natgillin/translations-raw huggingface dataset:
In four separate studies (N= 9 to 12) the mean steady state trough plasma concentration ranged from 2.6 to 3.4 μ g/ ml.
V štirih ločenih študijah (n = 9 do 12) so povprečne plazemske
As a peptide, enfuvirtide is expected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acids in the body pool.
Presnova: kot za peptid se za enfuvirtid pričakuje, da bo podvržen razgradnji v svoje sestavne aminokisline, s posledično predelavo aminokislin iz telesnih zalog za ponovno uporabo.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and late embryonal development.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in vpliva na pozni razvoj zarodka ne kažejo posebnega tveganja za ljudi.
24 6.2 Incompatibilities
6. 2 Inkompatibilnosti
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
V normalnih razmerah naj ne bi presegali 24 ur pri 2 do 8 °C, razen če je bila rekonstitucija opravljena v nadzorovanih in validiranih aseptičnih pogojih.
lyophilisate stopper, rubber (latex free) aluminum seal with flip-off cap
3 ml viala, brezbarvno steklo tipa 1 zamašek iz gume (brez lateksa) aluminijast pokrov z zaporko, ki se sproži.
Each pack contains 60 vials of Fuzeon.
Velikost pakiranja Vsako pakiranje vsebuje 60 vial zdravila Fuzeon.
6.6 Special precautions for disposal
25 6. 6 Posebni varnostni ukrepi za odstranjevanje
Fuzeon must only be reconstituted with 1.1 ml water for injections.
Zdravilo Fuzeon lahko pripravimo samo z 1, 1 ml vode za injekcije.
After the powder begins to dissolve they can set the vial aside to allow it to completely dissolve.
Po tem, ko se prašek začne raztapljati, lahko vialo odložijo, da se prašek popolnoma raztopi.
The injection should be given at a site different from the preceding injection site and
Injiciramo drugam, kot je bila dana prejšnja injekcija, in na mesto, kjer trenutno ni reakcije po injiciranju.
26 ANNEX II
26 DODATEK II
1, D-79639 Grenzach-Wyhlen, Germany
1, D- 79639 Grenzach- Wyhlen, Nemčija
The Marketing Authorisation Holder will submit the PSURs on a yearly basis
Imetnik dovoljenja za promet z zdravilom bo nadaljeval z vlaganjem letnih PSUR- ov.
OUTER CARTON FOR PACK 1
ZUNANJA OVOJNINA ZA PAKIRANJE 1
Fuzeon 90 mg/ ml powder and solvent for solution for injection Enfuvirtide
Fuzeon 90 mg/ ml prašek in vehikel za raztopino za injiciranje enfuvirtid
60 vials with powder for solution for injection 60 vials with solvent 60 3 ml syringes 60 1 ml syringes 180 alcohol swabs
60 vial s praškom za raztopino za injiciranje 60 vial z vehiklom 60 3- ml injekcijskih brizg 60 1- ml injekcijskih brizg 180 alkoholnih blazinic
Subcutaneous use Read the package leaflet before use
za subkutano uporabo Pred uporabo preberite priloženo navodilo
The remaining Water for Injections in the solvent vial after withdrawal of the 1.1 ml required for reconstitution has to be discarded
Preostanek vode za injekcije v viali z vehiklom je po odvzemu 1, 1 ml, potrebnega za rekonstitucijo, treba zavreči
32 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
32 PODATKI NA PRIMARNI OVOJNINI
IMMEDIATE OUTER CARTON FOR FUZEON VIALS WITHIN PACK 1
PRIMARNA ZUNANJA OVOJNINA ZA VIALE FUZEON V PAKIRANJU 1
Fuzeon 90 mg/ ml powder for solution for injection Enfuvirtide
Fuzeon 90 mg/ ml prašek za raztopino za injiciranje enfuvirtid
Fuzeon 90 mg/ ml powder for solution for injection Enfuvirtide Subcutaneous use
Fuzeon 90 mg/ ml prašek za raztopino za injiciranje enfuvirtid za subkutano uporabo
35 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
35 PODATKI NA PRIMARNI OVOJNINI
IMMEDIATE OUTER CARTON FOR WATER FOR INJECTIONS VIALS WITHIN PACK 1
PRIMARNA ZUNANJA OVOJNINA ZA VIALE Z VODO ZA INJEKCIJE V PAKIRANJU 1
Solvent for parenteral use Contained in this box are 60 vials of 2 ml water for injections
vehikel za parenteralno uporabo V tej škatli je 60 vial po 2 ml vode za injekcije
This water for injections is intended for the reconstitution of Fuzeon 90 mg/ ml powder for solution for injection to obtain a solution for subcutaneous use Read the package leaflet before use
Ta voda za injekcije je namenjena za pripravo raztopine za injiciranje zdravila Fuzeon 90 mg/ ml prašek za raztopino za injiciranje za subkutano uporabo Pred uporabo preberite priloženo navodilo
OUTER CARTON FOR PACK 2
ZUNANJA OVOJNINA ZA PAKIRANJE 2
Each vial with powder contains sodium carbonate (anhydrous), mannitol, sodium hydroxide and hydrochloric acid.
Viala s praškom vsebuje tudi natrijev karbonat (brezvoden), manitol, natrijev hidroksid in klorovodikovo kislino.
Each solvent vial contains 2 ml water for injections.
1 viala z vehiklom vsebuje 2 ml vode za injekcije.
Contents of this box:
Vsebina škatle:
40 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
40 PODATKI NA PRIMARNI OVOJNINI
IMMEDIATE OUTER CARTON FOR FUZEON VIALS WITHIN PACK 2
PRIMARNA ZUNANJA OVOJNINA ZA VIALE FUZEON V PAKIRANJU 2
Each Fuzeon vial contains 108 mg enfuvirtide.
1 viala Fuzeona vsebuje 108 mg enfuvirtida.
1 ml of reconstituted solution contains 90 mg enfuvirtide.
1 ml pripravljene raztopine vsebuje 90 mg enfuvirtida.
42 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
42 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
43 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
43 PODATKI NA PRIMARNI OVOJNINI
IMMEDIATE OUTER CARTON FOR WATER FOR INJECTIONS VIALS WITHIN PACK 2
PRIMARNA ZUNANJA OVOJNINA ZA VIALE Z VODO ZA INJEKCIJE V PAKIRANJU 2
This water for injections is intended for reconstitution of Fuzeon 90 mg/ ml powder for solution for injection to obtain a solution for subcutaneous use Read the package leaflet before use
Ta voda za injekcije je namenjena za pripravo raztopine za injiciranje zdravila Fuzeon 90 mg/ ml prašek za raztopino za injiciranje za subkutano uporabo Pred uporabo preberite priloženo navodilo
45 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
45 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Water for Injections Subcutaneous use
voda za injekcije za subkutano uporabo
OUTER CARTON FOR PACKAGE TO CONTAIN FUZEON VIALS ONLY
ZUNANJA OVOJNINA ZA PAKIRANJE, KI VSEBUJE LE VIALE FUZEON
them, even if their symptoms are the same as yours.
škodovalo, čeprav imajo znake bolezni, podobne vašim.
What Fuzeon is and what it is used for 2.
Kaj je zdravilo Fuzeon in za kaj ga uporabljamo 2.
Before you use Fuzeon 3.
Kaj morate vedeti, preden boste vzeli zdravilo Fuzeon 3.
How to use Fuzeon 4.
Kako jemati zdravilo Fuzeon 4.
How to store Fuzeon 6.
Možni neželeni učinki 5 Shranjevanje zdravila Fuzeon 6.
WHAT FUZEON IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO FUZEON IN ZA KAJ GA UPORABLJAMO
What Fuzeon is Fuzeon inhibits the entry of the human immunodeficiency virus (HIV) into the cells that HIV attacks (called CD4 or T-cells) in your blood.
Kaj je zdravilo Fuzeon Zdravilo Fuzeon zavira vstop virusa humane imunske pomanjkljivosti (HIV) v celice, ki jih HIV napada (imenovane CD4 ali T- celice), v vaši krvi.
It works by preventing the HIV from making contact with the affected cell membrane.
Deluje tako, da prepreči virusu HIV stik s celično membrano, katero napade.
This means that the HIV cannot enter the cell and then it cannot multiply.
To pomeni, da virus HIV ne more vstopiti v celico in se ne more razmnoževati.
This is because HIV needs the DNA in the host cell so it can multiply.
Razmnoževati se ne more zato, ker virus HIV potrebuje DNA v gostiteljski celici, da se lahko razmnožuje.
When Fuzeon should be used Fuzeon is used in combination with other antiretroviral medicinal products by persons who are infected with HIV, the virus which causes AIDS.
Kdaj naj se uporablja zdravilo Fuzeon Zdravilo Fuzeon se uporablja v kombinaciji z drugimi protiretrovirusnimi zdravili pri ljudeh, ki so okuženi z virusom HIV, ki povzroča AIDS.
Never use or share used needles.
Nikoli ne uporabljajte ali delite že uporabljenih igel z drugimi.
BEFORE YOU USE FUZEON
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO FUZEON
Do not use Fuzeon
Ne jemljite zdravila Fuzeon
(see
- če ste alergični na (preobčutljivi za) enfuvirtid ali katerokoli sestavino zdravila Fuzeon (glejte
section 6).
poglavje 6).
Take special care with Fuzeon:
Bodite posebno pozorni pri jemanju zdravila Fuzeon
Tell your doctor
Povejte svojemu zdravniku:
- if you have any other medical conditions,
- če imate kakršnekoli druge bolezni ali zdravstvena stanja,
- if you have had any lung disease in the past; are currently, or have been, an intravenous drug
- če ste imeli katerokoli bolezen pljuč v preteklosti; ste bili ali ste še vedno uporabnik
user; are a smoker,
intravenskih drog; kadite,
- if you have a history of any kidney problems.
- če ste imeli v preteklosti kakršnekoli težave z ledvicami.
Fuzeon does not reduce the risk of passing HIV to others through sexual contact or blood contamination.
Zdravilo Fuzeon ne zmanjšuje tveganja za prenos virusa HIV drugim s spolnim stikom ali s kontaminacijo krvi.
It is important to continue to take appropriate precautions to prevent passing HIV to others.
Pomembno je, da še naprej upoštevate ustrezne previdnostne ukrepe, da bi preprečili prenašanje virusa HIV drugim.
51 In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
51 Pri nekaterih bolnikih z napredovalo okužbo s HIV (AIDS) in z oportunističnimi okužbami v anamnezi se lahko kmalu po začetku anti- HIV zdravljenja pojavijo znaki in simptomi vnetja, povezani s prejšnjimi okužbami.
It is believed that these symptoms are due to a recovery of the body’ s immune system.
Menijo, da so ti simptomi posledica okrevanja imunskega sistema.
Patients with chronic hepatitis B and C and treated with antiretroviral therapy are at an increased risk for serious liver problems.
Bolniki s kroničnim hepatitisom B in C, ki prejemajo protiretrovirusno zdravljenje, imajo večje tveganje za resne težave z jetri.
Using Fuzeon with food and drink You can take Fuzeon with or without food but you still need to follow the instructions given in the package leaflets for your other medicines.
Jemanje zdravila Fuzeon skupaj s hrano in pijačo Zdravilo Fuzeon lahko jemljete ob obroku ali brez njega, še vedno pa se morate ravnati po navodilih za uporabo vaših drugih zdravil.
Pregnancy and breast-feeding Pregnant women and breast-feeding mothers should not take Fuzeon unless specifically directed to by their doctor.
Nosečnost in dojenje Nosečnice in doječe matere naj zdravila Fuzeon ne dobivajo, razen če jim je to izrecno naročil njihov zdravnik.
Be sure to tell your doctor immediately if you are or may be pregnant or if you are breast- feeding a baby.
Poskrbite, da svojemu zdravniku takoj poveste, če ste noseči ali bi lahko bili noseči ali dojite.
HIV-infected women should not breast-feed their infants because of the risk that your baby can be infected with HIV through your breast milk.
S HIV okužene ženske ne smejo dojiti, ker obstaja tveganje, da svojega otroka preko mleka okužijo z virusom HIV.
Driving and using machines Fuzeon has not been specifically tested for its possible effects on your ability to drive a car or operate machines.
Vpliv na sposobnost upravljanja vozil in strojev Možnih učinkov zdravila Fuzeon na vašo sposobnost vožnje avtomobila ali upravljanja strojev niso posebej preskušali.
However, if you feel dizzy while taking Fuzeon then please do not drive nor operate machines.
Ne vozite in ne upravljajte s stroji, če se med prejemanjem zdravila Fuzeon počutite omotični.
HOW TO USE FUZEON
KAKO JEMATI ZDRAVILO FUZEON
Always use Fuzeon exactly as your doctor has told you.
Pri uporabi zdravila Fuzeon natančno upoštevajte zdravnikova navodila.
The usual dose is 90 mg twice a day, given as a 1 ml subcutaneous (just below the skin) injection.
Običajen odmerek je 90 mg dvakrat na dan, dan kot 1- ml subkutana (tik pod kožo) injekcija.
See further instructions on how to use Fuzeon at the end of this leaflet.
Nadaljni napotki, kako uporabljati zdravilo Fuzeon so navedeni na koncu tega navodila za uporabo.
If you take more Fuzeon than you should There is no specific antidote for overdose with Fuzeon.
Če ste vzeli večji odmerek zdravila Fuzeon kot bi smeli Za preveliko odmerjanje zdravila Fuzeon ni specifičnega protistrupa.
If you take more than the recommended dose please consult your doctor.
Če ste vzeli odmerek, ki je večji od priporočenega, se prosimo, posvetujte s svojim zdravnikom.
If you forget to take Fuzeon Take the dose as soon as you remember and then take your next dose at its regular time.
52 Če ste pozabili vzeti zdravilo Fuzeon Vzemite odmerek, kakor hitro se spomnite, in nato vzemite naslednji odmerek ob običajnem času.
Do not take the forgotten dose if it is less than 6 hours before you are going to take your next regular dose and never take a double dose to make up for a forgotten dose.
Nikoli ne vzemite dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
Like all medicines, Fuzeon can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Fuzeon neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In clinical trials, pneumonia was seen more often in patients treated with Fuzeon.
V kliničnih preskušanjih so pri bolnikih, zdravljenih z zdravilom Fuzeon, pogosteje opažali pljučnico.
It is important for you to tell your doctor if you develop a cough with a high temperature, very fast breathing and/ or shortness of breath as these symptoms may mean you are developing pneumonia.
Pomembno je, da poveste svojemu zdravniku, če se pri vas pojavi kašelj s povišano telesno temperaturo, zelo pospešenim dihanjem in/ ali zadihanostjo, ker ti simptomi lahko predstavljajo začetek pljučnice.
The side effect that you may experience most commonly when taking Fuzeon, are reactions at the place on your body where you have given yourself the injection.
Neželeni učinek, ki ga boste mogoče najpogosteje izkusili med jemanjem zdravila Fuzeon, so reakcije na delu telesa, kjer si boste dali injekcijo.
You will probably experience one or more of the following mild to moderate reactions at the place where you inject your medicine: ● itchiness ● swelling ● redness ● pain or tenderness ● hardened skin or bumps.
Najbrž boste izkusili eno ali več od naslednjih blagih do zmernih reakcij na mestu injiciranja vašega zdravila: • srbenje, • oteklina, • rdečina, • bolečina ali občutljivost za dotik, • zatrdela koža ali izbokline.
These reactions can appear within the first week of treatment and generally do not get worse with continued use of Fuzeon.
Te reakcije se lahko pojavijo v prvem tednu zdravljenja in se v splošnem z nadaljnjo uporabo zdravila Fuzeon ne slabšajo.
Reactions at an individual injection site usually last for equal to or less than 7 days.
Reakcije na posameznem mestu injiciranja običajno trajajo 7 dni ali manj.
If you experience reactions at an injection site, it is important not to stop taking Fuzeon until you have talked with your doctor about any concerns you may have.
Če izkusite reakcije na mestu injiciranja, je pomembno, da ne prenehate z jemanjem zdravila Fuzeon, dokler se ne pogovorite s svojim zdravnikom.
Injection site reactions may be worse when injections are repeated in the same place on the body, or when the injection is given deeper than intended (for example, into a muscle).
Reakcije na mestu injiciranja so lahko hujše, če injiciranje ponavljate na istem delu telesa ali kadar injicirate globlje, kot je namenjeno (na primer v mišico).
In rare instances, patients experienced an infection at an individual injection site.
V redkih primerih se je pri nekaterih bolnikih pojavila okužba na posameznem mestu injiciranja.
To reduce the risk of infection, it is important that you follow the Fuzeon Injection Instructions provided below.
Pomembno je, da se ravnate po navodilih za injiciranje zdravila Fuzeon, navedenih spodaj, ker s tem zmanjšate tveganje za okužbo.
Apart from reactions at the injection site, the side effects most frequently reported in patients receiving antiretroviral treatment with or without Fuzeon are diarrhoea and feeling sick.
Poleg reakcij na mestu injiciranja sta bila najbolj pogosta neželena učinka, o katerih so poročali bolniki, ki so prejemali protiretrovirusno zdravljenje z zdravilom Fuzeon ali brez njega, driska in občutek slabosti.
Very common side effects (affects more than 1 in 10 persons) are pain and numbness in hands, feet or legs, and loss of weight.
Zelo pogosta neželena učinka (ki se pojavita pri več kot 1 bolniku od 10) sta bolečina in mrtvenje dlani, stopal ali nog ter izguba telesne mase.
Common side effects (affects 1 to 10 users in 100) are ● inflammation of the sinuses (cavities in the forehead), ● local swelling on the skin, ● reactions at injection sites, ● pneumonia, ● ear infection, ● swollen glands, ● decreased appetite, ● anorexia, ● increased blood fat values, ● diabetes, ● feeling anxious or irritated, ● nightmares, ● feeling dizzy, ● lack of concentration, ● tremor (shaking), ● inflamed eye lids, ● nasal congestion, ● inflammation of the pancreas, ● heart burn, ● dry skin, ● eczema, ● redness of the skin,
Pogosti neželeni učinki (ki se pojavijo pri 1 do 10 bolnikih od 100) so: • vnetje sinusev (obnosnih votlin), • omejene otekline kože, • reakcije na mestu injiciranja, • pljučnica, • ušesne okužbe, • otečene žleze, • zmanjšan apetit, • neješčnost, • zvišane vrednosti maščob v krvi, • sladkorna bolezen, • občutek tesnobe ali razdraženosti, • nočne more, • omotičnost, • pomanjkanje koncentracije,
● ● ● ● ● ●
• • • • • • • • • • • • • •
acne, muscle pain, kidney stones, 'flu-like' symptoms, feeling weak blood in the urine.
tremor (tresenje), vnete veke, nazalna kongestija (zamašen nos), vnetje trebušne slinavke, zgaga, suha koža, izpuščaj, pordečela koža, akne, bolečine v mišicah, ledvični kamni, gripi podobni simptomi, občutek šibkosti, kri v urinu.
Hypersensitivity (allergy) to Fuzeon is rare (affects 1 to 10 users in 10,000).
Preobčutljivost za (alergija na) zdravilo Fuzeon je redka (pojavi se pri 1 do 10 bolnikih od 10. 000).
However if you develop symptoms that may suggest that you are allergic to this medicine then you must stop taking it straight away and tell your doctor as soon as possible.
Če pa se pri vas pojavijo simptomi, ki bi lahko pomenili, da ste alergični na to zdravilo, takoj prenehajte z jemanjem in nemudoma obvestite svojega zdravnika.
Symptoms that you should look out for are rash, a high temperature or chill, feeling sick or being sick and sweating and shaking.
Simptomi, na katere bodite pozorni, so izpuščaj, visoka telesna temperatura ali mrazenje, slabost ali bruhanje ter znojenje in tresenje.
These symptoms do not definitely mean you are allergic to this medicine but you must discuss them with your doctor.
Ti simptomi ne pomenijo dokončno, da ste alergični na to zdravilo, vendar se morate o njih pogovoriti s svojim zdravnikom.
HOW TO STORE FUZEON
SHRANJEVANJE ZDRAVILA FUZEON
Do not use Fuzeon after the expiry date which is stated on the label of either the Fuzeon or the Water for Injections Vials after EXP.
Zdravila Fuzeon ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki vial zdravila Fuzeon ali vode za injekcije poleg oznake Uporabno do.
If it is not used immediately it must be stored in a refrigerator (2°C – 8°C) and used within 24 hours.
Če je ne uporabite takoj, jo shranite v hladilniku (2 °C - 8 °C) in uporabite v 24 urah.
Do not use Fuzeon if you notice any particles in the powder or the solution once the water for injection has been added.
Ne uporabljajte zdravila Fuzeon, če ste v prašku ali raztopini po dodatku vode za injekcije opazili trdne delce.
Also do not use the water for injections if you see any particles in the vial or if the water is cloudy.
Prav tako ne uporabljajte vode za injekcije, če ste v viali opazili trdne delce ali če je voda motna.
- The active substance is enfuvirtide.
- Zdravilna učinkovina je enfuvirtid.
After reconstitution
Po pripravi s priloženim
with the solvent provided 1 ml of reconstituted solution contains 90 mg enfuvirtide.
vehiklom 1 ml pripravljene raztopine vsebuje 90 mg enfuvirtida.
Powder Sodium Carbonate, anhydrous Mannitol Sodium Hydroxide Hydrochloric Acid
Prašek: brezvodni natrijev karbonat, manitol, natrijev hidroksid, klorovodikova kislina.
Solvent Water for Injections
54 Vehikel: voda za injekcije.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‛ brez natrija ’.
54 What Fuzeon looks like and contents of the pack
Izgled zdravila Fuzeon in vsebina pakiranja
Fuzeon powder and solvent for solution for injection comes in a carton containing:
Prašek in vehikel za raztopino za injiciranje zdravila Fuzeon sta v škatli, ki vsebuje:
60 vials of Fuzeon 60 vials of Water for Injections that is used to reconstitute the Fuzeon powder 60 3 ml syringes 60 1 ml syringes 180 alcohol swabs.
60 vial zdravila Fuzeon, 60 vial vode za injekcije, ki se uporablja za pripravo raztopine s praškom zdravila Fuzeon, 60 3- ml injekcijskih brizg, 60 1- ml injekcijskih brizg, 180 alkoholnih blazinic.
Fuzeon is also available in a carton containing 60 vials of Fuzeon and 60 vials of Water for Injections.
Zdravilo Fuzeon je na razpolago tudi v škatli s 60 vialami zdravila Fuzeon in 60 vialami vode za injekcije.
1, D-79639 Grenzach-Wyhlen Germany
1, D- 79639 Grenzach- Wyhlen Nemčija
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea. europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu.
HOW TO USE FUZEON
56 KAKO UPORABLJATI ZDRAVILO FUZEON
Always take Fuzeon exactly as your doctor has instructed you.
Natančno upoštevajte zdravnikova navodila.
The usual dose is 90 mg twice a day, given as a 1 ml subcutaneous (just below the skin) injection into the upper arm, anterior thigh or abdomen.
Običajen odmerek je 90 mg dvakrat na dan, dan kot 1 - ml subkutana (tik pod kožo) injekcija v nadlaket, sprednjo stran stegna ali trebuh.
56 the last place you injected and never where there is still an injection site reaction from an earlier dose.
Vsako injekcijo dajte na drugo mesto kot prejšnjo injekcijo in nikoli tja, kjer je še vedno reakcija na mestu injiciranja od prejšnjega odmerka.
You should not inject your medicine into moles, scar tissue, bruises or your navel.
Svojega zdravila ne smete injicirati v znamenja, brazgotine, modrice ali popek.
When to take Fuzeon It is best to take Fuzeon at the same time each day if you can.
Kdaj vzeti zdravilo Fuzeon Najbolje je, da vsak dan vzamete zdravilo Fuzeon ob istem času, če lahko.
Try and space the doses evenly apart whenever it is convenient for you.
Poskusite razporediti odmerke v enakih časovnih presledkih, kadar vam ustreza.
First thing in the morning and again in the evening are good times.
Ugodne ure so zjutraj, ko vstanete, in zvečer.
The following is a basic, step-by-step guide to injecting your medicine.
Sledijo osnovna navodila za injiciranje vašega zdravila po korakih.
Please contact your doctor or pharmacist if you have any questions about Fuzeon administration.
Če imate kakršnakoli vprašanja o dajanju zdravila Fuzeon, se posvetujte z zdravnikom ali farmacevtom.
How long should you take Fuzeon for?
Kako dolgo morate jemati zdravilo Fuzeon?
You should keep taking your medicine until your doctor tells you to stop.
Svoje zdravilo jemljite, dokler vam zdravnik ne naroči, da nehajte.