natgillin/translations-raw huggingface dataset:
Non-clinical data on the Matrix component reveal no special hazard for humans based on studies of cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, subchronic toxicity, genotoxicity, implantation, and hemocompatibility.
Predklinični podatki o sestavini matriksa na osnovi študij citotoksičnosti, preobčutljivosti, intrakutane reaktivnosti, akutne sistemske toksičnosti, z materialom povzročene pirogenosti, subkronične toksičnosti, genotoksičnosti, vsaditve in hemokompatibilnosti ne kažejo posebnega tveganja za človeka.
Unintentional fluid intake into the airway (aspiration), build up of excess fluid in the cavity surrounding the lungs; the frequency was uncommon (may affect up to 1 in 100 people).
Nenamerni vdor tekočine v dihalne poti (aspiracija), kopičenje odvečne tekočine v votlini, ki obdaja pljuča; pogostnost je bila občasno (lahko se pojavi pri največ 1 od 100 bolnikov).
Three subjects out of 145 (~2%) in a clinical trial group treated with EVARREST showed an increase in the titre of anti-thrombin antibodies after treatment.
Pri treh osebah od 145 (~2 %) oseb v skupini v kliničnem preskušanju, zdravljeni z zdravilom EVARREST, so po zdravljenju odkrili zvišanje titra protiteles proti trombinu.
● The lower portion of the tray contains EVARREST with the active side facing downwards.
● Na spodnjem delu pladnja je zdravilo EVARREST, pri čemer je stran z učinkovino usmerjena navzdol.
The incidence of thromboembolic events, the incidence of post-operative bleeding events specifically related to the target bleeding site and the incidence of increased blood fibrinogen levels were assessed and recorded up to the 30 days follow-up period.
V obdobju spremljanja do 30 dni so ocenili in evidentirali pojavnost trombemboličnih dogodkov, pojavnost dogodkov pooperativnih krvavitev, specifično povezanih s ciljnim mestom krvavitve, in pojavnost zvišanih ravni fibrinogena v krvi.
- surgery to the brain or spinal cord - controlling bleeding in the stomach or intestines by applying the product through an endoscope
- operacija možganov ali hrbtenjače, - obvladovanje krvavitve v trebušni votlini in črevesju z endoskopsko vstavitvijo zdravila (skozi cev), - tesnjenje pri kirurških posegih v črevesju.
EVARREST must not be used after the expiry date which is stated on the foil sachet as well as the carton after EXP.
Zdravila EVARREST ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Three subjects out of 145 (~2%) in the group treated with EVARREST showed an increase in the titre of anti-thrombin antibodies after treatment.
Pri treh osebah od 145 (~2 %) oseb v skupini, zdravljeni z zdravilom EVARREST, so po zdravljenju odkrili zvišanje titra protiteles proti trombinu.
To open the product, remove the foil sachet from the carton, carefully peel open the foil sachet avoiding contact with the inside of the foil or the white sterile tray containing EVARREST.
Zdravilo odprite tako, da iz škatle vzamete vrečko iz folije, jo previdno odprete s potegom, pri tem pa preprečite stik z notranjostjo folije ali belim sterilnim pladnjem, na katerem je zdravilo EVARREST.
● If bleeding is due to insufficient coverage of the bleeding area, additional EVARREST sealant matrices may be applied.
● Če je krvavitev še prisotna, ker krvaveči predel ni dovolj prekrit, lahko uporabite dodatne matrikse EVARREST.
It is strongly recommended that every time EVARREST is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Za vodenje evidence o uporabljenih serijah je zelo priporočljivo, da se pri vsaki uporabi zdravila EVARREST zabeležita ime in številka serije zdravila, kar omogoča povezavo bolnika s serijo zdravila.
One (1/75) adverse reaction of deep vein thrombosis was reported in the EVARREST group.
V skupini z zdravilom EVARREST so poročali o enem (1/75) primeru neželenega učinka globoke venske tromboze.
● EVARREST must not be used in closed spaces (e.g., in, around, or in proximity to foramina in bone or areas of bony confine) since swelling may cause nerve or blood vessel compression.
● Zdravila EVARREST se ne sme uporabljati na predelih telesa, kjer je malo prostora (npr. v, okoli ali v bližini odprtin v kosti ali v predelih med kostmi), saj lahko oteklina stisne živce ali krvne žile.
EVARREST can be cut to the size and shape required to fit the size of the bleeding area.
Zdravilo EVARREST je mogoče razrezati tako, da njegova velikost in oblika ustrezata velikosti krvavečega predela.
The quantity of EVARREST to be applied depends upon the area and location of the bleeding area to be treated.
Količina zdravila EVARREST, ki ga boste namestili, je odvisna od površine in mesta krvavitve, ki jo je treba zdraviti.
If not satisfied with the placement of EVARREST, remove the used EVARREST sealant matrix and repeat the application procedure above with a new EVARREST sealant matrix.
Če niste zadovoljni z namestitvijo zdravila EVARREST, uporabljen matriks odstranite in postopek namestitve ponovite z novim matriksom z lepilom za tkiva EVARREST.
In total, no more than the equivalent of two 10.2 cm x 10.2 cm units or four 5.1 cm x 10.2 cm units should remain in the body as there is only limited long-term experience with larger quantities.
Skupno je lahko na telesu zdravilo v površini, ki ustreza največ dvema enotama velikosti 10,2 cm × 10,2 cm ali štirim enotam velikosti 5,1 cm x 10,2 cm, saj so dolgoročne izkušnje z uporabo večjih količin zdravila omejene.
Blood clot (thromboembolism)
Krvni strdki (tromboembolizem)
Most Serious Side Effects Bleeding (haemorrhage)
Najresnejši neželeni učinki Krvavitev
● If bleeding is due to incomplete adherence to the tissue (where bleeding persists from under the dressing), remove EVARREST sealant matrix and use a new one.
● Če krvavitev ne preneha zaradi nepopolnega sprijetja s tkivom (krvavitev izpod obveze vztraja), odstranite matriks EVARREST in uporabite novega.
A further trial in 91 patients undergoing abdominal, retroperitoneal, pelvic, and (non-cardiac) thoracic surgery (59 treated with EVARREST and 32 with control) demonstrated haemostasis in severe soft tissue bleeding.
V nadaljnjem preskušanju pri 91 bolnikih (59 oseb je bilo zdravljenih z zdravilom EVARREST in 32 s kontrolnim zdravilom) med abdominalnimi in retroperitonealnimi operacijami ter operacijami medenice in prsnega koša (brez operacij srca) so dokazali hemostazo pri hudih krvavitvah mehkega tkiva.
40 IU Contains one sealant matrix (5.1 cm x 10.2 cm)
40 i.e. Vsebuje en matriks z lepilom za tkiva (5,1 cm × 10,2 cm)
5a) Hold dry or moist surgical gauze or laparotomy pads over EVARREST to achieve full contact with the bleeding surface.
5a) Da zagotovite popoln stik zdravila EVARREST s krvavečo površino, nanj pritisnite s suho ali vlažno kirurško gazo ali z blazinicami za laparotomijo.
NAME OF THE MEDICINAL PRODUCT EVARREST Sealant Matrix
IME ZDRAVILA EVARREST matriks z lepilom za tkiva
Using sterile scissors, carefully cut EVARREST to the size and shape as necessary to fit and maintain contact with the bleeding area with an overlap of approximately 1 to 2 cm. Keep the powdery white-to-yellow colour active side of EVARREST facing down while in the tray.
S sterilnimi škarjami previdno obrežite zdravilo EVARREST tako, da bo ustrezalo potrebni velikosti in obliki za prileganje ter ohranjanje stika s krvavečim mestom in da bo segalo približno 1 cm do 2 cm prek robov.
For epilesional use only.
Način uporabe Samo za epilezijsko uporabo.
It is strongly recommended that every time you are treated with EVARREST, the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Za vodenje evidence o uporabljenih serijah je zelo priporočljivo, da se pri vsaki uporabi zdravila EVARREST zabeležita ime in številka serije zdravila.
It can be cut to the size and shape required to fit the size of the bleeding area.
Matriks lahko razrežete tako, da njegova velikost in oblika ustrezata velikosti krvavečega mesta.
EVARREST must be kept dry at all times prior to application to avoid pre-activation.
Da bi preprečili aktivacijo zdravila EVARREST pred uporabo, mora biti zdravilo vselej suho.
Composite Matrix (Polyglactin 910 and oxidised regenerated cellulose) 20 mg/cm2 Arginine hydrochloride
6.1 Seznam pomožnih snovi kompozitni matriks (poliglaktin 910 in oksidirana regenerirana celuloza) 20 mg/cm2 argininijev klorid glicin natrijev klorid natrijev citrat kalcijev klorid humani albumin manitol natrijev acetat
Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Znaki preobčutljivostnih reakcij so urtikarija, generalizirana urtikarija, tiščanje v prsih, težko dihanje (sopihanje), hipotenzija in anafilaksa.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealants/haemostatic products.
Pri bolnikih, zdravljenih s fibrinskimi lepili/hemostatiki, se lahko v redkih primerih pojavijo preobčutljivostne ali alergijske reakcije (ki lahko vključujejo angioedem, pekoč občutek in zbadanje na mestu nanosa, bronhospazem, mrzlico, vročinske oblive, generalizirano urtikarijo, glavobol, koprivnico, hipotenzijo, letargijo, navzeo, nemirnost, tahikardijo, tiščanje v prsih, mravljinčenje, bruhanje, težko dihanje).
Increase in the levels of fibrinogen in the blood: the frequency was uncommon (may affect up to 1 in 100 people).
Zvišanje ravni fibrinogena v krvi; pogostnost je bila občasna (lahko se pojavi pri največ 1 od 100 bolnikov).
What EVARREST contains
Kaj vsebuje zdravilo EVARREST
The lower portion of the tray contains EVARREST with the active side facing downwards.
Na spodnjem delu pladnja je zdravilo EVARREST, pri čemer je stran z učinkovinama usmerjena navzdol.
● Intra-abdominal haemorrhage Localised intra-abdominal fluid collection
Lokalizirano nabiranje tekočine v trebuhu Nabiranje tekočine okoli trebušne slinavke
● If bleeding still occurs during or after the specified duration of compression, remove the used EVARREST sealant matrix and inspect the bleeding site.
● Če krvavitev po določenem času pritiskanja ne preneha, uporabljeno zdravilo EVARREST matriks z lepilom za tkiva odstranite in preglejte mesto krvavitve.
Keep EVARREST dry after opening.
Ko zdravilo EVARREST odprete, počakajte, da se posuši.
NAME OF THE MEDICINAL PRODUCT EVARREST Sealant Matrix EVARREST contains per cm2
EVARREST matriks z lepilom za tkiva Zdravilo EVARREST na cm2 vsebuje humani fibrinogen
As with any implantable product, foreign body reactions may occur.
Tako kot pri vseh vsadkih se lahko pojavi reakcija na tujek.
● Remove the white sterile tray from the pouch and place onto the sterile field.
● Beli sterilni pladenj vzemite iz vrečke in ga položite na sterilno mesto.
If not satisfied with the placement of EVARREST, remove the used EVARREST
Če niste zadovoljni z namestitvijo zdravila EVARREST, ga odstranite in uporabite novega.
Carton (10.2 cm x 10.2 cm, 5.1 cm x 10.2 cm) and Foil Sachet (10.2 cm x 10.2 cm)
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Škatla (10,2 cm × 10,2 cm, 5,1 cm x 10,2 cm) in vrečka iz folije (10,2 cm × 10,2 cm)
The use of EVARREST is restricted to experienced surgeons.
Zdravilo EVARREST lahko uporabljajo samo kirurgi.
EVARREST is presented as a sealant matrix which is 10.2 cm x 10.2 cm in size.
Zdravilo EVARREST je na voljo kot matriks z lepilom za tkiva velikosti 10,2 cm × 10,2 cm.
Accumulation of fluid in the stomach, swelling of the stomach; the frequency was uncommon (may affect up to 1 in 100 people).
Kopičenje tekočine v želodcu, oteklina želodca; pogostnost je bila občasna (lahko se pojavi pri največ 1 od 100 bolnikov).
How to store EVARREST
Kako uporabljati zdravilo EVARREST
EVARREST will remain in place and adhere to the tissue, and is absorbable.
Matriks zdravila EVARREST, ki je absorbilen, bo ostal na mestu in se sprijel s tkivom.
EVARREST should be applied so it extends approximately 1 to 2 cm beyond the margins of the target bleeding area.
Zdravilo EVARREST nanesete tako, da sega približno 1 do 2 cm čez robove ciljnega krvavečega mesta.
Sealant Matrix
V paketu je 1 matriks.
EVARREST should only be used in a single layer, with an overlap of approximately 1 to 2 cm onto non-bleeding tissue or an adjacent EVARREST sealant matrix.
Zdravilo EVARREST naj se uporablja le v enem sloju, in sicer tako, da sega približno 1 do 2 cm prek robov rane na nekrvaveče tkivo ali na sosednji matriks EVARREST.
Human Fibrinogen / Human Thrombin
EVARREST matriks z lepilom za tkiva humani fibrinogen/humani trombin
Storage of EVARREST
Shranjevanje zdravila EVARREST
Apply an appropriately sized piece of EVARREST to adequately cover the entire bleeding area, with an overlap of approximately 1 to 2 cm onto non-bleeding tissue, to assist with adherence to the wound site.
Uporabite zdravilo EVARREST ustrezne velikosti, da ustrezno pokrijete celotno krvaveče mesto in da sega približno 1 do 2 cm na nekrvaveče tkivo, kar pripomore k sprijetju na mesto rane.
8.1 mg
8,1 mg humani trombin
If these symptoms occur, the product should be removed immediately and other hemostatic agent or methods should be used.
Če se pojavijo ti simptomi, je treba takoj prenehati z uporabo zdravila.
From the connection of two vessels (anastomotic haemorrhage); the frequency was uncommon (may affect up to 1 in 100 people).
Iz povezave dveh žil (anastomozna krvavitev); pogostnost je bila občasna (lahko se pojavi pri največ 1 od 100 bolnikov).
- The active substances are as follows:
Pomožne snovi z znanim učinkom:
METHOD AND ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT(I) UPORABE ZDRAVILA za epilezijsko uporabo
From the stomach (intra-abdominal haemorrhage); the frequency was uncommon (may affect up to 1 in 100 people).
Iz želodca (intraabdominalna krvavitev); pogostnost je bila občasna (lahko se pojavi pri največ 1 od 100 bolnikov).
Life-threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.
Če matriks nenamerno namestite intravaskularno, lahko pride do življenjsko nevarnih tromboemboličnih zapletov.
After surgery (post-procedural haemorrhage); the frequency was uncommon (may affect up to 1 in 100 people).
Po kirurškem posegu (pooperativna krvavitev); pogostnost je bila občasna (lahko se pojavi pri največ 1 od 100 bolnikov).
Up to the equivalent of two 10.2 cm x 10.2 cm units or four 5.1 cm x 10.2 cm units should be used if needed to cover the entire bleeding area, with an overlap of approximately 1 to 2 cm.
Za prekritje celotnega krvavečega mesta se lahko uporabi zdravilo v velikosti dveh enot po 10,2 cm x 10,2 cm ali štirih enot po 5,1 cm x 10,2 cm, tako da se enote na robovih prekrivajo pribl.
Application of EVARREST EVARREST is to be applied with approximately 3 minutes of firm manual compression.
Zdravilo EVARREST namestite tako, da ga približno tri minute trdno pritiskate z roko.
- careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded.
- previdno izbiro darovalcev krvi in plazme za zagotovitev izključitve prenašalcev okužb, - pregledovanje posameznih darovanih količin in zbirov plazme na znake prisotnosti virusov/okužb, - vključitev korakov v postopke obdelave krvi in plazme, ki lahko viruse inaktivirajo ali odstranijo.
Your surgeon must not treat you with EVARREST in the following circumstances: EVARREST must not be applied inside blood vessels.
Kirurg matriksa EVARREST ne sme uporabljati v naslednjih primerih:
Contains two sealant matrices (5.1 cm x 10.2 cm) 2 units
Vrečka iz folije (5,1 cm x 10,2 cm)
In the veins, particularly of the legs (deep vein thrombosis) In the arteries supplying the lungs (pulmonary embolism) The frequency of both of these effects was uncommon (may affect up to 1 in 100 people).
- v venah, še posebej na nogah (globoka venska tromboza), - v pljučnih arterijah (pljučna embolija).
● Re-treatment may be required if there are folds, creases, or crimps in the EVARREST sealant matrix.
● Če je matriks z lepilom za tkiva EVARREST prepognjen, zmečkan ali zguban, ga bo morda treba ponovno namestiti.
5.1 cm x 10.2 cm sealant matrix in a tray (polyester).
Matriks z lepilom za tkiva 5,1 cm × 10,2 cm na pladnju (poliester).
10.2 cm x 10.2 cm sealant matrix in a tray (polyester).
Matriks z lepilom za tkiva 10,2 cm × 10,2 cm na pladnju (poliester).
Composite Matrix (Polyglactin 910 and oxidised regenerated cellulose) Arginine hydrochloride
Pomožne snovi: kompozitni matriks (poliglaktin 910 in oksidirana regenerirana celuloza) argininijev klorid glicin natrijev klorid natrijev citrat kalcijev klorid humani albumin manitol natrijev acetat
EVARREST should only be used in a single layer with an overlap of approximately 1 to 2 cm onto non-bleeding tissue to help it stick to the bleeding area.
Zdravilo EVARREST se sme uporabiti samo v enem sloju, da ustrezno pokrije celotno krvaveče mesto in da sega približno 1 cm do 2 cm na nekrvaveče tkivo, kar pripomore k sprijetju na krvaveče mesto.
Discard damaged packages.
V paketu sta 2 matriksa.
Pack size of 1 and as sealant matrices which are 5.1 cm x 10.2 cm in size, Pack size of 2.
V paketu sta 2 matriksa z lepilom za tkiva velikosti 5,1 cm x 10,2 cm.
EVARREST should only be used in a single layer, with an overlap of approximately 1 to 2 cm onto non-bleeding tissue, to assist with adherence to the wound site.
Zdravilo EVARREST se sme uporabiti samo v enem sloju, da ustrezno pokrije celotno krvaveče mesto in da sega približno 1 cm do 2 cm na nekrvaveče tkivo, kar pripomore k sprijetju na mesto rane.
(tube) - sealing surgical repairs to the intestines.
Zdravilo s poškodovano ovojnino zavrzite.
Keep out of sight and reach of children.
Shranjujte nedosegljivo otrokom!
The active side is powdery in appearance.
Stran z zdravilno učinkovino je videti prahasta.
Accumulation of fluid in the pancreas: the frequency was uncommon (may affect up to 1 in 100 people).
Kopičenje tekočine v trebušni slinavki; pogostnost je bila občasna (lahko se pojavi pri največ 1 od 100 bolnikov).
During surgery (operative haemorrhage); the frequency was uncommon (may affect up to 1 in 100 people).
Med kirurškim posegom (medoperativna krvavitev); pogostnost je bila občasna (lahko se pojavi pri največ 1 od 100 bolnikov).
EVARREST must be kept out of the sight and reach of children.
Zdravilo EVARREST shranjujte nedosegljivo otrokom!
EXPIRY DATE
Občasni Občasni
Name and address of the manufacturer(s) responsible for batch release Omrix Biopharmaceuticals N.V.
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
Bottle (HDPE)
Peroralna uporaba Plastenka (HDPE)
EU (MA) Number Invented Name
EU številka Ime Jakost Farmacevtska oblika
1.5 g 20 sachets Meat and offal: 3 days
V krmno mešanico Vrečke (papir/PE/a lu/PE),
Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/123)
Izid postopka v skladu s členom 34 Direktive 2001/82/ES (EMEA/V/A/123)
5 October 2017
5. oktober 2017
The European Commission issued a decision on 5 October 2017.
Evropska komisija je sklep izdala 5. oktobra 2017.
Lincocin is authorised in the EU via national procedures.
Zdravilo Lincocin je bilo v EU odobreno po nacionalnih postopkih.
Why was Lincocin reviewed?
Zakaj je bilo zdravilo Lincocin pregledano?
Lincocin (and associated names, such as Lincocine poudre soluble and Albiotic Pulver 400 mg/g) is marketed in Belgium, Denmark, France, Germany, Hungary, Ireland, Poland and United Kingdom.
Zdravilo Lincocin (in povezana imena, kot sta Lincocine poudre soluble in Albiotic Pulver 400 mg/g) se trži v Belgiji, na Danskem, v Franciji, v Nemčiji, na Madžarskem, Irskem, Poljskem in v Združenem kraljestvu.
On 13 July 2017, the European Medicines Agency (the Agency) completed a review of Lincocin.
Evropska agencija za zdravila (agencija) je 13. julija 2017 zaključila pregled zdravila Lincocin.
Questions and answers on Lincocin and its associated names EMA/585749/2017
Vprašanja in odgovori v zvezi z zdravilom Lincocin in povezanimi imeni EMA/585749/2017
Questions and answers on Lincocin and its associated names
Vprašanja in odgovori v zvezi z zdravilom Lincocin in povezanimi imeni
What is Lincocin?
Kaj je zdravilo Lincocin?
Lincomycin is a lincosamide antibiotic which is produced by Streptomyces lincolnensis.
Linkomicin je linkozamidni antibiotik, ki ga proizvajajo bakterije družine Streptomyces lincolnensis.
The European Commission noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Lincocin is marketed.
Evropska komisija je opozorila, da med državami članicami obstajajo razlike v načinu, kako se zdravilo za uporabo v veterinarski medicini lahko uporablja, kar se odraža v razlikah med povzetki glavnih značilnosti zdravila v državah, v katerih se zdravilo Lincocin trži.
Lincocin is indicated for the treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae in pigs and treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens in chickens.
Zdravilo Lincocin je indicirano za zdravljenje in metafilakso enzootske pljučnice pri prašičih, ki jo povzroča bakterija Mycoplasma hyopneumoniae, ter zdravljenje in metafilakso nekrotskega enteritisa pri piščancih, ki ga povzroča bakterija Clostridium perfringens.
Lincocin is a veterinary medicinal product available as powder for oral solution and contains 400 mg lincomycin per gram of product.
Lincocin je zdravilo za uporabo v veterinarski medicini, ki je na voljo kot prašek za peroralno raztopino in vsebuje 400 mg linkomicina na gram zdravila.
Based on the evaluation of the currently-available data, the CVMP concluded that the product information for Lincocin and its associated names should be harmonised across the EU.
Odbor CVMP je na podlagi vrednotenja trenutno razpoložljivih podatkov zaključil, da je treba informacije o zdravilu za zdravilo Lincocin in povezana imena uskladiti po vsej EU.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information [summary of product characteristics (SPC), labelling and package leaflet] for Lincocin in the European Union (EU).
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je treba uskladiti informacije o zdravilu (povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo) za zdravilo Lincocin v Evropski uniji (EU).
Consequently, the CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned product are required in order to amend the product information accordingly.
je treba za ustrezno spremembo informacij o zdravilu spremeniti pogoje dovoljenj za promet z zgoraj navedenim zdravilom.
On 5 July 2016, the European Commission referred the matter to the CVMP in order to harmonise the product information for Lincocin (and associated names) in the EU.
Da bi Evropska komisija uskladila informacije o zdravilu Lincocin (in povezanih imenih) v EU, je 5. julija 2016 zadevo napotila na odbor CVMP.
Do not drive or use machines until this has worn off.
Ne vozite ali ne upravljajte strojev, dokler ta učinek ne mine.
How much to use see side 1
Koliko zdravila uporabiti <glejte 1. stran
In the case of overdose, appropriate monitoring and management of the patient should be implemented.
V primeru prevelikega odmerjanja je treba izvajati ustrezno spremljanje in vodenje bolnika.
Do not give this medicine to children under the ages of 3 years because there is no data to indicate that it is safe and work in children under 3 years.
Ne dajajte tega zdravila otrokom, mlajšim od 3 let, ker ni podatkov, ki bi kazali, da je zdravilo varno in da deluje pri otrocih, mlajših od 3 let.