natgillin/translations-raw huggingface dataset:
Laboratory studies comparing Grasustek with Neulasta have shown that the active substance in Grasustek is highly similar to that in Neulasta in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Grasustek primerjali z zdravilom Neulasta, so pokazale, da je učinkovina zdravila Grasustek po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Neulasta.
How does Grasustek work? 
Kako zdravilo Grasustek deluje?
This summary was last updated in 06-2006. 
Ta povzetek je bil nazadnje posodobljen 06-2006.
The marketing authorisation was renewed on 4 July 2004. 
Dovoljenje za promet z zdravilom je bilo podaljšano dne 4. julija 2004.
Medicinal product no longer authorise©EMEA 2006 
Zdravilo nima veā dovoljenja za prome©EMEA 2006
The doses and duration of treatment depend on to the patient's response to the medicine. 
Odmerki in trajanje zdravljenja so odvisni od odziva bolnika na zdravilo.
The European Commission granted a marketing authorisation valid throughout the European Union, for Forcaltonin to Unigene UK Limited on 11 January 1999. 
Evropska komisija je dovoljenje za promet z zdravilom Forcaltonin, veljavno po vsej Evropski uniji, odobrila družbi Unigene UK Limited dne 11. januarja 1999.
This included the results of three studies of the effectiveness and safety of Forcaltonin in 94 women, including 58 with osteoporosis. 
To je obsegalo rezultate treh raziskav učinkovitosti in varnosti zdravila Forcaltonin pri 94 ženskah, od katerih jih je 58 imelo osteoporozo.
Other information about Forcaltonin: 
Druge informacije o zdravilu Forcaltonin:
These studies measured the markers of bone metabolism. 
V teh raziskavah so merili označevalce presnove kosti.
The most common side effect found in about 10% of patients is nausea (feeling sick) with or without vomiting. 
Najpogostejši neželeni učinek, opažen pri približno 10 % bolnikov, je bila slabost z ali brez bruhanja.
This side effect is less common when the injection is given in the evening and after meals. 
Ta neželeni učinek je redkejši, če se zdravilo injicira zvečer ali po obroku.
Salmon calcitonin, either extracted from salmon or synthetic (man-made), has been in use as a medicine since the mid-1970s. 
Lososov kalcitonin, ki se pridobi iz lososa ali izdela sintetično, uporabljamo kot zdravilo že od sredine 1970-ih.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FORCALTONIN EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) FORCALTONIN Povzetek EPAR za javnost
Other common side effects are skin flushes (face or upper body). 
Drugi pogosti neželeni učinek je rdečica na koži (obraza ali zgornjega dela telesa).
The active substance of Forcaltonin, salmon calcitonin, is a copy of the hormone produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce salmon calcitonin. 
Zdravilna učinkovina zdravila Forcaltonin, lososov kalcitonin, je kopija hormona, ki se izdeluje z metodo, imenovano „tehnologija rekombinantne DNA“: izdela ga celica, ki je prejela gen (DNA), s katerim lahko tvori lososov kalcitonin.
The doctor may decide to perform a skin test to check the patient's allergy status before prescribing the medicine. 
Pred izdajo recepta za zdravilo se lahko zdravnik odloči za izvedbo kožnega preskusa, s katerim preveri alergijski status bolnika.
In severe or emergency cases, Forcaltonin may be given as an intravenous infusion (10 IU per kg body weightover 6 hours). 
V hudih ali nujnih primerih lahko zdravilo Forcaltonin dajemo kot intravensko infuzijo (10 i.e. na kg telesne mase v trajanju 6 ur).
This side effect is more likely at the start of treatment and tends to decrease or disappear with further doses or smaller doses. 
Ta neželeni učinek je pogostejši na začetku zdravljenja, z nadaljevanjem zdravljenja ali zmanjšanjem odmerka pa se običajno zmanjša ali izzveni.
Each ampoule contains 100 IU (International Units) of the active substance salmon calcitonin. 
Vsaka ampula vsebuje 100 i.e. (mednarodnih enot) zdravilne učinkovine lososovega kalcitonina.
In hypercalcaemia, the recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection. 
Pri hiperkalciemiji je priporočeni začetni odmerek 100 i.e. vsakih 6 do 8 ur s podkožno ali intramuskularno injekcijo.
Forcaltonin can only be obtained with a prescription. 
Zdravilo Forcaltonin se dobi samo na recept.
Forcaltonin contains the active ingredient salmon calcitonin, which works in the same way as natural human calcitonin but it is more effective and longer lasting. 
Zdravilna učinkovina v zdravilu Forcaltonin je lososov kalcitonin, ki deluje kot naravni človeški kalcitonin, vendar je učinkovitejši in deluje dlje.
What benefit has Forcaltonin shown during the studies? 
Kakšne koristi je zdravilo Forcaltonin izkazalo med raziskavami?
Forcaltonin showed the same effectiveness and safety profile as synthetic salmon calcitonin. 
Zdravilo Forcaltonin je pokazalo enako učinkovitost in varnostni profil kot sintetični lososov kalcitonin.
Forcaltonin should not be used in people who have hypocalcaemia (low calcium levels in the blood) or who may be hypersensitive (allergic) to calcitonin or any of the other ingredients. 
Zdravila Forcaltonin ne smejo uporabljati osebe, ki imajo hipokalciemijo (nizke ravni kalcija v krvi) ali osebe, ki utegnejo biti preobčutljive za (alergične na) kalcitonin ali katerokoli drugo sestavino zdravila.
Because salmon calcitonin has been in use for some time, the company presented data to show that Forcaltonin has been compared with synthetic salmon calcitonin. 
Ker je lososov kalcitonin v uporabi že dolgo časa, je podjetje predstavilo podatke, ki kažejo, da so zdravilo Forcaltonin primerjali s sintetičnim lososovim kalcitoninom.
In Paget's disease, the recommended dosage is 100 IU per day given subcutaneously or intramuscularly, however, a minimum dose of 50 IU three times a week is also effective. 
Pri Pagetovi bolezni je priporočeni odmerek 100 i.e. dnevno, ki se daje podkožno ali intramuskularno, vendar je učinkovit tudi minimalni odmerek 50 i.e. trikrat tedensko.
This may be increased after one or two days, according to the patient's response to treatment, up to a maximum of 400 IU every 6 to 8 hours. 
Glede na odziv bolnika na zdravljenje je možno odmerek zvišati po enem do dveh dneh na največ 400 i.e. vsakih 6 do 8 ur.
What is the risk associated with Forcaltonin? 
Kakšna tveganja so povezana z zdravilom Forcaltonin?
The Committee for Medicinal products for Human Use (CHMP) concluded that Forcaltonin had been shown to have the same characteristics and properties as synthetic salmon calcitonin. 
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je bilo za zdravilo Forcaltonin dokazano, da ima enake značilnosti in lastnosti kot sintetični lososov kalcitonin.
To prevent bone loss, the recommended dosage is 100 IU daily or 50 IU twice daily for 2 to 4 weeks, given subcutaneously or intramuscularly. 
Za preprečevanje izgubljanja kostnine je priporočeni odmerek 100 i.e. dnevno ali 50 i.e. dvakrat dnevno, 2 do 4 tedne, ki se daje podkožno ali intramuskularno.
Calcitonin is a hormone produced by the thyroid gland that increases the amount of calcium and phosphorus laid down in the bones and lowers the level of calcium circulating in the blood. 
Kalcitonin je hormon, ki nastaja v ščitnici in povečuje nalaganje kalcija in fosforja v kosteh ter zmanjšuje količino kalcija, ki kroži v krvi.
It is also used in Paget's disease (a bone disease that involves bone destruction and regrowth that causes deformity), and in hypercalcaemia (increased blood calcium) caused by cancer. 
Uporabljamo ga tudi pri Pagetovi bolezni (bolezni kosti, pri kateri se kostnina izgublja in ponovno raste tako, da povzroči deformiranost) in hiperkalciemiji (zvišanih ravneh kalcija v krvi) zaradi raka.
Forcaltonin is given by subcutaneous injection (under the skin), intramuscular injection (into a muscle) or intravenous infusion (drip into a vein - only in hypercalcaemia). 
Zdravilo Forcaltonin se daje s subkutano (podkožno) injekcijo, intramuskularno injekcijo (v mišico) ali z intravensko infuzijo (dajanje v veno - le pri hiperkalciemiji).
The full EPAR for Forcaltonin is available here. 
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Forcaltonin je na voljo tukaj.
Why has Forcaltonin been approved? 
Zakaj je bilo zdravilo Forcaltonin odobreno?
They decided that Forcaltonin's benefits are greater than its risks for prevention of bone loss due to sudden immobilisation, such as in patients with recent bone fractures caused by osteoporosis (a disease that makes bones fragile), for treatment of Paget's disease, and treatment of hypercalcaemia of malignancy. 
Odbor je zato odločil, da so koristi zdravila Forcaltonin večje od z njim povezanih tveganj pri preprečevanju izgubljanja kostnine zaradi nenadne nepokretnosti, kot na primer pri bolnikih z nedavnim osteoporoznim zlomom (osteoporoza je bolezen, pri kateri postanejo kosti krhke), za zdravljenje Pagetove bolezni in zdravljenje hiperkalciemije zaradi maligne bolezni.
Forcaltonin is a clear solution for injection. 
Zdravilo Forcaltonin je prozorna raztopina za injiciranje.
Forcaltonin is used in adults to prevent bone loss due to sudden immobilisation such as in patients with recent bone fractures caused by osteoporosis (a disease that makes bones fragile). 
Zdravilo Forcaltonin se uporablja pri odraslih za preprečevanje izgubljanja kostnine zaradi nenadne nepokretnosti, kot na primer pri bolnikih z nedavnim osteoporoznim zlomom (osteoporoza je bolezen, pri kateri postanejo kosti krhke).
They recommended that Forcaltonin be given marketing authorisation. 
Odbor je za zdravilo Forcaltonin priporočil odobritev dovoljenja za promet z zdravilom.
How is Forcaltonin used? 
Kako se zdravilo Forcaltonin uporablja?
For the full list of side effects reported with Forcaltonin, see the Package Leaflet. 
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Forcaltonin, najdete v Navodilih za uporabo.
What is Forcaltonin used for? 
Za kaj se zdravilo Forcaltonin uporablja?
What is Forcaltonin? 
Kaj je zdravilo Forcaltonin?
How does Forcaltonin work? 
Kako zdravilo Forcaltonin deluje?
Kύπρος 
á
Number of 
Številka EU
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch. 
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
VIRACEPT 50 mg/g oral powder Nelfinavir 
50 mg/g peroralni prašek peroralna uporaba steklenica (HDPE) 144 g
Each bottle contains 144 grams of oral powder and is supplied with a 1 gram (white) and a 5 gram (blue) polypropylene scoop. 
1 steklenica + 1-g in 5-g polipropilenska merica
Date of first authorisation: 24/07/2008 Date of last renewal: 15/07/2013 
Datum pridobitve dovoljenja za promet: 24/07/2008 Datum zadnjega podaljšanja dovoljenja za promet: 15/07/2013
MIC90: 32 
MIK90: 32
Pigs: 16 days. 
Prašiči: 16 dni.
The cap may be safely punctured up to 60 times. 
Zaporka se lahko varno prebode do 60 krat.
Sheep: 29 days. 
Ovce: 29 dni.
Avoid contact with skin or eyes. 
Izogibajte se stiku zdravila s kožo ali očmi.
The injection volume should not exceed 5 ml per injection site. 
Volumen injekcije ne sme preseči 5 ml na mesto dajanja.
4, Chemin du Calquet 31000 Toulouse France 
4, Chemin du Calquet 31000 Toulouse Francija
The bioavailability of the compound was > 98 % with no gender differences. 
Biorazpoložljivost učinkovine je >98%, brez razlik med spoloma.
MBC90s µg/ml 
MBK90s µg/ml
Cattle and sheep: subcutaneous injection. 
NAVEDBA UČINKOVINE IN DRUGE(IH) SESTAVIN
MIC90s 
MIK90s
MIC µg/ml 
MIK µg/ml
Use only according to the risk/benefit assessment by the responsible veterinarian. 
Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
Interaction with other medicinal products and other forms of interaction: Cross resistance may occur with other macrolides. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Lahko se pojavi navzkrižna rezistenca z drugimi makrolidi.
The periodic safety update report (PSUR) cycle should be re-started for submission of 6- monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals. 
Cikel rednih posodobljenih poročil o varnosti zdravila (PSUR) se ponovno začne z oddajo šestmesečnih poročil (vključene so vse odobrene oblike zdravila) v obdobju naslednjih dveh let, ki mu sledi oddaja dveh letnih poročil za naslednji dve leti, po tem obdobju pa se poročila oddajajo v triletnih obdobjih.
The swellings typically resolve within 3 to 14 days but may persist in some animals for up to 35 days after treatment. 
Otekline se običajno zmanjšajo v 3 do 14 dneh, vendar lahko pri posameznih živalih izjemoma vztrajajo do 35 dni po zdravljenju.
Clinical studies have demonstrated the wide margin of safety for gamithromycin injection in the target species. 
Klinične študije so pokazale široko varnost uporabe gamitromicina za injiciranje pri ciljnih živalskih vrstah.
For the full list of excipients, see section 6.1. 
1 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
These local reactions are transient and typically resolve within 2 (pigs) to 4 (sheep) days. 
Te lokalne reakcije so prehodne in običajno minejo v 2 (prašiči) do 4 (ovce) dneh.
Gamithromycin may cause irritation to eyes and/or skin. 
Gamitromicin lahko draži oči in/ali kožo.
Wash hands after use. 
Po dajanju zdravila si umijte roke.
Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and local policies on the use of antimicrobials in farm animals. 
Uporaba zdravila za uporabo v veterinarski medicini naj temelji na testiranju občutljivosti in naj bo v skladu z uradnimi in lokalnimi načeli uporabe protimikrobnih zdravil pri proizvodnih živalih.
Cross resistance may occur with other macrolides. 
Lahko se pojavi navzkrižna rezistenca z drugimi makrolidi.
The compound is absorbed rapidly into the target tissue for SRD. 
Učinkovina se zelo hitro absorbira v tarčno tkivo za SRD.
France 
NEMČIJA
Muscle Skin and fat in natural proporti ons 
Mišice Koža in maščoba v naravnih razmerjih
Colourless to pale yellow solution. 
Brezbarvna do svetlo rumena raztopina.
Do not use this veterinary medicinal product after the expiry date which is stated on the vial after EXP. Shelf-life after first opening the container: 28 days. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na viali, po EXP. Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
Macrolides in general have both bacteriostatic and bactericidal action mediated through disruption of bacterial protein synthesis. 
Makrolidi v splošnem delujejo tako bakteriostatično kot baktericidno z zaviranjem sinteze bakterijskih proteinov.
The in vitro data show that gamithromycin acts in a bactericidal manner. 
In vitro podatki kažejo, da gamitromicin deluje baktericidno.
The active substance in ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: 
Učinkovina v zdravilu ZACTRAN 150 mg/ml raztopina za injiciranje za govedo, ovce in prašiče je dovoljena učinkovina, kot je navedena v tabeli 1 priloge Uredbe Komisije (EU) št. 37/2010:
The mechanisms involve the alteration of the ribosomal target site, the utilization of active efflux mechanism and the production of inactivating enzymes. 
Mehanizmi zajemajo spremembo tarčnega mesta na ribosomu, pospešitev mehanizma aktivnega izločanja antibiotika iz celice in produkcijo inaktivacijskih encimov.
For multiple vial entry, an automatic dosing device is recommended to avoid excessive broaching of the stopper. 
V primeru da je potrebno večkratno prebadanje, je priporočljiva uporaba naprave za avtomatsko doziranje v izogib prepogostega prebadanja.
People with known hypersensitivity to the macrolide class should avoid contact with the veterinary medicinal product. 
Osebe z znano preobčutljivostjo na makrolidne antibiotike naj se izogibajo stiku z zdravilom.
The 500 ml vial is for cattle and pigs only. 
500 ml viala je namenjena le govedu in prašičem.
• 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).
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products. 
Zaradi pomanjkanja študij o kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.
This is often referred to as MLSB resistance as it affects macrolides, lincosamides and streptogramins. 
To je t.i. MLSB rezistenca, ker zajema makrolide, linkozamide in streptogramine.
The bioavailability of gamithromycin was > 92 %. 
Biorazpoložljivost učinkovine je > 92%.
Injection site reactions were noted in a dose related manner. 
Reakcije na mestu dajanja so bile povezane z odmerkom.
The volume of distribution at steady-state was approximately 39 l/kg. 
Volumen distribucije pri ustaljenem stanju je 39 l/kg.
Treatment of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment. 
Zdravljenje nalezljive šepavost ovac (foot rot), povezane z viruletnima Dichelobacter nodosus in Fusobacterium necrophorum, ki zahteva sistemsko zdravljenje.
Accumulation of gamithromycin in the lung has been demonstrated by high and sustained concentrations in the lung and bronchial fluid which far exceed those in blood plasma. 
Akumulacija gamitromicina v pljučih je bila dokazana z visoko in dolgotrajno koncentracijo v pljučih in bronhialni tekočini, ki daleč presegajo vsebnost v krvni plazmi.
Meat and offal: Cattle: 64 days. 
Meso in organi: Govedo: 64 dni.
Three mechanisms are generally considered responsible for resistance to the macrolide class of compounds. 
Za nastanek rezistence na makrolidni razred so navadno odgovorni trije mehanizmi.
Do not use this veterinary medicinal product simultaneously with other macrolides or lincosamides (see section 4.8). 
Ne uporabite tega zdravila za uporabo v veterinarski medicini sočasno z drugimi makrolidnimi antibiotiki ali linkozamidi (glejte poglavje 4.8).
Monothioglycerol Succinic Acid Glycerol Formal 
Monotioglicerol Sukcinilna kislina Glicerol formal
Based on laboratory animal data, gamithromycin has not produced any evidence of specific developmental or reproductive effects. 
S študijami na laboratorijskih živalih niso bili ugotovljeni nobeni specifični učinki gamitromicina na razvoj ali reprodukcijo.
A single dose of 6 mg gamithromycin/kg body weight (equivalent to 1 ml/25 kg body weight) into the neck (cattle and pigs) or anterior to the shoulder (sheep). 
En odmerek s 6 mg gamitromicina/kg telesne teže (kar ustreza 1 ml/25 kg telesne teže) v področje vratu (govedo in prašiči) ali prednji del ramena (ovce).
This special chemistry facilitates rapid absorption at physiological pH and a long duration of action at the target tissues, the lung and the skin. 
Ta kemijska posebnost omogoča izjemno hitro absorbcijo pri fiziološkem pH in dolgotrajno učinkovanje v ciljnem tkivu,
During clinical trials transient injection site swellings were observed. 
Med kliničnimi testiranji so bile opažene prehodne otekline na mestu dajanja.
The efficacy of antimicrobial treatment of foot rot might be reduced by others factors, such as wet environmental conditions, as well as inappropriate farm management. 
Učinkovitost protimikrobnega zdravljenja nalezljive šepavosti ovc je lahko zmanjšana zaradi drugih dejavnikov, kot so mokri pogoji okolja in tudi neprimerni pogoji reje.
To ensure correct dose, body weight should be determined as accurately as possible to avoid underdosing. 
Za pravilno odmerjanje zdravila je potrebna kar se da natančna ocena telesne teže, da ne pride do premajhnega odmerjanja.
Gamithromycin is an azalide, 15-membered semisynthetic macrolide class antibiotic with uniquely positioned alkylated nitrogen at 7a-position of the lactone ring. 
Gamitromicin je azalid, antibiotik iz razreda 15-tih polsintetičnih makrolidnih antibiotikov z edinstvenim 7a položajem alkiliziranega dušika na laktonskem obroču.
EXP Once opened, use by __/__/__ 
EXP Odprto zdravilo uporabite do __/__/__
The volume of distribution at steady-state was 25 l/kg. 
Volumen distribucije pri ustaljenem stanju je 25 l/kg.
The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle, sheep and pigs. 
Varnost uporabe gamitromicina v obdobju brejosti in laktacije pri kravah, svinjah in ovcah ni bila raziskana.
Antibiotic treatment of benign foot rot is not considered appropriate. 
Zdravljenje benigne šepavosti ovac z antibiotiki je neprimerno.
In young adult cattle, sheep and pig studies, gamithromycin was administered by injection at 6, 18, and 30 mg/kg (1, 3, and 5 times the recommended dose) and repeated three times at 0, 5 and 10 days (three times the recommended duration of use). 
V študijah na mladem odraslem govedu, ovcah in na prašičih, so injicirali 6, 18 in 30 mg/kg gamitromicina (1, 3 in 5-kraten priporočen odmerek zdravila) in dajanje ponovili trikrat pri 0, 5 in 10 dneh (tri-kratno priporočeno trajanje zdravljenja).
For treatment of cattle over 250 kg and sheep over 125 kg body weight, divide the dose so that no more than 10 ml (cattle) or 5 ml (sheep) are injected at a single site. 
Za zdravljenje goveda težjega od 250 kg in ovc težjih od 125 kg razdelite odmerek tako, da na eno mesto ne aplicirate več kot 10 ml (govedo) ali 5 ml (ovce) zdravila.
Cardboard box containing 1 vial of 50, 100, 250 or 500 ml. 
Kartonska škatla z 1 vialo po 50, 100, 250 ali 500 ml.
The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required. 
Pomožne snovi, navedene v poglavju 6.1 SPC, so dovoljene snovi, za katere tabela 1 priloge Uredbe
Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment. 
Ob zdravljenju nalezljive šepavosti ovac je torej potrebno sočasno uvesti tudi druge ukrepe za izboljšanje pogojev reje, na primer živalim zagotoviti suho okolje.
Gamithromycin levels in lung reached a maximum in less than 24 hr, with lung-to-plasma ratio of > 264 indicating that gamithromycin was absorbed rapidly into the target tissue for BRD. 
Višek koncentracije gamitromicina v pljučih je v manj kot 24 urah, z razmerjem pljuča - plazma >264, kar kaže na izjemno hitro absorbcijo gamitromicina v tarčno tkivo za BRD.
Biliary excretion of the unchanged drug was the major route of elimination. 
Najpomembnejša pot izločanja nespremenjenega zdravila je z biliarno ekskrecijo.
Do not use in case of hypersensitivity to a certain type of antibiotics called macrolides or to any of the excipients. 
Ne uporabite v primeru preobčutljivosti na določeno vrsto antibiotikov, ki jim pravimo makrolidi, ali na katero od pomožnih snovi.
In vitro plasma protein binding studies determined that the mean concentration of the free active substance was 74 %. 
In vitro študije vezanja plazemskih proteinov kažejo, da je povprečna koncentracija proste aktivne učinkovine 74 %.
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
The MIC and MBC data (cattle and pig) are reported from a representative sample of isolates from field materials within different EU geographic areas. 
podatki so pridobljeni iz reprezentativnih vzorcev izolatov s terena iz različnih geografskih področij
If skin exposure occurs, wash the affected area immediately with clean water. 
Če pride do stika zdravila s kožo, takoj umijte izpostavljene dele s čisto vodo.