natgillin/translations-raw huggingface dataset:
This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Radiofarmaceutik smiju preuzeti, koristiti i primijeniti samo za to ovlaštene osobe u za to namijenjenim kliničkim uvjetima.
LeukoScan [99mTc] can be stored at room temperature after formulation.
Nakon pripreme LeukoScan [99mTc] se može čuvati na sobnoj temperaturi.
Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal antibody fragments) for the preparation of 99mTc labelled LeukoScan.
Bočica od 3 ml sadrži 0,31 mg sulesomaba (fragmente IMMU-MN3 mišjeg Fab′-SH antigranulocitnog monoklonskog protutijela) za pripremu 99mTc-obilježenog LeukoScana.
Due to the short six-hour, half-life of 99mTc, a dose of less than 1 mSv in mother's milk can be expected 24 hours after the administration of LeukoScan [99mTc].
Zbog kratkog poluživota 99mTc od 6 sati, doza zračenja u majčinom mlijeku manja od 1 mSv može se očekivati 24 sata nakon primjene
An evaluation of potential clinical impact of LeukoScan demonstrated that LeukoScan could change clinical management in 50.2% or improve clinical outcome in 43.4% of the 175 evaluable patients with suspected osteomyelitis.
Procjena mogućeg utjecaja LeukoScana na kliničku praksu, provedena na 175 bolesnika sa sumnjom na osteomijelitis, pokazala je da LeukoScan može promijeniti način liječenja u 50,2 % ili poboljšati rezultat liječenja u 43,3 % bolesnika.
One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Jedna bočica pripremljena tako da sadrži 0,31 mg liofiliziranog LeukoScan fragmenta monoklonskog protutijela.
The maximum amount of LeukoScan that can be administered has not been determined.
Maksimalna doza LeukoScana koja se sa sigurnošću može primijeniti nije utvrđena.
After use, the container should be disposed of as radioactive waste.
Nakon uporabe spremnik treba zbrinuti kao radioaktivni otpad.
In the unlikely event of the administration of a radiation overdose with LeukoScan, the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the
U malo vjerojatnom slučaju predoziranog zračenja LeukoScanom, doza koju je bolesnik apsorbirao može biti smanjena povećanim unosom tekućina na usta ili u venu radi poticanja izlučivanja radioizotopnog
• You should not be given LeukoScan if you are pregnant.
• Ako ste trudni, ne biste smjeli primiti LeukoScan.
Following reconstitution, unused radiopharmaceutical and vial should be handled as radioactive waste and disposed of in accordance with local requirements.
Nakon rekonstitucije, s neiskorištenim radiofarmaceutikom i bočicom potrebno je rukovati kao s radioaktivnim otpadom i potrebno ih je zbrinuti sukladno nacionalnim propisima.
INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS Quality control
12. UPUTE ZA PRIPREMU RADIOFARMACEUTIKA
The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous administration of LeukoScan labeled with 750 MBq of technetium-99m are provided in Table 1.
Procijenjene doze apsorpcije radijacije u prosječnog odraslog bolesnika (70 kg) nakon intravenske primjene LeukoScana obilježenog sa 750 MBq tehnecija-99m navedene su u tablici 1.
NAME OF MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LeukoScan 0.31 mg, powder for solution for injection 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA LeukoScan 0,31 mg, prašak za otopinu za injekciju 0,31 mg liofiliziranog sulesomaba, kositrov klorid i stabilizatori.
Hydrochloric Acid (Trace) Sodium Potassium Tartrate, Tetrahydrate Sodium Acetate, Trihydrate
natrijev kalij-tartarat, tetrahidrat natrijev acetat, trihidrat dušik
Rehydrate with sterile, non-pyrogenic 99mTc Na pertechnetate.
Rehidrirati sterilnim, apirogenim 99mTc
Important information about some ingredients of LeukoScan If you have been told that you have an intolerance to some sugars, inform your doctor before you are
Ako Vam je rečeno da ne podnosite neke vrste šećera, obavijestite o tome liječnika prije nego primite
The imaging agent, technetium-99m LeukoScan [technetium-99m sulesomab] is formed by reconstitution of the contents of the LeukoScan vial with 0.5 mL sodium chloride for injection followed by the addition of 1100 MBq of sodium pertechnetate [99mTc] in 1 mL of Sodium Chloride for Injection.
LeukoScan [tehnecij-99m sulesomab] priprema se rekonstitucijom sadržaja bočice LeukoScan s 0,5 ml otopine natrijevog klorida za injekciju, nakon čega se dodaje 1100 MBq natrijevog pertehnetata [99mTc] u
PACKAGE LEAFLET: INFORMATION FOR THE USER LeukoScan (0.31 powder for solution for injection) (sulesomab)
Uputa o lijeku: Informacije za bolesnika LeukoScan 0,31 mg, prašak za otopinu za injekciju (sulesomab)
Kit - Store in a refrigerator (2ºC - 8ºC).
Komplet - čuvati u hladnjaku (2 ºC - 8 ºC).
• This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
• Radiofarmaceutik smiju preuzeti i primijeniti samo za to ovlaštene osobe u za to namijenjenim kliničkim uvjetima.
Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal
Jedna bočica od 3 ml sadrži 0,31 mg sulesomaba (fragmente IMMU-MN3 mišjeg Fab′-SH antigranulocitnog monoklonskog protutijela).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIAL LABEL)
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI
(77.5% vs. 75.8%, respectively).
Ipak, postoji jednaka dijagnostička pouzdanost u ova dva oblika (77,5 % naspram 75,8 %,).
NAME OF THE MEDICINAL PRODUCT LeukoScan 0.31 mg, powder for solution for injection
NAZIV LIJEKA LeukoScan 0,31 mg, prašak za otopinu za injekciju
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE
Each vial contains stannous chloride, sodium chloride, sodium potassium tartrate, sodium acetate, sucrose,
Jedna bočica sadrži kositrov klorid, natrijev klorid, natrij-kalijev tartarat, natrijev acetat, saharozu, dušik
For this medicinal product, the effective dose equivalent resulting from an administered activity of 750 MBq is typically 7.7 mSv for a 70 kg individual.
Za ovaj lijek učinkovita doza koja odgovara primijenjenoj radioaktivnosti od 750 MBq iznosi tipično
In a subgroup of patients in whom LeukoScan was compared directly to the currently available 111Inlabelled (occasionally 99mTc-labelled) autologous white blood cell (WBC) scanning test, LeukoScan showed a statistically significant increase in sensitivity over that achieved by WBC scanning (87.7% vs. 72.6%, p = 0.003 by McNemar's Test), with no discernible decrease in specificity as compared to WBC
U podskupini bolesnika u kojoj je LeukoScan izravno uspoređivan s trenutno dostupnom pretragom pomoću111In-obilježenih (ponekad 99mTc-obilježenih) autolognih leukocita, LeukoScan je pokazao statistički značajan porast osjetljivosti u odnosu na pretragu pomoću radioaktivno obilježenih leukocita
When a bone scan is positive and imaging with LeukoScan is negative, infection is unlikely.
Ako je nalaz scintigrafije kosti pozitivan, a nalaz dobiven snimanjem uz pomoć LeukoScana negativan,
For reconstitution of lyophilised powder, with a sterile disposable syringe add 0.50 ml of saline injection into the shielded LeukoScan 3-ml vial.
Za rekonstituciju liofiliziranog praška, sterilnom štrcaljkom za jednokratnu uporabu dodajte 0,50 ml fiziološke otopine u bočicu
The product is more sensitive (93.9% vs. 80.6%), but less specific (51.6% vs. 72.9%), in diagnosing osteomyelitis in patients with diabetic foot ulcers than in patients with other sites of long bone osteomyelitis.
naspram 72,9 %), u dijagnosticiranju osteomijelitisa u bolesnika s dijabetičkim ulkusima stopala, nego u bolesnika s drugim lokacijama osteomijelitisa u dugim kostima.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I)
Kit for the preparation of 99mTc-labelled LeukoScan.
Sadržaj pakiranja i druge informacije Komplet za pripremu 99mTc-obilježenog LeukoScana.
If so, no inferences concerning the underlying mechanism(s) responsible may be derived from the clinical laboratory results.
Ako je tako, na temelju rezultata kliničkih laboratorijskih pretraga ne mogu se stvoriti zaključci o mehanizmu odnosno mehanizmima nastanka ove promjene.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U
Contains 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Sadrži 0,31 mg liofiliziranog sulesomaba, kositrov klorid i stabilizatore.
Reconstituted radiopharmaceuticals should be handled using waterproof gloves, adequate shielding of radioactivity, and aseptic technique.
odgovarajućom zaštitom od zračenja i uz primjenu aseptičkih tehnika.
What LeukoScan looks like and contents of the pack
Kako LeukoScan izgleda i sadržaj pakiranja Prašak za otopinu za injekciju.
Name and address of the manufacturer(s) of the biological active substance(s) Immunomedics, Inc.
Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
EXPIRY DATE
Tablica 1
Summary of Normal Organ Dosimetry to an Average Adult Patient (70 kg) from an Intravenous Dose of LeukoScan Labelled with 750 MBq of Technetium-99m [Dose Estimate from 13 Subjects 26 Administrations]
(70 kg) nakon intravenske doze LeukoScana obilježenog sa 750 MBq tehnecija99m [doza procijenjena na temelju 13 ispitanika i 26 primjena]
The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result.
Primijenjena radioaktivnost mora biti takva da doza zračenja bude što je moguće manja,
Name and address of the manufacturer responsible for batch release
Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet>
This leaflet only applies to LeukoScan.
Kako se primjenjuje LeukoScan
0.25 mg of LeukoScan will be labelled with 740-1110 MBq of technetium.
Liječnik će pripremiti LeukoScan i radioaktivni izotop tehnecija volumena 1,5 ml. 0,25 mg LeukoScana obilježit će se s 740-1110 MBq tehnecija.
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
300 American Road Morris Plains, New Jersey 07950, USA
Method and/or route(s) of administration
Način i put(evi) primjene lijeka
4.7 Effects on ability to drive and use machines
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedena ispitivanja o utjecaju na sposobnost upravljanja vozilima i rada sa strojevima.
No induction of human anti-mouse antibody (HAMA) reactive with fragment was observed in any
Indukcija ljudskih anti-mišjih protutijela (HAMA) koja reagiraju s fragmentom nije primijećena kod niti jednog bolesnika kojem je primijenjen LeukoScan.
This medicine
Organ
Medicinal product subject to medical prescriptio
SAŽETAK OPISA SVOJSTAVA LIJEKA
However, due to the low dose of protein administered and the short half-life of 99mTc, dosage adjustment is probably not
zbog male doze primijenjenog proteina i kratkog poluživota 99mTc, prilagođavanje doze u ovih bolesnika Radiofarmaceutike smije primjenjivati samo kvalificirano osoblje koje ima službeno odobrenje nadležnih tijela za primjenu i rukovanje radionuklidima.
• It does not contain all the information about your medicine that you may need to know, so please refer to the Summary of Product Characteristics or ask your doctor or nurse if you have any questions.
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
If either are present, the
Ako je nešto od navedenog prisutno, lijek se mora baciti.
LeukoScan 0.31 mg, powder for solution for injection
LeukoScan 0.31 mg, prašak za otopinu za injekciju ne smijete primiti:
4.2 Posology and method of administration
4.4 Posebna upozorenja i mjere opreza pri uporabi
Kit - 48 months.
10 dana.
RELEASE
A.
B. CONDITIONS OF THE MARKETING AUTHORISATION C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
6.3 Shelf-life
5.3 Neklinički podaci o sigurnosti primjene
It was intended for use only when other antibiotics were not suitable.
Lijek je bio namijenjen za primjenu samo kada drugi antibiotici nisu bili prikladni.
Because the medicine blocks the production of new proteins, the bacteria cannot multiply and they eventually die.
Budući da lijek blokira proizvodnju novih proteina, bakterije se ne mogu množiti i naposljetku umiru.
15 September 2017 EMA/589782/2017 EMEA/H/C/4419
EMA/589782/2017 EMEA/H/C/4419
As for every medicine, the company also provided studies on the quality of Tigecycline Accord.
Kao i za svaki lijek, tvrtka je dostavila i studije o kvaliteti lijeka Tigecycline Accord.
Tigecycline Accord was expected to be used to treat adults and children older than 8 years with complicated infections of the skin and soft tissue (the tissue below the skin), except foot infections in people with diabetes.
Lijek Tigecycline Accord trebao se primjenjivati u liječenju odraslih osoba i djece starije od osam godina s kompliciranim infekcijama kože i mekog tkiva (tkiva ispod kože), s izuzetkom infekcija stopala kod osoba s dijabetesom.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the medicine for marketing reasons because of the issues at the manufacturing site.
U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da povlači lijek iz marketinških razloga zbog problema na proizvodnoj lokaciji.
The CHMP's main concern was lack of compliance with Good Manufacturing Practice (GMP) by the manufacturing site for the medicine's active substance.
Glavna zabrinutost CHMP-a bila je nedostatak sukladnosti s dobrom proizvođačkom praksom (GMP) na proizvodnoj lokaciji djelatne tvari lijeka.
Tigecycline Accord was developed as a ‘generic medicine'.
Tigecycline Accord razvijen je kao „generički lijek”.
It works against the bacteria that cause infections by blocking the bacteria's ribosomes, the parts of the cell where new proteins are made.
Djeluje protiv bakterija koje uzrokuju infekcije blokiranjem ribosoma bakterija, dijela stanice u kojem se proizvode novi proteini.
EMA/589782/2017
Accord (tigeciklin) EMA/589782/2017
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Tigecycline Accord.
Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi lijek Tigecycline Accord.
This means that Tigecycline Accord contains the same active substance and was intended to work in the same way as a ‘reference medicine' already authorised in the European Union called Tygacil.
To znači da Tigecycline Accord sadržava istu djelatnu tvar i da je trebao djelovati na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Tygacil.
There was no need for ‘bioequivalence' studies to investigate whether Tigecycline Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Nije bilo potrebe za ispitivanjima bioekvivalencije kako bi se istražilo apsorbira li se Tigecycline Accord na sličan način kao referentni lijek radi proizvodnje jednake razine djelatne tvari u krvi.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Tygacil, and did not need to be repeated for Tigecycline Accord.
Ispitivanja o koristima i rizicima djelatne tvari pri odobrenoj primjeni već su provedena za referentni lijek, Tygacil, te ih ne treba ponavljati za lijek Tigecycline Accord.
On 12 September 2017, Accord Healthcare Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tigecycline Accord, for the treatment of certain complicated infections.
Accord Healthcare Limited službeno je obavijestio Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Tigecycline Accord za liječenje određenih kompliciranih infekcija.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Tigecycline Accord could not have been approved to treat complicated infections.
Na temelju pregleda podataka u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za Tigecycline Accord za liječenje kompliciranih infekcija.
It was to be available as a powder to make a solution for infusion (drip) into a vein.
Trebao je biti dostupan u obliku praška od kojeg se priprema otopina za infuziju (drip) u venu.
Tigecycline Accord is an antibiotic medicine that contains the active substance tigecycline.
Tigecycline Accord je antibiotički lijek koji sadržava djelatnu tvar tigeciklin.
This is because Tigecycline Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Razlog tome je činjenica da se Tigecycline Accord daje intravenoznom infuzijom i djelatna tvar odmah ulazi u krvotok.
What is Tigecycline Accord?
Što je Tigecycline Accord?
It was also intended to treat complicated infections in the abdomen (belly).
Također je bio namijenjen za liječenje kompliciranih infekcija u abdomenu (trbuhu). „Komplicirana” znači da se infekcija teško liječi.
The active substance in Tigecycline Accord and Tygacil, tigecycline, is one of a group of antibiotics called ‘glycylcyclines'.
Djelatna tvar lijekova Tigecycline Accord i Tygacil, tigeciklin, pripada skupini antibiotika pod nazivom „glicilciklini”.
How does Tigecycline Accord work?
Kako djeluje Tigecycline Accord?
What was Tigecycline Accord expected to be used for?
Za što se Tigecycline Accord trebao koristiti?
Calea Floreasca nr. 169A, Cladirea A, etaj 1, sector 1, Bucure ti
Cladirea A, etaj 1, sector 1, Bucure ti
If you are an elderly patient (over 65 years of age), you should take Pregabalin Sandoz GmbH normally except if you have problems with your kidneys.
Ako ste bolesnik u starijoj dobi (iznad 65 godina), lijek Pregabalin Sandoz GmbH trebate uzimati normalno, osim ako imate problema s bubrezima.
Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose.
Procjenjuje se da bioraspoloživost peroralno primijenjenog pregabalina iznosi ≥ 90 % i ne ovisi o dozi.
Do not take Pregabalin Sandoz GmbH: If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Pregabalin Sandoz GmbH: Ako ste alergični na pregabalin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
• A small number of people being treated with anti-epileptics such as Pregabalin Sandoz GmbH have had thoughts of harming or killing themselves.
• Mali broj ljudi koji se liječe antiepileptičkim lijekovima kao što je Pregabalin Sandoz GmbH razmišljali su o samoozljeđivanju ili samoubojstvu.
The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Sandoz GmbH is taken together with medicines containing:
Omaglica, pospanost i smanjenje koncentracije mogu se pojačati ako se Pregabalin Sandoz GmbH uzima zajedno s lijekovima koji sadrže:
Pregabalin Sandoz GmbH should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Pregabalin Sandoz GmbH se ne smije primjenjivati tijekom trudnoće osim ako to nije neophodno (ako korist liječenja za majku jasno nadilazi mogući rizik za plod).
If you take more Pregabalin Sandoz GmbH than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Ako uzmete više lijeka Pregabalin Sandoz GmbH nego što ste trebali Odmah nazovite svog liječnika ili otiđite u hitnu službu najbliže bolnice.
If you have the impression that the effect of Pregabalin Sandoz GmbH is too strong or too weak, talk to your doctor or pharmacist.
Ako Vam se čini da je djelovanje lijeka Pregabalin Sandoz GmbH prejako ili preslabo, porazgovarajte sa svojim liječnikom ili ljekarnikom.
• Pregabalin Sandoz GmbH may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
• Pregabalin Sandoz GmbH može uzrokovati zamagljen vid, gubitak vida ili druge promjene vida, od kojih su mnoge privremene.
It is important to take your Pregabalin Sandoz GmbH capsules regularly at the same time each day.
Važno je da Pregabalin Sandoz GmbH kapsule uzimate redovito, svakoga dana u isto vrijeme.
These symptoms may occur more commonly or severely if you have been taking Pregabalin Sandoz GmbH for a longer period of time.
Ti simptomi mogu biti češći ili ozbiljniji ako ste lijek Pregabalin Sandoz GmbH uzimali dulje vrijeme.
Pregabalin Sandoz GmbH and certain other medicines may influence each other (interaction).
Pregabalin Sandoz GmbH i neki drugi lijekovi mogu djelovati jedni na druge (interakcija).
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (< 2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.
Budući da se pregabalin pretežno izlučuje mokraćom u nepromijenjenom obliku, da je u čovjeka podložan zanemarivom metabolizmu (< 2 % doze pronađe se u mokraći u obliku metabolita), da ne inhibira metabolizam lijekova in vitro i ne veže se za proteine u plazmi, nije vjerojatno da će izazivati ili ulaziti u farmakokinetičke interakcije.
Pregabalin Sandoz GmbH with food, drink and alcohol Pregabalin Sandoz GmbH capsules may be taken with or without food.
Pregabalin Sandoz GmbH s hranom, pićem i alkoholom Pregabalin Sandoz GmbH kapsule mogu se uzimati s hranom ili bez nje.
• Your doctor will tell you to take Pregabalin Sandoz GmbH either twice or three times a day.
Liječnik će Vam reći da uzmete lijek Pregabalin Sandoz GmbH dva puta ili tri puta na dan.
• When Pregabalin Sandoz GmbH is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel).
• Kada se Pregabalin Sandoz GmbH uzima s drugim lijekovima koji mogu uzrokovati zatvor (kao što su neke vrste lijekova protiv bolova), moguće je da se pojave probavne tegobe (primjerice zatvor, blokada ili paraliza crijeva).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 June 2015
Datum prvog odobrenja: 19. lipanj 2015.
• Jaundice (yellowing of the skin and eyes).
žutica (žutilo kože i bjeloočnica)
Take your box or bottle of Pregabalin Sandoz GmbH capsules with you.
Uzmite sa sobom kutiju ili bočicu Pregabalin Sandoz GmbH kapsula.
Continue taking Pregabalin Sandoz GmbH until your doctor tells you to stop.
Nastavite uzimati lijek Pregabalin Sandoz GmbH dok Vam liječnik ne kaže da prestanete.
Pregabalin Sandoz GmbH should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor.
Pregabalin Sandoz GmbH se ne smije uzimati tijekom trudnoće ili dojenja, osim ako Vam liječnik nije rekao drugačije.
If while taking Pregabalin Sandoz GmbH you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
Ako tijekom uzimanja lijeka Pregabalin Sandoz GmbH primijetite da manje mokrite, morate o tome obavijestiti svog liječnika jer se prekidom primjene lijeka to može poboljšati.
Pregabalin Sandoz GmbH is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Pregabalin Sandoz GmbH nije namijenjen za samostalnu primjenu, nego se uvijek mora uzimati u kombinaciji s drugim antiepileptičkim lijekovima.