za kožni nanos.
METHOD AND ROUTE OF ADMINISTRATION Spot-on use.
NAČIN IN POT UPORABE Kožni nanos.
Specific tick detachment properties described as an expellant action causing ticks to withdraw their mouthparts rapidly and fall off the host animal have been reported for amitraz.
Opisano je tudi delovanje amitraza na sposobnost pritrjevanja klopov; amitraz povzroči hiter umik ustnega aparata klopa iz kože in posledično odpadanje z gostitelja.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI
In case of incorrect use, seek medical advice immediately and show the package leaflet or the label to
V primeru nepravilne uporabe zdravila, se takoj posvetujte z zdravnikom in mu pokažite navodilo za
If side effects are noted, seek immediate medical assistance and show the package leaflet or label to the physician.
Če se pojavijo neželeni učinki, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Each unit dose (dual cavity pipette) delivers:
Enkratni odmerek (merilna kapalka z dvema razdelkoma) vsebuje: CERTIFECT kožni nanos, raztopina
All stages of fleas can infest the dog's basket, bedding and regular resting areas such as carpets and soft furnishings.
Običajno se bolhe in razvojne oblike bolh z živali zanesejo tudi v košaro, odeje, ležišča ter druga mesta, kjer živali pogosto ležijo, kot so preproge in oblazinjeno pohištvo, na katerih je v primerih večje infestacije in v začetku preventivnih ukrepov priporočljivo uporabiti ustrezen insekticid in jih redno sesati.
These people may not appear to be depressed.
Ti ljudje morda niso videti depresivni.
• Unusual behaviour.
• Nenavadno vedenje.
These are the rules:
Ta pravila so:
Your doctor can give you more information.
Zdravnik vam lahko da več informacij.
• Existing depression getting worse
• Poslabšanje obstoječe depresije.
Discuss with your doctor which methods would be suitable for you.
Pogovorite se z zdravnikom, katere metode bi bile najbolj primerne za vas.
The prescriber must ensure that:
Lečeči zdravnik mora zagotoviti, da:
That may not be enough to stop the effects: you may need more help, and your doctor can arrange this.
To morda ne bo dovolj, da bi ustavilo učinke: morda boste potrebovali več pomoči, in za to lahko poskrbi zdravnik.
However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Vendar pa lahko posamezni dejavniki (npr. poškodovana kožna pregrada, prekomerna uporaba) prispevajo k povečani sistemski izpostavljenosti.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Informacije o zdravilu so lahko pozneje posodobljene s strani nacionalnih pristojnih organov zadevnih držav članic v sodelovanju z referenčno državo članico, kot je ustrezno v skladu s postopki opisanimi v Poglavju 4 naslova III Direktive 2001/83 / ES.
‘QR code to be included' + <URL>
‘vključiti QR kodo' + <URL>
The medicine is likely to pass into your milk and may harm your baby.
Zdravilo lahko prehaja v materino mleko in lahko škoduje vašemu otroku.
• [approved indications] (see section 4.1 „Therapeutic indications“).
• [odobrene indikacije] (glejte poglavje 4.1 „Terapevtske indikacije “).
The dates and results of pregnancy tests should be documented.
Datumi in rezultati nosečnostnih testov morajo biti zabeleženi.
Pregnancy prevention programme
Program za preprečevanje nosečnosti
Your doctor will discuss all these points with you, using a checklist and will ask you (or a parent/guardian) to sign it.
Zdravnik se bo z vami pogovoril o vsem tem in pri tem uporabil kontrolni obrazec ter vas (ali vašega skrbnika) prosil, da ga podpišete.
The same information is also available on the following URL: [URL to be included] <and the <NCA> website >>.
Iste informacije so na voljo tudi na URL naslovu: [vključite URL] <in na spletni strani <nacionalnega pristojnega organa> >>.
Advice for men
Nasveti za moške
• Becoming violent or aggressive
• Nasilno ali agresivno vedenje.
Contact your doctor straight away if you get signs of any of these mental problems.
Takoj obvestite zdravnika, če imate znake katere od duševnih motenj.
These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
Zgoraj omenjeni pogoji veljajo tudi za ženske, ki trenutno niso spolno aktivne, razen če zdravnik presodi, da obstaja prepričljiv razlog, da ni tveganja za nosečnost.
<Detailed and updated information on this product is available by scanning the QR code included in the PL with a smartphone.
<Podrobne in posodobljene informacije o tem zdravilu so na voljo v navodilu za uporabo, dostopnim pod QR kodo, ki jo preberete s pametnim telefonom.
End of treatment
Zaključek zdravljenja
• Signs of psychosis: a loss of contact with reality, such as hearing voices or seeing things that are not there.
• Znaki psihoze: izguba stika z resničnostjo, kot so prisluhi in prividi.
Prescribing and dispensing restrictions
Omejitve pri predpisovanju in izdajanju zdravila
A contraindication should be added as follows: Section 2
Dodati je potrebno naslednje kontraindikacije: Poglavje 2
If pregnancy occurs after stopping treatment there remains a risk of severe and serious malformation of the fetus.
Če pride do zanositve po prenehanju zdravljenja, obstaja tveganje za hude in resne malformacije ploda.
• She understands the teratogenic risk.
• Bolnica razume tveganje zaradi teratogenosti.
However, discontinuation of <INN> may be insufficient to alleviate symptoms and therefore further psychiatric or psychological evaluation may be necessary.
Vendar pa je prekinitev zdravljenja z <mednarodno nelastniško ime> lahko premalo za zmanjšanje teh simptomov in je zato potrebna nadaljnja ocena psihiatra ali psihologa.
The following sentence should be included at the end of the package leaflet (last sentence):
Naslednji stavek je treba dodati na koncu navodila za uporabo (zadnji stavek):
This monthly follow-up will allow ensuring that regular pregnancy testing and monitoring is performed and that the patient is not pregnant before receiving the next cycle of medication.
Ti mesečni kontrolni obiski bodo zagotovili izvajanje rednih testov nosečnosti ter spremljanje in da bolnica ne bo noseča, preden bo prejela naslednji cikel zdravila.
• If there is any chance you could become pregnant, you must follow the precautions under ”Pregnancy and prevention programme”, see section on ”Warnings and precautions”.
• Če obstaja možnost, da zanosite, morate slediti previdnostnim ukrepom v poglavju” Nosečnost in program za preprečevanje nosečnosti”, glejte odstavek” Opozorila in previdnostni ukrepi”.
Male patients should be reminded that they must not share their medication with anyone, particularly not females.
Bolnike je treba opozoriti, naj zdravila ne dajejo drugim, še posebno ne ženskam.
Your doctor may send you to a specialist for advice.
Zdravnik vas bo mogoče napotil k specialistu po nasvet.
According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25mUI/mL are recommended to be performed, as follows.
Glede na lokalna priporočila se priporoča, da se izvaja zdravniško nadzorovane teste nosečnosti z minimalno občutljivostjo 25 mi.e./ml, kot sledi.
This form confirms that you have been told about the risks and that you will follow the rules above.
Ta obrazec potrjuje, da ste bili seznanjeni s tveganjem in da sprejmete potrebne previdnostne ukrepe.
This may happen even if <TRADENAME> is taken only for a short time during pregnancy.
To se lahko zgodi tudi, če zdravilo <ZAŠČITENO IME> jemljete le kratek čas med nosečnostjo.
You must use contraception even if you do not have periods or you are not sexually active (unless your doctor decides this is not necessary).
• Kontracepcijo morate uporabljati tudi, če nimate menstruacije ali trenutno niste spolno aktivni (razen če zdravnik meni, da to ni potrebno).
Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment.
Bolniki morajo biti podučeni, da tega zdravila nikoli ne smejo dajati drugim in da morajo po končanem zdravljenju neporabljene kapsule vrniti farmacevtu.
Before you start treatment, your doctor will ask you to take a pregnancy test.
• Preden začnete z zdravljenjem, vas bo zdravnik prosil, da opravite test nosečnosti.
• The patient has acknowledged the aforementioned conditions.
• Bolnica mora potrditi, da je seznanjena s prej omenjenimi pogoji.
This medicine can seriously harm an unborn baby (the medicine is said to be ‘teratogenic') - it can cause serious abnormalities of the unborn baby's brain, face, ear, eye, heart and certain glands (thymus gland and parathyroid gland).
To zdravilo lahko resno škoduje nerojenemu otroku (v medicinskem izrazoslovju pravimo, da je teratogeno) - povzroči lahko hude nepravilnosti na možganih, obrazu, ušesih, očeh, srcu in nekaterih žlezah (priželjcu in obščitnici) nerojenega otroka.
However, you must never share your medication with anyone.
Svojega zdravila pa vseeno ne smete deliti z nikomer.
If the prescribing physician is not in a position to provide such information the patient should be referred to the relevant healthcare professional
Če zdravnik, ki predpiše zdravilo, ne more dati teh informacij, mora bolnico napotiti k ustreznemu zdravstvenemu delavcu.
When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption.
Če retinoide za lokalno uporabo uporabljamo v skladu z informacijami za njihovo predpisovanje, se zanje v splošnem smatra, da zaradi minimalne absorbcije skozi kožo povzročajo nizko sistemsko izpostavljenost.
− If you are planning a pregnancy
− Če ste noseči − Če načrtujete nosečnost
• She understands the need for rigorous follow-up on a monthly basis.
• Bolnica razume, da je potreben strog mesečni nadzor.
Women who could get pregnant are prescribed <TRADENAME> under strict rules.
Ženskam, ki lahko zanosijo, se zdravilo <ZAŠČITENO IME> lahko predpiše le pod strogimi pravili.
Particular care should be taken in patients with a history of depression.
Posebna previdnost je potrebna pri bolnikih z depresijo v anamnezi.
The need for repeated medically supervised pregnancy tests every month should be determined according to local practice including consideration of the patient's sexual activity, recent menstrual history (abnormal menses, missed periods or amenorrhea) and method of contraception.
Potrebo po ponavljajočih vsakomesečnih zdravniško nadzorovanih testih nosečnosti je treba določiti glede na lokalne smernice, z upoštevanjem bolničine spolne aktivnosti, anamneze menstruacij (nenormalna menstruacija, izostale menstruacije ali amenoreja) in metode kontracepcije.
Pregnancy, breastfeeding and fertility:
Nosečnost, dojenje in plodnost:
• She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy or if she might be pregnant.
• Bolnica je obveščena in razume možne posledice nosečnosti in potrebo po takojšnjem posvetu z zdravnikom, če obstaja tveganje zanositve ali če zanosi.
• The potential for pregnancy must be assessed for all female patients.
• Možnost zanositve je treba oceniti pri vseh bolnicah.
Talk to your doctor before taking <TRADENAME>: - If you have ever had any mental health problems including depression, aggressive tendencies or mood changes.
Pred začetkom jemanja zdravila <ZAŠČITENO IME> se posvetujte z zdravnikom: - če ste kadar koli imeli težave z duševnim zdravjem, vključno z depresijo, težnjami k agresivnemu vedenju ali spremembami razpoloženja.
You must agree to have regular pregnancy tests, ideally every month during treatment and, because some medicine may still be left in your body, 1 month after stopping <TRADENAME> (unless your doctor decides this is not necessary in your case).
• Strinjati se morate, da boste opravljali redne teste nosečnosti, najbolje vsak mesec med zdravljenjem in ker je lahko nekaj zdravila še vedno prisotnega v telesu, 1 mesec po končanem zdravljenju z zdravilom <ZAŠČITENO IME> (razen, če zdravnik odloči, da v vašem primeru to ni potrebno).
You must agree to extra pregnancy tests if your doctor asks you.
• Strinjati se morate z dodatnim testom nosečnosti, če vam tako naroči zdravnik.
This is because of the risk of serious harm to the unborn baby
To je zaradi tveganja za hude prirojene okvare (poškodbe nerojenega otroka).
Neuropsychiatric disorders
Nevropsihiatrične motnje
You must agree to use at least one very reliable method of contraception (for example an intra uterine device or contraceptive implant) or, two effective methods that work in different ways (for example a hormonal contraceptive pill and a condom).
• Strinjati se morate, da boste uporabljali vsaj eno zelo zanesljivo metodo kontracepcije (na primer maternični vložek ali kontracepcijski vsadek) ali dve učinkoviti metodi, ki delujeta na različen način (na primer hormonska kontracepcijska tableta in kondom).
• Some people have had thoughts or feelings about hurting themselves or ending their own lives (suicidal thoughts), have tried to end their own lives (attempted suicide), or have ended their lives (suicide).
• Nekateri bolniki so razmišljali o samopoškodovanju in samomoru (samomorilne misli), nekateri so poskušali narediti samomor (poskus samomora), nekateri pa so storili samomor.
Do not use <TRADENAME>:
Ne uporabljajte zdravila <ZAŠČITENO IME>:
They may notice these changes and help you quickly identify any problems that you need to talk to your doctor about.
Oni lahko te spremembe opazijo in vam pomagajo hitro odkriti morebitne težave, o katerih bi se morali pogovoriti z zdravnikom.
At least one month after the patient has started using contraception, and shortly (preferably a few days) prior to the first prescription, the patient should undergo a medically supervised pregnancy test.
Najmanj en mesec po tem, ko je bolnica pričela uporabljati kontracepcijo in tik preden (priporočljivo nekaj dni) ji je prvič predpisano zdravilo, mora bolnica opraviti zdravniško nadzorovan test nosečnosti.
1 month after stopping treatment, women should undergo a final pregnancy test.
1 mesec po zaključku zdravljenja mora ženska opraviti zadnji test nosečnosti.
This test should ensure the patient is not pregnant when she starts treatment with [INN].
Ta test mora zagotoviti, da bolnica ni noseča, ko prične z zdravljenjem z [mednarodno nelastniško ime].
Please take any unused <capsules> to your pharmacist at the end of treatment.
Neporabljene <kapsule> po zaključenem zdravljenju vrnite farmacevtu.
Follow-up visits should be arranged at regular intervals, ideally monthly.
Kontrolni obiski morajo biti vnaprej dogovorjeni v rednih presledkih, priporočljivo mesečno.
<TRADENAME> is contraindicated (see section 4.3) in pregnancy, or in women planning a pregnancy.
Zdravilo <ZAŠČITENO IME> je kontraindicirano (glejte poglavje 4.3) med nosečnostjo ali pri ženskah, ki načrtujejo nosečnost.
The following adverse reaction(s) should be included under the SOC Psychiatric disorders: Rare (may affect up to 1 in 1,000 people):
Nasledje neželene učinke je potrebno dodati pod organski sistem Psihiatrične motnje: Redki (pojavijo se lahko pri največ 1 od 1000 bolnikov):
This includes depression, aggressive tendencies or mood changes.
To vključuje depresijo, nasilno vedenje ali spremembe razpoloženja.
Your doctor must explain the risk of harm to the unborn baby - you must understand why you must not get pregnant and what you need to do to prevent getting pregnant.
• Zdravnik vas mora seznaniti s tveganjem za prirojene okvare - razumeti morate, zakaj ne smete zanositi, in vedeti, kako nosečnost preprečiti.
In order to assist prescribers, pharmacists and patients in avoiding fetal exposure to [INN] the Marketing Authorisation Holder will provide educational material to reinforce the warnings about the teratogenicity of [INN], to provide advice on contraception before therapy is started and to provide guidance on the need for pregnancy testing.
Da bi preprečili izpostavljenost ploda [mednarodno nezaščiteno ime], bo imetnik dovoljenj za promet z zdravilom, v pomoč zdravnikom, farmacevtom in bolnikom, priskrbel izobraževalno gradivo, v katerem so poudarjena opozorila o teratogenosti [mednarodno nelastniško ime], nasveti o kontracepciji pred začetkom zdravljenja in smernice o izvajanju testa nosečnosti.
It also includes thoughts about hurting yourself or ending your life.
Lahko vključuje tudi razmišljanje o samopoškodovanju ali samomoru.
These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Te spremembe relevantnih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo so izid napotitvenega postopka.
If pregnancy occurs in a woman treated with [INN], treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Če pride do zanositve pri bolnici, ki je zdravljena z [mednarodno nelastniško ime], je zdravljenje potrebno prekiniti in bolnico napotiti na pregled in posvet k zdravniku specialistu ali zdravniku z izkušnjami s področja teratologije.
The warning on psychiatric disorders should be revised as follows:
Opozorilo glede psihiatričnih motenj je treba posodobiti kot sledi:
Where indicated, follow-up pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Kjer je indiciran, je treba test nosečnosti izvesti na dan obiska, pri katerem se predpiše zdravilo, ali v roku 3 dni pred obiskom.
As these products will now be subject to additional monitoring the black symbol and relevant statement should be included preceding section 1.
Za ta zdravila se bo sedaj izvajalo dodatno spremljanje varnosti, zato je treba pred poglavje 1 dodati črni simbol in spremljajoče besedilo.
The warning regarding teratogenic effects and information on the pregnancy prevention programme should be aligned with the following text; furthermore a boxed warning as presented below should be added:
Opozorila glede teratogenih učinkov in informacije o programu za preprečevanje nosečnosti morajo biti usklajene s spodnjim besedilom; dodati je treba tudi opozorilo v okvirju kot je prikazano spodaj: Opozorilo v okvirju
• The patient understands that she must consistently and correctly use one highly effective method of contraception (i.e. a user-independent form) or two complementary user-dependent forms of contraception, for at least 1 month prior to starting treatment and is continuing to use effective contraception throughout the treatment period and for at least 1 month [3 years for acitretin] after cessation of treatment.
• Bolnica razume, da mora redno in pravilno uporabljati eno visoko učinkovito metodo kontracepcije (obliko neodvisno od uporabnice) ali dve dopolnjujoči metodi kontracepcije, ki sta odvisni od uporabnice, najmanj 1 mesec pred začetkom zdravljenja, uporablja učinkovito zaščito med celotnim zdravljenjem in še najmanj 1 mesec [3 leta za acitretin] po zaključku zdravljenja.
• She has acknowledged that she has understood the hazards and necessary precautions associated with the use of [INN].
• Bolnica potrdi, da je razumela tveganje in potrebno previdnost pri uporabi [mednarodno nezaščiteno ime].