natgillin/translations-raw huggingface dataset:
Brilliant Blue (E133) Red AC (E129) Vanillin
Pomoćne tvari: briljantno modra (E133) alurno crvena AC (E129)
It is normal to find vaccinal oocysts in the intestine or litter of vaccinated flocks.
Normalno je naći vakcinalne oociste u probavnom sustavu ili stelji cijepljenog jata pilića.
10 ml, 50 ml or 100 ml type I colourless glass vials containing 7 ml, 35 ml or 70 ml of suspension (1,000, 5,000 and 10,000 doses) closed with type I polymeric elastomer closures and aluminium caps.
I od 10 ml, 50 ml ili 100 ml koje sadrže 7 ml, 35 ml ili 70 ml suspenzije (1 000, 5 000 i 10 000 doza) zatvorene čepovima od polimerskog elastomera tipa
Evalon (vaccine)
Evalon (cjepivo)
The correct replication of the vaccine oocysts and consequently, the development of a solid immunity could be hindered.
To može spriječiti ispravno umnažanje vakcinalnih oocista i razvitak učinkovite imunosti.
ARBUSET, Produtos Farmacêuticos e Sanitários De Uso Animal, Lda
Portugal ARBUSET, Produtos Farmacêuticos e Sanitários
Before starting the preparation, make certain to have a clean container available with sufficient capacity for preparing the diluted vaccine suspension.
Prije početka pripreme, provjerite da je dostupan čisti spremnik dovoljne zapremnine za pripremu suspenzije razrijeđenog cjepiva.
Chickens must be strictly floor-reared in the first 3weeks after vaccination.
Pilići se prva 3 tjedna nakon cijepljenja moraju uzgajati isključivo podnim načinom.
HIPRA EΛΛAΣ A.E. Ψuχάρη 3 / 184 53 Níκαια Tηλ: 210 4978660 - Fax: 210 4978661 e-mail: greece@hipra.com
Ψuχάρη 3 / 184 53 Níκαια Tηλ: 210 4978660 - Fax: 210 4978661
HIPRAMUNE T (solvent):
HIPRAMUNE T (otapalo):
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vaccine vial of 10,000 doses
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Bočica cjepiva od 10 000 doza.
Shelf life after dilution according to directions: 10 hours.
Rok valjanosti poslije razrjeđenja prema uputi: 10 sati.
One dose of vaccine (0.007 ml) from 1 day of age.
Jedna doza cjepiva (0,007 ml) nakon 1 dana starosti.
Evalon (vaccine):
Evalon (cjepivo):
Innovation Center BioCity Nottingham Pennyfoot Street
BioCity Nottingham
Marketing authorisation holder and manufacturer responsible for batch release: Laboratorios Hipra, S.A.
Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: Laboratorios Hipra, S.A.
Vaccination schedule: One dose of vaccine (0.007 ml) from 1 day of age.
Raspored cijepljenja: Jedna doza cjepiva (0,007 ml) nakon 1 dana starosti.
Fill the reservoir of the spraying device with all the vaccine suspension prepared.
Napunite spremnik uređaja za raspršivanje cijelim pripremljenim sadržajem otopine za cijepljenje.
Each dose (0.007 ml) of undiluted vaccine contains:
Svaka doza (0,007 ml) nerazrijeđenog cjepiva sadrži:
To be mixed with the solvent.
Pomiješati s otapalom.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim s diluentom priloženim za primjenu s proizvodom.
HIPRAMUNE T (solvent) - Brilliant blue (E 133) - Red AC (E 129) - Vanillin - Montanide IMS
- boja briljantno modra (E 133) - boja alurno crvena AC (E 129)
Alignment of the supplier's specifications for Foetal Bovine Serum (FBS) with the applicant's internal specifications for FBS, ensuring Ph. Eur.
Foetal Bovine Serum, FBS) dobavljača s internim specifikacijama podnositelja zahtjeva za FBS, koje osigurava sukladnost s Europskom farmakopejom.
Polypropylene (PP) vials containing 50 ml, 250 ml and 500 ml of solvent closed with type I polymeric elastomer closures and aluminium caps.
Bočice od polipropilena (PP) koje sadrže 50 ml, 250 ml i 500 ml otapala zatvorene čepovima od polimerskog elastomera tipa
Do not use in birds in lay and within 2 weeks before the onset of the laying period
Ne primjenjivati na nesilicama za vrijeme nesenja i 2 tjedna prije početka razdoblja nesenja.
Alignment of the manufacturers' specifications for the plastic containers with the applicant's internal specifications for the plastic containers, ensuring Ph. Eur.
Usklađivanje specifikacija plastičnih spremnika proizvođača s unutarnjim specifikacijama podnositelja zahtjeva za plastične spremnike, koje osigurava sukladnost s Europskom farmakopejom (engl.
Phosphate buffered solution (PBS): - Potassium chloride - Disodium phosphate dodecahydrate - Potassium dihydrogen phosphate
- kalijev klorid - dinatrijev fosfat dodekahidrat
Each dose (0.007 ml) of undiluted vaccine contains
Svaka doza (0,007 ml) nerazrijeđenog cjepiva sadrži
For active immunisation of chicks from 1 day of age to reduce clinical signs (diarrhoea), intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Za aktivnu imunizaciju pilića od 1 dana starosti, za smanjivanje kliničkih znakova (proljeva), oštećenja crijeva i izlučivanja oocisti povezanih s kokcidiozom uzrokovanom s: Eimeria acervulina,
Eimeria acervulina, strain 003 ......................................... 332-450 Eimeria brunetti, strain 034 ............................................. 213-288 Eimeria maxima, strain 013 ............................................. 196-265 Eimeria necatrix, strain 033 ............................................. 340-460 Eimeria tenella, strain 004 ............................................... 276-374
Eimeria acervulina, soj 003 ............................................. 332-450 Eimeria brunetti, soj 034 ................................................. 213-288 Eimeria maxima, soj 013.................................................. 196-265 Eimeria necatrix, soj 033 ................................................. 340-460 Eimeria tenella, soj 004 ................................................... 276-374
de Susqueda, Amer, 17170 Gerona, Spain
Crta. de Susqueda, Amer, 17170 Gerona, Spain
The MAH shall complete, within the stated timeframe, the following measures:
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET Nositelj odobrenja treba u zadanom vremenskom razdoblju provoditi sljedeće mjere:
Vaccinate healthy chickens only.
Cijepite samo zdrave životinje.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČI BIOLOŠKI DJELATNEIH TVARI I PROIZVOĐAČI ODGOVORANI ZA PUŠTANJE SERIJE U PROMET
HIPRAMUNE T (solvent)
HIPRAMUNE T (otapalo)
Carretera C-63, km 48.300, Polígono Industrial El Rieral Amer, 17170 Gerona, Spain
Carretera C-63, km 48.300, Polígono Industrial El Rieral
Eimeria acervulina, strain 003 .................................... 332 - 450 * Eimeria brunetti, strain 034 ........................................ 213 - 288 * Eimeria maxima, strain 013 ........................................ 196 - 265 * Eimeria necatrix, strain 033 ........................................ 340 - 460 * Eimeria tenella, strain 004 .......................................... 276 - 374 *
Eimeria acervulina, soj 003 ......................................... 332 - 450* Eimeria brunetti, soj 034 ............................................. 213 - 288* Eimeria maxima, soj 013.............................................. 196 - 265* Eimeria necatrix, soj 033 ............................................. 340 - 460* Eimeria tenella, soj 004 ............................................... 276 - 374*
Administration route:
Put primjene:
No anticoccidial substances or other agents having anticoccidial activity via feed or water should be used for at least 3 weeks following vaccination of the chickens.
Najmanje 3 tjedna nakon cijepljenja pilićima se u hrani ili vodi ne smiju davati antikokcidijski veterinarsko-medicinski proizvodi ili bilo kakva druga sredstva koja imaju antikokcidijsku aktivnost.
Maintain the diluted vaccine suspension in continuous homogenisation by using a magnetic stirrer while the vaccine is being administered via coarse spray to the chicks.
Za vrijeme raspršivanja velikim kapljicama na pilićima, neka razrijeđena suspenzija cjepiva bude uvijek homogena pomoću magnetske miješalice.
Doses
Doze
BELGIUM e-mail: benelux@hipra.com
e-mail: benelux@hipra.com
HIPRA BENELUX NV Adequat Business Center Brusselsesteenweg 159 9090 Melle
Adequat Business Center Brusselsesteenweg 159
PACKAGE LEAFLET: Evalon suspension and solvent for oral spray for chickens
UPUTA O VMP: Evalon suspenzija i otapalo za peroralni sprej za piliće
Shelf life of HIPRAMUNE T as packaged for sale: 2 years.
Rok valjanosti veterinarsko-medicinskog proizvoda HIPRAMUNE T kada je zapakiran za prodaju: 2 godine.
Evalon suspension and solvent for oral spray for chickens.
Evalon suspenzija i otapalo za peroralni sprej za piliće.
Read package leaflet before use.
Pročitati uputu o VMP prije primjene.
Store and transport refrigerated.
PUT(EVI) PRIMJENE Čuvati i prevoziti na hladnom.
Suspension for oral spray.
OBLIK Suspenzija za peroralni sprej.
Shelf life of the veterinary medicinal product as packaged for sale: 10 months.
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 10 mjeseci.
Cardboard box with one vial of 5,000 doses (35 ml) and one vial with 250 ml of solvent.
Kartonska kutija s jednom bočicom od 5 000 doza (35 ml) i jednom bočicom s 250 ml otapala.
40470 Düsseldorf DEUTSCHLAND e-mail: deutschland@hipra.com
Münsterstraße 306 40470 Düsseldorf e-mail: deutschland@hipra.com
Shelf life of Evalon as packaged for sale: 10 months.
Rok valjanosti veterinarsko-medicinskog proizvoda Evalon kada je zapakiran za prodaju: 10 mjeseci.
HIPRA DEUTSCHLAND GmbH Münsterstraße 306
Deutschland HIPRA DEUTSCHLAND GmbH
Cardboard box with one vial of 10,000 doses (70 ml) and one vial with 500 ml of solvent.
Kartonska kutija s jednom bočicom od 10 000 doza (70 ml) i jednom bočicom s 500 ml otapala.
- Sodium chloride
- kalijev dihidrogenfosfat
Ul.
C.
compliance.
Odbora.
Cardboard box with one vial of 1,000 doses (7 ml) and one vial with 50 ml of solvent.
Kartonska kutija s jednom bočicom od 1 000 doza (7 ml) i jednom bočicom s 50 ml otapala.
Suspension and solvent for oral spray.
OBLIK Suspenzija i otapalo za peroralni sprej.
One vial of 5,000 doses and one vial with 250 ml of HIPRAMUNE T (solvent).
Jedna bočica od 5 000 doza i jedna bočica s 250 ml HIPRAMUNE T (otapalo).
- 02 51 80 77 91 Fax - 02 51 8082 20 e-mail: france@hipra.com
HIPRA FRANCE 7 rue Roland Garros, Batiment H 44700 - Orvault Tél. - 02 51 80 77 91 Fax - 02 51 8082 20
One vial of 10,000 doses and one vial with 500 ml of HIPRAMUNE T (solvent).
Jedna bočica od 10 000 doza i jedna bočica s 500 ml HIPRAMUNE T (otapalo).
One vial of 1,000 doses and one vial with 50 ml of HIPRAMUNE T (solvent).
Jedna bočica od 1 000 doza i jedna bočica s 50 ml HIPRAMUNE T (otapalo).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial of 50 ml, 250 ml or 500 ml
Bočice otapala od 50 ml, 250 ml ili 500 ml
NG1 1GF e-mail: ukandireland@hipra.com
e-mail: ukandireland@hipra.com
Coarse spray.
Raspršivanje velikim kapljicama.
Name and address of the manufacturer of the biological active substances
PROIZVOĐAČI BIOLOŠKI DJELATNIH TVARI I PROIZVOĐAČI
SPECIAL WARNING(S), IF NECESSARY
POSEBNO(A) UPOZORENJE(A), UKOLIKO JE POTREBNO Pročitati uputu o VMP-u prije primjene.
Pack sizes
Cjepivo Otapalo
Solvent: Dark brownish solution.
Otapalo: tamna smećkasta otopina.
02-954 - WARSZAWA e-mail: admin.polska@hipra.com
e-mail: admin.polska@hipra.com
SOLVENT
vanilin
Solvent
NUSPOJAVE
Withdrawal period: Zero days.
KARENCIJA(E) Karencija: nula dana.
Tél.
Ne zamrzavati
Shake the solvent vial.
UPUTA O VMP
NG1 1GF - UNITED KINGDOM e-mail: ukandireland@hipra.com
NG1 1GF - UNITED KINGDOM
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN I PUT(EVI) PRIMJENE Peroralna uporaba.
The method of administration is by coarse spray.
Način primjene je raspršivanje velikim kapljicama.
Batch {number}
<Serija> <Lot> {broj}
Evalon suspension for oral spray for chickens.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Evalon suspenzija za peroralni sprej za piliće.
ADVERSE REACTIONS
ODGOVORANI
Ask your pharmacist how to throw away medicines you no longer use.
Pitajte svog ljekarnika kako baciti lijekove koje više ne primjenjujete.
U Nákladového nádraží 10 CZ 130 00, Praha 3
Nákladového nádraží 10 CZ 130 00, Praha 3
Date of latest renewal: 13 April 2016
Datum posljednje obnove 13. travnja 2016.
Not known (frequency cannot be estimated from the available data) • asthma attack
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) • napadaj astme
• if you have or ever had low calcium in your blood.
• ako imate ili ste ikada imali nisku razinu kalcija u krvi.
Do not throw away any medicines via wastewater or household waste.
Ne bacajte lijekove u otpadne vode ili kućni otpad.
You may be having a serious, potentially life threatening allergic reaction.
Moguće je da imate ozbiljnu alergijsku reakciju koja može biti opasna za život.
• Take your tablet with a full glass of water only (about 200 mL).
• Uzmite tabletu samo uz punu čašu vode (oko 200 ml).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzimali ili biste mogli uzimati bilo koje druge lijekove.
Before receiving treatment, tell your doctor/nurse (health care professional) if:
Prije nego započnete liječenje obavijestite svog liječnika / medicinsku sestru (zdravstvenog radnika):
Frequency categories are defined using the following convention: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Kategorije učestalosti definirane su prema sljedećim pravilima: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
This helps to stop your bones from getting weaker.
To pomaže u zaustavljanju slabljenja kostiju.
Water with a high concentration of calcium should not be used.
Voda s visokom koncentracijom kalcija ne smije se uzimati.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 July 2011
Datum prvog odobrenja: 26. srpnja 2011.
Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear.
Bisfosfonati djeluju tako što inhibiraju aktivnost osteoklasta, iako točan mehanizam djelovanja još uvijek nije jasan.
They are available in packs of 3, 6, 9, 28 and 84 tablets.
Tablete su dostupne u pakovanjima od 3, 6, 9, 28 i 84 tablete.
When taken 30 minutes before a meal, the reduction in bioavailability is approximately 30%.
Ako se uzima 30 minuta prije jela, smanjenje bioraspoloživosti iznosi otprilike 30 %.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek navedeni su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107c stavkom 7 Direktive 2001/83/EZ i naknadnim izmjenama objavljenim na europskom internetskom portalu za lijekove.
Representative Office in Latvia K.Valdemāra Str. 33 - 30
Sandoz d.d. Representative Office in Latvia K.Valdemāra Str. 33 - 30
Talk to a nurse or a doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment:
Odmah se javite medicinskoj sestri ili liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava - možda ćete trebati hitnu medicinsku pomoć:
Do not take Ibandronic acid Sandoz if you are pregnant, planning to get pregnant or if you are breastfeeding.
Ne uzimajte Ibandronatnu kiselinu Sandoz ako ste trudni, planirate zatrudnjeti ili ako dojite.
Studies in rats have shown reproductive toxicity (see section 5.3).
Ispitivanja na štakorima su pokazala reproduktivnu toksičnost (vidjeti dio 5.3).
• It also helps to prevent other bone problems that may need surgery or radiotherapy.
• Također su namijenjene sprječavanju drugih komplikacija na kostima koje zahtijevaju operaciju ili radioterapiju.
If you develop these symptoms, stop taking Ibandronic acid Sandoz and tell your doctor straight away (see sections 3 and 4).
Ako razvijete te simptome prestanite uzimati Ibandronatnu kiselinu Sandoz i odmah recite to svom liječniku (vidjeti dijelove 3 i 4).
3 film-coated tablets 6 film-coated tablets 9 film-coated tablets 28 film-coated tablets 84 film-coated tablets
3 filmom obložene tablete 6 filmom obloženih tableta 9 filmom obloženih tableta 28 filmom obloženih tableta 84 filmom obložene tablete
In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50% of the circulating dose.
U ljudi prividni terminalni volumen distribucije iznosi najmanje 90 l, a procjenjuje se da količina doze koja dospijeva do kostiju iznosi oko 40-50% cirkulirajuće doze.
Do not take Ibandronic acid Sandoz with food or any other drinks except water as the medicine is less effective if it is taken with food or drink (see section 3).
Nemojte uzimati Ibandronatnu kiselinu Sandoz s hranom ili bilo kojim drugim pićem osim vodom jer je lijek manje djelotvorna ako se uzima s hranom ili vodom (vidjeti dio 3).
If there is concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.
U slučaju sumnje na moguće visoke razine kalcija u vodi iz slavine (tvrda voda) preporučuje se uzimanje vode iz boce s niskim sadržajem minerala.
Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6%.
Maksimalne zabilježene koncentracije u plazmi postignute su u vremenu od 0,5 do 2 sata (medijan vremena 1 sat) nakon uzimanja lijeka natašte, a apsolutna bioraspoloživost je iznosila oko 0,6 %.
The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Potrebno je odgoditi početak liječenja ili novi ciklus liječenja u bolesnika s nezacijeljenim otvorenim lezijama mekog tkiva u usnoj šupljini.
The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50%) and the remainder is eliminated unchanged by the kidney.
Apsorbirana frakcija ibandronatne kiseline se iz cirkulacije uklanja putem koštane apsorpcije (procjenjeno na 40-50 %), a ostatak se nepromijenjen izlučuje putem bubrega.
Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, Bisphosphonates, ATC Code: M05BA06.
Farmakoterapijska skupina: Lijekovi za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA06.
6, Dervenakion EL-15351 Pallini Attiki Greece
6, Dervenakion EL-15351 Pallini Attiki Grčka
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/
H2-antagonists or other medicinal products that increase gastric pH.
H2-antagonisti ili drugi lijekovi koji povećavaju pH želuca
Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus interaction with other medicinal products due to displacement is unlikely.
Vezanje za proteine plazme u ljudi iznosi otprilike 87 % pri terapijskim koncentracijama i stoga interakcija lijeka s drugim lijekovima zbog istiskivanja nije vjerojatna.
Package leaflet: Information for the patient
Uputa o lijeku: informacija za korisnika
Ibandronic acid Sandoz tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Tablete Ibandronatne kiseline Sandoz treba uzimati natašte, nakon noćnog gladovanja (barem 6 sati) i prije uzimanja prvog jutarnjeg obroka ili pića.
The serum calcium level may fall to hypocalcaemic values.
Razina kalcija u serumu može pasti na hipokalcemijske vrijednosti.
• if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6
• ako ste alergični na ibandronatnu kiselinu ili neki drugi sastojak ovog lijeka naveden u dijelu
• you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
• ako ste se prethodno liječili bisfosfonatom (koji se primjenjuje za liječenje ili sprječavanje koštanih poremećaja)
However, early plasma levels fall quickly, reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Početne vrijednosti u plazmi, međutim, brzo padaju, dostižući 10 % vršnih vrijednosti u roku od 3 do 8 sati nakon intravenske, odnosno peroralne primjene.
In healthy male volunteers and postmenopausal women, intravenous ranitidine caused an increase in ibandronic acid bioavailability of about 20% (which is within the normal variability of the bioavailability of ibandronic acid), probably as a result of reduced gastric acidity.
U zdravih muških ispitanika i žena u postmenopauzi, intravenski ranitidin je uzrokovao povećanje bioraspoloživosti ibandronatne kiseline za oko 20 % (što je u okviru normalne varijabilnosti bioraspoloživosti ibandronatne kiseline), vjerojatno kao rezultat smanjene kiselosti želuca.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Podrobnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu/
Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in both men and women.
Spol Bioraspoloživost i farmakokinetička svojstva ibandronatne kiseline su slični u žena i muškaraca.
Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Grčka
The usual dose of Ibandronic acid Sandoz is one tablet each day.
Uobičajena doza Ibandronatne kiseline Sandoz jest jedna tableta dnevno.
If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.
Ako Vam je liječnik rekao da ne podnosite ili ne možete probaviti neke šećere (npr. ako imate bolest nepodnošenja galaktoze, nedostatak enzima Lapp laktaze ili malapsorpciju glukoze-galaktoze, posavjetujte se sa liječnikom prije uzimanja ovog lijeka.
However, no dosage adjustment is required when ibandronic acid is administered with H2-antagonists or medicinal products that increase gastric pH.
Međutim, nije potrebna prilagodba doze kada se ibandronatna kiselina primjenjuje s H2-antagonistima ili lijekovima koji povećavaju pH želuca.
White round biconvex tablets
Bijele okrugle bikonveksne tablete
Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Germany
Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Njemačka
Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance.
Bubrežni klirens (oko 60 ml/min u zdravih žena u postmenopauzi) je zaslužan za 50-60 % ukupnog klirensa i vezan je uz klirens kreatinina.
Water may be taken at any time during the course of Ibandronic acid Sandoz treatment (see section 4.5).
Voda se smije uzimati bilo kada za vrijeme trajanja liječenja Ibandronatnom kiselinom Sandoz (vidjeti dio 4.5).
Acetylsalicylic acid and NSAIDs
Acetilsalicilna kiselina i NSAIDs
Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Greece
Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Grčka