natgillin/translations-raw huggingface dataset:
The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting haemostasis such as NonSteroidal Anti-Inflammatory Drugs (NSAIDs), with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity.
Rizik od tih događaja veći je kod uporabe poslijeoperacijskih trajnih epiduralnih katetera, istodobne primjene dodatnih lijekova koji utječu na hemostazu, poput nesteroidnih protuupalnih lijekova (NSAIL), traumatske ili ponovljene epiduralne ili spinalne punkcije, kao i u bolesnika koji u anamnezi imaju kirurški zahvat na kralježnici ili deformaciju kralježnice.
[to be completed nationally]
[Ispunjava država članica]
Initiate dosing with 75 IU/kg (0.75 mg/kg) SC every 12 hours (maximum 7,500 IU (75 mg) for each of the first two SC doses only, followed by 75 IU/kg (0.75 mg/kg) SC dosing for the remaining doses).
(0,75 mg/kg) svakih 12 sati (najviše 7500 IU [75 mg] samo za svaku od prve dvije supkutane doze,
LOVENOX (and associated names) 12,000 IU (120 mg)/0.8 mL solution for injection LOVENOX (and associated names) 15,000 IU (150 mg)/1 mL solution for injection
LOVENOX (i pridružena imena) 12 000 IU (120 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 15 000 IU (150 mg)/1 ml otopina za injekciju
In patients with severe renal impairment (creatinine clearance <30 mL/min), the AUC at steady state is significantly increased on average by 65% after repeated SC 4,000 IU (40 mg) once daily doses (see section 4.4).
U bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min), AUC u stanju dinamičke ravnoteže značajno je povišen za prosječno 65% nakon ponovljene supkutane primjene doze od 4000 IU (40 mg) jedanput na dan (vidjeti dio 4.4).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LOVENOX 10 x 4,000 IU (10 x 40 mg) Pen enoxaparin
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA LOVENOX 10 x 4000 IU (10 x 40 mg) brizgalica enoksaparin
Treatment of acute STEMI (patients under 75)
Liječenje akutnog STEMI-ja (bolesnici mlađi od
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 10,000 IU/10 mL (100 mg/10 mL) VIAL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA OD 10 000 IU/10 ml (100 mg/10 ml)
How to store LOVENOX (and associated names) [To be completed nationally]
Kako čuvati LOVENOX (i pridružena imena) [Ispunjava država članica]
What LOVENOX (and associated names) looks like and contents of the pack
Kako LOVENOX (i pridružena imena) izgleda i sadržaj pakiranja
[To be completed nationally] [See Annex I - To be completed nationally]
[Ispunjava država članica] [Vidjeti Prilog I.
For patients have an operation called percutaneous coronary intervention (PCI): Depending on when you were last given LOVENOX (and associated names), your doctor may decide to give an additional dose of LOVENOX (and associated names) before a PCI operation.
• Ovisno o tome kad ste zadnji put primili LOVENOX (i pridružena imena), Vaš će liječnik možda odlučiti primijeniti dodatnu dozu lijeka LOVENOX (i pridružena imena) prije perkutane koronarne intervencije.
However, since renal function is known to decline with age, elderly patients may show reduced elimination of enoxaparin sodium (see section 4.4).
Međutim, poznato je da se bubrežna funkcija smanjuje s porastom dobi, pa eliminacija enoksaparinnatrija može biti smanjena u starijih bolesnika (vidjeti dio 4.4).
If a manual compression method is used, sheath should be removed 6 hours after the last IV/SC enoxaparin sodium injection.
uvodnicu treba ukloniti 6 sati nakon posljednje i.v./s.c. injekcije enoksparinnatrija.
What LOVENOX (and associated names) looks like and contents of the pack [To be completed nationally]
Kako LOVENOX (i pridružena imena) izgleda i sadržaj pakiranja [Ispunjava država članica]
• Common: Injection site haematoma, injection site pain, other injection site reaction (such as oedema, haemorrhage, hypersensitivity, inflammation, mass, pain, or reaction)
Opći poremećaji i reakcije na mjestu primjene • Često: hematom na mjestu injiciranja, bol na mjestu injiciranja, ostale reakcije na mjestu injiciranja (kao što su edem, krvarenje, preosjetljivost, upala, masa, bol ili reakcija)
These included 1776 for prophylaxis of deep vein thrombosis following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of deep vein thrombosis in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI.
To je uključivalo 1776 slučajeva profilakse duboke venske tromboze nakon ortopedskog ili abdominalnog kirurškog zahvata u bolesnika s rizikom od tromboembolijskih komplikacija, 1169 slučajeva profilakse duboke venske tromboze u medikamentozno liječenih bolesnika s akutnom bolešću i izuzetno ograničenom pokretljivošću, 559 slučajeva liječenja DVT-a praćenog PE-om ili bez njega, 1578 slučajeva liječenja nestabilne angine i infarkta miokarda bez Q-zupca te 10 176 slučajeva liječenja akutnog STEMI-ja.
Do not use LOVENOX (and associated names)
Nemojte primjenjivati LOVENOX (i pridružena imena)
This helps your body to break them down and stops them from causing you harm2) Stopping blood clots from forming in your blood.
Time pomaže tijelu da ih razgradi i sprječava štetu koju bi Vam oni mogli nanijeti.
One vial (3.0 mL) contains 30,000 IU (300 mg) enoxaparin sodium One vial (5.0 mL) contains 50,000 IU (500 mg) enoxaparin sodium One vial (10.0 mL) contains 100,000 IU (1,000 mg) enoxaparin sodium
Jedna bočica (3,0 ml) sadrži 30 000 IU (300 mg) enoksaparinnatrija Jedna bočica (5,0 ml) sadrži 50 000 IU (500 mg) enoksaparinnatrija Jedna bočica (10,0 ml) sadrži 100 000 IU (1000 mg) enoksaparinnatrija
In the clinical studies for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) SC every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) IV bolus followed by 100 IU/kg (1 mg/kg) SC every 12 hours.
U kliničkim ispitivanjima primjene za liječenje nestabilne angine i infarkta miokarda bez Q-zupca, doza je iznosila 100 IU/kg (1 mg/kg) s.c. svakih 12 sati, dok je u kliničkom ispitivanju primjene za liječenje akutnog STEMI-ja režim liječenja enoksaparinnatrijem uključivao primjenu intravenske bolusne doze od 3000 IU
To obtain a 300 IU/mL (3 mg/mL) solution, using a 6,000 IU (60 mg) enoxaparin sodium pre-filled syringe, it is recommended to use a 50 mL infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water) as follows:
(60 mg) enoksaparinnatrija, preporučuje se upotrijebiti infuzijsku vrećicu volumena 50 ml (s fiziološkom otopinom [0,9%] ili vodenom otopinom glukoze [5%]) na sljedeći način:
Acetylsalicylic acid is recommended for all patients without contraindications at an initial oral loading dose of 150-300 mg (in acetylsalicylic acid-naive patients) and a maintenance dose of 75325 mg/day long-term regardless of treatment strategy.
uz početnu peroralnu udarnu dozu od 150 do 300 mg (u bolesnika koji prethodno nisu bili liječeni acetilsalicilatnom kiselinom) i dugoročnu terapiju održavanja dozom od 75 do 325 mg/dan, neovisno o strategiji liječenja.
LOVENOX (and associated names) contains the active substance called enoxaparin sodium that is a low molecular weight heparin (LMWH).
Što je LOVENOX (i pridružena imena) i za što se koristi LOVENOX (i pridružena imena) sadrži djelatnu tvar koja se zove enoksaparinnatrij, a koja pripada skupini heparina niske molekulske mase.
What LOVENOX (and associated names) is and what it is used for
Što se nalazi u ovoj uputi Što je LOVENOX (i pridružena imena) i za što se koristi
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX AMPOULE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA AMPULE
LOVENOX (and associated names) in a pen can be used to:
LOVENOX (i pridružena imena) u brizgalici može se koristiti za:
• Rare: Cholestatic liver injury*
• Manje često: hepatocelularno oštećenje jetre* • Rijetko: kolestatsko oštećenje jetre*
All Treated Medical Patients During Acute Illness Total VTE (%)
Svi medikamentozno liječeni bolesnici koji su primali terapiju tijekom akutne bolesti
METHOD OF ADMINISTRATION SC / IV
s.c./i.v.
Enoxaparin sodium is primarily metabolized in the liver by desulfation and/or depolymerization to lower molecular weight species with much reduced biological potency.
Biotransformacija Enoksaparinnatrij se prvenstveno metabolizira u jetri procesima desulfatacije i/ili depolimerizacije,
15,000 IU/mL (150 mg/mL) solution for injection:
15 000 IU/ml (150 mg/ml) otopina za injekciju:
10,000 IU/mL (100 mg/mL) solution for injection:
10 000 IU/ml (100 mg/ml) otopina za injekciju:
LOVENOX (and associated names) is indicated in adults for:
4.1 Terapijske indikacije LOVENOX (i pridružena imena) je indiciran u odraslih za:
Careful clinical monitoring is advised and dose reduction might be considered in patients older than 75 years treated for STEMI (see sections 4.2 and
U bolesnika starijih od 75 godina koji se liječe zbog STEMI-ja preporučuje se pažljivo kliničko praćenje, a može se razmotriti i smanjenje doze (vidjeti dijelove 4.2 i 5.2).
The treatment benefits of enoxaparin sodium, evident for a number of efficacy outcomes, emerged at 48 hours, at which time there was a 35 percent reduction in the relative risk of myocardial reinfarction, as compared with treatment with unfractionated heparin (p<0.001).
Terapijska korist enoksaparinnatrija, koja je primijećena kod niza ishoda djelotvornosti, nastupila je nakon 48 sati, kada je zabilježeno smanjenje relativnog rizika od ponovljenog infarkta miokarda za
LOVENOX (and associated names) 30,000 IU (300 mg)/3 mL solution for injection LOVENOX (and associated names) 50,000 IU (500 mg)/5 mL solution for injection LOVENOX (and associated names) 100,000 IU (1,000 mg)/10 mL solution for injection
LOVENOX (i pridružena imena) 30 000 IU (300 mg)/3 ml otopina za injekciju LOVENOX (i pridružena imena) 50 000 IU (500 mg)/5 ml otopina za injekciju LOVENOX (i pridružena imena) 100 000 IU (1000 mg)/10 ml otopina za injekciju
Hepatic impairment
- poremećaj hemostaze
One 3.0 mL pen contains enoxaparin sodium 40,000 IU anti-Xa activity (equivalent to 400 mg), equivalent to 10 single doses of 4,000 IU (40 mg) enoxaparin sodium, + 45 mg benzyl alcohol in 3.0 mL water for injections
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna brizgalica od 3,0 ml sadrži 40 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 400 mg), što odgovara 10 pojedinačnih doza od 4000 IU (40 mg) enoksaparinnatrija, + 45 mg benzilnog alkohola u 3,0 ml vode za injekcije.
For patients with creatinine clearance [15-30] mL/min, consider doubling the timing of puncture/catheter placement or removal to at least 48 hours.
U bolesnika s klirensom kreatinina od 15 do30 ml/min, razmotrite udvostručenje vremena do uboda/uvođenja ili uklanjanja katetera na najmanje 48 sati.
For continuous techniques, a similar delay of at least 12 hours should be observed before removing the catheter.
Kada se koriste kontinuirane tehnike, prije uklanjanja katetera također mora proći najmanje
• Skin necrosis / cutaneous vasculitis
tinzaparin ili dalteparin
15,000 IU/mL (150 mg/mL) solution for injection
15 000 IU/ml (150 mg/ml) otopina za injekciju
For patients with creatinine clearance [15-30] mL/min, consider doubling the timing of puncture/catheter placement or removal to at least 24 hours.
U bolesnika s klirensom kreatinina od 15 do30 ml/min, razmotrite udvostručenje vremena do uboda/uvođenja ili uklanjanja katetera na najmanje 24 sata.
{Name and Address} {tel} {fax} {e-mail}
{Naziv države članice} {Naziv lijeka} {Naziv države članice} {Naziv lijeka}
One vial contains enoxaparin sodium 50,000 IU anti-Xa activity (equivalent to 500 mg) + 75 mg benzyl alcohol in 5.0 mL water for injections.
Jedna bočica sadrži 50 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 500 mg) + 75 mg benzilnog alkohola u 5,0 ml vode za injekcije.
Limited data are available in patients with hepatic impairment (see sections 5.1 and 5.2) and caution should be used in these patients (see section 4.4).
i 5.2) i stoga je u tih bolesnika potreban oprez (vidjeti dio 4.4).
Ampoules
Ampule
A puncture-free interval of at least 24 hours shall be kept between the last injection of enoxaparin sodium at curative doses and the needle or catheter placement (see also section 4.3).
Između posljednje injekcije enoksaparinnatrija u terapijskim dozama i uvođenja igle ili katetera mora proći razdoblje od najmanje 24 sata bez ikakvih uboda (vidjeti i dio 4.3).
Multiple Dose Vials:
Višedozne bočice:
For patients with creatinine clearance [15-30 mL/minute], additional considerations are necessary because elimination of enoxaparin sodium is more prolonged.
Potrebno je dodatno razmotriti primjenu u bolesnika kojima je klirens kreatinina 15 - 30 ml/min jer je kod njih eliminacija enoksaparina dugotrajnija.
Treatment of deep vein thrombosis with or without pulmonary embolism In a multicenter, parallel group study, 900 patients with acute lower extremity DVT with or without PE were randomized to an inpatient (hospital) treatment of either (i) enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day SC, (ii) enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours SC, or (iii) heparin IV bolus (5,000 IU) followed by a continuous infusion (administered to achieve an aPTT of 55 to 85 seconds).
enoksaparinnatrijem u dozi od 150 IU/kg (1,5 mg/kg) s.c. jedanput na dan, (ii) enoksaparinnatrijem u dozi od 100 IU/kg (1 mg/kg) s.c. svakih 12 sati ili (iii) intravenskim bolusom heparina (5000 IU) nakon kojega je uslijedila kontinuirana infuzija (primijenjena radi postizanja aPTV-a od 55 do 85 sekundi).
In patients with severe renal impairment (creatinine clearance 15-30 mL/min), since exposure of enoxaparin sodium is significantly increased, a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges.
Zbog značajno povećane izloženosti enoksaparinnatriju u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina: 15 - 30 ml/min), preporučuje se prilagoditi doze u terapijskom i profilaktičkom rasponu.
Your doctor will request you perform blood tests called INR and tell you when to start LOVENOX (and associated names) accordingly.
Vaš će liječnik tražiti da napravite krvne pretrage za određivanje parametra koji se zove INR i reći će Vam kada trebate početi primjenjivati
For acute STEMI, treatment is to be initiated with a single IV bolus injection immediately followed by a SC injection.
Kod akutnog STEMI-ja, liječenje treba započeti jednokratnom intravenskom bolusnom injekcijom,
These included 1,776 for prophylaxis of deep vein thrombosis (DVT) following orthopaedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of deep vein thrombosis in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without pulmonary embolism (PE), 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI.
nakon ortopedskog ili abdominalnog kirurškog zahvata u bolesnika s rizikom od tromboembolijskih komplikacija, 1169 slučajeva profilakse duboke venske tromboze u medikamentozno liječenih bolesnika s akutnom bolešću i izuzetno ograničenom pokretljivošću, 559 slučajeva liječenja DVT-a praćenog plućnom embolijom (PE) ili bez nje, 1578 slučajeva liječenja nestabilne angine i infarkta miokarda bez Q-zupca te 10 176 slučajeva liječenja akutnog STEMI-ja.
One vial contains enoxaparin sodium 100,000 IU anti-Xa activity (equivalent to 1000 mg) + 150 mg benzyl alcohol in 10.0 mL water for injections.
Jedna bočica sadrži 100 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 1000 mg) + 150 mg benzilnog alkohola u 10,0 ml vode za injekcije.
If you forget to use LOVENOX (and associated names) If you forget to give yourself a dose, have it as soon as you remember.
Ako zaboravite primijeniti dozu, primijenite je čim se sjetite.
Pre-Filled Syringes:
Napunjene štrcaljke:
• For treatment of acute STEMI, the recommended dose of enoxaparin sodium is a single intravenous (IV) bolus of 3,000 IU (30 mg) plus a 100 IU/kg (1 mg/kg) SC dose followed by 100 IU/kg (1 mg/kg) administered SC every 12 hours (maximum 10,000 IU (100 mg) for each of the first two SC doses).
(i.v.) bolus od 3000 IU (30 mg) plus supkutana doza od 100 IU/kg (1 mg/kg), nakon koje slijedi supkutana primjena doze od 100 IU/kg (1 mg/kg) svakih 12 sati (najviše 10 000 IU (100 mg) za svaku od prve dvije supkutane doze).
VTE = venous thromboembolic event (DVT and/or PE) *The 95% Confidence Intervals for the treatment differences for total VTE were: - Enoxaparin sodium once a day versus heparin (-3.0 to 3.5) - enoxaparin sodium every 12 hours versus heparin (-4.2 to 1.7).
- enoksaparinnatrij jedanput na dan naspram heparina (-3,0 do 3,5) - enoksaparinnatrij svakih 12 sati naspram heparina (-4,2 do 1,7)
SPECIAL STORAGE CONDITIONS [to be completed nationally]
POSEBNE MJERE ČUVANJA [Ispunjava država članica]
R
o
STATEMENT OF ACTIVE SUBSTANCE(S) One vial (10.0 mL) contains 10,000 IU (100 mg) enoxaparin sodium.
Jedna bočica (10,0 ml) sadrži 10 000 IU (100 mg) enoksaparinnatrija
LMWHs are biological medicinal products.
Heparini niske molekulske mase su biološki lijekovi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX MULTIDOSE VIAL
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA BRIZGALICE
After repeated SC administration of 4,000 IU (40 mg) once daily and 150 IU/kg (1.5 mg/kg) once daily regimens in healthy volunteers, the steady-state is reached on day 2 with an average exposure ratio about 15% higher than after a single dose.
(1,5 mg/kg) jedanput na dan u zdravih dobrovoljaca, stanje dinamičke ravnoteže postiže se 2. dana, uz prosječan omjer izloženosti koji je približno 15% veći nego nakon jednokratne doze.
Package leaflet: Information for the user LOVENOX (and associated names) 10 x 4,000 IU (10 x 40 mg) doses solution for injection in a pen [See Annex I - To be completed nationally] enoxaparin sodium
Uputa o lijeku: Informacije za korisnika LOVENOX (i pridružena imena) 10 x 4000 IU (10 x 40 mg) otopina za injekciju u brizgalici
One vial contains enoxaparin sodium 30,000 IU anti-Xa activity (equivalent to 300 mg) + 45 mg benzyl alcohol in 3.0 mL water for injections.
Jedna bočica sadrži 30 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 300 mg) + 45 mg benzilnog alkohola u 3,0 ml vode za injekcije.
The usual dose is 100 IU (1 mg) for every kilogram of your weight.
Uobičajena doza je 100 IU (1 mg) po kilogramu tjelesne težine.
Major bleeding were respectively 1.7% in the enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day group, 1.3% in the enoxaparin sodium 100 IU/kg (1mg/kg) twice a day group and 2.1% in the heparin group.
Stopa velikih krvarenja iznosila je 1,7% u skupini liječenoj enoksaparinnatrijem u dozi od 150 IU/kg (1,5 mg/kg) jedanput na dan, 1,3% u skupini liječenoj enoksaparinnatrijem u dozi od 100 IU/kg
What LOVENOX (and associated names) contains
LOVENOX (i pridružena imena)
[To be completed nationally] [See Annex I - To be completed nationally] [For referral procedures]
- Ispunjava država članica] [za arbitražne postupke]
One pre-filled syringe (0.2 mL) contains 2,000 IU (20 mg) enoxaparin sodium One pre-filled syringe (0.4 mL) contains 4,000 IU (40 mg) enoxaparin sodium One pre-filled syringe (0.6 mL) contains 6,000 IU (60 mg) enoxaparin sodium One pre-filled syringe (0.8 mL) contains 8,000 IU (80 mg) enoxaparin sodium One pre-filled syringe (0.8 mL) contains 12,000 IU (120 mg) enoxaparin sodium One pre-filled syringe (1 mL) contains 10,000 IU (100 mg) enoxaparin sodium One pre-filled syringe (1 mL) contains 15,000 IU (150 mg) enoxaparin sodium
Jedna napunjena štrcaljka (0,2 ml) sadrži 2000 IU (20 mg) enoksaparinnatrija Jedna napunjena štrcaljka (0,4 ml) sadrži 4000 IU (40 mg) enoksaparinnatrija Jedna napunjena štrcaljka (0,6 ml) sadrži 6000 IU (60 mg) enoksaparinnatrija Jedna napunjena štrcaljka (0,8 ml) sadrži 8000 IU (80 mg) enoksaparinnatrija Jedna napunjena štrcaljka (0,8 ml) sadrži 12 000 IU (120 mg) enoksaparinnatrija Jedna napunjena štrcaljka (1 ml) sadrži 10 000 IU (100 mg) enoksaparinnatrija Jedna napunjena štrcaljka (1 ml) sadrži 15 000 IU (150 mg) enoksaparinnatrija
Very common: Thrombocytosisβ Common:
Vrlo rijetko: imunoalergijska trombocitopenija
How to use LOVENOX (and associated names) Always use this medicine exactly as your doctor or pharmacist has told you.
• LOVENOX (i pridružena imena) obično će Vam dati liječnik ili medicinska sestra.
After 12 hours of the enoxaparin sodium injection, protamine administration may not be required.
Ako je od injekcije enoksaparinnatrija prošlo 12 sati,
Careful clinical monitoring is advised and dose reduction might be considered in patients older than 75 years treated for ST-segment elevation myocardial infarction (STEMI) (see section 5.2).
U bolesnika starijih od 75 godina koji se liječe zbog infarkta miokarda s elevacijom ST-segmenta (engl.
- Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to LOVENOX (and associated names)
- Prelazak s lijekova za razrjeđivanje krvi koji se zovu antagonisti vitamina K (npr. varfarin) na
The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting haemostasis such as NonSteroidal-Anti Inflammatory Drugs (NSAIDs), with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity.
istodobne primjene dodatnih lijekova koji utječu na hemostazu, poput nesteroidnih protuupalnih lijekova (NSAIL), traumatske ili ponovljene epiduralne ili spinalne punkcije, kao i u bolesnika koji u anamnezi imaju kirurški zahvat na kralježnici ili deformaciju kralježnice.
Each prefilled syringe contains enoxaparin sodium 12,000 IU anti-Xa activity (equivalent to 120 mg) in 0.8 mL water for injections.
Jedna napunjena štrcaljka sadrži 12 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 120 mg) u 0,8 ml vode za injekcije.
All Treated DVT Patients with or without PE
Svi liječeni bolesnici s DVT-om praćenim
In moderate risk patients, enoxaparin sodium treatment should be maintained for a minimal period of 7-10 days whatever the recovery status (e.g. mobility).
7 - 10 dana, neovisno o statusu oporavka (npr. pokretljivosti).
Treatment of unstable angina and non ST elevation myocardial infarction In a large multicenter study, 3,171 patients enrolled at the acute phase of unstable angina or non-Qwave myocardial infarction were randomized to receive in association with acetylsalicylic acid (100 to 325 mg once daily), either SC enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours or IV unfractionated heparin adjusted based on aPTT.
Liječenje nestabilne angine i infarkta miokarda bez elevacije ST-segmenta U velikom multicentričnom ispitivanju sudjelovao je 3171 bolesnik uključen u ispitivanje u akutnoj fazi nestabilne angine ili infarkta miokarda bez Q-zupca.
• Traceability
• Sljedivost
Each ampoule contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 1.0 mL water for injections.
Jedna ampula sadrži 10 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 100 mg) u 1,0 ml vode za injekcije.
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Nositelj odobrenja za stavljanje lijeka u promet i proizvođač [Ispunjava država članica]
Each prefilled syringe contains enoxaparin sodium 15,000 IU anti-Xa activity (equivalent to 150 mg) in 1.0 mL water for injections.
Jedna napunjena štrcaljka sadrži 15 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 150 mg) u 1,0 ml vode za injekcije.