natgillin/translations-raw huggingface dataset:
Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint (in italics) they should be reported as resistant.
Dokler za potrjene izolate z MIK nad trenutnimi mejnimi vrednostmi odpornosti (v poševni pisavi) ni dokazov o kliničnem odzivu, jih je treba prijaviti kot odporne.
Non-species related breakpoints5
Mejne vrednosti, nepovezane z vrsto5
The data submitted in the Quality module concerning the stability of the products is completed with the most recent commercial data which support the shelf life of 4 years when the products are stored at up to 30 ºC.
Podatki, predloženi v modulu o kakovosti, ki zadeva stabilnost izdelkov, so dopolnjeni z najnovejšimi komercialnimi podatki, ki podpirajo rok uporabnosti 4 let, če se zdravila shranjuje na temperaturi do 30 °C.
In healthy subjects the mean plasma half-life is approximately 1 hour; the mean volume of distribution is approximately 0.25 l/kg (11-27 l) and the mean clearance is 287 ml/min at 250 mg falling to 205 ml/min at 2 g. Doses of 500, 1000 and 2000 mg doses infused over 30 minutes give mean Cmax values of approximately 23, 49 and 115 μg/ml respectively, corresponding AUC values were 39.3, 62.3 and 153 μg.h/ml.
Pri zdravih preiskovancih je povprečni plazemski razpolovni čas približno 1 uro; povprečni volumen porazdelitve je približno 0,25 l/kg (11-27 l), povprečni očistek pa je 287 ml/min pri odmerku 250 mg in se zmanjša na 205 ml/min z 2 g. 30-minutno infundiranje odmerkov 500, 1000 in 2000 mg da povprečno Cmax približno 23, 49 in 115 µg/ml in ustrezne AUC 39,3, 62,3 in 153 µg.h/ml.
The CHMP noted that the data from studies or reviews provided by the MAH reported a few cases of convulsions with meropenem.
CHMP je ugotovil, da podatki iz študij ali pregledov, ki jih je priskrbel imetnik dovoljenja za promet z zdravilom, navajajo nekaj primerov kolvuzij pri uporabi meropenema.
Treatment of febrile neutropenic patients
Zdravljenje febrilnih nevtropeničnih bolnikov
The decision to use meropenem as part of a combination regimen will be made by health care professionals taking into account individual patient characteristics, the infection being treated, the predominant local bacterial flora and their antibiotic susceptibility profiles.
O uporabi meropenema v kombinacijskem zdravljenju morajo odločiti zdravstveni delavci, pri tem pa morajo upoštevati značilnosti posameznega bolnika, zdravljeno okužbo, prevladujočo lokalno bakterijsko floro in njihove profile občutljivosti za antibiotike.
In vitro meropenem shows reduced susceptibility to hydrolysis by human dehydropeptidase-I (DHP-I) compared to imipenem and there is no requirement to co-administer a DHP-I inhibitor.
In vitro kaže meropenem manjšo dovzetnost za hidrolizo s človeško dehidropeptidazo I (DHP-I) kot imipenem, zato sočasno ni treba uporabljati zaviralca DHP-I.
It is preferable to avoid the use of meropenem during pregnancy.
Uporabi meropenema med nosečnostjo se je bolje izogniti.
Based on the Quality data submitted, the CHMP agreed that anhydrous sodium carbonate is the only inactive ingredient in the product.
CHMP se je na osnovi predloženih podatkov o kakovosti strinjal, da je brezvodni natrijev karbonat edina sestavina zdravila brez zdravilnih učinkov.
Each 1 g vial contains 208 mg sodium carbonate which equates to approximately 4.0 mEq of sodium (approximately 90 mg).
Ena viala z 1 g vsebuje 208 mg natrijevega karbonata, kar ustreza približno 4,0 mEq (približno 90 mg) natrija.
In preclinical models meropenem demonstrated activity when plasma concentrations exceeded the MIC of the infecting organisms for approximately 40 % of the dosing interval.
V predkliničnih modelih se je meropenem izkazal za aktivnega, kadar je njegova koncentracija v plazmi presegla MIK bakterije povzročiteljice v približno 40 % odmernega intervala.
The interest to use meropenem as an empirical treatment for febrile neutropenia is supported by the clinical experience and is recognized in the therapeutic guidelines.
Uporaba meropenema kot empiričnega zdravila za febrilno nevtropenijo je podprta s kliničnimi izkušnjami in priznana v terapevtskih smernicah.
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Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below).
Pri odmerjanju za zdravljenje bolnikov z insuficienco ledvic (glejte spodaj) je treba upoštevati dodatne vidike.
If you are using Meronem at home, dispose of any needles and infusion lines that you have used in an appropriate way.
Če zdravilo Meronem uporabljate doma, morate ustrezno zavreči vse uporabljene igle in infuzijske cevke.
Do not store above 30°C After reconstitution: Use within one hour.
Po pripravi: uporabite v eni uri.
Based on the discussed data, the MAH concluded that the safety profile reported in the population of patients with CF is similar to that reported overall and that meropenem is well tolerated.
Imetnik dovoljenja za promet je na osnovi podatkov iz razprave zaključil, da je varnostni profil, o katerem so poročali pri populaciji bolnikov s cistično fibrozo, podoben varnostnem profilu, o kateremu so poročali na splošno, in da bolniki učinkovino meropenem dobro prenašajo.
Furthermore, meropenem has not been formally evaluated in a clinical trial for VAP.
Poleg tega zdravilne učinkovine meropenem niso formalno ovrednotili v kliničnem preskusu za pljučnico, povezano z ventilatorji.
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If you have any further questions on the use of this product, ask your doctor or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali medicinsko sestro.
A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses.
Študija pri bolnikih z alkoholno cirozo ni pokazala, da bi bolezen jeter vplivala na farmakokinetiko meropenema po večkratnih odmerkih.
Your doctor will tell you how much of the diluent to use.
Zdravnik vam bo povedal, koliko topila uporabiti.
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including meropenem, and may range in severity from mild to life threatening.
Z antibiotikom povezani kolitis in psevdomembranski kolitis sta opisana pri skoraj vseh protimikrobnih zdravilih, tudi pri meropenemu, in lahko segata od blagega do smrtno nevarnega.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali medicinsko sestro.
Do not use Meronem
Ne uporabljajte zdravila Meronem
The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied.
Možni učinek meropenema na vezavo drugih zdravil na beljakovine ali presnovo ni raziskan.
Considering this, Section 4.4 was revised with amendments to the paragraphs on hypersensitivity and the gastro-intestinal system.
Odbor je ob upoštevanju tega pregledal poglavje 4.4 in vnesel dopolnila odstavkov, ki se navezujejo na preobčutljivost in prebavni sistem.
Not known angioedema, anaphylaxis (see sections 4.3 and 4.4)
Bolezni imunskega sistema Neznano angioedem, anafilaksija (glejte poglavji 4.3 in 4.4)
The CHMP considered that meropenem has a relatively low acute toxicity, even though effects on the kidney were seen in mice at 2200 mg/kg, dogs at 2000 mg/kg and monkeys at 500mg/kg.
CHMP je menil, da ima meropenem relativno nizko akutno toksičnost kljub opaženim učinkom na ledvice pri miših pri odmerku 2 200 mg/kg, pri psih pri odmerku 2 000 mg/kg in pri opicah pri odmerku 500 mg/kg.
Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes.
Druga možnost za dajanje odmerkov do 1 g je intravensko bolusno injiciranje, ki traja približno 5 minut.
If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.
Če vam potem, ko ste dokončali zdravljenje z antibiotikom tako, kot vam je naročil zdravnik, ostane kaj antibiotika, morate preostanek vrniti v lekarno za ustrezno odstranitev.
Open the cap on your cannula and connect the syringe.
Odprite zaporko na kanili in namestite brizgo.
• Pain and inflammation.
• Bolečine in vnetje.
You should not give antibiotics that were prescribed for you to other people.
Antibiotikov, ki so bili predpisani vam, ne smete dajati drugim.
Other micro-organisms Chlamydophila pneumoniae Chlamydophila psittaci Coxiella burnetii Mycoplasma pneumoniae
Drugi mikroorganizmi Chlamydophila pneumoniae Chlamydophila psittaci Coxiella burnetii Mycoplasma pneumoniae
1g/20 ml for injection or variable concentration for infusion
1g/20 ml za injiciranje ali različne koncentracije za infuzijo
Once you have finished giving the antibiotic and the syringe is empty, remove the syringe and use a flush as recommended by your doctor or nurse.
Ko končate dajanje antibiotika in je brizga prazna, brizgo odstranite in opravite izpiranje, kot vam je naročil zdravnik ali medicinska sestra.
Pharmacokinetic/Pharmacodynamic (PK/PD) relationship
Razmerje med farmakokinetiko in farmakodinamiko (FK/FD)
The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6 %) and increased hepatic enzymes (1.5-4.3 %).
Najpogostejša laboratorijska neželena učinka, povezana z meropenemom, sta bila trombocitoza (1,6 %) in zvišanje jetrnih encimov
Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes.
Druga možnost za dajanje odmerkov meropenema do 20 mg/kg je intravensko bolusno injiciranje, ki traja približno 5 minut.
Most specialists would recommend using combinations of antibiotics to treat patients with CF, including combinations administered intravenously, orally, or by inhalation.
Večina specialistov za zdravljenje bolnikov s cistično fibrozo priporoča uporabo kombinacije antibiotikov, vključno s kombinacijami, ki se jih daje intravensko, peroralno ali z inhaliranjem.
Connect the syringe and slowly push the plunger on the syringe to give the antibiotic steadily over about 5 minutes.
Namestite brizgo in počasi potiskajte bat brizge, da boste antibiotik enakomerno dajali približno 5 minut.
The pharmacokinetics in infants and children with infection at doses of 10, 20 and 40 mg/kg showed Cmax values approximating to those in adults following 500, 1000 and 2000 mg doses, respectively.
Farmakokinetika je po odmerkih 10, 20 oz. 40 mg/kg pri dojenčkih in otrocih z okužbami pokazala približno takšne vrednosti Cmax, kot pri odraslih po odmerkih 500, 1000 oz. 2000 mg.
The use of meropenem in meningitis is now considered as supported by the clinical experience and recognized in the therapeutic guidelines.
Uporaba meropenema pri meningitisu se zdaj obravnava kot podprta s kliničnimi izkušnjami in priznana v terapevtskih smernicah.
Therefore, the CHMP agreed that the two ADRs “blood creatinine increased” and “blood urea increased” should be included in the harmonised SPC for Meronem as ‘uncommon ADRs'.
Zaradi tega se je CHMP strinjal, da je treba neželena učinka „povečana koncentracija kreatinina v krvi“ in „zvišane ravni sečnine v krvi“ vključiti v usklajen povzetek glavnih značilnosti zdravila za Meronem kot „občasna neželena učinka“.
A positive direct or indirect Coombs test may develop during treatment with meropenem.
Med zdravljenjem z meropenemom se lahko pojavi pozitiven direktni ali indirektni Coombsov test.
Medicinal products that inhibit peristalsis should not be given.
Prepovedana je uporaba zdravil, ki zavirajo peristaltiko.
Acute bacterial meningitis
Akutni bakterijski meningitis
Meropenem is a member of the beta-lactam family of antibacterials and belongs to the class of carbapenems and is a broad-spectrum of in vitro antibacterial activity against Gram positive and Gram negative, aerobic and anaerobic pathogens, including extended-spectrum beta-lactamase (ESBL) and AMpC chromosomal beta-lactamase producing Enterobacteriaceae.
Zdravilo Meropenem iz družine betalaktamskih protibakterijskih zdravil spada v razred karbapenemov ter ima širok spekter protibakterijskega delovanja in vitro proti grampozitivnim in gramnegativnim, aerobnim in anaerobnim povzročiteljem bolezni, vključno z družino bakterij Enterobacteriaceae, ki tvorijo betalaktamaze razširjenega spektra (ESBL) in kromosomsko AMpC betalaktamazo.
Clean the grey rubber stopper once more with a new alcohol wipe and allow the rubber stopper to dry.
Sivi gumijasti zamašek še enkrat očistite z novim alkoholnim zložencem in pustite, da se gumijasti zamašek posuši.
Histological evidence of renal tubular damage was seen in mice and dogs only at doses of 2000 mg/kg and above after a single administration and above and in monkeys at 500 mg/kg in a 7-day study.
Histološke znake okvare ledvičnih tubulov so pri miših in psih ugotovili le z odmerki 2000 mg/kg in več po enkratni uporabi ter pri opicah z odmerki 500 mg/kg v 7-dnevni študiji.
• Infection affecting the lungs (pneumonia)
• Okužba pljuč (pljučnica)
500 mg or 1 g
500 mg ali 1 g
The information submitted in the Quality module concerning the stability of the products is completed with the most recent commercial data which support the shelf life of 4 years when the products are stored at up to 30 ºC.
Informacije, ki so predložene v modulu o kakovosti zdravila in se navezujejo na stabilnost zdravil, so dopolnjene z najnovejšimi komercialnimi podatki, ki podpirajo rok uporabnosti 4 let, če so zdravila shranjena pri temperaturi do 30 °C.
The MAH discussed the evidence of benefit with Meronem derived from trials, national and international named patient/compassionate use data and comparative studies.
Imetnik dovoljenja za promet z zdravilom je razpravljal o dokazanih koristi z zdravilom Meronem, podatke o katerih so pridobili iz preizkušanj, iz nacionalne in mednarodne uporabe pri imenovanih bolnikih/sočutne uporabe in primerjalnih študij.
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Tap the syringe so that any bubbles in the liquid rise to the top of the syringe.
Potrkajte po brizgi, tako da se mehurčki, ki so morda v tekočini, dvignejo na vrh brizge.
No dose adjustment is required in elderly patients, except in cases of moderate to severe renal impairment (see section 4.2).
Starejšim bolnikom odmerka ni treba prilagoditi, razen v primeru zmerne do hude okvare ledvic (glejte poglavje 4.2).
Not known antibiotic-associated colitis (see section 4.4)
Neznano z antibiotikom povezani kolitis (glejte poglavje 4.4)
• Sore veins where Meronem is injected.
• Vnetje ven, v katere je injicirano zdravilo Meronem.
Uncommon eosinophilia, thrombocytopenia, leucopenia, neutropenia
Občasni eozinofilija, trombocitopenija, levkopenija, nevtropenija
Not known agranulocytosis, haemolytic anaemia
Neznano agranulocitoza, hemolitična anemija
Therefore, your doctor will decide whether you should use Meropenem while breastfeeding.
Zato bo zdravnik odločil, ali naj dobite zdravilo Meronem med obdobjem dojenja.
The appropriateness of carbapenems including meropenem in UTI is supported by the clinical studies and the clinical experience.
Ustreznost karbapenemov, vključno z meropenemom, pri okužbi sečil je podprta s kliničnimi študijami in kliničnimi izkušnjami.
Where the data results in a variation, an application for a variation will be submitted to the RMS.
Če bodo ti podatki pripeljali do spremembe, bo referenčni državi članici predložena vloga za spremembo.
Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60-100 % decrease in valproic acid levels in about two days.
Med sočasno uporabo s karbapenemskimi zdravili je bilo opisano zmanjšanje koncentracije valprojske kisline v krvi, tako da se je ta v približno dveh dneh zmanjšala od 60 do 100 %.
Staphylococcus aureus (methicillin-susceptible) £
Staphylococcus aureus (občutljiv za meticilin)
It inhibits bacterial wall synthesis like other beta-lactam antibiotics, but is resistant to degradation by beta-lactamases or cephalosporinases.
Zdravilo zavira sintezo bakterijske stene tako kot drugi betalaktamski antibiotiki, vendar je odporno na razgrajevanje z betalaktamazami ali cefalosporinazami.
Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2.0 mEq of sodium (approximately 45 mg).
Ena viala s 500 mg vsebuje 104 mg natrijevega karbonata, kar ustreza približno 2,0 mEq (približno 45 mg) natrija.
After reconstitution: The reconstituted solutions for intravenous injection or infusion should be used immediately.
Po pripravi: Pripravljene raztopine za intravensko injiciranje ali infundiranje je treba uporabiti takoj.
Remove the coloured cap and clean the grey rubber stopper with an alcohol wipe.
Odstranite barvno zaporko in očistite sivi gumijasti zamašek z alkoholnim zložencem.
After infusion over 5 minutes Cmax values are 52 and 112 μg/ml after 500 and 1000 mg doses respectively.
Po 5-minutnem infundiranju je Cmax po odmerku 500 mg 52 µg/ml in po odmerku 1000 mg 112 µg/ml.
In contrast, taking into account the intended pathogens and the potential severity of these infections, the recent clinical studies, clinical practice, current microbiological context, international and national guidances, and considering the good use of antibiotics, meropenem can be considered as an appropriate antibacterial therapy in hospital acquired pneumonia (HAP).
V nasprotju s tem lahko ob upoštevanju predvidenih povzročiteljev bolezni in morebitne resnosti teh okužb, zadnjih kliničnih študij, klinične prakse, trenutnega mikrobiološkega konteksta, mednarodnih in nacionalnih smernic ter dobre uporabe antibiotikov, meropenem upoštevamo kot primerno protibakterijsko zdravljenje bolnišnično pridobljene pljučnice.
Symptomatic treatments should be considered.
V poštev pride simptomatsko zdravljenje.
A number of areas of disharmony in the product information for meropenem have been evaluated by the CHMP and the revised Product Information (PI) was adopted.
CHMP je ovrednotil številna območja neskladnosti informacij glede zdravilne učinkovine meropenem in sprejel spremenjene informacije o zdravilu.
To date, 7 AstraZeneca (AZ) sponsored studies have been conducted in UTIs.
Do zdaj je bilo izvedeno sedem študij, ki jih je sponzorirala družba AstraZeneca, v njih pa so proučevali okužbe sečil.
The safety of Meronem in CF derived from trials, national and international named patient/compassionate use data and comparative studies between meropenem and tobramycin or ceftazidim was also discussed.
Razpravljali so tudi o varnosti zdravila Meronem pri cistični fibrozi na podlagi podatkov, pridobljenih v preskušanjih, podatkov o nacionalni in mednarodni uporabi pri imenovanih bolnikih/sočutni uporabi ter primerjalnih študij med meropenemom in tobramicinom ali ceftazidimom.
Taking all the information into consideration, the CHMP considered that there was no compulsory need to qualify the CAP as it is not expected that a health practitioner would resort to the use of an intravenous agent for treating mild CAP.
CHMP je ob upoštevanju vseh informacij menil, da navedba izvenbolnišnično pridobljena pljučnica ni nujno potrebna, saj se ne pričakuje, da bo zdravstveni delavec uporabil intravensko zdravilo za zdravljenje blage izvenbolnišnično pridobljene pljučnice.
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The reconstituted solutions for intravenous injection or infusion should be used immediately.
Pripravljene raztopine za intravensko injiciranje ali infundiranje je treba uporabiti takoj.
HOW TO USE MERONEM
KAKO UPORABLJATI ZDRAVILO MERONEM
- the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet.
- obseg napotitvenega postopka je bil uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo,
The amount of liquid that you need is shown in the table below: Dose of Meronem Amount of ‘Water for Injections' needed for dilution 500 mg (milligrams) 10 ml (milliliters) 1 g (gram)
Količina "vode za injekcije", potrebna za razredčenje 500 mg (miligramov) 10 ml (mililitrov) 1 g (gram)
Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8).
Obstajajo redka poročila o napadih med zdravljenjem s karbapenemi, vključno z meropenemom (glejte poglavje 4.8).
The CHMP finally agreed the following indication:
Odbor CHMP se je končno strinjal z naslednjo indikacijo:
There are no established dose recommendations for patients receiving peritoneal dialysis.
Za bolnike na peritonealni dializi ni oblikovanih priporočil za odmerjanje.
Do not stop having Meronem until your doctor tells you to.
Če ste prenehali uporabljati zdravilo Meropenem Ne nehajte uporabljati zdravila Meronem, dokler vam tega ne naroči zdravnik.
As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy.
Iz previdnosti se je uporabi meropenema med nosečnostjo bolje izogniti.
Slowly push the plunger of the syringe to give the antibiotic steadily over about 5 minutes.
Počasi potiskajte bat brizge, da boste antibiotik enakomerno dajali približno 5 minut.
A dose is usually given every 8 hours.
Odmerek se po navadi uporabi na 8 ur.
However you may receive a dose less often if your kidneys do not work very well.
Če pa vam ledvice ne delujejo dobro, boste odmerek morda dobili manj pogosto.
The CHMP agreed with the following information added by the MAH in section 4.3 of the SPC on hypersensitivity to any other carbapenem antibacterial agent and severe hypersensitivity (eg anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (eg penicillins or cephalosporins).
CHMP se je strinjal, da imetnik dovoljenja za promet z zdravilom doda naslednje informacije v poglavje 4.3 povzetka glavnih značilnosti zdravila, ki se navezujejo na prekomerno občutljivost za katera koli druga karbapenemska protibakterijska zdravila in na hudo preobčutljivost (npr. anafilaktična reakcija, huda reakcija kože) za katero koli drugo vrsto betalaktamskih protibakterijskih sredstev (npr. penicilini ali cefalosporini).
Animal studies indicate that meropenem is well tolerated by the kidney.
Študije na živalih kažejo dobro ledvično prenašanje meropenema.
In summary, the CHMP harmonised the posology, for both adults and adolescents, and children over 50 kg body weight of 500 mg or 1 g (to be administered every 8 hours) and for children from 3 months (and under) to 11 years of age and up to 50 kg body weight a dose of 10 or 20 mg/kg (administered every 8 hours) for the following indications: Pneumonia , including community acquired pneumonia and nosocomial pneumonia Complicated urinary tract infections Complicated intra-abdominal infections Intra- and post-partum infections (for adults only) Complicated skin and skin tissue infections
CHMP je v povzetku uskladil odmerjanje zdravila za odrasle, mladostnike in otroke s telesno maso nad 50 kg, pri katerih se uporablja 500 mg ali 1 g zdravila (ki se daje vsakih 8 ur), ter za otroke od 3 mesecev do 11 let starosti in s telesno maso do 50 kg, pri katerih se uporablja odmerek od 10 do 20 mg/kg (ki se daje vsakih 8 ur) za naslednje indikacije: pljučnica, vključno z izvenbolnišnično pridobljeno pljučnico in bolnišnično pridobljeno pljučnico, zapletene okužbe sečil, zapletene intraabdominalne okužbe, okužba med porodom in po njem (samo za odrasle), zapletene okužbe kože in kožnih tkiv.
The usual dose is between 10 mg and 40 mg of Meronem for each kilogram (kg) that the child weighs.
Po navadi je odmerek od 10 do 40 mg zdravila Meronem na kilogram (kg) otrokove telesne mase.
Hold the syringe upright, with the needle pointing upwards.
Držite brizgo pokonci in tako, da je igla obrnjena navzgor.