FrancophonIA/ELRC3.0 huggingface dataset:
English: The reference medicinal product was Strefen Direct 8,75 mg Oromucosal spray (UK/H/5072/001).
Maltese: Il-prodott mediċinali ta' referenza kien Strefen Direct 8,75 mg Sprej Oromukożali (UK/H/5072/001).
English: Grounds for the CHMP opinion
Maltese: Raġunijiet għall-opinjoni tas-CHMP
English: Literature data (Radkova et al., 2017, Imai et al., 1988) demonstrate that different formulations of flurbiprofen (spray and lozenges) displayed comparable efficacy and safety profiles, despite the lack of cycloextrins from lozenges, and were also taken into consideration.
Maltese: Data mil-letteratura (Radkova et al., 2017, Imai et al., 1988) turi li formulazzjonijiet differenti ta' flurbiprofen (sprej u pastilji) urew profili komparabbli ta' effikaċja u ta' sigurtà, minkejja n-nuqqas ta' ċiklodestrini mill-pastilji, u ġew ikkunsidrati wkoll.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC;
Maltese: • Il-Kumitat qies ir-referenza skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE;
English: The application for Strefen Direct 8,75 mg Oromucosal spray was made under Article 8(3) of Directive 2001/83/EC.
Maltese: L-applikazzjoni għal Strefen Direct 8,75 mg Sprej Oromukożali saret skont l-Artikolu 8(3) tad-Direttiva 2001/83/KE.
English: Annex II Scientific conclusions
Maltese: Anness II Konklużjonijiet xjentifiċi
English: i) different concentration: 17.16 mg/ml in the test product versus 16.20 mg/ml in the reference product (0.096% difference of content of drug substance in weight/volume)
Maltese: i) konċentrazzjoni differenti: 17.16 mg/ml fil-prodott tat-test kontra 16.20 mg/ml fil-prodott ta' referenza (0.096 % differenza ta' kontenut tas-sustanza tal-mediċina f'piż/volum)
English: i) the concentration: 17.16 mg/ml in the test medicinal product versus 16.20 mg/ml in the reference product;
Maltese: i) il-konċentrazzjoni: 17.16 mg/ml fil-prodott mediċinali tat-test kontra 16.20 mg/ml fil-prodott ta' referenza;
English: The drug inhibits the synthesis of prostaglandins by mixed inhibition of the enzymes COX-1/COX-2 with some selectivity towards COX-1.
Maltese: prostaglandini b'inibizzjoni mħallta tal-enzimi COX-1/COX-2 b'xi selettività lejn COX-1.
English: Overall summary of the scientific evaluation by the CHMP Flurbiprofen Geiser 8,75 mg oromucosal spray, is a non-steroidal anti-inflammatory (NSAID) with analgesic, antipyretic, and anti-inflammatory properties.
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika mis-CHMP Flurbiprofen Geiser 8,75 mg sprej oromukożali, huwa antinfjammatorju nonsterojdali (NSAID) b'karatteristiċi analġeżiċi, antipirettiċi, u antinfjammatorji.
English: The test product has some quantitative and qualitative differences with the reference product, namely;
Maltese: Il-prodott tat-test għandu xi differenzi kwantitattivi u kwalitattivi mal-prodott ta' referenza, jiġifieri;
English: The proposed indication is ‘pain relief of mild to moderate symptoms of acute sore throat'.
Maltese: L-indikazzjoni proposta hija “serħan mill-uġigħ ta' sintomi ħfief sa moderati ta' wġigħ fil-griżmejn akut”.
English: The assessment was performed having in mind that this was this is a hybrid application under Article 10(3) of Directive 2001/83/EC.
Maltese: Il-valutazzjoni twettqet filwaqt li ġie kkunsidrat li din kienet applikazzjoni ibrida skont l-Artikolu 10(3) tad-Direttiva 2001/83/KE.
English: Moreover, it was emphasised that the originator has demonstrated bioequivalence between the oromucosal spray (Strefen Direct 8,75 mg Oromucosal spray) and lozenges (Strepflam 8,75 mg Lozenges), for which more significant formulation differences exist.
Maltese: Barra minn hekk, ġie enfasizzat li l-oriġinatur wera bijoekwivalenza bejn l-isprej oromukożali (Strefen Direct 8,75 mg Sprej oromukożali) u pastilji (Strepflam 8,75 mg Pastilji), li għalihom jeżistu differenzi ta' formulazzjoni aktar sinifikanti.
English: In addition, published evidence underline that completely different formulations of flurbiprofen (e.g. lozenge, granules and spray) applied to the oral cavity has demonstrated bioequivalence.
Maltese: Barra minn hekk, evidenza ppubblikata tenfasizza li formulazzjonijiet kompletament differenti ta' flurbiprofen (eż. pastilja, granuli u sprej) applikati għall-kavità orali wrew bijoekwivalenza.
English: Results from the in-vitro tests performed by the applicant have shown equivalence in the critical quality attributes that were tested (single actuation content, droplet size distribution, drug small particles, spray pattern, plum geometry and priming), suggesting that the quantitative and qualitative differences between the reference and the test medicinal products do not affect the deposition of the spray in the site of action (the buccal cavity).
Maltese: Ir-riżultati mit-testijiet in-vitro li twettqu mill-applikant urew ekwivalenza fl-attributi ta' kwalità importanti li ġew ittestjati (il-kontenut ta' attwazzjoni waħda, id-distribuzzjoni tad-daqs tal-qatra, ilpartiċelli żgħar tal-mediċina, ix-xejra tal-isprej, il-ġeometrija tal-fwar u l-ipprajmjar), li jissuġġerixxu li d-differenzi kwantitattivi u kwalitattivi bejn il-prodott mediċinali ta' referenza u dak tat-test ma jaffettwawx id-depożizzjoni tal-isprej fis-sit tal-azzjoni (il-kavità tal-ħalq).
English: This minor difference in concentration (5.93%) is expected to be reduced even more by the available saliva in the mouth.
Maltese: Din id-differenza żgħira fil-konċentrazzjoni (5.93 %) hija mistennija li titnaqqas saħansitra aktar mill-bżieq disponibbli fil-ħalq.
English: With regards to the different concentration (17.16 mg/ml vs. 16.20 mg/ml), it was noted that that due to the different sprayed volumes (0.17 mL vs. 0.18 mL), the delivered dose is eventually the same.
Maltese: 16 mg/ml kontra 16.20 mg/ml), ġie nnutat li minħabba lvolumi differenti sprejjati (0.17 mL kontra 0.18 mL), id-doża mogħtija hija eventwalment l-istess.
English: Flurbiprofen belongs to the non-steroidal anti-inflammatory class of medicines (NSAID) which have analgesic, antipyretic, and anti-inflammatory properties.
Maltese: Flurbiprofen jappartjeni għall-klassi ta' mediċini antinfjammatorji nonsterojdali (NSAID) li għandhom karatteristiċi analġeżiċi, antipirettiċi, u antinfjammatorji.
English: • The Committee considered (Co-)Rapporteur's assessment report;
Maltese: • Il-Kumitat qies ir-rapport ta' valutazzjoni tal-(Ko)Relatur;
English: First, the lower amount of cyclodextrins is preferable from a safety point of view.
Maltese: L-ewwel nett, lammont aktar baxx ta' ċiklodestrini huwa preferibbli mil-lat tas-sigurtà.
English: The therapeutic equivalence has been claimed to be demonstrated based on in-vitro data only.
Maltese: L-ekwivalenza terapewtika ġiet iddikjarata li ntweriet abbażi ta' data in-vitro biss.
English: The applicant Geiser Pharma S.L.
Maltese: L-applikant talab rinunzja tal-ħtieġa li jitwettqu studji kliniċi.
English: The originator product is Strepflam 8.75 Lozenges by Crookes Healthcare/Reckitt Benckiser Healthcare, which has been registered since June 2001.
Maltese: Pastilji minn Crookes Healthcare/Reckitt Benckiser Healthcare, li ilu rreġistrat minn Ġunju 2001.
English: According to the Guideline on the equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract (CPMP/EWP/239/95 Rev.1) preclinical and clinical trials are considered necessary in order to bridge the test to the reference medicinal product in case the definition of a generic medicinal product is not met.
Maltese: Skont il-Linja Gwida dwar l-istudji ta' ekwivalenza għall-wiri ta' ekwivalenza terapewtika għal prodotti applikati lokalment, li jaġixxu lokalment fl-apparat gastrointestinali (CPMP/EWP/239/95 Rev.1) provi prekliniċi u kliniċi huma kkunsidrati meħtieġa sabiex jingħalaq it-test għall-prodott mediċinali ta' referenza f'każ li d-definizzjoni ta' prodott mediċinali ġeneriku ma tiġix issodisfata.
English: The present referral was triggered on the grounds that the waiver for clinical studies is not in line with the “Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract” (CPMP/EWP/239/95 Rev.1) and that the differences may impact on the clinical performance of the test product.
Maltese: Din ir-referenza attwali ngħatat bidu fuq il-bażi li r-rinunzja għal studji kliniċi mhijiex konformi mal“Linji gwida dwar l-istudji ta' ekwivalenza għall-wiri ta' ekwivalenza terapewtika għal prodotti applikati lokalment, li jaġixxu lokalment fl-apparat gastrointestinali” (CPMP/EWP/239/95 Rev.1) u li d-differenzi jistgħu jħallu impatt fuq il-prestazzjoni klinika tal-prodott tat-test.
English: submitted an application under the decentralised procedure for Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names (ES/H/0552/001/DC).
Maltese: L-applikant Geiser Pharma S.L. issottometta applikazzjoni skont il-proċedura deċentralizzata għal Flurbiprofen Geiser 8,75 mg sprej oromukożali, soluzzjoni u ismijiet assoċjati (ES/H/0552/001/DC). Lapplikazzjoni ġiet sottomessa skont l-Artikolu 10(3) tad-Direttiva 2001/83/KE.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as potential serious risk to public health and the questions asked by the CHMP;
Maltese: • Il-Kumitat ikkunsidra t-totalità tad-data sottomessa mill-applikant fir-rigward tal-oġġezzjonijiet li tqajmu bħala riskju serju potenzjali għas-saħħa pubblika u l-mistoqsijiet li saru mis-CHMP;
English: On the top of that, flurbiprofen is a highly permeable and passively absorbed drug of which the permeability is not altered by a difference in concentration.
Maltese: Minbarra dan, flurbiprofen huwa mediċina permeabbli ħafna u li tiġi assorbita b'mod passiv li minnha l-permeabilità ma tinbidilx b'differenza fil-konċentrazzjoni.
English: Second, flurbiprofen is moderately bound to the cyclodextrins and the release of the active substance is immediate when it comes in contact with the buccal membrane.
Maltese: Għalhekk, fix-xenarju ipotetiku ta' differenza fl-ammont ta' bżieq prodott, dan ma jkollux impatt fuq lammont assorbit tas-sustanza attiva.
English: Based on the in-vitro tests, equivalence has been shown between the reference and the test products with respect to the following quality attributes: amount of active substance in each dose, the particle size, the plume geometry and the spray pattern.
Maltese: Abbażi ta' testijiet in-vitro, intweriet ekwivalenza bejn il-prodott ta' referenza u dak tat-test fir-rigward tal-attribwiti tal-kwalità li ġejjin: ammont ta' sustanza attiva f'kull doża, id-daqs tal-partiċella, ilġeometrija tal-fwar u x-xejra tal-isprej.
English: Acknowledging that deviations from the guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract (CPMP/EWP/239/95 Rev.1) could be accepted if they are justified appropriately and having reviewed all the data submitted and the responses submitted by the applicant, the CHMP considered that the waiver of the clinical trials to demonstrate therapeutic equivalence has been adequately substantiated.
Maltese: Filwaqt li ġie rikonoxxut li d-devjazzjonijiet mil-linja gwida dwar l-istudji ta' ekwivalenza għall-wiri ta' ekwivalenza terapewtika għal prodotti applikati lokalment, li jaġixxu lokalment fl-apparat gastrointestinali (CPMP/EWP/239/95 Rev.1) jistgħu jiġu aċċettati jekk ikunu ġġustifikati kif xieraq, u wara li rrieżamina d-data kollha sottomessa u t-tweġibiet sottomessi mill-applikant, is-CHMP ikkunsidra li r-rinunzja tal-provi kliniċi biex tintwera ekwivalenza terapewtika ġiet sostanzjata b'mod adegwat.
English: ii) lower amount of cyclodextrins iii) one flavour less: in the test product one flavour is employed (cherry) instead of two flavours employed in the reference product (cherry and mint)
Maltese: iii) it-togħmiet: fil-prodott tat-test, tintuża togħma waħda (ċirasa) minflok żewġ togħmiet użati filprodott mediċinali ta' referenza (ċirasa u nagħniegħ)
English: Therefore, this difference in concentration is considered insignificant and clinically irrelevant, taking into consideration that eventually the same dose is administered locally.
Maltese: Għalhekk, din id-differenza fil-konċentrazzjoni titqies bħala insinifikanti u klinikament irrilevanti, filwaqt li jitqies li eventwalment listess doża tiġi mogħtija lokalment.
English: The Committee, as a consequence, considers that the benefit-risk balance of Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Maltese: B'konsegwenza ta' dan, il-Kumitat iqis li l-bilanċ bejn il-benefiċċju u r-riskju ta' Flurbiprofen Geiser 8,75 mg sprej oromukożali, soluzzjoni u ismijiet assoċjati huwa favorevoli u għalhekk jirrakkomanda lgħoti tal-awtorizzazzjoni(jiet) għat-tqegħid fis-suq għall-prodotti mediċinali msemmija fl-Anness I għall-opinjoni tas-CHMP.
English: However, there are some quantitative and qualitative differences among the products which concern:
Maltese: Madankollu, hemm xi differenzi kwantitattivi u kwalitattivi fost il-prodotti li jikkonċernaw:
English: The proposed indication is short-term symptomatic relief of sore throat.
Maltese: L-indikazzjoni proposta hija serħan sintomatiku fuq perjodu ta' żmien qasir ta' wġigħ fil-griżmejn.
English: ATC code: A10AD01.
Maltese: A10AD01.
English: 12 units
Maltese: 12-il unità
English: - The active substance is human insulin.
Maltese: - Is-sustanza attiva hi insulina umana.
English: Dose scale
Maltese: Skala ta'
English: Further important information
Maltese: Aktar informazzjoni importanti
English: Date of first authorisation: 07 October 2002 Date of latest renewal: 18 September 2007
Maltese: Data tal-aħħar tiġdid: 18 ta' Settembru 2007
English: Novo Nordisk Production SAS 45, Avenue d'Orléans F-28000 Chartres France
Maltese: Novo Nordisk Production SAS 45, Avenue d'Orléans F-28000 Chartres
English: Name and address of the manufacturers of the biological active substance Novo Nordisk A/S
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva Novo Nordisk A/S
English: Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
Maltese: Prodotti mediċinali antidijabetiċi orali, inibituri ta' monamine oxidase (MAOI), beta-blokkanti, inibituri ta' l-enzima li tikkonverti l-anġjotensin (ACE), saliċilati, sterojdi anaboliċi u sulfonamidi.
English: • Anabolic steroids (such as testosterone)
Maltese: • Sterojdi anaboliċi (bħal testosterone)
English: This reduces the risk of contamination, infection,
Maltese: Dan inaqqas ir-riskju ta' kontaminazzjoni,
English: SAS, 45 Avenue d'Orléans, F-28000 Chartres, France.
Maltese: Avenue d'Orléans F-28000 Chartres, Franza.
English: Store below 25°C.
Maltese: Aħżen taħt 25°C.
English: Before opening: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: List of other side effects Uncommon side effects
Maltese: Lista ta' effetti sekondarji oħra
English: Actraphane 30 vial (100 international units/ml) EU/1/02/229/003
Maltese: Actraphane 30 vial (100 unità internazzjonali/ml) EU/1/02/229/003
English: • Monoamine oxidase inhibitors (MAOI) (used to treat depression)
Maltese: • Inibituri ta' monoamine oxidase (MAOI) (użati fil-kura tad-dipressjoni)
English: Very rare - Refraction disorders Uncommon - Diabetic retinopathy
Maltese: Rari ħafna - Disturbi rifrazzjonali
English: • Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma)
Maltese: • Simpatomimetiċi ( bħal epinephrine [adrenaline], salbutamol jew terbutaline użati fil-kura tal ażma)
English: Store below 30°C.
Maltese: Aħżen taħt 30°C.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu
English: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Maltese: Kontraċettivi orali, tijażidi, glukokortikojdi, ormoni tat-tirojde, simpatomimetiċi, l-ormon tat-tikbir u danazol.
English: Before opening: Store in a refrigerator at 2°C - 8°C.
Maltese: Aħżen fi friġġ f'temperatura ta' 2°C - 8°C.
English: Uncommon - Urticaria, rash Very rare - Anaphylactic reactions*
Maltese: Mhux komuni - Urtikarja, raxx Rari ħafna - Reazzjonijiet anafilattiċi*
English: Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Maltese: Hu rrappurtat li l-insulina umana tiġi degradata mill-protease insulinika jew mill-enżimi degradanti ta' l-insulina u possibbilment mill-proteina disulfide isomerase.
English: • Glucocorticoids (such as ‘cortisone' used to treat inflammation)
Maltese: • Glukokortikojdi (bħal “cortisone” użat fil-kura tal-infjammazzjoni)
English: 24 units selected
Maltese: Intagħżlu 24 unità
English: Disodium phosphate dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Protamine sulfate
Maltese: Disodium phosphate dihydrate Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH)
English: Batch:
Maltese: Lott:
English: Pointer
Maltese: Indikatur
English: STATEMENT OF ACTIVE SUBSTANCE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: *Human insulin is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Maltese: *L-insulina umana hija magħmula f'Saccharomyces cerevisiae permezz tat-teknoloġija tad-DNA rikombinanti
English: Suspension for injection 1 x 3 ml pre-filled pen 5 x 3 ml pre-filled pens 10 x 3 ml pre-filled pens
Maltese: U KONTENUT Suspensjoni għall-injezzjoni 1 x 3 ml pinna mimlija għal-lest 5 x 3 ml pinen mimlijin għal-lest 10 x 3 ml pinen mimlijin għal-lest
English: • Sulfonamides (used to treat infections).
Maltese: • Sulfonamides (użati fil-kura ta' infezzjonijiet)
English: 1 vial contains 10 ml equivalent to 1,000 IU.
Maltese: Kunjett fih 10 ml ekwivalenti għal 1,000 UI.
English: Warning signs of high blood sugar:
Maltese: Sinjali ta' allerġija:
English: Suspension for injection Multipack: 5 packs of 1 x 10 ml vial
Maltese: U KONTENUT Suspensjoni għall-injezzjoni Pakkett multiplu: 5 pakketti ta' kunjett 1 x 10 ml
English: Uncommon - Lipodystrophy*
Maltese: Mhux komuni - Lipodistrofija*
English: Frequency categories are defined according to the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 u <1/10); mhux komuni (≥1/1,000 u <1/100); rari (≥1/10,000 u <1/1,000); rari ħafna (<1/10,000), mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: Animal reproduction studies with human insulin have not revealed any adverse effects on fertility.
Maltese: Studji ta' riproduzzjoni fl-annimali bl-insulina umana ma wrew ebda effett avvers fuq il-fertilità.
English: zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide/hydrochloric acid for pH adjustment, protamine sulfate and water for injections
Maltese: TA' EĊĊIPJENTI zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide/hydrochloric acid għall-aġġustament tal-pH, protamine sulfate u ilma għall-injezzjonijiet
English: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Maltese: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Id-Danimarka
English: Uncommon - Peripheral neuropathy (painful neuropathy)
Maltese: Mhux komuni - Newropatija periferali (newropatija bl-uġigħ)
English: • Thyroid hormone (used to treat thyroid gland disorders)
Maltese: • Ormoni tat-tirojde ( użati fil-kura ta' disturbi fil-glandola tat-tirojde)
English: Actraphane contains sodium
Maltese: Actraphane fih sodium
English: Suspension for injection 1 vial of 10 ml.
Maltese: U KONTENUT Suspensjoni għall-injezzjoni kunjett 1 x 10 ml.
English: Pull off the pen cap (see A).
Maltese: Neħħi l-għatu tal-pinna (ara A).
English: The individual insulin requirement is usually between 0.3 and 1.0 international unit/kg/day.
Maltese: Il-ħtieġa individwali tal-insulina normalment hi ta' bejn 0.3 u 1.0 unitajiet internazzjonalii/kg/kuljum..
English: You can carry it with you and keep it at room temperature (below 25°C) for up to 6 weeks.
Maltese: Tista' ġġorru miegħek u żżommu f'temperatura ta' kamra (taħt 25°C) sa mhux iżjed minn 6 ġimgħat.
English: - If the second and third characters are T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d'Orléans, F-28000 Chartres, France.
Maltese: Jekk it-tieni u t-tielet karattri huma H7 jew T6, il-manifattur huwa Novo Nordisk Production SAS, 45, Avenue d'Orléans, F-28000 Chartres, Franza
English: • Drink alcohol, see Actraphane with alcohol in section 2.
Maltese: • Tixrob l-alkoħol, ara Actraphane mal-alkoħol f'sezzjoni 2
English: Residual scale
Maltese: Skala taddoża
English: Suspension for injection.
Maltese: suspensjoni għall-injezzjoni.
English: EU/1/02/229/036 5 packs of 1 x 10 ml vial
Maltese: EU/1/02/229/036 5 pakketti ta' kunjett 1 x 10 ml
English: Actraphane 30 vial (40 international units/ml)/Actraphane 30 vial (100 international units/ml)
Maltese: Actraphane 30 f'kunjett (40 unità internazzjonali/ml)/Actraphane 30 f'kunjett (100 unità internazzjonali/ml)
English: See Summary of serious and very common side effects in section 4.
Maltese: Ara Sommarju ta' effetti sekondarji serji u komuni ħafna f'sezzjoni 4.
English: 5 units selected
Maltese: Intagħżlu 5 unitajiet
English: Resuspension of Actraphane
Maltese: Kif tinjetta Actraphane
English: If there are less than 12 units left, use a new InnoLet.
Maltese: Jekk ikun baqa' inqas minn 12-il unità, uża InnoLet ġdida.
English: These measures will help protect the environment.
Maltese: ► Jekk l-għatu protettiv huwa laxk jew nieqes.
English: Injecting the insulin
Maltese: • Ma injettajtx biżżejjed insulina
English: - The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.
Maltese: - Is-sustanzi l-oħra huma zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate u ilma għall-injezzjonijiet.
English: Actraphane is a mixture consisting of 50% soluble human insulin and 50% isophane human insulin.
Maltese: Actraphane huwa taħlita li tikkonsisti minn 50 % ta' insulina umana li tinħall u 50 % ta' insulina umana isophane.
English: You can select doses from 1 to 60 units in increments of 1 unit.
Maltese: tisselezzjona dożi minn unità 1 sa 60 unità f'inkrementi ta' unità 1.
English: • Danazol (medicine acting on ovulation).
Maltese: • Danazol (mediċina li għandha effett fuq l-ovulazzjoni)
English: Administration with FlexPen
Maltese: It-teħid b'FlexPen
English: Actraphane with alcohol
Maltese: Actraphane mal-alkoħol
English: Suspension for injection 1 x 3 ml cartridge 5 x 3 ml cartridges 10 x 3 ml cartridges
Maltese: 5 x 3 ml pinen mimlijin għal-lest 10 x 3 ml pinen mimlijin għal-lest
English: Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of suspension.
Maltese: Skartoċċ (tal-ħġieġ ta'tip 1) bi planġer (bromobutyl) u għatu tal-lastku (bromobutyl/polyisoprene) u li fih suspensjoni ta' 3 ml.
English: Normally this soon disappears.
Maltese: Normalment dan malajr imur.
English: You can carry it with you and keep it at room temperature (below 30°C) for up to 6 weeks.
Maltese: Tista' ġġorru miegħek u żżommu f'temperatura ta' kamra (taħt 30°C) sa mhux iżjed minn 6 ġimgħat.
English: See Effects from diabetes in section 4.
Maltese: Ara Effetti tad-dijabete f'sezzjoni 4.
English: 1 vial contains 10 ml equivalent to 400 IU.
Maltese: Kunjett fih 10 ml ekwivalenti għal 400 UI.