natgillin/translations-raw huggingface dataset:
On 8 January 2016, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs, due to concerns related to the withdrawal periods set for the aforementioned products.
Belgija je 8. januarja 2016 sprožila postopek v skladu s členom 35 Direktive 2001/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje za dajanje govedu in prašičem, in sicer zaradi pomislekov glede karenc, določenih za zgoraj navedene
Belgium noted that there are different approved withdrawal periods for cattle and pigs for veterinary medicinal products containing gentamicin presented as solutions for injection across the European Union, e.g. cattle meat and offal from 28 days to 210 days; cattle milk from 2 to 7 days, with some of the products stating ‘do not use in cows whose milk is intended for human consumption'; and pig meat and offal from 28 days to 150 days.
Na primer karenca za goveje meso in organe je od 28 do 210 dni, za kravje mleko od 2 do 7 dni, pri čemer je za nekatera zdravila navedeno „ne uporabljajte pri kravah, katerih mleko je namenjeno za prehrano ljudi“, za prašičje meso in organe pa od 28 do 150 dni.
On 10 November 2016, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) for veterinary medicinal products containing gentamicin presented as solutions for injection.
Evropska agencija za zdravila (agencija) je 10. novembra 2016 zaključila pregled varnosti potrošnikov glede karenc za govedo (meso in mleko) in prašiče (meso in organi) za zdravila za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje.
Why were veterinary medicinal products containing gentamicin presented as solutions for injection reviewed?
Zakaj so bila pregledana zdravila za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje?
Questions and answers on veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs
Vprašanja in odgovori o zdravilih za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje za dajanje govedu in prašičem
The CVMP recommended that the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection should be varied in order to amend the product information accordingly.
Odbor CVMP je priporočil spremembo dovoljenj za promet z zdravili za zdravila za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje, da bo mogoče ustrezno spremeniti informacije o zdravilu.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for veterinary medicinal products containing gentamicin presented as solutions for injection is positive and recommended amendments to withdrawal periods for cattle and pigs to provide assurance for consumer safety.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je splošno razmerje med tveganji in koristmi zdravil za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje, pozitivno, ter je zaradi zagotavljanja varnosti potrošnikov priporočil spremembe karenc za govedo in prašiče.
Based on the evaluation of the currently available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing gentamicin presented as solutions for injection is positive and agreed that the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) should be amended to provide assurance for consumer safety and also agreed that the subcutaneous route should no longer be recommended for cattle and pigs since the depletion kinetics from the injection site remain unknown.
Odbor CVMP je na podlagi vrednotenja trenutno razpoložljivih podatkov zaključil, da je splošno razmerje med tveganji in koristmi zdravil za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje, pozitivno, ter soglašal, da je treba karence za govedo (meso in mleko) in prašiče (meso in organe) zaradi zagotavljanja varnosti potrošnikov spremeniti.
75009 Paris
75009 Pariz Francija
Macrogol 6000
− makrogol 6000
ATC code: G 03 AA 07
Oznaka ATC: G 03 AA 07
Changes usually remain within the normal laboratory reference range.
Spremembe navadno ostanejo v mejah normalnih laboratorijskih referenčnih vrednosti.
− allergic reactions.
− - alergijske reakcije
Rarely:
Redko:
Assessment and examination prior to starting combined oral contraceptives
Preiskave in pregledi pred začetkom jemanja kombiniranih peroralnih kontracepcijskih sredstev
SCIENTIFIC CONCLUSIONS OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RIGEVIDON (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA RIGEVIDON (glej Dodatek I)
The area under curve and Cmax may over time be expected to increase slightly.
Pričakujemo lahko, da se področje pod krivuljo in vrednost Cmax sčasoma nekoliko povečata.
This risk increases with age and with the extent of smoking and is particularly marked in women over 35 years of age.
Ta nevarnost se povečuje s starostjo in količino pokajenih cigaret ter je posebno značilna za ženske, starejše od 35 let.
Based on the finding that:
Izsledki, na katerih temeljijo ugotovitve:
There is no antidote, and further treatment should be symptomatic.
Antidot ne obstaja, nadaljnje zdravljenje pa je simptomatsko.
− worsening of epilepsy
− poslabšanje epilepsije
It is important to emphasise that the tablet-free interval should not be extended.
Pomembno je poudariti, da obdobja brez tablet ne sme podaljševati.
− ocular irritation when wearing contact lenses.
− - draženje oči pri nošenju kontaktnih leč
These studies do not present evidence for a causal relationship.
Te študije ne dokazujejo vzročne povezave.
In this case, it is not necessary to take further contraceptive precautions.
V tem primeru ni potrebna nobena dodatna kontracepcija.
For long-term users of these medicinal products, use of other contraceptives should be advised.
Dolgotrajnim uporabnicam teh zdravil je treba priporočiti uporabo drugih kontracepcijskih sredstev.
Effect at cessation of treatment:
Učinki ob prekinitvi zdravljenja:
copovidone K90
− kopovidon K90
Pack sizes: 1×21 and 3×21 coated tablets
Velikosti pakiranj: 1 x 21 in 3 x 21 obloženih tablet
Reduced cycle control
Zmanjšan nadzor menstrualnega cikla
If there is risk of STI/HIV the correct and consistent use of condoms is recommended, either alone or with another contraceptive method.
Če obstaja nevarnost SPO/aidsa, se priporoča pravilna in dosledna uporaba kondoma, samega ali v kombinaciji z drugimi kontracepcijskimi sredstvi.
Ethinylestradiol is to 98.8% bound to plasma proteins, almost entirely to albumin.
Etinilestradiol se do 98,8 % veže na plazemske beljakovine, skoraj v celoti na albumin.
One tablet is taken daily for 21 consecutive days.
Ženska jemlje eno tableto dnevno, 21 dni zaporedoma.
- Smoking (women over 35 should be warned not to smoke if they wish to use combined oral contraceptives).
− -kajenjem (ženske starejše od 35 let je treba opozoriti, da prenehajo kaditi, če hočejo uporabljati kombinirana peroralna kontracepcijska sredstva)
How to delay or shift a period:
Kako preprečiti ali prestaviti menstruacijo?
Following presystemic conjugation and first-pass metabolism, the absolute bioavailability is 60%.
Po predsistemski konjugaciji in prvem prehodu skozi jetra je absolutna biološka razpoložljivost 60 %.
Used COCs for 5 years
KPKS Uporabljale KPKS 5 let
The reduced contraceptive protection may, however, be prevented by adjusting the tablet intake.
Zmanjšano kontracepcijsko zaščito lahko preprečimo s prilagoditvijo jemanja tablet.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
PRILOGA I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV UPORABE ZDRAVILA, VLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
The woman may start the tablet intake immediately.
Ženska lahko začne jemati tablete takoj.
Ethinylestradiol Absorption:
Etinilestradiol Absorpcija:
After delivery or abortion in 2nd trimester
Po porodu ali splavu v drugem trimesečju
Levonorgestrel and its metabolites are primarily excreted in the urine (40%-68%) and approximately 16%-48% is excreted in the faeces.
Levonorgestrel in njegovi presnovki se večinoma izločajo z urinom (40-68 %) in približno 16-48 % z blatom.
No serious, harmful effects after overdose have been reported.
O resnih, škodljivih učinkih niso poročali.
Before the start or resumption of treatment with oral contraceptives a complete personal and family medical history must be obtained and a physical examination performed, in accordance with the contraindications (see section 4.3) and warnings (see “Warnings” in this section).
Pred začetkom uporabo peroralnih kontracepcijskih sredstev je treba pregledati celotno osebno in družinsko anamnezo ter opraviti zdravstveni pregled v skladu s kontraindikacijami (glejte 4.3) in opozorili (glejte »Opozorila« v tem poglavju).
In this case, a withdrawal bleed should not be expected until the end of the second pack.
V tem primeru odtegnitvene krvavitve ne pričakujemo do konca druge škatle.
If the delay exceeds 12 hours, the contraceptive protection may be reduced.
Če je zamuda daljša od 12 ur, se kontracepcijska zaščita zmanjša.
Levonorgestrel is to a large extent bound to albumin and SHBG (Sex Hormon Binding Globulin) in plasma.
Levonorgestrel je v veliki meri vezan na albumin in globulin, ko veže spolne hormone (SHBG - Sex Hormon Binding Globulin) v plazmi.
Number of breast cancers
Število primerov raka dojk
− serious mastodynia, benign mastopaty
− resna mastodinija, benigna mastopatija
In experimental animals estrogens displayed an embryolethal effect already at relatively low doses;
Pri preizkusnih živalih so imeli estrogeni embrioletalni učinek že pri razmeroma majhnih odmerkih.
− depressions;
− - depresije
Never took COCs
Nikoli niso uporabljale
Diarrhoea may reduce the efficacy by preventing full absorption.
Driska lahko zmanjša učinkovitost tablete, ker preprečuje popolno absorpcijo.
Metabolism:
Metabolizem:
Elimination: Ethinylestradiol disappears from plasma with a T½ of approximately 29 hours (26-33 hours), plasma clearance varies from 10-30 l/hour.
Eliminacija: Etinilestradiol izgine iz plazme s T1/2 približno 29 ur (26-33 ur), plazemski očistek pa je od 10 do 30
Rigevidon may increase the bioavailability of imipramin leading to an increased risk of toxicity.
Rigevidon lahko poveča biološko razpoložljivost imipramina, kar vodi v povečano tveganje toksičnosti.
The increased risk of thromboembolism during the puerperal period should be taken into consideration (for further information - see section 4.6).
Treba je upoštevati tudi povečano tveganje za nastanek tromboembolije v poporodnem obdobju (za dodatne informacije glejte 4.6.)
Ethinylestradiol is rapidly and completely absorbed, and peak plasma levels are reached after 1.5 hours.
Etinilestradiol se absorbira hitro in popolno, največjo koncentracijo v plazmi pa doseže v 1,5 ure.
Levonorgestrel displayed a virilising effect in female fetuses.
Levonorgestrel je imel pri ženskih zarodkih virilizirajoče učinke.
- Atrial fibrillation.
− -atrijsko fibrilacijo
Rigevidon has been on the market in some member states without any signal of insufficient efficacy or safety,
V nekaterih državah članicah je Rigevidon že na voljo, pri čemer pa ni nobenega znaka, da bi bil ta neučinkovit ali nezanesljiv.
Aluminium-PVC/PVDC blister
Pretisni omot iz aluminija-PVC/PVDC
One tablet contains 150 micrograms levonogestrel and 30micrograms ethinylestradiol.
Ena tableta vsebuje 150 mikrogramov levonogestrela in 30 mikrogramov etinilestradiola.
In this case the advice concerning missed tablets, described above should be followed.
V tem primeru je treba upoštevati zgoraj navedene nasvete glede pozabljenih tablet.
Metabolism is mainly by reduction of the Δ4-3-oxo group and hydroxylation at the positions 2α, 1β and 16β, followed by conjugation.
Presnavlja se večinoma z redukcijo skupine Δ4-3-oxo in hidroksilacijo na pozicijah 2α, 1β in 16β, ki jima sledi konjugacija.
The frequency and nature of these assessments should be adapted to the individual woman, but should, in general, include special reference to blood pressure, breasts, abdomen and abdominal organs, including cervical cytology and relevant laboratory tests.
Pogostnost in naravo teh preiskav je treba prilagoditi vsaki ženski posebej, vendar morajo na splošno vsebovati posebno skrb za krvni pritisk, prsi, trebuh in notranje organe, vključno s cervikalno citologijo in ustreznimi laboratorijskimi preiskavami.
sucrose talc calcium carbonate titanium dioxide (E171)
− titanov dioksid (E171)
Contraceptive failure has also been reported with antibiotics such as ampicillin and tetracyclines, although the mechanism of action is unclear.
O neučinkovitosti kontracepcije so poročali tudi pri uporabi antibiotikov, kot sta ampicilin in tetraciklin, čeprav mehanizem delovanja ni znan.
Breakthrough bleeding and unintended pregnancies have been reported.
Poročali so o vmesnih krvavitvah in neželenih nosečnostih.
The risk for development of thromboembolism (venous and/or arterial) increases with:
Tveganje pojava tromboembolije (venske in/ali arterijske )se povečuje s:
Rigevidon contains lactose and sucrose.
Rigevidon vsebuje laktozo in saharozo.
Since breast cancer is a rare condition in women below 40 years of age, the increase in number of diagnosed cases of breast cancer in current and previous users of oral contraceptives is small compared to the risk of breast cancer during their entire life time.
Ker je pojav raka dojk pri ženskah, mlajših od 40 let redek, je povečanje v številu diagnosticiranih primerov med trenutnimi in nekdanjimi uporabnicami peroralnih kontracepcijskih sredstev majhno v primerjavi s tveganjem za pojav raka v njihovem celotnem življenju.
More frequent but smaller events that usually do not demand interruption of treatment, but in which a change to another combined oral contraceptive may be considered:
Pogostejši, a manjši zapleti, ki navadno ne zahtevajo prekinitve zdravljenja, priporoča pa se zamenjava kombiniranega peroralnega kontracepcijskega sredstva:
After abortion in 1st trimester
Po splavu v prvem trimesečju
Rigevidon has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Rigevidon nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
This has been demonstrated with hydantoins (e.g. phenytoin, barbiturates, primidone, carbamazepine and rifampicin.
To se je pokazalo pri hidantoinih (npr. fenitoin, barbiturati, primidon, karbazepin in rifampicin).
The tablets must be taken in the order given on the blister pack, every day at approximately the same time point.
Tablete je treba jemati po zaporedju, predpisanem na pretisnem omotu, vsak dan ob približno istem času.
In the case of acute or chronic impairment of liver function the use of the preparation should be stopped until liver function tests return to normal.
V primeru akutne ali kronične okvare delovanja jeter je treba prenehati z jemanjem pripravka, dokler se delovanje jeter ne normalizira.
Cancers found up to the age of:
Rak najden do starosti:
The contraceptive effect of Rigevidon is based on the interaction between various factors, the most important of which are the inhibition of ovulation and changes in the cervical mucus.
Kontracepcijski učinek Rigevidona temelji na interakciji med različnimi dejavniki, med katerimi sta najpomembnejša zaviranje ovulacije in spremembe v cervikalni sluzi.
The bioavailability is approximately 100% and levonorgestrel is not subject to first-pass metabolism.
Biološka razpoložljivost je približno 100 %, levonorgestrel pa ni podrvržen presnovi pri prvem prehodu skozi jetra.
These tumours have, in isolated cases, lead to life threatening, intra-abdominal haemorrhage.
Ti tumorji so v posameznih primerih vodili do smrtno nevarnih intraabdominalnih
No preceding hormonal contraceptive use in the past month.
Če ženska prejšnji mesec ni jemala nobenih hormonskih kontracepcijskih sredstev.
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use.
Kajenje cigaret povečuje nevarnost resnih kardiovaskularnih neželenih učinkov uporabe peroralnih kontracepcijskih sredstev.
Concomitant use of ritonavir may also induce the liver enzymes with a similar negative effect on contraceptive efficacy.
Sočasna uporaba ritonavirja prav tako inducira jetrne encime s podobnim negativnim učinkom na učinkovitost kontraceptivov.
Thus, the current prerequisite for bioequivalence, i.e. the demonstration of bioequivalence within 80 - 125%, is considered appropriate for Rigevidon.
Zato je obstoječ predpogoj glede bioekvivalence (dokazana bioekvivalenca znotraj 80 - 125 %) ustrezen tudi za Rigevidon.
Handling of missed tablets may be managed by the following two basic rules:
Pri ravnanju z izpuščenimi tabletami upoštevamo dve pravili:
The shorter the interval, the greater the risk that she will not have a withdrawal bleed and she may have break through bleeding or spotting during the second blister pack (which is also the case when delaying a period).
Čim krajši je premor, tem večja je možnost, da ne bo prišlo do odtegnitvene krvavitve in da bo ob jemanju drugega omota prišlo do vmesne krvavitve ali mazanja (kar se dogaja tudi ob prestavljanju menstruacije).
The symptoms which may occur in connection with overdose are: Nausea, vomiting, and in young girls a slight vaginal bleeding.
Simptomi, ki se lahko pojavijo pri prevelikem odmerjanju so: navzeja, bruhanje in pri mladih dekletih rahla vaginalna krvavitev.
- Hereditary predisposition (e.g. venous or arterial thromboembolism in siblings or parents at a relatively young age).
− -dedno nagnjenostjo (venski ali arterijski tromboembolizem pri bratih, sestrah ali starših v razmeroma mladih letih).
Estimated cumulative numbers of breast cancers per 10,000 women diagnosed in 5 years of use and up to 10 years after stopping COCs, compared with numbers of breast cancers diagnosed in 10,000 women who had never used COCs
Ocenjeno kumulativno število primerov raka dojk na 10.000 žensk diagnosticirano v petih letih uporabe in do deset let po prenehanju jemanja kombiniranih peroralnih kontracepcijskih sredstev (KPKS), v primerjavi s številom pojava raka dojk diagnosticiranega pri 10.000 ženskah, ki KPKS niso nikoli jemale pod krvavitev.
Tablets should never be delayed for longer than 7 days.
Prekinitev jemanja tablet ne sme biti daljša od 7 dni.
Some of the original levonorgestrel is also circulating as 17β-sulphate.
Nekateri od originalnih levonorgestrelov krožijo kot 17β-sulfati.
Advice in the case of vomiting/diarrhoea
Nasvet v primeru bruhanja/driske
If the woman has forgotten tablet intake for less than 12 hours, the contraceptive protection is not reduced.
Če ženska pozabi vzeti tableto v času manj kot 12 ur, se kontracepcijska zaščita ne zmanjša.
The more forgotten tablets, and the closer to the usual tablet-free interval this takes place, the greater the risk of pregnancy.
Večje, kot je število izpuščenih tablet in bližje kot je to intervalu v katerem tablet ne jemlje, večja je možnost zanositve.
Oral contraceptives may have an influence on the peripheral insulin resistance and glucose tolerance.
Peroralna kontracepcijska sredstva lahko vplivajo na periferno inzulinsko rezistenco in toleranco za glukozo.
Steroid hormones may be poorly metabolised in patients with impaired liver function.
Steroidni hormoni se pri bolnikih z okvarjeno jetrno funkcijo slabo presnavljajo.
This should be repeated at least once a year during oral contraceptive use.
Med uporabo peroralnega kontracepcijskega sredstva je to treba ponoviti vsaj enkrat letno.
The woman should be advised to start on day 21-28 after delivery or abortion in the 2nd trimester, because there is an increased risk of thromboembolic disorders during the post partum period.
Priporočamo, da ženska začne jemati tablete med 21. in 28. dnem po porodu ali splavu v drugem trimesečju, ker obstaja nevarnost tromboemboličnih motenj v poporodnem obdobju.
Combined contraceptives must not be used in the presence of the conditions mentioned below.
Uporaba kombiniranih kontracepcijskih tablet ni dovoljena pri spodaj navedenih boleznih.
Acute toxicity of ethinylestradiol and levonorgestrel is low.
Akutna toksičnost etinilestradiola in levonorgestrela je majhna.
A meta-analysis from 54 epidemiological studies has shown that women using combined oral contraceptives have a slightly increased relative risk (RR=1.24) of having breast cancer diagnosed.
Metaanaliza iz 54 študij je pokazala, da je pri ženskah, ki uporabljajo kombinirana peroralna kontracepcijska sredstva, tveganje za diagnozo raka dojk nekoliko večje (RR = 1,24).
Periodic medical assessments are also important since contraindications (e.g. transient cerebral ischaemia) or risk factors (e.g. hereditary venous or arterial thrombotic disorders) may occur for the first time during oral contraceptive use.
Pomembni so tudi občasni zdravstveni pregledi, ker se kontraindikacije (npr. prehodna cerebralna ishemija) ali dejavniki tveganja (npr.dedne motnje venske ali arterijske tromboze) lahko prvič pojavijo med uporabo peroralnih kontracepcijskih tablet.
Rigevidon may increase the plasma concentration of cyclosporin and diazepam (and other benzodiazepines that are hydroxylated), possibly via inhibiting hepatic elimination.
Rigevidon lahko poveča koncentracijo ciklosporinov in diazepama (in drugih hidroksiliranih benzodiazepinov) v plazmi, verjetno prek zaviranja jetrnega izločanja.
If nonhormonal causes are excluded, oral contraceptives with a higher hormonal content may need to be considered.
Če so izključeni nehormonski vzroki, je treba pretehtati možnost uporabe peroralnih kontracepcijskih tablet z večjo vsebnostjo hormonov.
malformations of the urogenital tract and feminisation of male fetuses were observed.
Opazili so deformacije urogenitalnega trakta in feminizacijo moških zarodkov.
In this case, she should keep a tablet-free interval of up to 7 days, including the days she forgot to take her tablets, and thereafter continue with the next blister pack.
V tem primeru naj premor pri jemanju tablet traja sedem dni, vključno z dnevi, ko je pozabila vzeti tablete, potem pa naj nadaljuje z naslednjim omotom.
The observed pattern of an increased risk may be caused by an earlier diagnosing of breast cancer in users of oral contraceptives, the biological effects of oral contraceptives or a combination of both.
Opazovani vzorec povečanega tveganja je lahko povezan z zgodnejšo diagnostiko raka dojk pri uporabnicah peroralnih kontracepcijskih sredstev, njihovimi biološkimi učinki ali kombinacijo obojega.
Reproduction toxicology studies in rats, mice and rabbits revealed no hint for teratogenicity beyond the effect on sexual differentiation.
Študije reprodukcijske toksičnosti na podganah, miših in kuncih niso pokazale znakov teratogenosti, razen vpliva na diferenciacijo spola.
The tablets should be started on day 1 in the woman's normal cycle (i.e. on the first day the woman has a menstrual bleed).
Tablete naj začne jemati prvi dan normalnega menstrualnega cikla (tj. prvi dan menstruacije).
How is Rigevidon taken ?
Kako jemati Rigevidon?
2-OH-Ethinylestradiol is further metabolised to chemically reactive metabolites.
2-OH-etinilestradiol se nadalje presnavlja v kemično reaktivne presnovke.
If vomiting occurs within 3-4 hours after tablet taking, absorption may not be complete.
Če v 3 do 4 urah po jemanju tablete pride do bruhanja, se tableta morda ni povsem absorbirala.