natgillin/translations-raw huggingface dataset:
Official control authority batch release is required for this product.
Za to zdravilo je potreben postopek uradne kontrole in sproščanja (OCABR postopek).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml or 240 ml
PODATKI NA STIČNI OVOJNINI Nalepka na viali 100 ml ali 240 ml
Duration of immunity: 12 months after completion of the primary vaccination course.
Trajanje imunosti: 12 mesecev po končanem osnovnem cepljenju .
PACKAGE SIZE 100 ml (50 doses) 240 ml (120 doses)
100 ml (50 odmerkov) 240 ml (120 odmerkov)
Do not use after the expiry date which is stated on the carton and label after EXP. Once broached use immediately.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po {EXP}.
Pack sizes
VELIKOST PAKIRANJA
Pack of 1 bottle of 120 doses (240 ml).
Pakiranje z 1 vialo s 120 odmerki (240 ml).
IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus ATCvet code: QI02AA08.
Farmakoterapevtska skupina: Inaktivirana virusna cepiva - virus bolezni modrikastega jezika.
Onset of immunity: 21 days after completion of the primary vaccination course.
Začetek imunosti: 21 dni po končanem osnovnem cepljenju.
2nd injection: after 3 weeks.
1. injekcija: od 3 meseca starosti.
Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1, Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02.
Inaktiviran virus modrega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 Inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02
Pack of 1 bottle of 50 doses (100 ml).
Pakiranje z 1 vialo s 50 odmerki (100 ml).
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Če se cepivo uporablja pri drugih domačih in divjih vrstah prežvekovalcev, ki jih ogroža okužba, je potrebna previdnost.
Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies.
Lokalne reakcije v velikosti do 5 cm v premeru so bile zelo pogosto opažene in reakcije v velikosti >5 cm v premeru so bile pogosto opažene po večkratnem dajanju enkratnega odmerka v v terenskih varnostnih študijah.
Adjuvants: Aluminium hydroxide
Aluminijev hidroksid
MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/001 (20 ml)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/139/001 (20 ml)
A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of two-fold overdose.
Po dajanju dvojnega odmerka se pri 10 % živali v 24 urah po injiciranju lahko pojavi prehodno povišanje rektalne temperature do 2°.
EXPIRY DATE EXP {month/year} Once broached use immediately.
EXP {mesec/leto}
MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/139/001
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains:
Vsak 2 ml odmerek vsebuje:
MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/002
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/139/002
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each 2 ml dose contains:
Vsak odmerek (2 ml) vsebuje:
A transient increase in rectal temperature, not exceeding 2 C, may occur in 10% of the animals during the 24 hours following administration of a two-fold overdose.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Po dajanju dvojnega odmerka se pri 10 % živali v 24 urah po injiciranju lahko pojavi prehodno povišanje rektalne temperature do 2 °C.
Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5 cm diameter were commonly observed after administration of a single dose in field safety studies.
Lokalne reakcije, manjše od 2 cm v premeru so bile zelo pogosto opažene, medtem ko so bile reakcije do 5 cm v premeru opažene pogosto po enkratnem odmerku v terenskih varnostnih študijah.
Special warnings for each target species:
Posebna opozorila za vsako ciljno živalsko vrsto: Cepite samo zdrave živali.
Active substance(s):
NAVEDBA UČINKOVIN(E) IN
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 20 ml
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
Packaging Content Package size Withdrawal period
Način uporabe Pakiranje Vsebina Velikost pakiranja
This has been subject to previous reviews leading to risk minimisation measures at national level.
To je bil tudi predmet predhodnih preučevanj, ki so privedli do ukrepov za zmanjšanje tveganj na nacionalnih ravneh.
• For bromocriptine: Restriction of the maximum dose to 30 mg per day.
• Za bromokriptin: Omejitev največjega odmerka na dan na 30 mg dnevno.
A contraindication for patients treated for a long period and with pre-existing cardiac valulopathy .
Kontraindikacija za bolnike, zdravljene dolgo časa in s predhodno prisotno kardialno valvulopatijo.
A warning on the possible risk of fibrosis in patients taking these medicines at high doses for long periods.
Opozorilo o možnih tveganjih fibroze pri bolnikih, ki ta zdravila jemljejo v večjih odmerkih in dlje časa.
Four main observational studies looked into the risk of cardiac valvulopathy in patients treated with dopamine agonists for Parkinson's disease (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
V štirih glavnih opazovalnih študijah so opazovali tveganje pojava srčne valvulopatije pri bolnikih s Parkinsonovo boleznijo, zdravljenimi z agonisti dopamina (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
This warning includes recommendations for the monitoring of patients for signs of fibrosis during treatment.
Opozorilo vključuje priporočilo, da je treba med zdravljenjem opazovati bolnike zaradi pojava znakov fibroze..
On 21 June 2007, the UK asked the CHMP, under article 31 of Directive 2001/83/EC, as amended, to review the risk of fibrosis and cardiac valvulopathy associated with the use of all ergot-derived dopamine agonists, and to provide an opinion on whether the marketing authorisations for all products of the class should be maintained, varied, suspended or withdrawn.
Dne 21. junija 2007 je Združeno kraljestvo v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, zaprosilo Odbor za zdravila za uporabo v humani medicini, predlog za ponovno preučitev tveganj fibroznih obolenj in srčne valvulopatije, povezanih z uporabo iz rženega rožička pridobljenih agonistov dopamina, ter poda mnenje o tem, ali naj ostanejo dovoljenja za promet z vsemi zdravili te skupine še dalje veljavna, oziroma se spremenijo, začasno ukinejo ali umaknejo.
The degree of 5-HT2B receptor agonism varies across ergot derived dopamine agonists and fits well with the difference in incidence rates of fibrotic events for the different ergot-products (C.Hofmann et al., Clin Neuropharmacol, 2006).
Stopnja agonističnega delovanja na receptor 5-HT2B se razlikuje med posameznimi agonisti dopamina, ki so pridobljeni iz rženega rožička, in dobro ustreza razlikam v pojavnosti dogodkov fibroze v različnih skupinah zdravil, pridobljenih iz rženega rožička (C.Hofmann et al., Clin Neuropharmacol, 2006).
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BROMOCRIPTINE, DIHYDROERGOCRYPTINE AND LISURIDE AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA BROMOKRIPTINA, DIHIDROERGOKRIPTINA IN LIZURIDA IN Z NJIMI POVEZANIH IMEN (GLEJTE DODATEK I)
As a result, cabergoline and pergolide containing medicinal products are indicated only as 2nd line therapy in Parkinson's disease, and their use is contraindicated for patients with evidence of valve problems.
Zaradi tega so zdravila, ki vsebujejo kabergolin in pergolid indicirana le kot zdravljenje druge izbire pri zdravljenju Parkinsonove bolezni, njihova uporaba pa je kontraindicirana pri bolnikih z dokazanimi težavami srčne zaklopke.
Ergot derived dopamine agonists are mainly used to treat Parkinson's disease, either on their own or in combination with other medicines.
Agonisti dopamina, pridobljeni iz rženega rožička, se v glavnem uporabljajo za zdravljenje Parkinsonove bolezni, samostojno ali v kombinaciji z drugimi zdravili.
Spontaneous cases of fibrotic reactions were reported for all ergot derived dopamine agonists, especially at high doses and after long period of treatment.
O spontanih primerih fibroznih reakcij so poročali pri uporabi vseh agonistov dopamina, pridobljenih iz rženega rožička, zlasti pri večjih odmerkih in po daljših obdobjih zdravljenja.
They are also used to treat conditions including hyperprolactinaemia and prolactinoma, and to prevent lactation and migraine.
Uporabljajo se tudi za zdravljenje drugih stanj, kot sta hiperprolaktinemija in prolaktinoma ter za preprečevanje laktacije in migren.
• For bromocriptine and dihydroergocryptine:
• Za bromokriptin in dihidroergokriptin:
In view of the differences in the level risk amongst ergot derived dopamine agonists, the CHMP recommended that a separate opinion is issued for cabergoline and pergolide.
Zaradi razlik v stopnji tveganja pri uporabi različnih agonistov dopamina, pridobljenih iz rženega rožička, je CHMP predlagal, da se za kabergolin in pergolid izda ločeno mnenje.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
- In view of the available data, the Committee concluded that the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
- Glede na razpoložljive podatke je Odbor odločil, da tveganje fibroznih dogodkov, vključno z srčno valvulopatijo, ni enako pri vseh agonistih dopamina, pridobljenih iz rženega rožička.
- The CHMP, as a consequence, recommended amendments to the relevant sections of the Summary of product characteristics and Package leaflets for the medicinal products containing bromocriptine, dihydroergocryptine and lisuride (see Annex III).
- CHMP je posledično priporočil dopolnitev ustreznih poglavij povzetka glavnih značilnostih zdravila in navodila za uporabo zdravil, ki vsebujejo bromokriptin, dihidroergokriptin in lizurid (glejte Dodatek III).
The Schade study reported higher adjusted incidence rate ratio (IRR) for symptomatic valvular regurgitation for cabergoline and pergolide, compared to bromocriptine, lisuride, and non ergot derived dopamine agonists pramipexole and ropirinole for which no cases were reported.
Rezultati študije Schade so pokazali višje prilagojeno razmerje stopnje pojavnosti (IRR) simptomatske regugitacije valvul pri bolnikih, zdravljenih z kabergolinom in pergolidom, v primerjavi s tistimi, zdravljenimi z bromokriptinom, lizuridom in drugimi agonisti dopamina, ki niso pridobljeni iz rženega rožička, na primer pramipeksol in ropinirol, pri katerih ni bilo poročil o takšnih primerih.
Bromocriptine, dihydroergocryptine and lisuride belong to the class of ergot derived dopamine agonists, which also comprises cabergoline and pergolide.
Bromokriptin, dihidroergokriptin in lizurid pripadajo razredu agonistov dopamina, pridobljenih iz rženega rožička, kamor spadata tudi kabergolin in pergolid.
• For bromocriptine, dihydroergocryptine and lisuride:
• Za bromokriptin, dihidroergokriptin in lizurid:
At its June 2008 meeting, the CHMP concluded that the amount of evidence on the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Odbor za zdravila za uporabo v humani medicini je na svojem zasedanju junija 2008 menil, da dokazi o tveganju fibroznih dogodkov, vključno z boleznimi zaklopke, kažejo, da tveganje ni enako pri vseh agonistih dopamina, pridobljenih iz rženega rožička.
Ergot-derived dopamine agonists have been associated with an increased risk of fibrotic disorders and valvular heart disease.
Dopaminski agonisti, pridobljeni iz rženega rožička, so povezani s povečanim tveganjem fibroznih motenj in obolenj srčnih zaklopk.
In view of the above, the CHMP recommended the maintenance of the marketing authorisation for bromocriptine, dihydroergocryptine and lisuride containing medicinal products with amendments to their product information (Summary of product characteristics and Package leaflet), as outlined below.
Zaradi tega je CHMP priporočil ohranitev dovoljenja za promet z zdravili, ki vsebujejo kabergolin in pergolid, s tem da se dopolnijo informacije o teh zdravilih (povzetek glavnih značilnosti zdravila in navodilo za uporabo), kot je navedeno spodaj:
- The CHMP considered the referral made under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide.
2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo bromokriptin, kabergolin, dihidroergokriptin, lizurid in pergolid;
For bromocriptine, dihydroergocryptine and lisuride, an increased risk of fibrosis, including cardiac valvulopathy, cannot be excluded.
Pri uporabi bromokriptina, dihidroergokriptina in lizurida, ni mogoče izključiti povečanega tveganja fibroze, vključno z boleznijo srčne zaklopke.
Overall, data from spontaneous reports indicate that subjects using carbergoline and pergolide are more at risk for fibrotic events and valvulopathy than subjects using bromocriptine, lisuride or dihydroergocryptine.
Podatki iz spontanih poročil tako kažejo, da so uporabniki karbergolina in pergolida izpostavljeni večjemu tveganju fibroznih dogodkov in bolezni srčne zaklopke kot uporabniki bromokriptina, lizurida ali dihidroergokriptina.
However, cases of valvulopathy were reported for bromocriptine, cabergoline, dihydroergocryptine and pergolide, but not for lisuride.
O primerih težav s srčnimi zaklopkami pa so poročali pri uporabi bromokriptina, kabergolina, dihidroergokriptina in pergolida, ne pa tudi lizurida.
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
For bromocriptine, dihydroergotamine and lisuride, no fibrotic events have been reported by MAHs from clinical trials or observational studies.
Imetniki dovoljenj za promet z zdravili pri uporabi bromokriptina, dihidroergotamina in lizurida v kliničnih preskušanjih ali opazovalnih študijah niso poročali o fibroznih dogodkih.
13 days.
13 dni.
This summary was last updated in June 2007.
Ta povzetek je bil nazadnje posodobljen junija 2007.
This contributes to the spread of the disease to other animals.
Slednje prispeva k širjenju bolezni na druge živali.
The marketing authorisation was renewed on 29 October 2004.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 29. oktobra 2004.
Any unused product or waste materials should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadne snovi je treba odstraniti v skladu z nacionalnimi določili.
Information on the prescription status of this product may be found on the label of the bottle.
Informacije o predpisovanju tega izdelka najdete na nalepki na steklenički.
It was also shown to prevent diarrhoea following 11 days of treatment.
Izkazalo se je tudi, da prepreči drisko po 11 dneh zdravljenja.
Such symptoms can include diarrhoea, visible blood in the faeces, a decline in milk consumption, dehydration, apathy (lack of responsiveness), weakness and collapse.
Takšni simptomi lahko vključujejo drisko, vidne sledi krvi v iztrebkih, manjše uživanje mleka, dehidracijo, apatijo (pomanjkanje odzivnosti), šibkost in kolaps.
Users should avoid skin and eye contact with the product and if such contact happens, they should wash the exposed area thoroughly with clean water.
Uporabniki se morajo izogibati stiku zdravila s kožo in očmi; v primeru takšnega stika morajo izpostavljen predel temeljito umiti s čisto vodo.
The exact way halofuginone works is unknown.
Natančen način delovanja halofuginona ni znan.
Other information about Halocur:
Druge informacije o zdravilu Halocur:
In one trial, calves were included from 40 farms.
Ena izmed raziskav je vključevala teleta s 40 kmetij.
A number of field trials were performed involving calves from different farms.
Izvedenih je bilo več terenskih raziskav s teleti z različnih kmetij.
Halocur should not enter watercourses as this may be dangerous for fish and other aquatic organisms.
Zdravilo Halocur ne sme priti v vodotoke, ker je lahko nevarno za ribe in druge vodne organizme.
Protective gloves should be worn while handling the product and hands should be washed after use.
Med rokovanjem z zdravilom je treba nositi zaščitne rokavice, po uporabi pa si je treba umiti roke.
In all cases, Halocur is given to the calf by mouth after a feed, not on an empty stomach, once a day for seven consecutive days.
V vseh primerih se zdravilo Halocur daje teletu peroralno po krmi, ne na prazen želodec, enkrat dnevno sedem dni zaporedoma.
The European Commission granted a marketing authorisation, valid throughout the European Union for Halocur to Intervet International B.V. on 29 October 1999.
Evropska komisija je dovoljenje za promet z zdravilom Halocur, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
What is the time to allow before milk can be taken from the animal for human consumption?
Koliko časa je potrebno počakati pred uporabo mleka živali za prehrano ljudi?
If eye irritation persists, medical advice should be sought.
Če draženje oči ne izgine, je treba poiskati pomoč zdravnika.
Halocur should not be administered to calves in cases where diarrhoea has been established for more than 24 hours, or to weak animals.
Zdravilo Halocur se ne sme uporabljati pri teletih v primerih, ko driska traja več kot 24 ur, ali pri šibkih živalih.
Halocur can be used:
Zdravilo Halocur se lahko uporablja:
Not applicable since the product is only to be used in newborn calves.
Navedba smiselno ni potrebna, ker se zdravilo uporablja samo pri novorojenih teletih.
What benefit has Halocur shown during the studies?
Kakšne koristi je zdravilo Halocur izkazalo med raziskavami?
What is the risk associated with Halocur?
Kakšna tveganja so povezana z zdravilom Halocur?
It also prevents it from forming oocysts, which are formed at a certain stage in the lifecycle of the parasite and are excreted (shed) in the faeces.
Preprečuje tudi tvorjenje oocist, ki nastajajo v določeni stopnji življenjskega cikla zajedavca in se izločajo v iztrebke.
They recommended that Halocur be given a marketing authorisation.
Zato je priporočil, da se za zdravilo Halocur odobri dovoljenje za promet.
People who handle Halocur repeatedly may develop skin allergies.
Pri ljudeh, ki pogosto rokujejo z zdravilom Halocur, se lahko pojavijo kožne alergije.
• to reduce diarrhoea, when it is given in the 24 hours after the onset of diarrhoea.
• za blažitev driske, če se daje v 24 urah po nastopu driske.
Why has Halocur been approved?
Zakaj je bilo zdravilo Halocur odobreno?
Early treatment in the first 24 to 48 hours after birth was shown to be most beneficial.
Kot najučinkovitejše se je izkazalo zgodnje zdravljenje v prvih 24 do 48 urah po skotitvi.
Treatment with the recommended dose of Halocur orally during 7 consecutive days, in calves aged from 4 to 10 days was shown to reduce diarrhoea compared to placebo.
Dokazano je bilo, da zdravljenje s priporočenim odmerkom zdravila Halocur peroralno 7 zaporednih dni pri teletih, starih od 4 do 10 dni, v primerjavi s placebom ublaži drisko.
These studies compared treatment with Halocur to placebo.
V teh raziskavah so zdravilo Halocur primerjali s placebom.
Clinical signs of Cryptosporidium parvum infection are seen mainly as diarrhoea.
Klinični znaki okužbe s Cryptosporidium parvum se kažejo pretežno kot driska.
Halocur contains the active substance halofuginone lactate, which is used against parasitic diseases caused by protozoa.
Zdravilo Halocur vsebuje zdravilno učinkovino halofuginon laktat, ki se uporablja proti zajedavskim boleznim, ki jih povzročajo protozoji.
Halocur should be given after feeding.
Zdravilo Halocur je treba dajati po krmi.
This is a parasite belonging to the ‘protozoa' family that invades the digestive system causing diarrhoea.
To je zajedavec iz družine protozojev, ki vdre v prebavni sistem in povzroči drisko.
The active substance in Halocur, halofuginone lactate, prevents the growth of Cryptosporidium parvum.
Zdravilna učinkovina zdravila Halocur, halofuginon laktat, preprečuje rast Cryptosporidium parvum.
Another trial of calves aged from 24 to 48 hours demonstrated that Halocur can prevent diarrhoea due to Cryptosporidium parvum compared with placebo.
Druga raziskava s teleti, starimi od 24 do 48 ur, je pokazala, da zdravilo Halocur v primerjavi s placebom lahko prepreči drisko, ki jo povzroča Cryptosporidium parvum.
What is Halocur used for?
Za kaj se zdravilo Halocur uporablja?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Halocur outweigh the risks in the prevention and reduction of diarrhoea due to Cryptosporidium parvum in newborn calves.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je odločil, da so koristi zdravila Halocur pri preprečevanju in zmanjševanju driske, ki jo povzroča Cryptosporidium parvum, pri novorojenih teletih večje od z njim povezanih tveganj.
How has Halocur been studied?
Kako je bilo zdravilo Halocur raziskano?
What is Halocur?
Kaj je zdravilo Halocur?
Halocur is used in newborn calves to prevent or reduce diarrhoea due to an organism called Cryptosporidium parvum.
Zdravilo Halocur se uporablja pri novorojenih teletih za preprečevanje ali blaženje driske, ki jo povzroča organizem Cryptosporidium parvum.
• to prevent diarrhoea in farms with a history of cryptosporidiosis (infection with
• za preprečevanje driske na kmetijah, na katerih se je že v preteklosti pojavljala kriptosporidioza (okužba s Cryptosporidium), če se daje novorojenim teletom v prvih 24 do 48
Halocur is presented as a clear, yellow solution for administration by mouth.
Zdravilo Halocur je na voljo kot bistra rumena raztopina za peroralno uporabo.
Halocur treatment was shown to reduce the level of excretion of Cryptosporidium parvum by the calves and to reduce diarrhoea.
Raziskave so pokazale, da zdravilo Halocur pri teletih zmanjša raven izločanja Cryptosporidium parvum in ublaži drisko.
How does Halocur work?
Kako zdravilo Halocur deluje?
Symptoms of toxicity may occur if Halocur is administered at twice the recommended dose.
Če se zdravilo Halocur daje v odmerku, ki je dvakrat večji od priporočenega, se lahko pojavijo simptomi toksičnosti.
1 pre-filled syringe (singledose)
1 napolnjen injekcijski peresnik (enoodmerni)
Date of first authorisation: 27 January 1999 Date of latest renewal: 13 January 2009
Datum prve odobritve: 27. januar 1999 Datum zadnjega podaljšanja: 13. januar 2009
• Wash your hands.
• Umijte si roke.
• Tilt your head back.
• Nagnite glavo nazaj.
Do not drive or use machines until your vision is clear.
Ne vozite ali ne uporabljajte strojev, dokler ne boste jasno videli.
For single use only; one container is sufficient to treat both eyes.
Samo za enkratno uporabo; en vsebnik zadostuje za zdravljenje obeh očes.
Now turn over>
Obrnite stran >
Don't put in any more drops until it's time for your next regular dose.
Kapljic ne vkapajte ponovno, dokler ne bo čas za naslednji redni odmerek.
If a drop misses your eye, try again.
Če kapljica zgreši oko, poskusite ponovno.
There are no adequate data from the use of emedastine in pregnant women.
Ni ustreznih podatkov o uporabi emedastina pri nosečnicah.
Not Known (frequency cannot be estimated from the available data) • General side effects: increased heart rate
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) • Splošni neželeni učinki: povečana srčna frekvenca