natgillin/translations-raw huggingface dataset:
The serum IGF-1 was normalised at the end of the study (week 12) in 9.7%, 38.5%, 75% and 82% of subjects treated with placebo, 20 mg/ day, 15 mg/ day or 20 mg/ day SOMAVERT respectively.
IGF- I v serumu je bil na koncu študije (12. teden) normalen pri 9, 7% preiskovancev, ki so dobivali placebo, med prejemniki zdravila SOMAVERT pa pri 38, 5% tistih, ki so ga dobivali 10 mg/ dan, pri 75% tistih, ki so ga dobivali 15 mg/ dan, in pri 82% tistih, ki so ga dobivali 20 mg/ dan.
Pegvisomant is slowly eliminated from serum, with
Ledvični očistek pegvisomanta je zanemarljiv; na njegov račun gre 20 manj kot 1% celotnega telesnega očistka.
20 mean estimates of half-life generally ranging from 74 to 172 hours following either single or multiple- doses.
Pegvisomant se iz seruma odstranjuje počasi; povprečne ocene razpolovnega časa na splošno so od 74 do 172 ur po posamičnem ali večkratnih odmerkih.
After reconstitution:
21 Po pripravi:
Pack sizes of 1 or 30.
Velikost pakiranj po 1 ali 30.
13/ 11/ 2002 Date of last renewal:
13. 11. 2002 Datum zadnejga podaljšanja dovoljenja za promet:
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK (I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJEO
Box 13865, Research Triangle Park, North Carolina 27709-3865, USA
Box 13865, Research Triangle Park, North Carolina 27709- 3865, ZDA
Pfizer Manufacturing Belgium NV Rijksweg 12, B-2870 Puurs, Belgium
Pfizer Manufacturing Belgium NV Rijksweg 12, B- 2870 Puurs, Belgija
The MAH will continue to submit yearly PSURs for the following three years, unless otherwise specified by the CHMP.
Imetnik dovoljenja za promet bo v naslednjih treh letih vlagal letna poročila PSUR, razen če CHMP ne odloči drugače.
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
26 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
SOMAVERT 10 mg powder and solvent for solution for injection Pegvisomant
SOMAVERT 10 mg prašek in vehikel za raztopino za injiciranje pegvisomant
Each vial contains 10 mg pegvisomant
Ena viala vsebuje 10 mg pegvisomanta.
Glycine Mannitol (E421) Sodium phosphate dibasic anhydrous Sodium phosphate monobasic monohydrate
Pomožne snovi: glicin manitol (E421) brezvodni natrijev hidrogenfosfat natrijev dihidrogenfosfat monohidrat
30 vials of powder for solution for injection 30 vials of water for injections
30 vial s praškom za raztopino za injiciranje 30 vial z vodo za injekcije
27 SPECIAL STORAGE CONDITIONS
POSEBNA NAVODILA ZA SHRANJEVANJE
SOMAVERT 10 mg powder for solution for injection Pegvisomant Subcutaneous use
SOMAVERT 10 mg prašek za raztopino za injiciranje pegvisomant Za subkutano uporabo
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
29 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
SOMAVERT 15 mg powder and solvent for solution for injection Pegvisomant
SOMAVERT 15 mg prašek in vehikel za raztopino za injiciranje pegvisomant
Each vial contains 15 mg pegvisomant
Ena viala vsebuje 15 mg pegvisomanta.
MM/ YYYY
MM/ LLLL 30 9.
30 SPECIAL STORAGE CONDITIONS
POSEBNA NAVODILA ZA SHRANJEVANJE
SOMAVERT 15 mg powder for solution for injection Pegvisomant Subcutaneous use
SOMAVERT 15 mg prašek za raztopino za injiciranje pegvisomant Za subkutano uporabo
SOMAVERT 20 mg powder and solvent for solution for injection Pegvisomant
SOMAVERT 20 mg prašek in vehikel za raztopino za injiciranje pegvisomant
Each vial contains 20 mg pegvisomant
Ena viala vsebuje 20 mg pegvisomanta.
MM/ YYYY
MM/ LLLL 33 9.
33 SPECIAL STORAGE CONDITIONS
POSEBNA NAVODILA ZA SHRANJEVANJE
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
34 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
1 vial of powder for solution for injection 1 vial of water for injections
1 viala s praškom za raztopino za injiciranje 1 viala z vodo za injekcije
35 SPECIAL STORAGE CONDITIONS
POSEBNA NAVODILA ZA SHRANJEVANJE
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
36 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
SOMAVERT 20 mg powder for solution for injection Pegvisomant Subcutaneous use
SOMAVERT 20 mg prašek za raztopino za injiciranje pegvisomant Za subkutano uporabo
SOMAVERT powder for solution for injection Pegvisomant Subcutaneous use
SOMAVERT prašek za raztopino za injiciranje pegvisomant Za subkutano uporabo
SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection Pegvisomant
Somavert 10 mg prašek in vehikel za raztopino za injiciranje Somavert 15 mg prašek in vehikel za raztopino za injiciranje Somavert 20 mg prašek in vehikel za raztopino za injiciranje pegvisomant
What SOMAVERT is and what it is used for 2.
Kaj je zdravilo SOMAVERT in za kaj ga uporabljamo 2.
Before you use SOMAVERT 3.
Kaj morate vedeti, preden boste uporabili zdravilo SOMAVERT 3.
How to use SOMAVERT 4.
Kako uporabljati zdravilo SOMAVERT 4.
How to store SOMAVERT 6.
Shranjevanje zdravila SOMAVERT 6.
WHAT SOMAVERT IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO SOMAVERT IN ZA KAJ GA UPORABLJAMO
SOMAVERT is used for the treatment of acromegaly, a hormonal disorder resulting from the increased secretion of growth hormone (GH) and IGF-I (Insulin-like growth factors), which is characterised by overgrowth of bone, soft tissue swelling, heart disease and related disorders.
Značilni zanjo so čezmerna rast kosti, oteklost mehkih tkiv, bolezen srca in sorodne motnje.
SOMAVERT is a product of biotechnology.
Zdravilo SOMAVERT je pridobljeno biotehnološko.
These substances decrease the action of GH and levels of IGF-I circulating in the blood.
Ta snov zmanjšuje delovanje rastnega hormona in raven IGF- I v obtoku.
BEFORE YOU USE SOMAVERT
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO SOMAVERT
Do not use SOMAVERT
Ne uporabljajte zdravila SOMAVERT
• If you are allergic (hypersensitive) to pegvisomant or any of the other ingredients of SOMAVERT.
če ste alergični na (preobčutljivi za) pegvisomant ali katerokoli sestavino zdravila SOMAVERT. •
Take special care with SOMAVERT
Bodite posebno pozorni pri uporabi zdravila SOMAVERT
- If you experience disturbed vision or headaches while using SOMAVERT you must contact
- Če se vam med uporabo zdravila SOMAVERT pojavijo motnje vida ali glavoboli, se morate
your doctor immediately.
nemudoma posvetovati z zdravnikom.
- Your doctor or nurse will monitor the levels of IGF-I (Insulin-like growth factors) circulating in
- Vaš zdravnik bo spremljal raven IGF- 1 (insulinu podobnih rastnih dejavnikov) v krvi in, če bo
the blood and adjust the dose of SOMAVERT if necessary.
potrebno, ustrezno prilagodil odmerek zdravila SOMAVERT.
- Your doctor should also monitor your adenoma (benign tumour).
- Vaš zdravnik bi moral prav tako spremljati vaš adenom (benigni tumor).
- Your doctor or nurse will monitor the level of liver enzymes in the blood every 4-6 weeks for
- Vaš zdravnik ali medicinska sestra bosta v prvih 6 mesecih zdravljenja z zdravilom
the first six months of treatment with SOMAVERT.
SOMAVERT na 4 do 6 tednov preverila raven jetrnih encimov v vaši krvi.
- If you are diabetic, your doctor may need to adjust the amount of insulin or other medicines you
- Če imate sladkorno bolezen, bo zdravnik morda moral prilagoditi odmerek insulina ali drugih
are using.
zdravil, ki jih jemljete.
See also the
- Ženske bolnice morajo uporabljati ustrezno kontracepcijo, ker je plodnost lahko povečana.
section about Pregnancy below.
Glejte tudi spodnje poglavje o nosečnosti.
You must tell your doctor if you have previously used other medicines for the treatment of acromegaly or medicines for the treatment of diabetes.
Zdravniku morate tudi povedati, če ste že prej dobivali kakšna druga zdravila za zdravljenje akromegalije ali zdravila za zdravljenje sladkorne bolezni.
It is important to keep using all your medicines as well as SOMAVERT unless you are told otherwise by your doctor or pharmacist.
Pomembno je, da še naprej jemljete vsa svoja zdravila in tudi zdravilo SOMAVERT, razen če vam zdravnik ali farmacevt naročita drugače.
The effects of SOMAVERT in pregnant women are not known, and so the use of SOMAVERT in pregnant women is not recommended.
Učinki zdravila SOMAVERT na nosečnice niso znani in uporaba tega zdravila pri nosečnicah ni priporočljiva.
You are advised to not become pregnant while taking SOMAVERT therapy.
Odsvetujemo vam, da bi med zdravljenjem z zdravilom SOMAVERT zanosili.
In case you become pregnant, you must consult your doctor.
Če zanosite, se morate posvetovati z zdravnikom.
It is not known if SOMAVERT passes into breast milk.
Ni znano, ali zdravilo SOMAVERT prehaja v materino mleko.
You should not breast-feed while taking SOMAVERT unless your doctor has discussed this with you.
Med uporabo zdravila SOMAVERT ne smete dojiti, razen če ste se o tem posvetovali s svojim zdravnikom.
Important information about some of the ingredients of SOMAVERT
Pomembne informacije o nekaterih sestavinah zdravila SOMAVERT
This medicinal product contains less than 1 mmol sodium (23 mg) per 10 mg dose, less than 1 mmol sodium (23 mg) per 15 mg dose, or less than 1 mmol sodium (23 mg) per 20 mg dose i. e. essentially ‘ sodium-free’.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 10 mg odmerek, manj kot 1 mmol natrija (23 mg) na 15 mg odmerek oziroma manj kot 1 mmol natrija (23 mg) na 20 mg odmerek, kar v bistvu pomeni 'brez natrija'.
HOW TO USE SOMAVERT
KAKO UPORABLJATI ZDRAVILO SOMAVERT
Always inject SOMAVERT exactly as your doctor has told you.
Zdravilo SOMAVERT vedno injicirajte natančno po zdravnikovih navodilih.
A starting dose of 80 mg of SOMAVERT will be given subcutaneously (just under the skin) by your doctor.
Začetni odmerek 80 mg zdravila SOMAVERT vam bo zdravnik dal subkutano (tik pod kožo).
Following this, the usual daily dose of SOMAVERT is 10 mg, which is given by subcutaneous injection (just under the skin).
Nato je običajni dnevni odmerek 10 mg zdravila SOMAVERT; uporablja se v subkutanih injekcijah (injekcijah tik pod kožo).
Every four to six weeks your doctor will make appropriate dose adjustments, made in increments of 5 mg pegvisomant/ day, based on your so-called serum IGF-I levels to maintain an optimal therapeutic response.
Zdravnik bo na štiri do šest tednov ustrezno prilagodil odmerek s povečanji po 5 mg pegvisomanta/ dan; pri tem bo upošteval vaš izvid t. i. koncentracije IGF- I v serumu, da bo ohranil najboljši odziv na zdravljenje.
Method and route of administration
Postopek in pot uporabe zdravila
The injection can be self-administered or given by another person, for example your doctor or his/ her assistant.
Injekcijo si lahko daste sami ali vam jo da kdo drug, npr. zdravnik ali medicinska sestra.
The detailed instructions on injection procedure
Podrobna navodila za injiciranje so navedena na koncu tega lističa.
You should continue to inject SOMAVERT for as long as instructed by your doctor.
Injiciranje zdravila SOMAVERT morate nadaljevati toliko časa, kot vam naroči zdravnik.
SOMAVERT must be dissolved before use.
41 Pred uporabo je treba zdravilo SOMAVERT raztopiti.
To avoid this, use a slightly different place for your injection each time, as described in Step 2 of the ‘ Instructions for Preparing and Giving an Injection of Somavert’ section of this leaflet.
Da bi to preprečili, zdravilo vsakič injicirajte nekoliko drugam, tako kot je opisano v 2. koraku poglavja "Navodila za pripravo in injiciranje zdravila Somavert" tega navodila.
If you have the impression that the effect of SOMAVERT is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila SOMAVERT premočan ali prešibak, se posvetujte z zdravnikom ali s farmacevtom.
If you accidentally inject more SOMAVERT than told to by your doctor it is unlikely to be serious, but you should contact your doctor or pharmacist immediately.
Če si pomotoma injicirate več zdravila SOMAVERT, kot vam je naročil zdravnik, to praviloma sicer ni nič resnega, kljub temu pa se morate takoj posvetovati s svojim zdravnikom ali s farmacevtom.
Like all medicines, SOMAVERT can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo SOMAVERT neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Headache, dizziness, sleepiness, uncontrolled trembling.
Glavobol, omotica, zaspanost, neobvladano tresenje.
Diarrhoea, constipation, feeling sick, being sick, feeling bloated, indigestion, gas.
Driska, zaprtje, slabost, bruhanje, napihnjenost, prebavne motnje, vetrovi.
Sweating, itching, rash.
Znojenje, srbenje, izpuščaj.
Joint pain, muscle pain, swelling of the extremities.
Bolečina v sklepih, bolečina v mišicah, oteklost okončin.
Bruising or bleeding at injection site, soreness or swelling at injection site, build up of fat below the surface of the skin at injection site.
Zvišana raven holesterola v krvi, povečanje telesne mase, zvišana raven glukoze v krvi, povečan apetit.
Flu-like illness, fatigue.
Zvišan krvni tlak.
These can be seen in the results of blood tests.
Podplutba ali krvavitev na mestu injiciranja, bolečina ali oteklina na mestu injiciranja, povečanje količine podkožnega maščobnega tkiva na mestu injiciranja.
Abnormal dreams, problems sleeping.
Nenormalne sanje, težave s spanjem.
Decreased platelets in the blood, increased or decreased white cells in the blood, tendency to bleed.
Zmanjšano število krvnih ploščic v krvi, zvečano ali zmanjšano število belih krvnih celic v krvi, nagnjenost h krvavitvam.
Decreased sense of touch, abnormal sense of taste, migraine.
Zmanjšan občutek za dotik, nenormalno okušanje, migrena.
Eyestrain, eye pain, inner ear problems.
Naprezanje oči, bolečina v očeh, težave z notranjim ušesom.
Shortness of breath.
Kratka sapa.
Dry mouth, increased saliva, tooth problems, hemorrhoids.
Suha usta, povečano slinjenje, težave z zobmi, hemoroidi.
Blood in the urine, protein in the urine, increased urine, kidney problems.
Kri v urinu, proteini v urinu, večje izločanje urina, težave z ledvicami.
Arthritis.
Artritis.
Increased fatty substances in the blood, decreased blood glucose.
Zvišana raven maščob v krvi, znižana raven glukoze v krvi.
Fever, weakness, feeling abnormal, impaired healing.
Vročina, šibkost, nenormalno počutje, počasnejše celjenje.
Anger, lack of interest, feeling confused, increased sex drive, panic attack, loss of memory.
Jeza, pomanjkanje zanimanja, občutek zmedenosti, zvišan libido, napad panike, izguba spomina.
About 17% of patients will develop antibodies to growth hormone during treatment.
Pri približno 17% bolnikov se bodo med zdravljenjem razvila protitelesa proti rastnemu hormonu.
The antibodies do not seem to stop SOMAVERT from working.
Kaže, da protitelesa ne preprečujejo učinka zdravila SOMAVERT.
HOW TO STORE SOMAVERT
SHRANJEVANJE ZDRAVILA SOMAVERT
Do not use SOMAVERT after the expiry date which is stated on the vial and the carton after EXP.
Zdravila SOMAVERT ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vialah in škatlici.
Carefully dispose of any SOMAVERT solution that has not been injected.
Pazljivo zavrzite vso raztopino zdravila SOMAVERT, ki je niste injicirali.
Do not use SOMAVERT if you notice that the solution is cloudy or contains particulate matter.
Zdravila SOMAVERT ne uporabljajte, če opazite, da je raztopina motna ali vsebuje delce.
What SOMAVERT contains
Kaj vsebuje zdravilo SOMAVERT
- The active substance is pegvisomant.
- Zdravilna učinkovina je pegvisomant.
- One vial of powder contains either 10 mg, 15 mg, or 20 mg.
- Ena viala s praškom vsebuje 10 mg, 15 mg oziroma 20 mg pegvisomanta.
After reconstitution with 1 ml of
Po pripravi z 1 ml
solvent, 1 ml of the clear solution contains either 10 mg, 15 mg or 20 mg pegvisomant.
vehikla vsebuje 1 ml bistre raztopine 10 mg, 15 mg oziroma 20 mg pegvisomanta.
- The other ingredients are glycine, mannitol (E421), sodium phosphate dibasic anhydrous and
- Pomožne snovi so glicin, manitol (E421), brezvodni natrijev hidrogenfosfat in natrijev
sodium phosphate monobasic monohydrate.
dihidrogenfosfat monohidrat.
- The solvent is water for injections.
- Vehikel je voda za injekcije.
One vial of solvent contains 8 ml water for injections.
Ena viala z vehiklom vsebuje 8 ml vode za injekcije.
SOMAVERT is presented as a powder and a solvent for injection, in a vial.
SOMAVERT je na voljo kot prašek in vehikel za raztopino za injiciranje v vialah.
Powder in a vial (either 10 mg, 15 mg, or 20 mg pegvisomant) and solvent in a vial (8 ml).
Prašek v viali (10 mg, 15 mg oziroma 20 mg pegvisomanta) in vehikel v viali (8 ml).
Pack sizes of 1 and 30.
Velikosti pakiranj po 1 in 30.
The powder is white and the solvent is clear and colourless.
Prašek je bel in vehikel je bister in brezbarven.
Marketing Authorisation holder:
Imetnik dovoljenja za promet z zdravilom:
43 Manufacturer:
Pfizer Limited Sandwich Kent CT13 9NJ Velika Britanija 43 Izdelovalec:
Τηλ: +30 210 6785800
Τηλ: +30 210 6785500
Tel.: +48 22 335 61 00
Tel.: +48 22 3356100
1 800 633 363
1 1800 633 363
44 Italia Pfizer Italia S.r.l.
44 Italia Pfizer Italia S. r. l.
This leaflet was last approved in {MM/YYYY}.
{MM/ LLLL}
45 INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF SOMAVERT
45 NAVODILO ZA PRIPRAVO IN INJICIRANJE ZDRAVILA SOMAVERT
The following instructions explain how to prepare and inject SOMAVERT.
Spodnja navodila pojasnjujejo, kako pripravite in injicirate zdravilo SOMAVERT.
You will be instructed by your doctor or his/her assistant on the technique of self-injection.
Zdravnik ali medicinska sestra vas bosta naučila postopka za samoinjiciranje.
Do not attempt to self-inject until you are sure that you understand how to prepare and give an injection.
Zdravila si ne poskušajte injicirati sami, dokler niste prepričani, da obvladate pripravo in dajanje injekcij.
The powder must be dissolved with the solvent before use.
Prašek je treba pred uporabo raztopiti z vehiklom.
This injection should not be mixed in the same syringe or vial with any other medicine.
Tega zdravila ne smete mešati z nobenim drugim zdravilom v isti brizgi ali viali.
STEP 1.
KORAK:
CHOOSING THE METHOD FOR PREPARING THE SOMAVERT SOLUTION
Izbira načina za pripravo raztopine zdravila SOMAVERT.
There are 2 methods for preparing the SOMAVERT solution.
Raztopino zdravila SOMAVERT je mogoče pripraviti na 2 načina.
Please discuss with your healthcare professional which method is best for you: a) The Vial Adapter Method (MIXJECT™), b) The Non-Vial Adapter Method.
Prosimo vas, da se posvetujete s svojim zdravnikom, kateri način je za vas najboljši: a) z nastavkom za vialo (Mixject™), b) brez nastavka za vialo.
a) VIAL ADAPTER METHOD (MIXJECT™)
a) PRIPRAVA Z NASTAVKOM ZA VIALO (Mixject™)
GETTING STARTED
PREDPRIPRAVA
• Wash your hands thoroughly. • Collect:
• Dobro si umijte roke. • Pripravite:
1 vial of powder (SOMAVERT), 1 vial of solvent (Water for Injections), 1 luer-lock syringe of 1ml (for both reconstituting the SOMAVERT solution and giving the injection) is recommended.
1 vialo s praškom (SOMAVERT) 1 vialo z vehiklom (voda za injekcije) Priporočljiva je ena 1- ml brizga z nastavkom luer (za pripravo raztopine zdravila SOMAVERT in njeno injiciranje), vendar lahko za pripravo in injiciranje zdravila SOMAVERT uporabite tudi brizge drugih vrst in velikosti.
However, other sizes and types of syringes can be used for the preparation and injection of SOMAVERT.
Za dodatne informacije se posvetujte z zdravnikom.
2 MIXJECT™ vial adapters, 1 detachable needle (25 to 30 gauge), Alcohol or antiseptic swabs and a proper disposal container for used needles and syringes. • Inspect the expiry dates on both the vial label and the syringe label.
2 nastavka za vialo Mixject™ 1 snemno iglo (številka 25 do 30) alkoholne ali antiseptične zložence in ustrezen vsebnik za porabljene igle in brizge • Preverite datume izteka roka uporabnosti na nalepkah vial in brizg.
They should not be used after the month and year shown.
Po označenem mesecu in letu jih ne smete uporabiti.
After reconstitution with 1 ml of solvent, 1 ml of the clear solution contains either 10 mg, 15 mg, or 20 mg pegvisomant.
Po pripravi z 1 ml vehikla vsebuje 1 ml bistre raztopine 10 mg, 15 mg oziroma 20 mg pegvisomanta.
PREPARING THE SOMAVERT DOSE FOR INJECTION
PRIPRAVA ODMERKA ZDRAVILA SOMAVERT ZA INJICIRANJE
Figure1
Slika 1
Remove the protective plastic caps from the tops of both vial of solvent and vial of SOMAVERT (Fig.
Odstranite plastična zaščitna pokrovčka z vrha viale z vehiklom in viale z zdravilom SOMAVERT (slika 1).
Take care not to touch the rubber vial stoppers.
Pazite, da se ne dotaknete gumijastih zamaškov vial.
At this point, the stoppers are clean.
Ko zamaška odkrijete, sta čista.
If the stoppers are touched or otherwise contaminated, you must clean them with an antiseptic or alcohol swab before inserting a vial adapter through the stopper.
Če se ju dotaknete ali ju kako drugače onesnažite, ju morate očistiti z alkoholnim ali antiseptičnim zložencem, preden skoznju zabodete nastavek za vialo.
Open only one of the vial adapters by peeling back the protective cover.
Odprite le enega od nastavkov za vialo, tako da odtrgate zaščitno prevleko.
Leave the adapter in the plastic packaging and do not touch the spike of the adapter.
Pustite nastavek v plastični ovojnini in se ne dotikajte njegove konice.
46 Figure 2
46 Slika 2
(Fig.
Držite plastično ovojnino nastavka, položite nastavek na vialo z vehiklom in potisnite, da bo predorna konica nastavka povsem prebodla gumijasti zamašek viale z vehiklom (slika 2).
Remove the plastic packaging from the vial adapter and discard.
Odstranite plastično ovojnino z nastavka za vialo in ovojnino zavrzite.
Remove the syringe from the protective packaging.
Vzemite brizgo iz zaščitne ovojnine.
Pull the plunger of the syringe out to the 1 ml mark.
Izvlecite bat brizge navzdol do oznake 1 ml.
Hold the solvent vial, placed on a flat surface, with one hand and connect the tip of the syringe to the vial adapter by twisting the syringe on the vial adapter clockwise (Fig.
Držite jo z eno roko in namestite brizgo v nastavek za vialo tako, da jo v smeri urnega kazalca zasukate vanj (slika 3).
Gently push the plunger until the air is injected into the vial.
Počasi potiskajte bat, dokler v vialo ne iztisnete vsega zraka.
ADDING SOLVENT
DODAJANJE VEHIKLA
Securely grasp the solvent vial, adapter and syringe assembly.
Trdno primite vialo z vehiklom, nastavek in nameščeno brizgo.
Carefully turn the vial, adapter and syringe assembly upside down.
Previdno obrnite vialo, nastavek in nameščeno brizgo tako, da bo viala na vrhu.
Bring to eye level (Fig.
Dvignite v višino oči.
4).
(Slika 4)
Slide one hand carefully down the solvent vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper part of the syringe.
Eno dlan previdno pomaknite navzdol ob viali z vehiklom, da boste lahko s palcem in kazalcem trdno prijeli vrat viale, s preostalimi prsti pa zgornji del brizge.
With the other hand, slowly pull the syringe plunger down to slightly past the 1 ml mark.
Z drugo roko počasi potegnite bat navzdol, da bo nekoliko čez oznako 1 ml.
Examine the solution in the syringe for air bubbles.
Preglejte, ali so v raztopini, ki je v brizgi, zračni mehurčki.
If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe.
Če v raztopini so mehurčki, potrkajte po brizgi, da se dvignejo na njen vrh.
Carefully push the plunger up to eject only the air bubbles back into the vial.
Previdno potisnite bat navzgor, da boste nazaj v vialo iztisnili samo zračne mehurčke.
Recheck that 1 ml of solvent remains in the syringe.
Preverite, da je v brizgi ostal 1 ml vehikla.
Carefully turn the solvent vial, adapter and syringe assembly and place them upright on a clean surface.
Previdno obrnite vialo z vehiklom, nastavek in nameščeno brizgo ter jih pokonci položite na čisto površino.