natgillin/translations-raw huggingface dataset:
• Vermax Pour-On 5mg/ml & 200 mg/ml Soluzione Pour-On per bovini (Italy).
• Vermax Pour-On 5mg/ml i 200 mg/ml Soluzione Pour-On per bovini (Italija).
Additionally the MAH proposed to implement a risk management plan comprising submission of annual ‘combined' PSUR reports for the products concerning Closamectin Pour-On Solution and associated names (as detailed in Annex I of the Opinion); detailed investigation of future pharmacovigilance reports which should include data collection from treated un-affected animals within the same herd (including farm history and herd health status, assessment of animal health and nutritional status involving biochemistry and micronutrient analysis; investigation of potential closantel toxicity (via blood plasma sampling and post-mortem examinations); and ‘education, training and guidance' for end-users to ensure that the risks of the products and the precautions for use are fully understood.
I Mišljenja); detaljna istraga budućih farmakovigilancijskih izvještaja koja treba uključivati skup podataka iz liječenih nezaraženih životinja unutar istog krda (uključujući povijest farme i zdravstveni status krda, ocjenu životinjskog zdravlja i nutricijski status koji obuhvaća biokemijsku i mikronutritivnu analizu; istraga potencijalne toksičnosti klosantela (putem uzoraka krvne plazme i post-mortem ispitivanja); i "edukacija, obuka i vođenje" za krajnje korisnike kako bi se osiguralo da su isti u potpunosti razumjeli rizike proizvoda i mjere opreza za uporabu.
Overall summary of the scientific evaluation of Closamectin Pour-On Solution and associated names (see Annex I)
Sažetak znanstvenog vrednovanja otopina za polijevanje po koži Closamectin i srodnih lijekova (vidjeti Prilog I.)
The measures detailed in the risk management plan proposed by the MAH were supported, with additional refinement described below.
Uz niže opisana dodatna pojašnjenja podržane su mjere detaljno opisane u planu upravljanja rizikom koje je predložio nositelj odobrenja.
the CVMP has recommended lifting of the suspension of the marketing authorisation for CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS in France; variations of the marketing authorisations for Closamectin Pour-On Solution and associated names as referred in Annex I in order to amend the summary of product characteristics and package leaflet in line with recommended changes in the product information as set out in Annex III; and conditions of the marketing authorisations as set out in Annex IV.
CVMP preporučio je uklanjanje suspenzije odobrenja za stavljanje VMP-a OTOPINA ZA POLIJEVANJE PO KOŽI GOVEDA CLOSAMECTIN u promet u Francuskoj; izmjene odobrenja za stavljanje VMP-a u promet za otopinu za polijevanje u koži Closamectin i srodne proizvode navedene u Dodatku
ADVERSE REACTIONS
Jačina
Add, to all products (if not already present): 4.5 Special precautions for use Special precautions for use in animals
4.5 Posebne mjere opreza prilikom primjene Posebne mjere opreza prilikom primjene na životinjama
Sweden Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Švedska Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
Germany Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Njemačka Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
Slovakia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Slovačka Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
Slovenia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Slovenija Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
Romania Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Rumunjska Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
Belgium Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Španjolska Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Sjeverna Irska
Do not freeze.
Ne zamrzavaj.
SPECIAL WARNING, IF NECESSARY
POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO
EXP (month/year)
EXP (mjesec/godina)
Date of first authorisation: 18/02/2011 Date of last renewal: 02/12/2015
Datum prvog odobrenja: 18/02/2011 Datum posljednjeg produljenja odobrenja: 02/12/2015
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/
The reactions may last longer.
Neželjeni učinci mogu trajati i duže.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
SADRŽAJ: PO TEŽINI, VOLUMENU ILI BROJU DOZA
Not all pack sizes may be marketed.
Ne moraju sve veličine pakovanja biti na tržištu.
Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Vrlo rijetko može se javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajući simptomatski tretman.
Suspension for injection.
Suspenzija za injekcije.
Keep out of the sight and reach of children.
Drži izvan pogleda i dosega djece.
Apply usual aseptic procedures.
Prilikom cijepljenja treba primijeniti uobičajene aseptičke procedure.
Store and transport refrigerated (2 °C-8 °C).
Čuvaj i prevozi rashlađeno (2°C - 8°C).
The best time for a blood sample to be taken is around 28 days after vaccination.
Najpogodnije vrijeme za uzimanje uzoraka krvi je oko 28 dana nakon cijepljenja.
Vaccinate healthy animals only.
Cijepi samo zdrave životinje.
Light pink to pale yellow homogeneous suspension
Svjetlo ružičasta do blijedo žuta homogena suspenzija.
Veterinary surgeons may wish to consider two vaccinations.
Tada veterinar može uzeti u obzir dvije vakcinacije.
As a consequence, the vaccine stimulates active immunity against rabies virus in cats.
Posljedica toga je da cjepivo stimulira aktivni imunitet protiv virusa bjesnoće kod mačaka.
Potassium chloride Sodium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections
Kalijev klorid Natrijev klorid Kalijev dihidrogenfosfat Dinatrijev fosfatdihidrat Magnezijev kloridheksahidrat Kalcijev klorid-dihidrat Voda za injekcije
After inoculation, the virus expresses the protective protein, but does not replicate in the cat.
Nakon inokulacije virus izražava zaštitne proteine, ali se ne množi u mački.
Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 LYON FRANCE
Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 LYON FRANCUSKA
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 10 vials of suspension for injection Box of 50 vials of suspension for injection Box of 2 vials of suspension for injection
PODACI NA VANJSKOM PAKOVANJU Kutija s 10 bočica suspenzije za injekciju Kutija s 50 bočica suspenzije za injekciju Kutija s 2 bočice suspenzije za injekciju
EXP (month/year) Once broached, use immediately.
EXP (mjesec/godina) Jednom otvoreno, primijeni odmah.
Do not mix with any other veterinary medicinal product except those mentioned above.
Ne miješati ni s jednim drugim veterinarsko medicinskim proizvodom osim s onim prethodno navedenim.
EU/2/10/117/001 (10 vials) EU/2/10/117/002 (50 vials) EU/2/10/117/003 (2 vials)
EU/2/10/117/001 (10 bočica) EU/2/10/117/002 (50 bočica) EU/2/10/117/003 (2 bočice)
Type I glass vial with a butyl elastomer closure, sealed with an aluminium cap.
Tip I staklena bočica zatvorena gumenim čepom i zapečaćena aluminijskom kapicom.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
OSNOVNI PODACI KOJI TREBAJU BITI NAPISANI NA MALIM JEDINICAMA UNUTARNJEG PAKOVANJA
Most of these reactions were noted during the 2 days following the vaccine injection.
Većina je ovih reakcija zabilježena tijekom 2 dana nakon vakcinacije.
Laboratoire Porte des Alpes Rue de l'Aviation 69800 SAINT PRIEST FRANCE
Laboratoire Porte des Alpes Rue de l'Aviation 69800 SAINT PRIEST FRANCUSKA
Travel to countries requiring a rabies serology test: experience has shown that some vaccinated animals, while protected, may not show the 0.5 IU/ml antibody titre required by some countries.
Kod putovanja u zemlje koje zahtijevaju serološko testiranje na bjesnoću:iskustvo pokazuje da neke cijepljene životinje, dok su zaštićene, možda neće iskazivati titar protutijela od 0,5 IU/ml koji se zahtijeva u nekim zemljama.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
U slučaju nehotičnog samo injiciranja, odmah potraži pomoć liječnika i pokaži mu uputu o VMP ili etiketu.
Duration of immunity after revaccination: 3 years.
Trajanje imuniteta nakon revakcinacije: 3 godine.
In very rare cases, transient and slight apathy may occur, as well as mild anorexia or hyperthermia (above 39.5 °C), usually lasting 1 or 2 days.
Vrlo rijetko može se javiti blaga prolazna apatija, kao i blaga anoreksija ili povišena temperatura (iznad 39,5 °C), koje obično traju 1 ili 2 dana.
Purevax Rabies suspension for injection
Purevax Rabies suspenzija za injekcije
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Neškodljivost veterinarsko medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Bilo koji neupotrijebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni kod primjene ovih veterinarsko-medicinskih proizvoda moraju se odlagati u skladu s lokalnim propisima.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with MERIAL non-adjuvanted vaccines containing various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components.
Podaci o neškodljivosti i djelotvornosti su dostupni i dokazujuda se ovo cjepivo smije pomiješati i primijeniti s ne adjuviranim cjepivima MERIAL koja sadrže različite kombinacije komponenti protiv virusnog rinotraheitisa mačaka, kaliciviroze, panleukopenije i klamidioze mačaka.
The vaccine strain vCP65 is a recombinant Canarypox virus expressing the glycoprotein G gene of rabies virus.
Cijepni soj vCP65 je rekombinantni virus boginja kanarinca koji izražava glikoprotein G gena od virusa bjesnoće.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja jednog tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja)
Canarypox recombinants are known to be safe for humans.
Poznato je da su rekombinirani virusia boginja kanarinca sigurni su za ljude.
Efficacy data are available which demonstrate that this vaccine can be administered at least 14 days before or after the administration of MERIAL non-adjuvanted vaccine against feline leukaemia.
Dostupni podaci o djelotvornosti dokazuju da se ovo cjepivo smije primijeniti najmanje 14 dana prije ili poslije primijene MERIAL-ovog ne adjuviranog cijepiva protiv leukemije mačaka.
Shelf life after first opening the immediate packaging: use immediately.
Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: odmah upotrijebi.
Most of these reactions were noted during the 2 days following the vaccine injection
Većina jeovih reakcija zabilježena tijekom 2 dana nakon vakcinacije
A transient local reaction may very rarely occur (pain at palpation, limited swelling that may become nodular, heat at the injection site, and in some cases erythema), that usually disappears within 1 or 2 weeks at most.
Vrlo rijetko se može javiti i prolazna lokalna reakcija (bol pri palpaciji, ograničen otok koji može postati čvorast, hipertermija na mjestu vakcinacije, a u nekim slučajevima eritem), koja obično nestaje tijekom 1 ili najviše 2 tjedna.
METHOD AND ROUTE OF ADMINISTRATION
METODE I NAČIN PRIMJENE
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
NAVOĐENJE DJELATNE TVARI I DRUGIH SASTOJAKA
Administer one dose of 1 ml according to the following vaccination scheme:
Inicirajte jednu dozu od 1 ml cjepiva u skladu sa sljedećim rasporedom cijepljenja:
DOSAGE FOR EACH SPECIES, ROUTEAND METHOD OF ADMINISTRATION
DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, METODE I NAČIN PRIMJENE
Disposal: Read package leaflet.
Odlaganje: pročitaj uputu o VMP-u.
Vaccine against rabies infection.
Cjepivo protiv zaraze bjesnoćom.
4.2 Indications for use, specifying the target species
4.2 Indikacije za primjenu, s navedenimciljnim vrstama životinja
Do not mix with any other veterinary medicinal product, except those mentioned in section 4.8.
Ne miješaj s bilo kojim drugim veterinarsko-medicinskim proizvodom osim onih navedenih u odjeljku
Primary vaccination: 1 injection from 12 weeks of age, Revaccination: 1 year after primary vaccination, then at intervals of up to 3 years.
Prvo cijepljenje: 1 injekcija od 12 tjedana starosti, Revakcinacija: 1. godina nakon prvog cijepljenja, a zatim u razmacima od po 3 godine.
Duration of immunity after primary vaccination: 1 year.
Trajanje imuniteta nakon prvog cijepljenja: 1 godina.
ATC vet code:QI06AD08.
Farmakoterapijska grupa: Drugi imunološki lijekovi za mačke, ATC vet code:QI06AD08.
1 ml contains: Rabies recombinant canarypox virus (vCP65) ................................................................. ≥ 106.8 FAID50
1 ml sadrži Rekombinirani virus boginja kanarinca, (vCP65) ........................................................... ≥ 106.8 FAID50
Box of 2 or 10 or 50 vials of 1 dose.
Kutija s 2 ili 10 ili 50 bočica koje sadrže jednu dozu.
Onset of immunity: 4 weeks after the primary vaccination course.
Početak imuniteta: 4 tjedna nakon prvog ciklusa iz kalendara cijepljenja.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
12. POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih kod primjene ovog proizvoda
No adverse reactions other than those already mentioned in section 4.6 have been observed after the administration of 10 doses.
Nakon primjene 10 doza cjepiva nisu primijećeni nikakvi neželjeni učinci osim onih već spomenutih u odjeljku 4.6. Reakcije mogu potrajati i duže.
Rabies recombinant canarypox virus (vCP65) ................................................................ ≥ 106.8 FAID*50 *Fluorescent assay infectious dose 50 %
Rekombinirani virus boginja kanarinca(vCP65) ........................................................... ≥ 10 6.8 FAID*50 * Za flourescentnu podlogu infektivna doza je 50 %
Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije.
No adverse reactions other than those already mentioned in the section “Adverse Reactions” have been observed after the administration of 10 doses.
Nakon primjene 10 doza nisu primijećeni drugačiji neželjeni učinci od onih koji su navedeni u odjeljku „Nuspojave“.
Administer one dose of 1 ml according to the following vaccination scheme: Primary vaccination course: 1 injection from 12 weeks of age, Revaccination: 1 year after primary vaccination, then at intervals of up to 3 years.
Prvo cijepljenje: 1 injekcija nakon 12 tjedana starosti, Revakcinacija: 1. godinu nakon prvog cijepljenja, a zatim u razmacima od po 3 godine.
Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily.
U slučaju nehotičnog samo iniciranja prolazno se mogu pojaviti blage lokalne i/ili sistemske reakcije.
Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.
Kako bi se spriječila smrtnost izazvana infekcijom virusom bjesnoće aktivno se imuniziraju mačake a stare 12 tjedana i starije.
For animal treatment only
Samo za primjenu na životinjama.
Box of 50 vials of 1 dose.
Kutija s 50 bočica sa po jednom dozom.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOÐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I PROIZVOÐAČ(I) ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
SPECIAL STORAGE PRECAUTIONS
11. POSEBNE MJERE PREDOSTROŽNOSTI KOD ČUVANJA
Box of 10 vials of 1 dose.
Kutija s 10 bočica sa po jednom dozom.
Box of 2 vials of 1 dose.
Kutija s 2 bočice sa po jednom dozom.
Memantine should not be used during pregnancy unless clearly necessary.
Memantin ne bi trebalo upotrebljavati tijekom trudnoće, osim ako to nije izričito potrebno.
In another case of a large overdose, the patient also survived and recovered.
U drugom slučaju predoziranja velikom dozom, bolesnik je također preživio, te se oporavio.
2 Isolated cases reported in post-marketing experience.
2 Izolirani slučajevi prijavljeni u postmarketinškom razdoblju.
Date of latest renewal: 08 January 2018
Datum posljednje obnove odobrenja: 8. siječnja 2018
It belongs to a group of medicines known as anti-dementia medicines.
Spada u skupinu lijekova poznatih kao lijekovi protiv demencije.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži važne podatke za Vas.
Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful monitoring of the patient.
Neki čimbenici koji mogu povisiti pH mokraće (vidjeti dio 5.2 »Eliminacija«) mogu zahtijevati pažljivo nadziranje bolesnika.
Memantine has an absolute bioavailability of approximately 100%.
Memantin ima apsolutnu bioraspoloživost od približno 100%.
Continue to take Memantine Mylan as long as it is of benefit to you.
Nastavite uzimati Memantin Mylan onoliko dugo koliko od nje imate koristi.
Moderate to severe Alzheimer's disease usually causes impairment of driving performance and compromises the ability to use machinery.
Umjerena do teška Alzheimerova bolest obično uzrokuje oštećenje sposobnosti upravljanja vozilima i kompromitira sposobnost rada na strojevima.
Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Liječnik će Vam reći dopušta li Vam bolest sigurno upravljanje vozilima i rad na strojevima.
Do not take Memantine Mylan: - if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Memantin Mylan: - ako ste alergični (preosjetljivi) na memantin ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
Children and adolescents Memantine Mylan is not recommended for children and adolescents under the age of 18 years.
Memantin Mylan se ne preporučuje za djecu i adolescente mlađe od 18 godina.
The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 9 (see section 4.4).
Stopa bubrežne eliminacije memantina u uvjetima alkalnog urina može biti smanjena za faktor od 7 do 9 (vidjeti dio 4.4).
Memantine Mylan with food and drink
Memantin Mylan s hranom i pićem
What Memantine Mylan is and what it is used for
Što je Memantin Mylan i za što se koristi
This leaflet was last revised in {month YYYY}.
Ova uputa je zadnji puta revidirana u {mjesec/GGGG}.
If you go into hospital, let your doctor know that you are taking Memantine Mylan.
Ako dođete u bolnicu, obavijestite svog liječnika da uzimate Memantin Mylan.
Linearity Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Linearnost Ispitivanja na dobrovoljcima pokazala su linearnu farmakokinetiku u rasponu doza od 10 do 40 mg.
Adverse reactions are ranked according to system organ class, 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).
Nuspojave su razvrstane prema klasifikaciji organskih sustava, koristeći sljedeću konvenciju: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
If you forget to take Memantine Mylan - If you find you have forgotten to take your dose of Memantine Mylan, wait and take your next dose at the usual time.
Ako ste zaboravili uzeti Memantin Mylan - Ako ustanovite da ste zaboravili uzeti dozu Memantin Mylan, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia.
Sve je više dokaza da slabo funkcioniranje glutamatergične neurotransmisije, posebice na NMDAreceptorima, doprinosi izraženosti simptoma i progresiji bolesti kod neurodegenerativne demencije.
Package leaflet: Information for the patient
Uputa od lijeku: Informacije za bolesnika
Memantine Mylan should be administered orally once a day and should be taken at the same time every day.
Memantin Mylan treba primjenjivati peroralno jedanput na dan i potrebno ga je uzimati svaki dan u isto vrijeme.
- If you take a large overdose of Memantine Mylan, contact your doctor or get medical advice, as you may need medical attention.
- Ako ste uzeli preveliku dozu Memantin Mylan, javite se Vašem liječniku za savjet, jer bi Vam mogla zatrebati medicinska pomoć.
Elevated liver function test
Često povišeni rezultat testa jetrene funkcije
Pharmacotherapeutic group: Psychoanaleptics, other anti-dementia drugs, ATC code: N06DX01.
Farmakoterapijska skupina: Psihoanaleptici, ostali lijekovi protiv demencije, ATK oznaka: N06DX01.
117 Allée des Parcs, 69800 Saint-Priest, France.
117 Allée des Parcs, 69800 Saint-Priest, Francuska.
69800 Saint-Priest
69800 Saint-Priest Francuska
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
POSEBNO UPOZORENJE DA LIJEK TREBA ČUVATI IZVAN DOHVATA I POGLEDA DJECE
Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse effects of memantine were noted on fertility.
Memantin nije bio teratogen kod štakora i kunića, čak ni kod maternalno toksičnih doza, a nisu zamijećeni niti štetni događaji memantina na plodnost.
In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20 days, more than 99% being excreted renally.
U ispitivanju u kojem je korišten oralno primijenjen 14C-memantin, uklonjeno je prosječno 84% doze unutar 20 dana, više od 99% izlučeno je putem bubrega.
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom.
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire EN6 1TL, Ujedinjeno Kraljevstvo.
The most frequently occurring adverse reactions with a higher incidence in the memantine group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
Nuspojave koje su se najčešće pojavljivale s većom učestalošću u skupini bolesnika liječenih memantinom nego u skupini koja je uzimala placebo bile su omaglica (6,3% naspram 5,6%), glavobolja (5,2% naspram 3,9%), konstipacija (4,6% naspram 2,6%), somnolencija (3,4% naspram 2,2%) i hipertenzija (4,1% naspram 2,8%).