natgillin/translations-raw huggingface dataset:
• dry mouth, inflammation of the inner lining of the mouth
• suha usta, vnetje ustne sluznice;
• severe reactions at the site of infusion
• hude reakcije na mestu infundiranja; • alergijska reakcija;
• joint or muscle pain or discomfort
• bolečine ali nelagodje v sklepih ali mišicah;
• abnormal sensation such as tingling, burning, pricking or numbness of the skin or in the mouth
• zmanjšana občutljivost za dotik ali bolečino; • nenormalni občutki, kot so mravljinčenje, pekoč občutek, zbadanje ali omrtvelost, ki se pojavijo na koži ali v ustih;
• diarrhoea, nausea, vomiting
• driska, siljenje na bruhanje, bruhanje;
Gastrointestinal adverse reactions are very common.
Neželeni učinki na prebavila so zelo pogosti.
• low level of blood platelets or red blood cells
• nizka raven belih krvničk, imenovanih levkociti in granulociti; • nizka raven krvnih ploščic ali rdečih krvničk;
Neuropathy
Nevropatija
Common (may affect up to 1 in 10 people):
pogosti (pojavijo se lahko pri največ 1 od 10 bolnic):
General disorders and administration site conditions Asthenia and fatigue were very common and occurred in 23% and 11% of patients, respectively.
Zelo pogosti sta bili astenija (pri 23 % bolnic) in utrujenost (pri 11 % bolnic).
• chest pain or discomfort
• bolečine ali nelagodje v prsnem košu;
For patients with moderate to severe impairment (total bilirubin > 1.5 to ≤ 5 × ULN and AST ≤ 10 × ULN), a 20% reduction in dose is recommended.
Pri bolnicah z zmerno do hudo okvaro (skupna količina bilirubina > 1,5 do ≤ 5 × ULN in
• have a count of white blood cells called neutrophils below 1.5 × 109/L before start of the therapy
• če imate pred začetkom zdravljenja število belih krvničk, imenovanih nevtrofilci, nižje od
When reconstituted, this medicinal product contains up to approximately 1.6 g sodium per dose (0.9 g/m2 BSA; 3.6 mg per mL), equivalent to 80% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
3,6 mg/ml), kar je enako 80 % največjega dnevnega vnosa za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
• Common (may affect up to 1 in 10 people):
• zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnic):
• numbness, tingling, pricking sensation, sensitivity to touch or muscle weakness You may need additional medicines if you develop any of these symptoms.
• omrtvelost, mravljinčenje, zbadanje, občutljivost na dotik ali oslabelost mišic.
Shelf life after reconstitution
Rok uporabe po rekonstituciji
• cancer of the fallopian tubes (the connection between the ovaries and the womb) It is used when other therapies have not worked.
• rak jajcevodov (povezave med jajčniki in maternico).
• blurred vision, eye discomfort or irritation, watery eyes
• zamegljen vid, neprijeten občutek v očeh ali draženje oči, solzne oči;
However, a population pharmacokinetics study of 168 patients (86 males and 82 females) treated with solvent-based paclitaxel has been reported.
Vpliv starosti, spola, rase in telesne velikosti Analize vpliva starosti, spola ali telesne velikosti na izločanje zdravila Apealea niso izvedli, so pa poročali o farmakokinetični študiji pri skupini 168 bolnikov (86 moških in 82 žensk), ki so jih zdravili s paklitakselom na osnovi topila.
Hypersensitivity
hiperemija
d Includes the following preferred terms: infusion site pain, infusion site phlebitis, infusion site reaction, infusion site discolouration, infusion site erythema, infusion site extravasation, infusion site inflammation, infusion site oedema, infusion site paraesthesia, infusion site irritation, and infusion site rash.
reakcija na mestu infundiranja, sprememba barve kože na mestu infundiranja, eritem na mestu infundiranja, ekstravazacija na mestu infundiranja, vnetje na mestu infundiranja, edem na mestu infundiranja, parestezija na mestu infundiranja, draženje na mestu infundiranja in izpuščaji na mestu infundiranja.
Apealea is a cancer medicine containing the active substance paclitaxel, which belongs to a group of medicines called taxanes.
Apealea je zdravilo proti raku z učinkovino paklitaksel.
Hypotension, flushing, phlebitis, vein pain, hyperaemia
hipotenzija, rdečica, flebitis, bolečine v venah,
The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 (see section 5.2).
Dajanje paklitaksela skupaj z zdravili, za katera je znano, da inducirajo CYP2C8 ali CYP3A4 (npr.
Forest plot for OS by relapse (PP population)
Drevesni diagram za OS glede na recidiv (populacija PP)
Uncommon: Vaginal haemorrhage, pelvic pain, breast pain
vaginalne krvavitve, medenična bolečina, bolečina v dojkah
Posology
Ugotoviteva
Tell your doctor or nurse immediately if you have any of the following: • Very common (may affect more than 1 in 10 people):
• otekanje gležnjev, stopal, obraza ali prstov; občasni (pojavijo se lahko pri največ 1 od 100 bolnic):
Paclitaxel (solvent-based)
Paklitaksel (na osnovi topila)
Not known:
Občasni:
− N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt
− natrijeva sol metilnega estra N-(all-trans retinol)-L-cisteinske kisline
Dose recommendations for Apealea as well as for carboplatin in the case of myelosuppression should be followed (see section
Pri mielosupresiji je treba upoštevati priporočila glede odmerkov zdravila Apealea in karboplatina (glejte poglavje 4.2).
Almost all patients experienced anaemia, decreased platelet count and decreased white blood cell count of any grade during the treatment period (98%, 93% and 98%, respectively).
zmanjšano število krvnih ploščic oziroma zmanjšano število belih krvnih celic katere koli stopnje (pri
Hypersensitivity Uncommon: Anaphylactic shock, drug hypersensitivity
anafilaktični šok, preobčutljivost za zdravilo
• mouth and throat pain or discomfort, throat disorder, bleeding gums
• bolečine ali nelagoden občutek v ustih in grlu, bolezen grla, krvavitev iz dlesni; • vnetje želodčne sluznice, nelagodje ali napihnjenost v trebuhu, bolečine v spodnjem delu trebuha;
− blood vessel inflammation
− vnetje krvnih žil;
Administration precautions
Previdnostni ukrepi pri dajanju zdravila
Nervous system disorders
ali motorična nevropatija stopnje
infection
ZDRAVILA
− N-(13-cis-retinoyl)-L-cysteic acid methyl ester sodium salt
− natrijeva sol metilnega estra N-(13-cis retinol)-L-cisteinske kisline
• breathing difficulties, nasal congestion
• odpoved pljuč, zožitev dihalnih poti;
Uncommon: Respiratory failure, epistaxis, cough, rhinorrhoea, oropharyngeal pain, pharyngeal disorder, asphyxia, bronchospasm, dysphonia, rhinitis allergic, allergic cough, oropharyngeal discomfort Gastrointestinal disorders Very common: Diarrhoeaa, nauseaa, vomitinga
asfiksija, bronhospazem, disfonija, alergijski rinitis, alergijski kašelj, orofaringealno nelagodje
Gastrointestinal disorders
diseminirana intravaskularna koagulacijaa,
Dyspnoea, nasal congestion
hematohezija, parestezija ust
Only reconstitute Apealea using one of the following commercially available solutions for reconstitution: - sodium chloride 9 mg/mL (0.9%) solution suitable for infusion; - lactated Ringer's solution suitable for infusion; - acetated Ringer's solution suitable for infusion.
• natrijev klorid 9 mg/ml (0,9 %) raztopina, primerna za infundiranje;
• inflammation of the stomach lining, abdominal discomfort or bloating, lower abdominal pain
bolečina v spodnjem delu trebuha, dispepsija, trdo blato, motnja delovanja črevesja, krvavitev dlesni,
Antihistamines
Žilne bolezni
− puffing of the face
− zabuhel obraz.
This is similar to that seen in most of the earlier studies.
To je podobno kot v večini predhodnih študij.
The uptake of water should be monitored frequently.
Vnos vode je treba pogosto spremljati.
No other source of drinking water should be available.
Noben drug vir pitne vode ne sme biti na voljo.
Chickens were authorised as a target species in Belgium, France, Hungary and Poland.
Piščanci Piščanci so bili dovoljeni kot ciljna živalska vrsta v Belgiji, Franciji, na Madžarskem in Poljskem.
However, also see text under section 4.4.
Glejte tudi poglavje 4.4.
The possible risk for the environment has not been considered as part of this referral.
Morebitno tveganje za okolje ni bilo obravnavano kot del tega napotitvenega postopka.
There is no specific antidote, treatment is symptomatic.
Specifičnega antidota ni, zdravljenje je simptomatsko.
Hungary Zoetis Hungary Kft. Budapest, Alkotás u.
Madžarska Zoetis Hungary Kft. Budapest, Alkotás u.
• The restriction of the indications to those that are adequately substantiated by efficacy data;
• omejitve indikacij na tiste, ki so ustrezno utemeljene s podatki o učinkovitosti;
The main areas of disharmony in the existing product information relate to:
Glavna področja neskladja v obstoječih informacijah o zdravilu se nanašajo na:
ATC Vet Code: QJ01FF02
Oznaka ATC vet: QJ01FF02
This evaluation focuses on issues in regards to the harmonisation that may change the benefit-risk balance.
To vrednotenje se osredotoča na vprašanja v zvezi z usklajevanjem, ki lahko spremenijo razmerje med koristmi in tveganjem.
Human and animal bacteria share the same resistance determinants.
Bakterije človeka in živali imajo enake determinante odpornosti.
The description and validation of the GC/MS analytical method was considered acceptable.
Opis in validacija analitične metode GC/MS sta se štela za sprejemljivo.
The daily amount is to be added to the drinking water in such a way that all medication will be consumed within 24 hours.
Dnevno količino dodamo v pitno vodo tako, da bo vso zdravilo porabljeno v 24 urah.
Care should be taken not to raise and inhale any dust.
Treba je paziti, da se ne dviguje in vdihava prahu.
The medicated water should be the only source of drinking water for the animals for the entire duration of the treatment period.
Medicirana voda mora biti edini vir pitne vode za živali za celotno trajanje zdravljenja.
Contact with skin and eyes should be avoided.
Izogibajte se stiku s kožo in očmi.
As such, these data are considered to support extrapolation of the findings from the abovementioned studies conducted in the USA in the 1980s to the current EU situation.
Podatki v tej obliki se štejejo, da podpirajo ekstrapolacijo ugotovitev iz zgoraj omenjenih študij, izvedenih v ZDA v 1980-ih, na trenutne razmere v EU.
The intake of medicated water depends on the physiological and clinical condition of the animals.
Vnos medicirane vode je odvisen od fiziološkega in kliničnega stanja živali.
In order to obtain the correct dosage, the concentration of the lincomycin has to be adjusted accordingly.
Da bi dobili pravilen odmerek, je treba ustrezno prilagoditi koncentracijo linkomicina.
The concentration to be used depends on the actual body weight and the water consumption of the animals and can be calculated according to the following formula:
Koncentracija, ki jo je treba uporabiti, je odvisna od dejanske telesne mase in porabe vode živali in se lahko izračuna v skladu z naslednjo formulo:
Repeated or prolonged use should be avoided by improving the farm management and hygiene practices.
Večkratni ali dolgotrajnejši uporabi se je treba izogniti z izboljšanjem upravljanja kmetij in higienskih dobrih praks.
The use of suitably calibrated weighing equipment is recommended if part packs are used.
Priporoča se uporaba primerne kalibrirane opreme za tehtanje, če se uporabljajo delne količine.
Pigs were already authorised as a target species for all products concerned by this referral procedure.
Prašiči so že bili odobreni kot ciljna živalska vrsta za vsa zdravila, na katera se nanaša ta napotitveni postopek.
In both studies significant differences were noted in mortality rates between birds treated with lincomycin (0% and 0.7%, respectively) and negative controls (14% and 7.5%, respectively).
V obeh študijah so opazili pomembne razlike v stopnji smrtnosti med pticami, zdravljenimi s linkomicinom (0 % in 0,7 %) ter negativnimi kontrolami (14 % in 7,5 %).
Average daily water intake (litre/animal)
Povprečni dnevni vnos vode (l/žival)
The number of animals (18 castrated males and 18 females) included in the study and their weights (36.5 to 71 kg) were adequate.
Število živali (18 kastriranih samcev in 18 samic), vključenih v študijo, in njihova telesna masa (36,5-71 kg) sta bila primerni.
Both of these studies included 1116 birds which were divided into treatment and negative control groups.
V študijo je bilo vključenih 1116 ptic, ki so bile razdeljene v skupini za zdravljenje in negativno kontrolo.
Do not eat, drink or smoke while handling the product.
Med ravnanjem z zdravilom ne jejte, ne pijte ali kadite.
Excipients: For the full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
The referral leads to full harmonisation of the product information.
Rezultat napotitve je popolna uskladitev informacij o zdravilu.
In case of insufficient uptake of water, pigs should be treated parenterally.
V primeru nezadostnega vnosa vode je treba prašiče zdraviti parenteralno.
Levels were detectable for 12 to 16 hours, with peak concentrations occurring at 4 hours.
Vrednosti so bile zaznane za 12 do 16 ur, največje koncentracije pa so se pojavile pri 4 urah.
The potential risk of resistance development, which might impact product efficacy, and overall animal and human health, is limited through:
Tveganje za razvoj odpornosti, ki bi lahko vplivalo na učinkovitost zdravila in splošno zdravje živali in ljudi, je omejeno zaradi:
Use only according to the benefitrisk assessment by the responsible veterinarian.
Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
Administration conditions: Administration under the control or direct responsibility of a veterinary surgeon.
Uporabe pogoji: Uprava pod nadzorom ali neposredno odgovornost veterinarja.
While the lincosamides are generally considered to be bacteriostatic agents, the activity depends on the sensitivity of the organism and concentration of the antibiotic.
Medtem ko se linkozamidi na splošno štejejo za bakteriostatične, je aktivnost odvisna od občutljivosti organizma in koncentracije antibiotika.
The bioequivalence between the soluble powder and the premix formulation was investigated in two studies, but could not be formally demonstrated.
Biološko enakovrednost med topnim praškom in formulacijo predmešanice so proučili v dveh študijah, vendar je niso mogli formalno dokazati.
The European Commission referred the issue due to divergent national decisions having been taken by the Member States (EU/EEA) resulting in discrepancies in the product information for Lincocin and its associated names (thereafter called Lincocin).
Evropska komisija je to vprašanje napotila zaradi različnih nacionalnih odločitev držav članic (EU/EGP), ki so privedle do razlik v informacijah o zdravilu za zdravilo Lincocin in povezana imena (v nadaljevanju imenovano Lincocin).
The oral absorption of lincomycin was found to be 53% +/- 19%.
Ugotovljeno je bilo, da peroralna absorpcija linkomicina znaša 53% +/- 19%.
The doses used in these studies were in line with the proposed dose of 10 mg/kg body weight.
Odmerki, uporabljeni v teh študijah, so bili v skladu s predlaganim odmerkom 10 mg/kg telesne mase.
The indication against swine dysentery caused by B. hyodysenteriae could no longer be maintained and was removed.
Indikacije proti prašičji dizenteriji, ki jo povzroča B. hyodysenteriae, ni več mogoče ohraniti in je bila izbrisana.
PROHIBITION OF SALE, SUPPLY AND/OR USE Dispensing conditions: Veterinary medicinal product subject to veterinary prescription.
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Pogoji za dostavo: veterinarsko zdravilo, za katerega velja veterinarski recept.
Lincomycin is eliminated unchanged or in the form of various metabolites in bile and urine.
Linkomicin se izloči nespremenjeno ali v obliki različnih metabolitov v žolču in urinu.
Overall summary of the scientific evaluation of Lincocin and its associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Lincocin in povezanih imen (glejte Prilogo I)
• The inclusion of information about resistance status and warnings about prudent use as regards resistance, in SPC sections 4.4 ‘Special warnings for each target species', 4.5 (i) ‘Special precautions for use in animals' and 5.1 ‘Pharmacodynamic properties'.
• vključitvijo informacij o stanju odpornosti in opozoril o preudarni rabi v zvezi z odpornostjo v poglavja 4.4 „Posebna opozorila za vsako ciljno živalsko vrsto“, 4.5 (i) „Posebni previdnostni ukrepi za uporabo pri živalih“ in 5.1 „Farmakodinamične lastnosti“ v povzetku glavnih značilnosti zdravila.
The slaughter times (0 hours after 3 days of medication and 0, 6, 12 and 24 hours after 21 days of medication) were well distributed to support the proposed zero-day withdrawal period.
Časi zakola (0 ur po 3 dneh zdravljenja in 0, 6, 12 in 24 ur po 21 dneh zdravljenja) so bili dobro razporejeni, da bi podprli predlagano karenco nič dni.
Risks for users were considered low and adequate information is included in the product information to ensure the safety for the user.
Tveganje za uporabnike je bilo ocenjeno kot nizko, informacije o zdravilu pa vsebujejo ustrezne informacije za zagotavljanje varnosti uporabnikov.
At 2 days after the end of treatment, residues in liver, kidney and muscle were all below the MRLs.
Po 2 dneh po koncu zdravljenja so bili vsi ostanki v jetrih, ledvicah in mišicah pod ravnijo MRL.
After the end of the medication period, the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
Po končanem zdravljenju je treba vodovodni sistem ustrezno očistiti, da se prepreči vnos subterapevtskih količin zdravilne učinkovine.
The excreta contained mostly unmetabolised lincomycin (60-85%) during treatment.
Med zdravljenjem so izločki vsebovali večinoma ne-metaboliziran linkomicin (60-85%).
On 5 July 2016 the European Commission sent a referral notification under Article 34 of Directive 2001/82/EC to the European Medicines Agency for Lincocin and its associated names.
Evropska komisija je 5. julija 2016 Evropsko agencijo za zdravila obvestila o napotitvi na podlagi člena 34 Direktive 2001/82/ES za zdravilo Lincocin in povezana imena.
Allergic/hypersensitive reactions occur on rare occasions.
Alergične/preobčutljivostne reakcije so redke.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Lincomycin and one unknown metabolite comprised >50% of the muscle residue at zero hours.
Linkomicin in en neznan metabolit sta predstavljala > 50% mišičnega ostanka v ničelnih urah.
It was calculated that a concentration of 16.9 mg/l was the minimal dose that would give the maximum effect; this corresponds with a calculated dose of 3.9 mg/kg body weight.
Izračunali so, da je koncentracija 16,9 mg/l minimalni odmerek, ki bi imel največji učinek; to ustreza izračunanemu odmerku 3,9 mg/kg telesne mase.
The harmonised warnings and precautions proposed in the product information were considered adequate to ensure safety to users of the product.
Usklajena opozorila in previdnostni ukrepi, predlagani v informacijah o zdravilu, so se šteli za primerne za zagotovitev varnosti uporabnikov zdravila.
Do not use in cases of hepatic dysfunction.
Ne uporabite v primeru jetrne disfunkcije.
For example, the results of the study conducted by the marketing authorisation holder in 2016 with 92 European isolates showed a MIC range of 0.5 μg/ml to >256 μg/ml and a tri-modal MIC distribution for lincomycin against C. perfringens (peaks at 1 μg/ml, 8 μg/ml and >256 μg/ml), with the majority of isolates falling outside the apparent wild-type population.
Na primer, rezultati študije, ki jo je leta 2016 opravil imetnik dovoljenja za promet na 92 evropskih izolatih, kažejo razpon vrednosti MIK od 0,5 μg/ml do > 256 μg/ml in trimodalno porazdelitev vrednosti MIK linkomicina proti C. perfringens (vrhovi pri 1 μg/ml, 8 μg/ml in > 256 μg/ml), pri čemer večina izolatov ne spada v navidezno populacijo sevov divjega tipa.
The minimum effective dose would appear to be approximately 4 mg/kg per kg of body weight and selection of this dose would result in a maximal therapeutic index.
Kaže, da je najmanjši učinkovit odmerek približno 4 mg/kg na kg telesne mase in izbira tega odmerka bi privedla do največjega terapevtskega indeksa.
Laboratory studies in rats have not produced any evidence of teratogenic effects, although foetotoxicity has been reported.
Z laboratorijskimi študijami na podganah niso bili dokazani teratogeni učinki, čeprav so poročali o fetotoksičnosti.
Indeed, there was evidence, albeit from a subclinical infection model, that MIC values above those for the apparent wild-type population do not necessarily correlate to a lack of clinical effectiveness of lincomycin (Lanckriet et al., 2010)2.
Prav nasprotno, obstajajo dokazi, čeprav iz modela subklinične okužbe, da vrednosti MIK, ki so višje od koncentracij za navidezno populacijo divjega tipa, niso nujno povezane z zmanjšano klinično učinkovitostjo linkomicina (Lanckriet et al., 2010)2.
Metabolites comprised more than 75% of total residues in the liver.
Presnovki so predstavljali več kot 75% vseh ostankov v jetrih.
Tissue residues levels were measured in composite samples from 4 birds at 0, 2 and 7 days after the end of treatment.
Raven ostankov v tkivu so izmerili v sestavljenih vzorcih iz 4 ptic, odvzetih 0, 2 in 7 dni po koncu zdravljenju.
Similar results were observed following single oral doses of 4.4 and 11.0 mg/kg body weight in pigs.
Podobne rezultate so opazili po enkratnih peroralnih odmerkih 4,4 in 11,0 mg / kg telesne mase pri prašičih.
This benefit-risk evaluation is performed in the context of Article 34 of Directive 2001/82/EC, which in the present procedure has the purpose of obtaining harmonisation within the EU of the conditions of authorisation for the product Lincocin and its associated names.
To vrednotenje koristi in tveganja je bilo opravljeno v okviru člena 34 Direktive 2001/82/ES, ki je v tem postopku namenjen uskladitvi pogojev za izdajo dovoljenja za zdravilo Lincocin in z njim povezanih imen v EU.
List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskih vrst, poti uporabe, imetnikov dovoljenja za promet v državah članicah
However, as the dosing regimens and indications have not been extended, there is no increase in the exposure of the environment to the active substance.
Ker se sheme odmerjanja in indikacije niso razširile, se izpostavljenost okolja zdravilni učinkovini ne poveča.
If respiratory symptoms develop following exposure, seek medical advice and show this warning to the physician.
Če se po izpostavitvi pojavijo dihalni simptomi, poiščite zdravniško pomoč in to opozorilo pokažite zdravniku.
Use of the veterinary medicinal product preferably should be based on identification of the target pathogen and susceptibility testing of the bacteria isolated from the animal.
Uporaba zdravila mora prednostno temeljiti na identifikaciji ciljnega patogena in občutljivostnih testih bakterij, izoliranih iz živali.
In case of accidental exposure to the skin, eyes or mucous membranes, wash the affected area thoroughly with plenty of water.
V primeru nenamernega kontakta s kožo, očmi ali sluznicami, temeljito sperite prizadeto območje z veliko vode.
Evaluation and conclusions on the benefit-risk balance
Vrednotenje in zaključki o razmerju med tveganji in koristmi
Resistance can be a direct concern when affecting zoonotic pathogens such as Campylobacter and Enterococcus, or can be transferred horizontally to human pathogens via mobile genetic elements.
Odpornost je lahko neposredno zaskrbljujoča, če se pojavi pri povzročiteljih zoonoz, kot sta Campylobacter in Enterococcus, ali če se je zmožna horizontalno prenesti na človeške bolezenske povzročitelje prek mobilnih genskih elementov.
• The revised harmonised SPC of Lincocin contains the necessary information to ensure the safe and effective use of the product.
• Usklajen in popravljen povzetek glavnih značilnosti zdravila Lincocin vsebuje potrebne informacije za zagotavljanje varne in učinkovite uporabe zdravila.