natgillin/translations-raw huggingface dataset:
• Healthcare professionals will be sent a letter with further details.
• Zdravstveni delavci so prejeli dopis z dodatnimi podrobnostmi.
Further information on the PRAC recommendation and the background to this review can be found on Agency's website.
Dodatne informacije o priporočilu odbora PRAC ter ozadju te presoje so na voljo na spletni strani agencije.
A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Presojo teh podatkov je najprej izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC).
• If you have any questions you should speak to your doctor or pharmacist.
• Če imate dodatna vprašanja, se pogovorite s svojim zdravnikom ali farmacevtom.
Diane 35 was first authorised in 1985.
Zdravilo Diane 35 je bilo prvič odobreno leta 1985.
However, to minimise this risk, further measures should be implemented in addition to the updated product information.
Vendar je treba za zmanjšanje tega tveganja poleg posodobljenih informacij o zdravilu uvesti še dodatne ukrepe.
Healthcare professionals should follow these recommendations:
Informacije za zdravstvene delavce Zdravstveni delavci naj upoštevajo naslednja priporočila:
The CMDh is a medicines regulatory body representing the EU Member States.
CMDh je regulatorni organ za zdravila, ki zastopa države članice EU.
The risk of thromboembolism occurring with these medicines is low and well known.
Tveganje za tromboembolijo, ki se pojavlja pri teh zdravilih, je nizko in dobro znano.
The French decision followed a national review of the medicine by ANSM.
Francoska odločitev je sledila nacionalni presoji zdravila s strani ANSM.
These recommendations have been endorsed by the CMDh, a body representing EU Member States.
Ta priporočila je sprejel CMDh, organ, ki zastopa države članice EU.
The review of Diane 35 and its generics was initiated in February 2013 at the request of France, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Presoja zdravila Diane 35 in njegovih generičnih zdravil se je začela februarja 2013 na zahtevo Francije, v skladu s členom 107i Direktive 2001/83/ES, znanim tudi kot nujni postopek Unije.
• You should not stop taking these medicines before speaking to your doctor.
• Z jemanjem teh zdravil ne prenehajte, dokler se ne pogovorite s svojim zdravnikom.
• You should always read the package leaflet and be aware that there is a low risk of blood clots with these medicines.
• Vedno preberite navodila za uporabo in upoštevajte, da obstaja pri teh zdravilih nizko tveganje za nastanek krvnih strdkov.
These medicines work by blocking the effects of a class of hormones called androgens.
Ta zdravila delujejo tako, da zavirajo učinek skupine hormonov, imenovanih androgeni.
The PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Priporočila odbora PRAC so bila posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
Its main responsibility is to resolve disagreements between Member States involved in mutual recognition or decentralised procedures, to ensure that patients have the same level of protection, no matter where they are in the EU.
Njegova glavna naloga je reševanje nesoglasij med državami članicami, vključenimi v postopke za medsebojno priznavanje in decentralizirani postopek, da se zagotovi enaka raven zaščite za bolnike po vsej EU.
Medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms have been approved via national procedures and are available on prescription under various trade names in all EU Member States except Cyprus.
Zdravila, ki vsebujejo ciproteron acetat 2 mg in etinilestradiol 35 mikrogramov so bila odobrena z nacionalnimi postopki in so na voljo na recept pod različnimi tržnimi imeni v vseh državah članicah EU, razen na Cipru.
• In the treatment of alopecia androgenetica and acne without androgenic features, the data on efficacy is limited.
• Za zdravljenje androgene alopecije in aken brez androgenih lastnosti so podatki o učinkovitosti omejeni.
The efficacy in moderate and severe acne with or without seborrhoea and /or hirsutism is demonstrated in more than 30 clinical trials.
Učinkovitost pri zmernih do hudih aknah s seborejo ali brez nje in/ali hirzutizmu je dokazana v več kot 30 kliničnih preskušanjih.
Despite the PRAC recommendation ANSM proceeded with the suspension of the marketing authorisation of these medicines in France.
ANSM je kljub priporočilu PRAC začasno umaknil dovoljenje za promet s temi zdravili v Franciji.
• If you are using these medicines for other conditions you should make a non-urgent appointment with your doctor to review your treatment.
• Če ta zdravila jemljete za druge namene, se dogovorite za nenujen obisk pri svojem zdravniku, ki bo izvedel presojo vašega zdravljenja.
Cyproterone also supresses ovulation and therefore has a contraceptive effect.
Ciproteron prav tako zavira ovulacijo in zato deluje kot kontracepcijsko sredstvo.
The review of Diane 35 and its generics was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following its decision to suspend Diane 35 and its generics in France within three months.
Presojo zdravila Diane 35 in njegovih generičnih zdravil je sprožila francoska nacionalna agencija za varnost zdravil in medicinskih pripomočkov (ANSM) po odločitvi, da v treh mesecih začasno umakne zdravilo Diane 35 in njegova generična zdravila v Franciji.
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority (26:1) the recommendation of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (formation of blood clots in blood vessels).
29. maja 2013 je Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) z večino glasov (26:1) sprejela priporočilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) Evropske agencije za zdravila, v katerem so zaključili, da so koristi zdravila Diane 35 (ciproteron acetat 2 mg/etinilestradiol 35 mikrogramov) in njegovih generičnih zdravil večje od z njimi povezanih tveganj, pod pogojem, da se izvaja več ukrepov za zmanjšanje tveganja za trombembolijo (oblikovanja krvnih strdkov v krvnih žilah).
These include providing educational materials to prescribers and patients highlighting the risks of thromboembolism, for example a prescriber checklist to ensure that the risks, together with the signs and symptoms, are discussed with the patient.
Mednje spadajo izobraževalna gradiva za predpisovalce in bolnice, v katerih so jasno izpostavljena tveganja za tromboembolijo, na primer kontrolni seznam za predpisovalca, ki zagotavlja, da se predpisovalec z bolnico pogovori o tveganjih ter s tem povezanih znakih in simptomih.
• You should be aware that there are factors that can increase the risk of blood clots in blood vessels, such as increasing age, smoking, obesity and prolonged immobility.
• Upoštevajte, da lahko nekateri dejavniki povečajo tveganje za nastanek krvnih strdkov v krvnih žilah, na primer višja starost, kajenje, debelost in dolgotrajna gibalna nedejavnost.
These recommendations are based on a review of all available data on the risk of thromboembolism as well as the benefits of Diane 35 and its generics:
Ta priporočila temeljijo na presoji vseh razpoložljivih podatkov v zvezi s tveganjem za tromboembolijo ter koristmi zdravila Diane 35 in njegovih generičnih zdravil:
As the CMDh position was adopted by majority vote and not by consensus, the CMDh position will now be sent to the European Commission, which will take a legally binding decision throughout the EU.
Ker je bilo stališče CMDh sprejeto z večino glasov, ne pa soglasno, je bilo stališče CMDh posredovano Evropski komisiji, ki ga je potrdila in dne 25. julija 2013 sprejela pravno zavezujočo odločbo, ki velja za celotno EU.
This review highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only.
V presoji so izpostavili pojave resne tromboembolije in obsežno uporabo teh zdravil izključno kot kontracepcijskega sredstva, kar ni v skladu z odobrenimi indikacijami.
• Doctors should discuss with their patients the risk of thromboembolism and risk factors such as increasing age, smoking, obesity and prolonged immobility.
• Zdravniki naj se s svojimi bolnicami pogovorijo o tveganju za tromboembolijo in dejavnikih tveganja, kot so višja starost, kajenje, debelost in dolgotrajna gibalna nedejavnost.
Because the CMDh took this position by majority it will now be sent to the European Commission, which will adopt a legally binding decision.
Ker je CMDh to stališče sprejel z večino, je bilo poslano Evropski komisiji, ki ga je potrdila in dne 25. julija 2013 sprejela pravno zavezujočo odločbo.
You should immediately report any relevant symptoms to your doctor, such as pain and swelling in the legs, or breathlessness and a sharp pain in the chest.
O vseh zadevnih simptomih, kot so na primer bolečine in otekanje nog, zasoplost in ostra bolečina v prsih, nemudoma obvestite svojega zdravnika.
• The review also showed that the excess risk of VTE is highest during the first year of use of Diane 35 and its generics or when restarting or switching from an oral hormonal contraceptive to Diane 35 and its generics after a pill-free interval of at least one month.
• Presoja je prav tako pokazala, da je povečano tveganje za venozno tromboembolijo višje v prvem letu uporabe zdravila Diane 35 in njegovih generičnih zdravil oz. pri ponovnem začetku jemanja ali prehodu s peroralnega hormonskega kontracepcijskega sredstva na zdravilo Diane 35 in njegova generična zdravila po najmanj enomesečnem intervalu neuporabe kontracepcijskih tabletk.
The risk of blood clots in the veins with these medicines is 1.5 to 2 times higher than for combined oral contraceptives (COCs) containing levonorgestrel and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone.
Tveganje za nastanek krvnih strdkov v venah pri teh zdravilih je 1,5- do 2-krat večje kot pri kombiniranih peroralnih kontracepcijskih sredstvih, ki vsebujejo levonorgestrel, in je lahko podobno tveganju pri kontracepcijskih sredstvih, ki vsebujejo gestoden, dezogestrel ali drospirenon.
• For the treatment of acne, these medicines should only be used after topical therapy or systemic antibiotic treatment has failed.
• Za zdravljenje aken se lahko ta zdravila uporabljajo samo, kadar je bilo lokalno zdravljenje ali zdravljenje s sistemskimi antibiotiki neuspešno.
• Doctors should review patients on Diane 35 and generics in line with these recommendations at their next scheduled appointment.
• Zdravniki naj bolnice, ki jemljejo zdravilo Diane 35 in njegova generična zdravila, ob naslednjem obisku pregledajo skladno s tem priporočili.
• The review confirmed the rare and known risk of thromboembolism with Diane 35 and its generics.
• Pri presoji so potrdili redko in znano tveganje za tromboembolijo pri zdravilu Diane 35 in njegovih generičnih zdravilih.
Data on the risk of arterial thromboembolism (ATE) with Diane and its generics are sparse and indicate that this risk is lower than for VTE.
Podatki o tveganju za arterijsko tromboembolijo pri zdravilu Diane in njegovih generičnih zdravilih so obširni in kažejo, da je to tveganje nižje kot tveganje za venozno tromboembolijo.
Observational studies have shown that the risk of venous thromboembolism (VTE) with these medicines is 1.5 to 2 times higher than for COCs containing levonorgestrel and may be similar to the risk with contraceptives containing gestodene, desogestrel or drospirenone.
Opazovalne študije so pokazale, da je tveganje za venozno trombembolijo pri teh zdravilih 1,5- do 2-krat večje kot pri kombiniranih peroralnih kontracepcijskih sredstvih, ki vsebujejo levonorgestrel, in je lahko podobno tveganju pri kontracepcijskih sredstvih, ki vsebujejo gestoden, dezogestrel ali drospirenon.
However, when used for acne, they should only be used if other treatments, such as those applied to the skin and antibiotics, have failed.
Za zdravljenje aken se lahko uporabljajo samo, če so bila druga zdravljenja, na primer z zdravili, nanesenimi na kožo, in antibiotiki, neuspešna.
These medicines should be used solely in the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age.
Ta zdravila se lahko uporabljajo izključno za zdravljenje zmernih do hudih aken, povezanih z občutljivostjo na androgen, in/ali hirzutizma (prekomerne rasti neželenih dlak pri ženskah) pri ženskah v rodni dobi.
Concomitant use of Diane 35 and its generics with another hormonal contraceptive will expose women to a higher dose of oestrogen and increase the risk of thromboembolism.
Sočasna uporaba zdravila Diane 35 ali njegovih generičnih zdravil z drugim hormonskim kontracepcijskim sredstvom žensko izpostavi višjemu odmerku estrogena ter tako poveča tveganje za tromboembolijo.
• In terms of effectiveness, the available data support the use of Diane 35 and its generics in the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism, in women of reproductive age.
• V zvezi z učinkovitostjo razpoložljivi podatki podpirajo uporabo zdravila Diane 35 in njegovih generičnih zdravil pri zdravljenju zmernih do hudih aken, povezanih z občutljivostjo na androgen, in/ali hirzutizma pri ženskah v rodni dobi.
Diane 35 and its generics act also as hormonal contraceptives and stopping them means that you will have to use another form of contraception to prevent unwanted pregnancies.
Zdravilo Diane 35 in njegova generična zdravila delujejo tudi kot hormonska kontracepcijska sredstva, zato boste morali ob prekinitvi njihovega jemanja vzeti drugo obliko kontracepcije, da preprečite neželeno nosečnost.
• Since Diane 35 and its generics act also as hormonal contraceptives, they should not be used in combination with other hormonal contraceptives.
• Ker zdravilo Diane 35 in njegova generična zdravila delujejo tudi kot hormonska kontracepcijska sredstva, jih ni dovoljeno jemati v kombinaciji z drugimi hormonskimi kontracepcijskimi sredstvi.
Furthermore, Diane 35 and generics should only be used for the treatment of acne when alternative treatments, such as topical therapy and antibiotic treatment, have failed.
Zdravilo Diane 35 in njegova generična zdravila se lahko uporabljajo za zdravljenje aken samo, kadar so bile druge oblike zdravljenja, kot sta denimo lokalno zdravljenje ali zdravljenje z antibiotiki, neuspešne.
Once the European Commission has adopted its decision, all EU Member States where Diane 35 and its generics are authorised must follow it and ensure that all agreed risk minimisation measures, including changes to the information to prescribers and patients, are implemented.
Vendar pa bo v vseh državah članicah EU obveljala poznejša odločitev Evropske komisije za ohranitev dovoljenja za promet z zdravili z dogovorjenimi ukrepi za zmanjšanje tveganja, vključno s spremembami informacij za predpisovalce in bolnice.
Since Diane 35 and its generics act as hormonal contraceptives, women should not take these medicines in combination with other hormonal contraceptives.
Ker zdravilo Diane 35 in njegova generična zdravila delujejo kot hormonska kontracepcijska sredstva, jih ženske ne smejo jemati v kombinaciji z drugimi hormonskimi kontracepcijskimi sredstvi.
• Diane 35 and its generics should only be used to treat moderate to severe acne (related to sensitivity to hormones called androgens) and/or hirsutism in women of child-bearing age.
• Zdravilo Diane 35 in njegova generična zdravila se lahko uporabljajo samo za zdravljenje zmernih do hudih aken (povezanih z občutljivostjo na hormone, imenovane androgeni) in/ali hirzutizma pri ženskah v rodni dobi.
• Diane 35 and its generics should only be used for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age.
• Zdravilo Diane 35 in njegova generična zdravila se lahko uporabljajo samo za zdravljenje zmernih do hudih aken, povezanih z občutljivostjo na androgen (s seborejo ali brez je), in/ali hirzutizma pri ženskah v rodni dobi.
10 x 1 dose 50 x 1 dose
10 x 1 odmerek 50 x 1 odmerek
Massachusetts 01702, USA
Massachusetts 01702, ZDA
Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu/).
ATCvet code: QI06AH07.
Oznaka ATC vet: QI06AH07.
This resolves without any treatment.
Ti preidejo brez zdravljenja.
It has been demonstrated that this spread did not cause adverse reactions on non-vaccinated cats.
Dokazano je bilo, da to širjenje ni povzročilo neželenih učinkov pri necepljenih mačkah.
Subcutaneous use (under the skin).
Subkutana uporaba (pod kožo).
Interaction with other medicinal products and other forms of interaction:
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:
In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
V primeru anafilaktičnega šoka je potrebno ustrezno simptomatsko zdravljenje.
After the second injection, and subsequent administrations, this reaction is markedly reduced.
Po drugem injiciranju in nadaljnjih dajanjih je ta reakcija opazno blažja.
Do not use in pregnant cats.
Ne uporabite pri brejih mačkah.
Store and transport refrigerated (2 C - 8 C).
Shranjujte in prevažajte v hladilniku (2ºC - 8ºC).
4.6 Adverse reactions (frequency and seriousness)
Neželeni učinki (pogostost in resnost)
This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 3 to 4 weeks at the most.
Ta lokalna reakcija je lahko oteklina, edem ali vozliček in spontano izgine v največ od 3 do 4 tednih.
In such cases where maternally derived antibodies are expected, a third injection may be appropriate from 15 weeks of age.
V primerih, kjer lahko pričakujemo maternalna protitelesa, je morebiti potrebno še tretje injiciranje od starosti 15 tednov.
PROHIBITION OF SALE, SUPPLY AND/OR USE
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli stranske učinke, tudi tiste, ki so navedeni v tem navodilu za uporabo ali mislite da zdravilo ni delovalo obvestite svojega veterinarja.
Date of last renewal: 06/06/2014.
Datum zadnjega podaljšanja dovoljenja za promet: 06/06/2014
Date of first authorisation: 25/06/2009.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 25/06/2009
Pregnancy and lactation: Do not use in pregnant cats.
Brejosti in laktacija: Ne uporabite pri brejih mačkah.
The use is not recommended during lactation.
Uporaba v obdobju laktacije ni priporočljiva.
In this case, since annual revaccination is required for calicivirus, rhinotracheitis virus and panleucopenia virus components, a single dose of FELIGEN RCP can be used annually.
V tem primeru, ker je potrebno vsakoletno ponovno cepljenje za komponente kalcivirus, virus rinotraheitisa in virus panklevkopenije, lahko uporabite en sam odmerek FELIGEN RCP letno.
Anaphylactic reactions have been reported in very rare cases.
V zelo redkih primerih so poročali o anafilaktičnih reakcijah.
* Cell culture infectious dose 50%.
* Infektivni odmerek za celične kulture 50%.
Special warnings for each target species: Vaccinate healthy animals only.
Posebna opozorila za vsako ciljno živalsko vrsto Cepite samo zdrave živali.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila za uporabo v veterinarski medicini odločamo od primera od primera.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno)
Name and address of the manufacturers of the biological active substances
Ime in naslov proizvajalcev bioloških učinkovin
For active immunisation of cats from eight weeks of age against:
Za aktivno imunizacijo mačk, starih osem tednov in več, proti:
Suspension: Opalescent liquid.
Suspenzija: opalescentna tekočina.
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Pain at palpation, sneezing or conjunctivitis may be noted in rare cases.
Bolečina na otip, kihanje ali konjunktivitis se pojavijo v redkih primerih.
Primary vaccination: - first injection in kittens from 8 weeks of age - second injection 3 or 4 weeks later.
Prvo cepljenje: - prvo injiciranje mačjih mladičev, starih nad 8 tednov - drugo injiciranje 3 ali 4 tedne kasneje.
Vaccinate healthy animals only.
Cepite samo zdrave živali.
De-worming at least 10 days prior to vaccination is recommended.
Priporočljivo je odstranjevanje glist vsaj 10 dni pred cepljenjem.
Store and transport refrigerated.
Shranjujte in prevažajte v hladilniku.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Za vse nadaljnje informacije o tem zdravilu za uporabo v veterinarski medicini se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.
Febrile limping syndrome reactions may occur very rarely in kittens, as reported in the literature after the use of any vaccine containing a Feline Calicivirus component.
Pri mačjih mladičih se zelo redko lahko pojavi sindrom febrilne šepavosti, kot literatura poroča po uporabi katerega koli cepiva, ki vsebuje komponento mačjega Kalicivirusa.
EXP {month/year} Once reconstituted use immediately.
EXP {mesec/leto} Rekonstruirano zdravilo uporabite takoj.
Pharmacotherapeutic group: immunologicals for Felidae, live and inactivated viral vaccines for cats.
Farmakoterapevtska skupina: imunološka sredstva za felidae, živa in inaktivirana virusna cepiva za mačke.
Adjuvants: 3% aluminium hydroxide gel expressed as mg Al
Dodatki: 3% gel aluminijevega hidroksida, izražen kot mg Al
The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed.
Prehodni znaki po cepljenju, kot so hipertermija (ki traja od 1 do 4 dni), apatija in prebavne motnje so prav tako pogosto opaženi.
Overdose (symptoms, emergency procedures, antidotes):
Preveliko odmerjanje (simptomi, nujniukrepi, protistrupi):
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti o uporabi tega cepiva skupaj s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
MANUFACTURER'S BATCH NUMBER
PROIZVAJALČEVA ŠTEVILKA SERIJE
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
The vaccine contains the purified p45 FeLV-envelope antigen, obtained by genetic recombination of the E. coli strain.
Cepivo vsebuje prečiščen antigen ovojnice p45 FeLV, pridobljen z genetsko rekombinacijo seva E. coli.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
BESEDILO “SAMO ZA ŽIVALI”