natgillin/translations-raw huggingface dataset:
To ensure correct dose, body weight should be determined as accurately as possible to avoid underdosing.
Pentru a asigura o doza corecta, greutatea corporala trebuie determinata cat mai precis posibil, pentru a evita subdozarea.
Not authorised for use in lactating animals producing milk for human consumption.
Nu este autorizat pentru a fi utilizat la animalele in lactatie care produc lapte pentru consum uman.
Piglet, newborn Piglet, 3-4 weeks Growing
Purcei, nou nascuti Purcei, 3-4 saptamani Faza de crestere Crestere- Finisare Finisare/Scroafe/Vieri
800 μg/kg 5,000 μg/kg 10,000 μg/kg
5,000 μg/kg 10,000 μg/kg
Recommended needle size and diameter per production stage
Marimile de ace recomandate si diametrul in functie de stadiul de pruductie
It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection.
Se recomanda ca animalele sa se trateze in faza incipienta a bolii si sa se evalueze raspunsul la tratament in 48 de ore dupa injectare.
Accumulation at the site of respiratory tract infection is demonstrated by high and sustained tildipirosin concentrations in lung and bronchial fluid (collected post mortem), which far exceed those in blood plasma.
Acumularea in zona de infectie a tractului respirator este demonstrata prin concentratii mari si sustinute de tildipirosin in fluidul bronsic si pulmonar (colectate post-mortem), care depasesc cu mult pe cea din plasma sangvina.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE C. STATEMENT OF THE MRLs
B. CONDIŢII SAU RESTRICŢII PRIVIND ELIBERAREA SAU UTILIZAREA C. DECLARAŢIE REFERITOARE LA LIMITELE MAXIME DE REZIDUURI
For E. coli, Campylobacter and Enterococci, both wild type and non-wild type phenotypes were observed (MIC range 1-> 64 µg/ml).
Coli, Campylobacter şi Enterococci, au fost luate în evidenţă ambele fenotipuri, de tip salbatic si de tip nonsalbatic (CMI interval 1->64).
Do not use in case of hypersensitivity to macrolide antibiotics, citric acid monohydrate or propylene glycol.
Nu se utilizează în caz de hipersensibilitate la antibiotice macrolide, acid citric monohidrat sau propilen glicol.
In vitro, the effect of tildipirosin is bacteriostatic against Pasteurella multocida and B. bronchiseptica, and bactericidal for A. pleuropneumoniae and H. parasuis.
In vitro, efectul tildipirosin este bacteriostatic impotriva Pasteurellei multocida si B. bronchiseptica si bactericid pentru A. pleuropneumoniae si H. parasuis.
Accumulation at the site of respiratory tract infection is demonstrated by high and sustained tildipirosin concentrations in lung and bronchial fluid, which far exceed those in blood plasma.
Acumularea in zona de infectie a tractului respirator este demonstrata prin concentratii mari si sustinute de tildipirosin in fluidul bronsic si pulmonar, care depasesc cu mult pe cea din plasma sangvina.
Needle length (cm)
Lungime ac (cm)
In pigs, it is postulated that the metabolism of tildipirosin proceeds by reduction and sulphate conjugation with subsequent hydration (or ring opening), by demethylation, by dihydroxylation and by S-cysteine and S-glutathione conjugation.
La porci, este cunoscut faptul ca metabolizarea de tildipirosin se realizeaza prin reductie si sulfatconjugarea cu hidratare ulterioara (sau inel de deschidere), prin demetilare, prin dihidroxilare si prin conjugarea de S-cisteina si S-glutationa.
Pain on injection and injection site swellings are very common in treated animals.
Durere la injectare si umflaturi la locul injectarii sunt intalnite des la animalele tratate.
Disk content
Continut disc
Box
Cutie
In vitro binding of tildipirosin to bovine plasma and bronchial fluid proteins is limited with approximately 30%.
In vitro, legarea tildipirosinei de proteinele plasmatice bovine este limitata la aproximativ 30%.
Following the maximum recommended injection site volume of 10 ml, injection site swellings may be associated with pain on palpation for about one day in individual animals.
In urma administrarii printr-o injectare a unui volum maxim recomandat (10 ml), umflaturile de la locul injectarii se pot asocia cu durere la palpare pentru aproximativ o zi la unele animale.
Muscle Skin+fat Liver Kidney
Muschi Piele+grasime
In vitro, the effect of tildipirosin is bactericidal against M. haemolytica and H. somni, and bacteriostatic against P. multocida.
In vitro, efectul tildipirosin este bactericid impotriva Mannheimia haemolytica si H. somni si bacteriostatic impotriva P. multocida.
Vial (100 ml, 250 ml)
Flacon (100 ml, 250 ml)
In target animal safety studies, administration of the maximum recommended injection volume (5 ml) very commonly caused slight swellings at the injection site that were not painful on palpation.
In studiile de siguranta pe speciile tinta, administrarea unui volum maxim recomandat la o injectare (5ml), poate cauza foarte des usoare umflaturi la locul de injectare, care nu sunt dureroase la palpare.
Overdoses of 10 times the recommended dose as well as repeated subcutaneous administration of the veterinary medicinal product only led to transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in calves.
La vitei, o singura injectare subcutanata a unei doze de 10 ori mai mare decat doza recomandata precum si repetarea administrarii subcutanate de produs medicinal veterinar a fost bine tolerata, cu excepția de semnele clinice tranzitorii atribuite disconfortului si umflaturilor de la locul de injectare asociate cu durerea la vitei.
Other provisions
ALTE INFORMAŢII
In calves, a single subcutaneous injection of 10 times the recommended dose (40 mg/kg body weight) and repeated subcutaneous administration of tildipirosin (on three occasions in intervals of 7 days) at 4, 12 and 20 mg/kg (1, 3 and 5 times the recommended clinical dose) were well tolerated, apart from transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in some animals.
La vitei, o singura injectare subcutanata a unei doze de 10 ori mai mare decat doza recomandata (40 mg/kg greutate corporala) si administrarea repetata subcutanata de tildipirosin (de trei ori la interval de 7 zile) de 4, 12 si 20 mg/kg (de 1, 3 si 5 ori doza clinica recomadata) a fost bine tolerata, in afara de semnele clinice tranzitorii atribuite disconfortului si umflaturilor de la locul de injectare asociate cu durerea la unele animale.
In cattle, it is postulated that metabolism of tildipirosin proceeds by cleavage of the mycaminose sugar moiety, by reduction and sulphate conjugation with subsequent hydration (or ring opening), by demethylation, by mono- or dihydroxylation with subsequent dehydration and by S-cysteine and Sglutathione conjugation.
La bovine, este postulat faptul ca metabolizarea de tildipirosin se realizeaza prin clavaj al fractiunii de zahar, prin reductia si conjugarea ulterioara a sulfatului (sau inel de deschidere), prin demetilare, prin mono sau dihidroxilare cu dehidrare ulterioara si prin conjugarea de S-cisteina si S-glutationa.
Pathomorphological injection site reactions resolved completely within 21 days.
Reactiile locale patomorfologice s-au rezolvat complet in decurs de 21 zile.
Injection site reactions will largely resolve within 35 days.
Reactii la locul de injectare se remit in general in 35 de zile.
Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, the bacterial pathogens most commonly associated with bovine respiratory disease (BRD).
Mannheimia haemolytica, Pasteurella multocida si Histophilus somni, agentii patogeni bacterieni cei mai des asociati cu boala respiratorie bovina (SRB).
Not for use in animals from which milk is produced for human consumption.
Nu se utilizeaza la animalele care produc lapte pentru consumul uman.
Tildipirosin administered subcutaneously to cattle at a single dose of 4 mg/kg body weight resulted in rapid absorption with average peak plasma concentration of 0.7 µg/ml within 23 minutes (Tmax) and high absolute bioavailability (78.9%).
Tildipirosin administrat subcutanat la bovine in doza unica de 4 mg/kg greutate corporala a fost absorbit rapid, atingand media concentratiei plasmatice maxime de 0.7 µg/ml in 23 minute (Tmax) si o mare biodisponibilitate absoluta (78.9%).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Cattle
INFORMAŢII MINIME CARE TREBUIE ÎNSCRISE PE UNITĂŢILE MICI DE AMBALAJ
Tildipirosin administered intramuscularly to pigs at a single dose of 4 mg/kg body weight was rapidly absorbed reaching average peak plasma concentration of 0.9 µg/ml within 23 minutes (Tmax).
Tildipirosin administrat intramuscular la purcei in doza unica de 4 mg/kg greutate corporala a fost absorbit rapid, atingand media concentratiei plasmatice maxime de 0.9 µg/ml in 23 minute (Tmax).
Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Nu se utilizează la animale gestante care sunt destinate producţiei de lapte pentru consum uman, în interval de 2 luni până la data aşteptată a fătării.
For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin.
INDICAŢIE (INDICAŢII) Tratamentul si prevenirea bolilor respiratorii la bovine (BRB) asociate cu with Mannheimia haemolytica, Pasteurella multocida si Histophilus somni sensibile la tildipirosin.
Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis, which are the bacterial pathogens most commonly associated with swine respiratory disease (SRD).
Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica si Haemophilus parasuis, care sunt agentii patogeni bacterieni cei mai des asociati cu boala respiratorie suina (BRS).
Clear yellowish solution.
Solutie limpede, de culoare galbuie
Meat and offal: 9 days.
Carne si organe: 9 zile.
Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/45 kg body weight) once only.
Se administreaza 4 mg tildipirosin/kg greutate corporala (echivalent cu 1 ml/45 kg greutate corporala) o singura data.
Citric acid monohydrate Propylene glycol Water for injections
Acid citric monohidrat
Box containing 1 vial of 20 ml, 50 ml, 100 ml or 250 ml.
Cutie de carton care contine 1 flacon de 20 ml, 50 ml, 100 ml sau 250 ml.
Special precautions for use in animals:
ATENŢIONARE (ATENŢIONĂRI) SPECIALĂ (SPECIALE) Precauţii pentru utilizare la animale:
Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/10 kg body weight) once only.
Se administreaza 4 mg tildipirosin/kg greutate corporala (echivalent cu 1 ml/10 kg greutate corporala) o singura data.
Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosin.
INDICAŢIE (INDICAŢII) Tratamentul şi metafilaxia bolilor respiratorii la suine (BRS) asociate cu Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica si Haemophilus parasuis sensibile la tildipirosin.
Zone diameter (mm) MIC breakpoint (µg/ml) S I
Diametrul zonei (mm) Punct de rupere CMI (µg/ml)
STATEMENT OF ACTIVE AND OTHER SUBSTANCES 180 mg/ml of tildipirosin
DECLARAREA SUBSTANŢELOR ACTIVE ŞI A ALTOR SUBSTANŢE 180 mg/ml de Tildipirosin
QUANTITY OF THE ACTIVE SUBSTANCE(S) 180 mg/ml of tildipirosin
CANTITATEA DE SUBSTANŢĂ (SUBSTANŢE) ACTIVĂ (ACTIVE) 180 mg/ml de Tildipirosin
SPECIAL WARNINGS Read the package leaflet before use.
ATENŢIONARE (ATENŢIONĂRI) SPECIALĂ (SPECIALE), DUPĂ CAZ Citiţi prospectul înainte de utilizare.
Tildipirosin Bovine 400 μg/kg
Bovine 400 μg/kg 200 μg/kg
In piglets, intramuscular administration of tildipirosin (on three occasions in intervals of 4 days) at 8, 12 and 20 mg/kg body weight (BW) (2, 3 and 5 times the recommended clinical dose), resulted in transient slightly subdued behaviour in one piglet each from the 8 and 12 mg/kg BW group and 2 piglets from the 20 mg/kg BW group following the first or second injection.
La purcei, administrarea intramsuculară de tildipirosin (de trei ori la interval de 4 zile) în doze de 8, 12 şi 20 mg/kg greutate corporală ( de 2, 3 şi 5 ori doza clinică recomandată) a avut ca rezultat un comportament uşor modificat la un purcel din fiecare grup de 8 şi 12 mg/kg greutate corporală (GC) şi la 2 purcei din grupul cu 20 mg/kg GC după prima sau a doua injectare.
If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed using another antibiotic, and continued until clinical signs have resolved.
Daca semnele clinice ale bolii respiratorii persistă sau se agravează, sau dacă recidivează, tratamentul trebuie schimbat, utilizând alt antibiotic si continuând până când semnele clinice dispar.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Precauţii care trebuie luate de persoana care administrează produsul:
Muscle tremors to the hind legs were observed following the first treatment in one pig each from the 12 and 20 mg/kg BW group.
S-a observat tremor muscular localizat la membrele posterioare după primul tratament la câte un purcel din fiecare grup de 12 si 20 mg/kg GC.
PHARMACEUTICAL FORM Solution for injection.
FORMA FARMACEUTICĂ Soluţie injectabila Soluţie limpede, de culoare gălbuie.
In very rare cases, anaphylactic reactions, with a potentially fatal outcome, might occur.
In cazuri foarte rare, pot apare reactii anafilactice cu un potential final letal,
Meat and offal: 47 days
Carne si organe: 47 zile.
WITHDRAWAL PERIOD Meat and offal: 9 days.
TIMP DE AŞTEPTARE Carne si organe: 9 zile.
Vial (20 ml, 50 ml)
Suine Flacon (20 ml, 50 ml)
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) The veterinary medicinal product is a clear yellowish solution for injection containing 40 mg/ml of tildipirosin
Produsul medicinal veterinar este o solutie injectabila limpede, de culoare galbuie care contine 40 mg/ml de tildipirosin.
Type I amber glass vial with chlorobutyl rubber stopper and an aluminium cap.
Flacoane din sticla maronie de tip I cu dop de cauciuc si capsa de aluminiu.
Pigs
Suine
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cattle
INFORMAŢII CARE TREBUIE ÎNSCRISE PE AMBALAJUL SECUNDAR Bovine
Tildipirosin Porcine 1,200 μg/kg
Suine 1,200 μg/kg 800 μg/kg
PACKAGE LEAFLET FOR: ZUPREVO 180 mg/ml solution for injection for cattle
ZUPREVO 180 mg/ml solutie injectabila pentru bovine
4.2 Indications for use, specifying the target species
4.4 Atenţionări speciale pentru fiecare specie ţintă
PHARMACEUTICAL FORM Solution for injection
Solutie injectabila
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 animals in 10,000 animals, including isolated reports).
• Mai puţin frecvente (mai mult de 1 dar mai puţin de 10 animale din 1,000 de animale)
NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle tildipirosin
ZUPREVO 180 mg/ml solutie injectabila pentru bovine Tildipirosin
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) ZUPREVO is a clear yellowish solution for injection containing 180 mg/ml of tildipirosin
Produsul medicinal veterinar este o solutie injectabila limpede, de culoare galbuie care contine 180 mg/ml de tildipirosin.
Liver Kidney
Propilen glicol
PACKAGE LEAFLET FOR: ZUPREVO 40 mg/ml solution for injection for pigs
ZUPREVO 40 mg/ml solutie injectabilă pentru suine
QUANTITY OF THE ACTIVE SUBSTANCE 40 mg/ml of tildipirosin
40 mg/ml de Tildipirosin
Pathomorphological injection site reactions will largely resolve within 35 days.
Reactiile morfopatologice de la locul de injectare se remit complet in 35 de zile.
Target tissues
Tildipirosin Tildipiro sin
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pigs
INFORMAŢII CARE TREBUIE ÎNSCRISE PE AMBALAJULPRIMAR Suine
NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 40 mg/ml solution for injection for pigs tildipirosin
ZUPREVO 40 mg/ml solutie injectabila pentru suine Tildipirosin
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Pigs
INFORMAŢII CARE TREBUIE ÎNSCRISE PE AMBALAJUL SECUNDAR Suine
MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/007
NUMĂRUL (NUMERELE) AUTORIZAŢIEI DE COMERCIALIZARE EU/2/11/124/007
MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/005
NUMĂRUL (NUMERELE) AUTORIZAŢIEI DE COMERCIALIZARE EU/2/11/124/005
M. haemolytica
Rinichi
MANUFACTURER'S BATCH NUMBER Batch:
NUMĂRUL DE FABRICAŢIE AL SERIEI DE PRODUS
MRL
I.M.
See package leaflet.
Citiţi prospectul.
MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/003
NUMĂRUL (NUMERELE) AUTORIZAŢIEI DE COMERCIALIZARE EU/2/11/124/003
MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/001-004
NUMĂRUL (NUMERELE) AUTORIZAŢIEI DE COMERCIALIZARE EU/2/11/124/001
Antibiotics
Antibiot iceMacr olide
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).
• Foarte rare (mai puţin de 1 din 10,000 animale, inclusiv raportarile izolate)
BLISTER (CALENDAR)
BLISTER BLISTER (CALENDAR)
Always take Tekturna exactly as your doctor has told you.
Utilizaţi întotdeauna Tekturna exact aşa cum v-a spus medicul dumneavoastră.
Do not take Tekturna if you are pregnant.
Nu utilizaţi Tekturna dacă sunteţi gravidă.
If you forget to take Tekturna
Dacă uitaţi să utilizaţi Tekturna
The use of Tekturna in children and adolescents is not recommended.
Nu este recomandată utilizarea Tekturna la copii şi adolescenţi.
Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Tekturna.
Înainte de a conduce un vehicul, folosi utilaje sau efectua alte activităţi care necesită concentrare, trebuie să vă asiguraţi că ştiţi cum reacţionaţi la efectele Tekturna.
Tekturna is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Tekturna nu este recomandat pentru utilizare la copii şi adolescenţi cu vârsta sub 18 ani datorită lipsei datelor privind siguranţa şi eficacitatea (vezi pct. 5.2).
Not known (frequency cannot be estimated from the available data): Kidney problems.
Cu frecvenţă necunoscută (frecvenţa nu poate fi estimată din datele disponibile): Probleme renale.
In addition, an updated RMP should be submitted
Suplimentar, un PGR actualizat trebuie depus
Do not use Tekturna after the expiry date which is stated on the carton and blister.
Nu utilizaţi Tekturna după data de expirare înscrisă pe cutie şi blister.
If you forget to take a dose of Tekturna, take it as soon as you remember and then take the next dose at its usual time.
Dacă uitaţi să luaţi o doză de Tekturna, luaţi-o imediat ce vă amintiţi şi luaţi apoi doza următoare la ora obişnuită.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
• CONDIŢII SAU RESTRICŢII PRIVIND FURNIZAREA ŞI UTILIZAREA, IMPUSE
Due to the lack of data a potential interaction between grapefruit juice and aliskiren cannot be excluded.
Datorită lipsei informaţiilor, nu poate fi exclusă o posibilă interacţiune între sucul de grepfrut şi aliskiren.
This condition should be corrected prior to administration of Tekturna, or the treatment should start under close medical supervision.
Această stare trebuie corectată înainte de administrarea Tekturna sau tratamentul trebuie iniţiat sub strictă supraveghere medicală.
In experimental animals, it has been shown that P-gp is a major determinant of Tekturna bioavailability.
În experimentele la animale, s-a demonstrat că P-gp este un factor determinant principal al biodisponibilităţii Tekturna.
There are no special dose recommendations for patients aged 65 years or older.
Nu există recomandări specifice privind doza pentru pacienţii cu vârsta de 65 ani sau peste.
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
• În interval de 60 zile de la atingerea unui obiectiv important (farmacovigilenţă sau reducerea
Tekturna has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Siguranţa Tekturna a fost evaluată la peste 7800 pacienţi, între care mai mult de 2300 trataţi timp de peste 6 luni şi mai mult de 1200, timp de peste 1 an.
Taking Tekturna with food and drink
Utilizarea Tekturna cu alimente şi băuturi
The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports.
Reacţiile adverse la medicament (tabelul 1) sunt ordonate în funcţie de frecvenţă, cele mai frecvente primele, folosind următoarea convenţie: foarte frecvente (≥1/10); frecvente (≥1/100, <1/10); mai puţin frecvente (≥1/1000, <1/100); rare (≥1/10000, <1/1000); foarte rare (<1/10000), inclusiv raportările izolate.
The MAH must ensure that the system of pharmacovigilance, as described in version 2 (dated 5 July 2006) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
DAPP trebuie să se asigure că sistemul de farmacovigilenţă, conform descrierii din versiunea 2 (datată 5 Iulie 2006) prezentă în Modulul 1.8.1 al Cererii de autorizare de punere pe piaţă, există şi este funcţional înainte ca medicamentul să fie pus pe piaţă.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Conform Directivei CHMP privind Sistemele de gestionare ale riscurilor pentru medicamentele de uz uman, trebuie depus un Plan actualizat de gestionare a riscurilor în acelaşi timp cu următorul Raport periodic actualizat privind siguranţa (RPAS).
Tekturna belongs to a new class of medicines called renin inhibitors.
Tekturna aparţine unei noi clase de medicamente numite inhibitori ai reninei.
As for any medicine that acts directly on the RAS, Tekturna should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Ca în cazul oricărui medicament care acţionează direct asupra SRA, Tekturna nu trebuie utilizat în timpul primului trimestru de sarcină sau de către femeile care intenţionează să rămână gravide şi este contraindicat în timpul celui de-al doilea şi al treilea trimestru de sarcină (vezi pct. 4.3).
Tekturna has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Tekturna a fost studiat la 1864 pacienţi cu vârste de 65 ani sau peste şi la 426 pacienţi cu vârste de 75 ani sau peste.
If any of these apply to you, tell your doctor before you take Tekturna.
Dacă oricare din aceste cazuri este valabil pentru dumneavoastră, informaţi-vă medicul înainte de a utiliza Tekturna.
In this leaflet: What Tekturna is and what it is used for
Ce este Tekturna şi pentru ce se utilizează
A possible mechanism is saturation of transporters at the absorption site or at the hepatobiliary clearance route.
Un mecanism posibil este saturarea transportorilor la locul de absorbţie sau la nivelul căii de eliminare
However, CYP3A4 inhibitors often also affect P-gp.
Totuşi, inhibitorii CYP3A4 afectează adesea şi P-gp.