natgillin/translations-raw huggingface dataset:
c) An immediate visual inspection of the solution for particulate matter and discoloration should be performed after reconstitution.
c) Po rekonstituciji je treba raztopino nemudoma pregledati glede trdnih delcev in obarvanja.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Velmanase alfa is a protein and is predicted to be metabolically degraded into amino acids.
Velmanaza alfa je protein in se med presnovo predvidoma razgradi v aminokisline.
Name and address of the manufacturer responsible for batch release
Nemčija Ime in naslov izdelovalca, odgovornega za sproščanje serij
November 2020
Končno poročilo o študiji: november 2020
How Lamzede is used
Kako uporabljati zdravilo Lamzede
[95% CI] p-value p=0.692
[95-odstotni IZ] vrednost p p = 0,692
After reconstitution, the medicine should be used immediately.
Zdravilo je treba uporabiti nemudoma po rekonstituciji.
Table 2: Results from placebo-controlled clinical study rhLAMAN-05 (source data: rhLAMAN-05)
Preglednica 2: Rezultati s placebom nadzorovane klinične študije rhLAMAN-05 (vir podatkov:
Lamzede should be reconstituted and administrated by a healthcare professional.
Zdravilo Lamzede smejo rekonstituirati in dajati zdravstveni delavci.
What Lamzede looks like and contents of the pack
Izgled zdravila Lamzede in vsebina pakiranja
Absolute change from baseline Mean
Absolutna sprememba od izhodišča Povprečna vrednost
[95% CI] p-value p=0.278
[95-odstotni IZ] vrednost p p = 0,278
These medicines may include medicines used to treat allergies (antihistamines), medicines used to treat fever (antipyretics) and medicines to control inflammation (corticosteroids).
(antihistaminiki), zdravila za zdravljenje povišane telesne temperature (antipiretiki) in zdravila za nadzor vnetja (kortikosteroidi).
Package leaflet: Information for the patient Lamzede 10 mg powder for solution for infusion velmanase alfa This medicine is subject to additional monitoring.
Navodilo za uporabo Lamzede 10 mg prašek za raztopino za infundiranje velmanaza alfa Za to zdravilo se izvaja dodatno spremljanje varnosti.
Loss of consciousness(2)
Bolezni živčevja zmedenost izguba zavesti(2)
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, juvenile toxicity and toxicity to reproduction and development.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, toksičnosti za mladostnike ter vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Velmanase alfa vs. placebo
Velmanaza alfa v primerjavi s placebom
The results (serum oligosaccharide concentration, 3MSCT, 6MWT and FVC%) are presented in table 2.
Rezultati (koncentracija oligosaharidov v serumu, 3MSCT, 6MWT in
All but one patient were naïve to the treatment with velmanase alfa.
Razen enega bolnika predhodno nobeden od njih ni bil zdravljen z velmanazo alfa.
A total of 25 patients were enrolled, including 12 paediatric subjects (age range: 6 to 17 years; mean: 10.9 years) and 13 adult subjects (age range: 18 to 35 years; mean: 24.6).
Vključenih je bilo skupaj 25 bolnikov, od tega 12 pediatričnih oseb (razpon starosti od 6 do 17 let; povprečna vrednost:
Store and transport refrigerated.
Zdravilo shranjujte in prevažajte na hladnem.
Name and address of the manufacturer of the biological active substance
SPROŠČANJE SERIJ Ime in naslov izdelovalca biološke učinkovine
Talk to your doctor before Lamzede is used.
Pred začetkom uporabe zdravila Lamzede se posvetujte z zdravnikom.
In order to obtain long-term data on effectiveness and safety of treatment with Lamzede and to characterize the entire alpha-mannosidosis population, including variability of clinical manifestation, progression and natural history, the MAH is requested to submit the results of a study based on adequate source of data deriving from a registry of patients with alpha-mannosidosis.
vključno z variabilnostjo klinične manifestacije, napredovanja in naravnega poteka bolezni, mora imetnika dovoljenja za promet z zdravilom predložiti rezultate študije na podlagi ustreznih izvornih podatkov, izpeljanih iz registra bolnikov z alfa manozidozo.
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih glavobol zaradi posega
Serum oligosaccharide concentration (μmol/l) Overall(1)
Koncentracija oligosaharidov v serumu (μmol/l)
Dose (mL)
Odmerek (ml)
Common side effects (may affect up to 1 in 10 people) - low heart beat (bradycardia) - psychotic behaviour (mental illness with hallucinations, difficulty in thinking clearly and understanding reality, anxiety), initial difficulty in sleeping - confused state, fainting, tremor, dizziness, headache - intestinal (abdominal) pain, irritation of the stomach caused by digestive acids (reflux gastritis),
Pogosti neželeni učinki (lahko prizadenejo največ 1 od 10 bolnikov) - nizek srčni utrip (bradikardija) - psihotično vedenje (psihična bolezen s halucinacijami, oteženo jasno razmišljanje in razumevanje realnosti, anksioznost), začetne težave s spanjem
Lamzede 10 mg powder for solution for infusion velmanase alfa
Lamzede 10 mg prašek za raztopino za infundiranje velmanaza alfa
Feeling hot(1)
občutek vročine(1)
Each mL of reconstituted solution contains 2 mg of velmanase alfa.
En ml rekonstituirane raztopine vsebuje 2 mg velmanaze alfa.
Appropriate medical support should be readily available when velmanase alfa is administered.
Pri uporabi velmanaze alfa mora biti nujno na voljo ustrezna zdravniška podpora.
Pharmacodynamic
Farmakodinamika
One vial contains 10 mg of velmanase alfa*.
Ena viala vsebuje 10 mg velmanaze alfa*.
Lamzede is a white to off-white powder for solution for infusion, supplied in a glass vial.
Zdravilo Lamzede bel do belkast prašek za raztopino za infundiranje, ki je na voljo v stekleni viali.
A volume of 10 mL sodium chloride solution should be administered through the infusion system to infuse the remaining fraction of Lamzede in the line to the patient.
Preostali del zdravila Lamzede je bolniku treba infundirati tako, da mu aplicirate 10 ml raztopine natrijevega klorida s sistemom za infundiranje.
Reconstituted solution for infusion
3 leti Rekonstituirana raztopina za infundiranje
Lamzede contains sodium
Zdravilo Lamzede vsebuje natrij
Nausea(1)
bruhanje(1)
Antibodies may play a role in treatment-related reactions observed with the use of velmanase alfa.
Pri reakcijah, povezanih z zdravljenjem, o katerih so poročali pri uporabi velmanaze alfa, lahko igrajo vlogo protitelesa.
nausea, vomiting - pain at the site the infusion is given, chills, feeling hot, malaise, tiredness (fatigue) - skin rashes (urticaria), increased sweating (hyperhidrosis) - nosebleed - joint pain, back pain, joint stiffness, muscle pain, pain in extremity (hands, feet) - eye irritation, eyelid swelling (eyelid oedema), eye redness - increased appetite
- bolečine v sklepih, bolečine v hrbtu, okorelost sklepov, bolečine v mišicah, bolečine v okončinah (rokah, nogah) - draženje oči, otekanje vek (edem vek), pordelost oči - povečan apetit
One vial contains 10 mg of velmanase alfa.
Ena viala vsebuje 10 mg velmanaze alfa.
Common side effects (may affect up to 1 in 10 people) - loss of consciousness (fainting, which may be preceded by feeling dizzy, lightheaded or confused) - acute renal insufficiency (kidney problems which can be recognised from fluid retention, swelling in legs, ankles or feet, drowsiness, shortness of breath or fatigue) - hypersensitivity and serious allergic reaction (symptoms including localised or diffuse skin itching, dizziness, difficulty breathing, chest pain, gastrointestinal symptoms such as nausea, vomiting, diarrhea or intestinal pain, swelling of the throat, face, lips or tongue)
- preobčutljivost in resna alergijska reakcija (simptomi, ki vključujejo lokalno ali razpršeno kožno srbečico, vrtoglavico, težave z dihanjem, bolečine v prsnem košu, prebavne simptome, kot so siljenje na bruhanje, bruhanje ali črevesne bolečine, otekanje žrela, obraza, ustnic ali jezika)
IRRs (including hypersensitivity, nausea, vomiting, pyrexia, chills, feeling hot, malaise, urticaria, anaphylactoid reaction and hyperhidrosis) were reported in 9% of the patients (3 out of 33 patients) in clinical studies.
Pri 9 % bolnikov (3 od 33 bolnikov) v kliničnih študijah so poročali o IRR (vključno s preobčutljivostjo, navzeo, bruhanjem, pireksijo, mrzlico, občutkom vročine, neugodjem, urtikarijo, anafilaktoidno reakcijo in hiperhidrozo).
If you experience any side effect like these, please tell your doctor immediately.
Če doživite katerega od teh neželenih učinkov, se nemudoma posvetujte z zdravnikom.
Contents of the pack and other information
Shranjevanje zdravila Lamzede Vsebina pakiranja in dodatne informacije
Very common side effects (may affect more than 1 in 10 people) - diarrhoea - weight increase - fever/increased body temperature
- povečanje telesne mase - povišanje telesne temperature/vročina
The patient should be kept under observation for IRRs for one hour or longer after the infusion, according to the treating physician's judgement.
Glede na presojo zdravnika, je treba bolnika opazovati glede morebitnih IRR eno uro po infundiranju ali dlje.
Pharmacodynamic Domain Response
Odziv na področju farmakodinamike Oligosaharidi
STATEMENT OF ACTIVE SUBSTANCE(S)
Povprečna vrednost (SD)
[95% CI] p-value p=0.406
Vrednost p p = 0,406
Administration of Lamzede should be carried out by a healthcare professional with the ability to manage ERT and medical emergencies.
Zdravilo Lamzede mora dati zdravstveni delavec, ki obvladuje
White to off-white powder.
prašek za raztopino za infundiranje Prašek bele do belkaste barve.
<18 years(2) ≥18 years(2) 3MSCT (steps/min) Overall(1)
3MSCT (koraki/min) Celokupna vrednost(1)
Statistically significant improvements were detected in serum oligosaccharide levels, 3MSCT, pulmonary function, serum IgG
Do zadnjega opazovanja so ugotovili statistično značilna izboljšanja v koncentracijah oligosaharidov v serumu, vrednosti 3MSCT, pljučni funkciji, koncentraciji IgG v serumu ter indeksu zdravja EQ-5D-5L (euro quality of life-5 dimensions) v daljšem časovnem obdobju (preglednica 3).
Malaise(1)
utrujenost neugodje(1)
Renal or hepatic impairment
sinkopa tremor vrtoglavica glavobol
Initial insomnia
Psihiatrične motnje psihotično vedenje začetna nespečnost
[95% CI] p-value p<0.001
Vrednost p p < 0,001
Functional Domain Response Combined
Odziv na področju funkcije
<18 years(2) ≥18 years(2) FVC (% of predicted) Overall(1)
FVC (% predvidene) Celokupna vrednost(1)
<18 years(2) ≥18 years(2) 6MWT (metres) Overall(1)
6MWT (metri) Celokupna vrednost(1)
Eyelid oedema
OVOJNINAH NALEPKA VIALE
In the clinical studies at any time under treatment, 8 patients out of 33 (24%) developed IgG-class antibodies to velmanase alfa.
V kliničnih študijah so se v času zdravljenja pri 8 bolnikih od 33
Hypersensitivity(1)
Bolezni imunskega sistema preobčutljivost(1)
Pregnancy and breast-feeding
siljenje na bruhanje, bruhanje
Musculoskeletal and connective tissue disorders
Jasne povezave med titri protiteles
SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO
Strength Pharmaceutical Form Route of administration Packaging
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
Strength Pharmaceutical Form
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Ref.: EMEA/CHMP/643056/2009 EMEA/H/C/805
EMEA/CHMP/643048/2009 EMEA/H/C/805
This summary was last updated in 09-2009.
Povzetek je bil nazadnje posodobljen 09-2009.
They can be taken with or without food.
Lahko se vzamejo s hrano ali brez nje.
At the start of the study, the patients could exercise for about 7 minutes.
Na začetku študije so lahko bolniki telovadili približno 7 minut.
1 Previously known as Latixa.
1 Prej znano kot Latixa.
The marketing authorisation holder is Menarini International Operations Luxembourg S.A.
Imetnik dovoljenja za promet z zdravilom je družba Menarini International Operations Luxembourg S.A.
The main measure of effectiveness was how long patients could exercise after 12 weeks of treatment, compared with before treatment.
Glavno merilo učinkovitosti je bil čas, kako dolgo so lahko bolniki telovadili po 12tedenskem zdravljenju, v primerjavi s časom pred zdravljenjem.
The name of the medicine was changed to Ranexa on 11 August 2008.
Ime zdravila je bilo 11. avgusta 2008 spremenjeno v Ranexa.
The European Commission granted a marketing authorisation valid throughout the European Union for Latixa on 9 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Latixa, veljavno po vsej Evropski uniji, odobrila družbi dne 9. julija 2008.
It is available as oval prolongedrelease tablets (blue: 375 mg; orange: 500 mg; green: 750 mg).
Na voljo je v obliki ovalnih tablet s podaljšanim sproščanjem (modrih: 375 mg; oranžnih: 500 mg; zelenih: 750 mg).
Ranexa tablets should be swallowed whole and should not be broken, crushed or chewed.
Tablete Ranexa je treba pogoltniti cele in se jih ne sme prelomiti, zdrobiti ali žvečiti.
Ranexa was more effective than placebo at increasing the length of time the patients could exercise.
Zdravilo Ranexa je bilo učinkovitejše od placeba pri povečevanju dolžine časa, ko so bolniki lahko telovadili.
Other information about Ranexa:
Druge informacije o zdravilu Ranexa:
The card will be inserted in the boxes containing the tablets and will include information for patients and healthcare workers explaining how to use the medicine safely.
Kartica bo priložena škatlici s tabletami in bo vsebovala informacije za bolnike in zdravstvene delavce o varni uporabi zdravila.
After two to four weeks, the dose should be increased to 500 mg twice a day, and then to 750 mg twice a day, depending on the patient's response.
Po dveh do štirih tednih je treba odmerek povečati na 500 mg dvakrat na dan in nato na 750 mg dvakrat na dan, odvisno od bolnikovega odziva.
Ranexa has been studied in one main study including a total of 823 patients with an average age of 64 years who had had angina pectoris for at least three months.
Zdravilo Ranexa so proučevali v eni glavni študiji, v katero je bilo skupaj vključenih 823 bolnikov povprečne starosti 64 let, ki so imeli angino pektoris vsaj tri mesece.
‘Prolonged release' means that ranolazine is released slowly from the tablet over a few hours.
„Podaljšano sproščanje“ pomeni, da se ranolazin iz tablet počasi sprošča več ur.
Which measures are being taken to ensure the safe use of Ranexa?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Ranexa?
ranolazine EPAR summary for the public
Povzetek EPAR za javnost
This interferes with the activity of special channels on the cell surface called ‘sodium-dependent calcium channels' through which calcium ions normally enter the cells.
To ovira delovanje posebnih kanalčkov na površini celice, imenovanih „od natrija odvisni kalcijevi kanalčki“, skozi katere kalcijevi ioni običajno vstopajo v celico.
Dose increases should be carried out carefully in the elderly, in patients who weigh less than 60 kg, and in patients who have problems with their kidneys, liver or heart.
Odmerek je treba previdno povečevati pri starejših ljudeh, bolnikih, ki tehtajo manj kot 60 kg, in bolnikih, ki imajo težave z ledvicami, jetri ali srcem.
This reduces the number of calcium ions that enter the cells.
Tako se zniža število kalcijevih ionov, ki vstopajo v celice.
The company that makes Ranexa will agree on the wording of the patient alert card in each Member State.
Družba, ki izdeluje zdravilo Ranexa, se bo dogovorila o besedilu opozorilne kartice za bolnike v posameznih državah članicah.
It must also not be used in patients who are taking other medicines that are broken down in the same way as ranolazine, or certain other medicines that are used to correct the heart rhythm.
Prav tako se ne sme uporabljati pri bolnikih, ki jemljejo druga zdravila, ki se razgrajujejo enako kot ranolazin, ali nekatera druga zdravila, ki se uporabljajo za uravnavanje srčnega ritma.
Ranexa is a medicine that contains the active substance ranolazine.
Ranexa je zdravilo, ki vsebuje zdravilno učinkovino ranolazin.
The recommended starting dose of Ranexa is 375 mg twice a day.
Priporočeni začetni odmerek zdravila Ranexa je 375 mg dvakrat na dan.
The Committee recommended that Ranexa be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Ranexa odobri dovoljenje za promet.
What benefit has Ranexa shown during the studies?
Kakšne koristi je zdravilo Ranexa izkazalo med študijami?
Two doses of Ranexa (750 and 1000 mg twice a day) were compared with placebo (a dummy treatment) as an add-on to commonly used medicines for angina pectoris (atenolol, amlodipine or diltiazem).
Dva odmerka zdravila Ranexa (750 in 1000 mg dvakrat na dan) so primerjali s placebom (zdravilom brez zdravilne učinkovine) kot dodatek k običajno uporabljenim zdravilom za zdravljenje angine pektoris (atenolol, amlodipin ali diltiazem).
After 12 weeks, this increased by an average of 1 minute 56 seconds in the patients adding either dose of Ranexa, and by an average of 1 minute 32 seconds in those adding placebo.
Po 12 tednih se je ta čas pri bolnikih, ki so prejemali kateri koli odmerek zdravila Ranexa, povprečno povečal za 1 minuto in 56 sekund in za povprečno 1 minuto in 32 sekund pri tistih, ki so prejemali placebo.
Ranexa should not be used in people who may be hypersensitive (allergic) to ranolazine or any of the other ingredients.
Zdravila Ranexa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) ranolazin ali katero koli drugo sestavino zdravila.
The most common side effects with Ranexa (seen in between 1 and 10 patients in 100) are dizziness, headache, constipation, vomiting, nausea (feeling sick) and asthenia (weakness).
Najpogostejši neželeni učinki zdravila Ranexa (opaženi pri 1 do 10 bolnikov izmed 100) so omotica, glavobol, zaprtje, bruhanje, navzeja (slabost) in astenija (oslabelost).
The Committee for Medicinal Products for Human Use (CHMP) noted that the effectiveness of Ranexa in improving the symptoms of patients with stable angina pectoris is modest but that it could be of value in patients who have not responded fully to other medicines.
Odbor za zdravila za uporabo v humani medicini (CHMP) je opozoril, da je učinkovitost zdravila Ranexa pri lajšanju simptomov pri bolnikih s stabilno angino pektoris zmerna, a bi lahko bila koristna pri bolnikih, ki se niso popolnoma odzvali na druga zdravila.
For the full list of these medicines, see the Package Leaflet.
Za celoten seznam teh zdravil glejte navodilo za uporabo.
It must not be used in patients who have severe problems with their kidneys or moderate or severe problems with their liver.
Ne smejo ga uporabljati niti bolniki, ki imajo hude težave z ledvicami oziroma zmerne ali hude težave z jetri.
It is used as an add-on to existing treatment in patients whose disease is not adequately controlled by other medicines for angina pectoris, such as beta-blockers or calcium antagonists, or in patients who cannot take these medicines.
Uporablja se kot dodatek k obstoječemu zdravljenju pri bolnikih, pri katerih bolezen ni ustrezno nadzorovana z drugimi zdravili za zdravljenje angine pektoris, kot so zaviralci receptorjev beta ali antagonisti kalcija, ali pri bolnikih, ki ne smejo jemati teh zdravil.
Patients who take Ranexa must be given a ‘patient alert card' that summarises the key safety information on the medicine.
Bolnikom, ki jemljejo zdravilo Ranexa, je treba dati posebno opozorilno kartico, ki povzema najpomembnejše informacije o varnosti zdravila.
Ranexa is used to treat the symptoms of stable angina pectoris (chest pain caused by reduced blood flow to the heart).
Zdravilo Ranexa se uporablja za zdravljenje simptomov stabilne angine pektoris (bolečin v prsih, ki jih povzroča zmanjšan dotok krvi v srce).
By reducing the flow of calcium into the cells, ranolazine is thought to help the heart to relax, improving blood flow to the heart muscle and relieving the symptoms of angina pectoris.
Ranolazin naj bi z zmanjševanjem pretoka kalcija v celice pomagal pri sprostitvi srca, izboljšal pretok krvi v srčno mišico in ublažil simptome angine pektoris.
What is the risk associated with Ranexa?
Kakšna tveganja so povezana z zdravilom Ranexa?
For the full list of all side effects reported with Ranexa, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ranexa, glejte navodilo za uporabo.
Calcium ions normally cause the heart muscle to contract.
Kalcijevi ioni običajno povzročajo krčenje srčne
The full EPAR for Ranexa can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ranexa je na voljo tukaj.
The active substance in Ranexa, ranolazine, is thought to work by reducing the flow of sodium ions into the heart muscle cells.
Zdravilna učinkovina zdravila Ranexa, ranolazin, naj bi delovala tako, da znižuje pretok natrijevih ionov v celice srčne mišice.
Why has Ranexa been approved?
Zakaj je bilo zdravilo Ranexa odobreno?
The Committee decided that Ranexa's benefits are greater than its risks as an add-on treatment of the symptoms of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal medicines (such as beta-blockers and/or calcium antagonists).
Odbor je zaključil, da so koristi zdravila Ranexa kot dodatek k zdravljenju simptomov pri bolnikih s stabilno angino pektoris, katerih bolezen ni ustrezno nadzorovana ali ki se ne odzivajo na antianginozna zdravila prve izbire (kot so zaviralci receptorjev beta in antagonisti kalcija), večje od z njim povezanih tveganj.
What is Ranexa used for?
Za kaj se zdravilo Ranexa uporablja?
How is Ranexa used?
Kako se zdravilo Ranexa uporablja?
How has Ranexa been studied?
Kako je bilo zdravilo Ranexa raziskano?
Doses may need to be lower in patients who have certain side effects.
Najvišji odmerek je 750 mg dvakrat na dan. Odmerke bo morda treba zmanjšati pri bolnikih, pri katerih se pojavijo nekateri neželeni učinki.
What is Ranexa?
Kaj je zdravilo Ranexa?
How does Ranexa work?
Kako zdravilo Ranexa deluje?
Prazitel Plus was first launched in the EU market in May 2009.
Zdravilo Prazitel Plus je prvič prišlo na trg EU maja 2009.
Nematodes:
Nematodi:
Since first marketing, the product has been shown to be well tolerated (very few reports of adverse effects) and there have been no reports of suspected lack of expected efficacy.
Od prvega trženja naprej se je izkazalo, da se izdelek dobro prenaša (zelo malo poročil o neželenih učinkih) in ni bilo nobenih poročil o domnevnem pomanjkanju pričakovane učinkovitosti.
ATC vet code: QP52AA51
Oznaka ATC vet : QP52AA51
A pale yellow tablet with a cross breakline on one side.
Bledo rumena tableta s prelomno linijo na eni strani.
Excipients: For a full list of excipients, see section 6.1.
Pomožne snovi: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
The tablets can be divided into equal halves or equal quarters.
Tableta se lahko razdeli na enaki polovici ali enake četrtine.
Discussion of the data available
Razprava o razpoložljivih podatkih
After absorption, the drug is distributed to all organs.
Po absorbciji se zdravilo prenese v vse organe.
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Navedba ni smiselna
Therefore, use of the product to eliminate the target parasites will benefit both the treated animal and public health.
Zato uporaba zdravila za odpravo ciljnih parazitov koristi tako zdravljeni živali kot tudi javnemu zdravju.
Further, it is considered that use of this product, in accordance with label recommendations in the product literature, sufficiently manages the risk associated with its use.
Poleg tega velja, da uporaba tega zdravila v skladu s priporočili na etiketi v strokovni literaturi o zdravilu v zadostni meri obvladuje tveganje, povezano z njegovo uporabo.