natgillin/translations-raw huggingface dataset:
haemorrhage, hypersensitivity, inflammation, mass, pain, or reaction) o Uncommon: Local irritation, skin necrosis at injection site
Opći poremećaji i reakcije na mjestu primjene o 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) o Manje često: lokalna nadraženost; nekroza kože na mjestu injiciranja
Supplied in packs of: - 2, 10 and 30 pre-filled syringes, - 10 and 30 pre-filled syringes with needle guard.
Dostupno u pakiranjima od: - 2, 10 i 30 napunjenih štrcaljke - 10 i 30 napunjenih štrcaljki sa štitnikom
One vial (10 mL) contains 100,000 IU (1000 mg) enoxaparin sodium.
Jedna bočica (10 ml) sadrži 100 000 IU (1000 mg) enoksaparinnatrija.
Inhixa 50,000 IU (500 mg)/5 mL solution for injection in multidose vial enoxaparin sodium
Inhixa 50 000 IU (500 mg)/5 ml otopina za injekciju u višedoznoj bočici enoksaparinnatrij
The syringe can be additionally equipped with needle guard; or - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a white polycarbonate plunger rod equipped with UltraSafe Passive needle guard.
Štrcaljka može biti dodatno opremljena štitnikom za iglu; ili - štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i bijelim polikarbonatnim klipom opremljenoj UltraSafe Passive štitnikom za iglu, s pričvršćenom iglom i pokrovom za iglu.
One pre-filled syringe (1 mL) contains 10,000 IU (100 mg) enoxaparin sodium
Jedna napunjena štrcaljka (1 ml) sadrži 10 000 IU (100 mg) enoksaparinnatrija.
Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection enoxaparin sodium
Inhixa 2000 IU (20 mg)/0,2 ml otopina za injekciju enoksaparinnatrij
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).
VTE = venski tromboembolijski događaj (DVT i/ili PE) *Intervali pouzdanosti od 95% za razlike između liječenja za ukupni VTE bili su: - enoksaparinnatrij jedanput na dan naspram heparina ( -3,0 do 3,5) - enoksaparinnatrij svakih 12 sati naspram heparina ( -4,2 do 1,7).
A 3,000 IU (30 mg) intravenous bolus immediately followed by a 100 IU/kg (1 mg/kg) subcutaneous every 12 hours provided initial maximum anti-Xa activity level of 1.16 IU/mL (n=16) and average exposure corresponding to 88% of steady-state levels.
Intravenska bolusna doza od 3000 IU (30 mg) i neposredno zatim supkutane doze od 100 IU/kg (1 mg/kg) svakih 12 sati dovele su do početne vršne anti-Xa aktivnosti od 1,16 IU/ml (n = 16) i prosječne izloženosti koja je iznosila 88% razine u stanju dinamičke ravnoteže.
A 3,000 IU (30 mg) intravenous bolus immediately followed by a 100 IU/kg (1 mg/kg) subcutaneous every 12 hours provided initial maximum anti-Xa activity level of 1.16 IU/mL (n = 16) and average exposure corresponding to 88% of steady-state levels.
Intravenska bolusna doza od 3000 IU (30 mg) i neposredno zatim supkutane doze od 100 IU/kg (1 mg/kg) svakih 12 sati dovele su do početne vršne anti-Xa aktivnosti od 1,16 IU/ml (n=16) i prosječne izloženosti koja je iznosila 88% razine u stanju dinamičke ravnoteže.
No dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment.
Ne preporučuje se prilagodba doze u bolesnika s umjerenim (klirens kreatinina: 30 - 50 ml/min) i blagim (klirens kreatinina: 50-80 ml/min) oštećenjem bubrežne funkcije.
Volume to inject when diluted to a final concentration of 300 IU (3 mg)/mL
Volumen koji treba injicirati nakon razrjeđivanja do konačne koncentracije od 300 IU (3 mg)/ml
Because of the content of benzyl alcohol (see section 6.1), enoxaparin sodium multiple dose vial formulation must not be given to newborns or premature neonates (see sections 4.4 and 4.6).
• spinalnom ili epiduralnom anestezijom ili lokoregionalnom anestezijom kada je enoksaparinnatrij primijenjen za liječenje unutar prethodna 24 sata (vidjeti dio 4.4) Zbog sadržaja benzilnog alkohola (vidjeti dio 6.1) formulacija enoksaparinnatrija u višedoznoj bočici ne smije se dati novorođenčadi ili nedonoščadi (vidjeti dijelove 4.4 i 4.6).
Inhixa 100,000 IU (1000 mg)/10 mL solution for injection in multidose vial enoxaparin sodium
Inhixa 100 000 IU (1000 mg)/10 ml otopina za injekciju u višedoznoj bočici enoksaparinnatrij
2 pre-filled syringes with needle guard 5 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 20 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard 50 pre-filled syringes with needle guard 90 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 6 pre-filled syringes with UltraSafe Passive needle guard
2 napunjene štrcaljke sa štitnikom za iglu 5 napunjenih štrcaljki sa štitnikom za iglu 6 napunjenih štrcaljki sa štitnikom za iglu 10 napunjenih štrcaljki sa štitnikom za iglu 20 napunjenih štrcaljki sa štitnikom za iglu 30 napunjenih štrcaljki sa štitnikom za iglu 50 napunjenih štrcaljki sa štitnikom za iglu 90 napunjenih štrcaljki sa štitnikom za iglu 2 napunjene štrcaljke sa UltraSafe Passive štitnikom za iglu 6 napunjenih štrcaljki sa UltraSafe Passive štitnikom za iglu
Enoxaparin sodium may be safely administered with sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose in water for injections.
Enoksaparinnatrij se može sigurno primjenjivati zajedno s otopinom natrijeva klorida od 9 mg/ml (0,9 %) za infuziju ili 5 %-tnom vodenom otopinom glukoze za injekcije.
In a second double-blind study, 262 patients without VTE disease and undergoing hip replacement surgery initially treated, while hospitalized, with enoxaparin sodium 4,000 IU (40 mg) subcutaneously were randomized to a post-discharge regimen of either enoxaparin sodium 4,000 IU (40 mg) (n = 131) once a day subcutaneously or to placebo (n = 131) for 3 weeks.
U drugom dvostruko slijepom ispitivanju, 262 bolesnika bez VTE-a podvrgnuta kirurškom zahvatu zamjene kuka, koja su prvotno (tijekom hospitalizacije) bila liječena enoksaparinnatrijem u supkutanoj dozi od 4000 IU (40 mg), randomizirana su da nakon otpuštanja iz bolnice primaju enoksaparinnatrij u dozi od 4000 IU (40 mg) (n = 131) supkutano jedanput na dan ili placebo (n = 131) tijekom 3 tjedna.
In a second double-blind study, 262 patients without VTE disease and undergoing hip replacement surgery initially treated, while hospitalized, with enoxaparin sodium 4,000 IU (40 mg) subcutaneously were randomized to a post-discharge regimen of either enoxaparin sodium 4,000 IU (40 mg) (n=131) once a day subcutaneously or to placebo (n=131) for 3 weeks.
U drugom dvostruko slijepom ispitivanju, 262 bolesnika bez VTE-a podvrgnuta kirurškom zahvatu zamjene kuka, koja su prvotno (tijekom hospitalizacije) bila liječena enoksaparinnatrijem u supkutanoj dozi od 4000 IU (40 mg), randomizirana su da nakon otpuštanja iz bolnice primaju enoksaparinnatrij u dozi od 4000 IU (40 mg) (n=131) supkutano jedanput na dan ili placebo (n=131) tijekom 3 tjedna.
There is a lower weightadjusted clearance in obese subjects with subcutaneous dosing.
Klirens prilagođen prema tjelesnoj težini u pretilih ispitanika manji je kod supkutane primjene.
What Inhixa looks like and contents of the pack Inhixa 12,000 IU (120 mg)/0.8 mL is 0.8 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a purple polypropylene plunger rod.
Inhixa 12 000 IU (120 mg)/0,8 ml jest 0,8 ml otopine u: štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil gume i ljubičastim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 12 pre-filled syringes with needle guard 24 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 10 pre-filled syringes with UltraSafe Passive needle guard
2 napunjene štrcaljke sa štitnikom za iglu 6 napunjenih štrcaljki sa štitnikom za iglu 10 napunjenih štrcaljki sa štitnikom za iglu 12 napunjenih štrcaljki sa štitnikom za iglu 24 napunjenih štrcaljki sa štitnikom za iglu 30 napunjenih štrcaljki sa štitnikom za iglu 2 napunjene štrcaljke sa UltraSafe Passive štitnikom za iglu 10 napunjenih štrcaljki sa UltraSafe Passive štitnikom za iglu
0.8 mL of solution in: - a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a red polypropylene plunger rod.
0,8 ml otopine u: graduiranoj štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i crvenim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
Packs of: - 2, 5, 6, 10, 30 and 50 pre-filled syringes - 2, 5, 6, 10, 20, 30, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard
Pakiranja od: - 2, 5, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 5, 6, 10, 20, 30, 50 i 90 napunjenih štrcaljki sa štitnika za iglu - 2 i 6 napunjenih štrcaljki sa UltraSafe Passive štitnika za iglu
0.2 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a blue polypropylene plunger rod.
0,2 ml otopine u: štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i plavim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
What Inhixa contains
Kako Inhixa izgleda i sadržaj pakiranja
2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 12 pre-filled syringes with needle guard 20 pre-filled syringes with needle guard 24 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 10 pre-filled syringes with UltraSafe Passive needle guard
2 napunjene štrcaljke sa štitnikom za iglu 6 napunjenih štrcaljki sa štitnikom za iglu 10 napunjenih štrcaljki sa štitnikom za iglu 12 napunjenih štrcaljki sa štitnikom za iglu 20 napunjenih štrcaljki sa štitnikom za iglu 24 napunjenih štrcaljki sa štitnikom za iglu 30 napunjenih štrcaljki sa štitnikom za iglu 2 napunjene štrcaljke sa UltraSafe Passive štitnikom za iglu 10 napunjenih štrcaljki sa UltraSafe Passive štitnikom za iglu
5 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and grey aluminium-plastic cap in a cardboard box.
5 ml otopine u bočici od prozirnog, bezbojnog stakla tipa I, s gumenim čepom i sivim zatvaračem od aluminija i plastike u kartonskoj kutiji.
Supplied in packs of: - 2, 5, 6, 10, 30 and 50 pre-filled syringes - 2, 5, 6, 10, 20, 30, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard
Dostupno u pakiranjima od: - 2, 5, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 5, 6, 10, 20, 30, 50 i 90 napunjenih štrcaljki sa štitnikom za iglu - 2 i 6 napunjenih štrcaljki s UltraSafe Passive štitnikom za iglu
Prevention of venous thromboembolic disease associated with surgery Extended prophylaxis of VTE following orthopaedic surgery In a double blind study of extended prophylaxis for patients undergoing hip replacement surgery, 179 patients with no venous thromboembolic disease initially treated, while hospitalized, with enoxaparin sodium 4,000 IU (40 mg) subcutaneously, were randomized to a post-discharge regimen of either enoxaparin sodium 4,000 IU (40 mg) (n=90) once a day subcutaneously or to placebo (n=89) for 3 weeks.
U dvostruko slijepom ispitivanju produljene profilakse u bolesnika podvrgnutih kirurškom zahvatu zamjene kuka, 179 bolesnika bez venske tromboembolijske bolesti, koji su prvotno (tijekom hospitalizacije) bili liječeni enoksaparinnatrijem u supkutanoj dozi od 4000 IU (40 mg), randomizirano je da nakon otpusta iz bolnice prima enoksaparinnatrij u dozi od 4000 IU (40 mg) (n=90) supkutano jedanput na dan ili placebo (n=89) tijekom 3 tjedna.
2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 20 pre-filled syringes with needle guard 50 pre-filled syringes with needle guard 90 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 6 pre-filled syringes with UltraSafe Passive needle guard
2 napunjene štrcaljke sa štitnikom za iglu 6 napunjenih štrcaljki sa štitnikom za iglu 10 napunjenih štrcaljki sa štitnikom za iglu 20 napunjenih štrcaljki sa štitnikom za iglu 50 napunjenih štrcaljki sa štitnikom za iglu 90 napunjenih štrcaljki sa štitnikom za iglu 2 napunjene štrcaljke sa UltraSafe Passive štitnikom za iglu 6 napunjenih štrcaljki sa UltraSafe Passive štitnikom za iglu
0.4 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a yellow polypropylene plunger rod.
0,4 ml otopine u: štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i žutim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
1 mL of solution in: - a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a black polypropylene plunger rod.
1 ml otopine u: graduiranoj štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i crnim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
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).
• PE (%) VTE = venski tromboembolijski događaj (DVT i/ili PE) *Intervali pouzdanosti od 95% za razlike između liječenja za ukupni VTE bili su: enoksaparinnatrij jedanput na dan naspram heparina (-3,0 do 3,5) enoksaparinnatrij svakih 12 sati naspram heparina (-4,2 do 1,7)
0.6 mL of solution in: - a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and an orange polypropylene plunger rod.
0,6 ml otopine u: graduiranoj štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i narančastim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
10 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and white aluminium-plastic cap in a cardboard box.
10 ml ml otopine u bočici od prozirnog, bezbojnog stakla tipa I, s gumenim čepom i bijelim zatvaračem od aluminija i plastike, u kartonskoj kutiji.
3 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and white aluminium-plastic cap in a cardboard box.
3 ml otopine u bočici od prozirnog, bezbojnog stakla tipa I, s gumenim čepom i bijelim zatvaračem od aluminija i plastike u kartonskoj kutiji.
0.8 mL of solution in a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a purple polypropylene plunger rod.
0,8 ml otopine u: štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i ljubičastim klipom od polipropilena, s pričvršćenom iglom i pokrovom za iglu.
Monitoring of platelet counts
Praćenje broja trombocita
4,000 IU (40 mg) of Inhixa each day.
(40 mg) lijeka Inhixa.
Packs of: - 2, 6, 10, 30, 50 and 90 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Pakiranja od: - 2, 6, 10, 30, 50 i 90 napunjenih štrcaljki - 2, 6, 10, 12, 24 i 30 napunjenih štrcaljki sa štitnika za iglu - 2 i 10 napunjenih štrcaljki sa UltraSafe Passive štitnika za iglu
Treatment of acute ST-segment elevation myocardial infarction In a large multicentre study, 20,479 patients with STEMI eligible to receive fibrinolytic therapy were randomized to receive either enoxaparin sodium in a single 3,000 IU (30 mg) intravenous bolus plus a 100 IU/kg (1 mg/kg) subcutaneous dose followed by an subcutaneous injection of 100 IU/kg (1 mg/kg) every 12 hours or intravenous unfractionated heparin adjusted based on aPTT for 48 hours.
Bolesnici su bili randomizirani za primanje enoksaparinnatrija u jednokratnoj bolusnoj dozi od 3000 IU (30 mg) intravenski plus 100 IU/kg (1 mg/kg) supkutano, nakon kojih su slijedile supkutane injekcije enoksaparinnatrija u dozi od 100 IU/kg (1 mg/kg) svakih 12 sati, ili za primanje nefrakcioniranog heparina u intravenskoj dozi prilagođenoj prema aPTV-u tijekom 48 sati.
Supplied in packs of: - 2, 6, 10, 30, 50 and 90 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Dostupno u pakiranjima od: - 2, 6, 10, 30, 50 i 90 napunjenih štrcaljki - 2, 6, 10, 12, 24 i 30 napunjenih štrcaljki sa štitnikom za iglu - 2 i 10 napunjenih štrcaljki s UltraSafe Passive štitnikom za iglu
Immunoallergic thrombocytope nia
Vrlo rijetko: imunoalergijsk a trombocitopeni ja
Packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 20, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Pakiranja od: - 2, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 6, 10, 12, 20, 24 i 30napunjenih štrcaljki sa štitnika za iglu - 2 i 10 napunjenih štrcaljki sa UltraSafe Passive štitnika za iglu
- Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to Inhixa Stop taking the vitamin-K antagonist.
- Prelazak s lijekova za razrjeđivanje krvi koji se zovu antagonisti vitamina K (npr. varfarin) na Inhixu
Supplied in packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 20, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Dostupno u pakiranjima od: - 2, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 6, 10, 12, 20, 24 i 30 napunjenih štrcaljki sa štitnikom za iglu - 2 i 10 napunjenih štrcaljki s UltraSafe Passive štitnikom za iglu
Supplied in packs of: - 1, 2, 6, 10 and 50 pre-filled syringe(s) - 2, 6, 10, 20, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard
Dostupno u pakiranjima od: - 1 napunjena štrcaljka i 2, 6, 10, 50 napunjenih štrcaljki - 2, 6, 10, 20, 50 i 90 napunjenih štrcaljki sa štitnikom za iglu - 2 i 6 napunjenih štrcaljki s UltraSafe Passive štitnikom za iglu
Packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Pakiranja od: - 2, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 6, 10, 12, 24 i 30 napunjenih štrcaljki sa štitnika za iglu - 2 i 10 napunjenih štrcaljki sa UltraSafe Passive štitnika za iglu
- Changing from Inhixa to treatment with direct oral anticoagulant Stop taking Inhixa.
- Prelazak s lijeka Inhixa na liječenje direktnim oralnim antikoagulansima
Packs of: - 1, 2, 6, 10 and 50 pre-filled syringe(s) - 2, 6, 10, 20, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard
Pakiranja od: - 1 napunjena štrcaljka i 2, 6, 10, 50 napunjenih štrcaljki - 2, 6, 10, 20, 50 i 90 napunjenih štrcaljki sa štitnika za iglu - 2 i 6 napunjenih štrcaljki sa UltraSafe Passive štitnika za iglu
Supplied in packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard
Dostupno u pakiranjima od: - 2, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 6, 10, 12, 24 i 30 napunjenih štrcaljki sa štitnikom za iglu - 2 i 10 napunjenih štrcaljki s UltraSafe Passive štitnikom za iglu
1 mL of solution in a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a dark blue polypropylene plunger rod.
1 ml otopine u: - štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i tamnoplavim klipom od polipropilena, s pričvršćenom iglom i pokrovom za iglu.
Enoxaparin sodium may be safely administered with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% dextrose in water.
Enoksaparinnatrij se može sigurno primjenjivati zajedno s otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju ili vodenom otopinom glukoze (5%).
Changing from Inhixa to treatment with direct oral anticoagulant Stop using Inhixa.
Prelazak s lijeka Inhixa na liječenje direktnim oralnim antikoagulansima
• you have kidney problems
• ako imate bubrežnih tegoba
Unopened vial: 3 years.
Neotvorena bočica: 3 godine.
Date of first authorisation: 18 January 2017
Datum prvog odobrenja: 18 siječnja 2017.
• It is very important that you do not miss the dose of this medicine.
• Vrlo je važno je da ne propustite primiti dozu ovog lijeka.
Activity in vitro and in vivo
Aktivnost in vitro i in vivo
Genotoxicity and carcinogenic potential have not been evaluated.
Genotoksičnost i kancerogeni potencijal nisu ocijenjeni.
From a microbiological point of view, the product must be used immediately.
S mikrobiološkog stanovišta, lijek se mora odmah primijeniti.
• We don't know if ZINPLAVA will harm your baby while you are pregnant.
• Nije poznato hoće li ZINPLAVA naškoditi Vašem djetetu dok ste trudni.
Adjusted Difference (95% CI)
Prilagođena razlika (95% CI)
• The diluted solution can be infused via a central line or peripheral catheter.
• Razrijeđena otopina može se dati infuzijom putem centralne linije ili perifernog katetera.
No formal interactions studies with other medicinal products were conducted.
Nisu provedena formalna ispitivanja interakcija s drugim lijekovima.
• If you are pregnant or trying to get pregnant, tell your doctor.
• Ako ste trudni ili pokušavate zatrudnjeti, obavijestite svog liječnika.
• You will get ZINPLAVA in one dose and it will take about 1 hour.
• Lijek ZINPLAVA primit ćete u jednoj dozi, a primjena će trajati približno 1 sat.
• You and your doctor should decide together if you will use ZINPLAVA.
• Vi i Vaš liječnik trebate zajedno odlučiti hoćete li primiti lijek ZINPLAVA.
• ZINPLAVA must not be co-administered with other medicinal products simultaneously through the same infusion line.
• ZINPLAVA se ne smije primijeniti istodobno s drugim lijekovima u istoj infuzijskoj liniji.
ATC code: J06BB21
ATK oznaka: J06BB21
What ZINPLAVA is and what it is used for
Što je ZINPLAVA i za što se koristi
Children and adolescents ZINPLAVA should not be used in children and adolescents below 18 years of age.
Djeca i adolescenti ZINPLAVA se ne smije davati djeci i adolescentima mlađim od 18 godina.
Tell your doctor or health care professional if you notice any of the side effects above.
Obratite se svom liječniku ili zdravstvenom radniku ako primijetite bilo koju od gore navedenih nuspojava.
• Call your doctor or health care professional right away to reschedule your appointment.
• Odmah nazovite svog liječnika ili zdravstvenog radnika i dogovorite novi termin.
Store in a refrigerator 2 °C to 8 °C.
Čuvati u hladnjaku na temperaturi od 2°C do 8°C.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza.
These patients presented with risk factors primarily but not exclusively associated with higher risk of CDI recurrence.
Ti su bolesnici imali faktore rizika koji su prvenstveno, ali ne i isključivo povezani s višim rizikom od recidiva CDI-a.