FrancophonIA/ELRC3.0 huggingface dataset:
English: NutropinAq 10 mg/2 ml
Maltese: INFORMAZZJONI BIL-BRAILLE NutropinAq 10 mg/2 ml
English: This was accompanied by a significant increase in height SDS from -0.1 to 0.5 at baseline to 0.0 to 0.7 at Month 12 and 1.6 to 1.7 at Month 48.
Maltese: Dan kien akkumpanjat minn żieda sinifikanti fl-SDS tat-tul minn -0.1 sa 0.5 fil-linja bażi għal 0.0 sa 0.7 f'Xahar 12 u 1.6 sa 1.7 f'Xahar 48.
English: Other medicines and NutropinAq
Maltese: Mediċini oħra u NutropinAq
English: The effects of growth hormone on recovery were studied in two placebo-controlled clinical trials involving 522 adult patients who were critically ill due to complications following open-heart or abdominal surgery, multiple accidental traumas, or who were having acute respiratory failure.
Maltese: L-effetti tal-ormon tat-tkabbir fuq l-irkupru kienu studjati f'żewġ provi klinċi kkontrollati bil-plaċebo li involvew 522 pazjent adult li kienu morda b'mod kritiku minħabba komplikazzjonijiet wara kirurġija open-heart jew kirurġija fl-addome, korrimenti aċċidentali multipli, jew li kellhom falliment respiratorju akut.
English: The NutropinAq Pen allows for administration of a minimum dose of 0.1 mg to a maximum dose of 4.0 mg, in 0.1 mg increments.
Maltese: Il-Pinna NutropinAq tippermetti l-għoti ta' doża minima ta' 0.1 mg sa doża massima ta' 4.0 mg, f'żidiet ta' 0.1 mg.
English: The available literature indicates that the pharmacokinetics of somatropin are similar in men and women.
Maltese: Il-letteratura disponibbli tindika li l-farmakokinetika ta' somatropin hija simili fl-irġiel u n-nisa.
English: Common: Glucose tolerance impaired Uncommon: Hypoglycaemia, hyperphosphatemia
Maltese: Indeboliment fittolleranza għall-glucose Mhux komuni: Ipogliċemija, iperfosfatemija
English: Absorption The absolute bioavailability of recombinant human growth hormone after subcutaneous administration is about 80%.
Maltese: Il-bijodisponibilità assoluta tal-ormon tat-tkabbir rikombinanti uman wara għoti taħt il-ġilda hija ta' madwar 80%.
English: The safety of continuing somatropin treatment in patients with acute critical illness in intensive care units due to complications following open-heart or abdominal surgery, multiple accidental trauma or acute respiratory failure receiving replacement doses for approved indications has not been established.
Maltese: Is-sigurtà ta' kontinwazzjoni ta' kura b'somatropin f'pazjenti b'kondizzjoni akuta kritika fi swali ta' kura intensiva minħabba komplikazzjonijiet wara kirurġija open-heart jew kirurġija fl-addome, korrimenti aċċidentali multipli, jew falliment respiratorju akut li kienu qed jirċievu dożi ta' sostituzzjoni għall-indikazzjonijiet approvati ma ġietx stabbilita.
English: Adults with growth hormone deficiency (n=127) Very common: paraesthesia.
Maltese: Adulti b'defiċjenza tal-ormon tat-tkabbir (n=127)
English: The effect of NutropinAq has not been assessed in conventional animal fertility studies (see section 5.3) or clinical studies.
Maltese: L-effett ta' NutropinAq ma ġiex evalwat fi studji konvenzjonali dwar il-fertilità fuq l-annimali (ara sezzjoni 5.3) jew fi studji kliniċi.
English: Reporting of suspected adverse reactions after authorization of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: The volume of distribution at steady state for somatropin in healthy adult males is about 50 ml/kg bodyweight, approximating the serum volume.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss ta' somatropin f'irġiel adulti f'saħħithom huwa ta' madwar 50 ml/kg ta' piż tal-ġisem, bejn wieħed u ieħor il-volum tas-serum.
English: Adults with growth hormone deficiency commonly reported abnormal sensations of tingling, pricking or numbness (paraesthesia), abnormally high levels of blood glucose, excess of lipids (fat) in the blood, sleeplessness, joint disorders, arthrosis (degenerative joint disease), muscle weakness, back pain, breast pain and breast enlargement (gynaecomastia).
Maltese: Adulti b'defiċjenza tal-ormon tat-tkabbir irrappurtaw b'mod komuni sensazzjonijiet mhux normali ta' tnemnim, tingiż jew tirżiħ (parasteżija), livelli għolja b'mod mhux normali ta' glucose fid-demm, lipidi (xaħam) żejda fid-demm, nuqqas ta' rqad, disturbi fil-ġogi, artrożi (marda deġenerattiva talġogi), dgħjufija fil-muskoli, uġigħ fid-dahar, uġigħ fis-sider u tkabbir tas-sider (ġinekomastija).
English: The most frequently reported adverse reactions from the pivotal and supportive clinical trials were hypothyroidism, impaired glucose tolerance, headache, hypertonia, arthralgia, myalgia, peripheral oedema, oedema, asthenia, injection site reaction and the presence of drug specific antibodies.
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod frekwenti mill-provi kliniċi pivitali u ta' appoġġ kienu ipotirojdiżmu, tolleranza indebolita għall-glucose, uġigħ ta' ras, ipertonija, artralġja, majalġja, edima periferali, edima, astenja, reazzjoni fis-sit tal-injezzjoni u l-preżenza ta' antikorpi speċifiċi għallmediċina.
English: France, Hrvatska Ipsen Pharma
Maltese: France, Hrvatska
English: Uncommon: Papilloedema, diplopia Rare: Papilloedema, vision blurred
Maltese: Mhux komuni: Papilloedima, diplopja
English: Wipe the rubber seal of the NutropinAq with rubbing alcohol or an antiseptic solution to prevent contamination of the contents by microorganisms that may be introduced by repeated needle insertions.
Maltese: Imsaħ is-siġill tal-lasktu ta' NutropinAq bl-alkoħol jew soluzzjoni antisettika sabiex tipprevjeni kontaminazzjoni tal-kontenut minn mikroorganiżmi li jistgħu jidħlu permezz ta' inserzjoni ripetuta tal-labra.
English: System Organ Class Reactions observed in Pivotal and Supportive Clinical Trials (in 642 patients)
Maltese: Reazzjonijiet osservati fi Provi Kliniċi Pivitali u ta' Appoġġ (f'642 pazjent)
English: Date of first authorisation: 16 February 2001 Date of latest renewal: 16 February 2006
Maltese: Data tal-aħħar tiġdid: 16 ta' Frar 2006
English: A small percentage of patients may develop antibodies to the protein somatropin.
Maltese: Persentaġġ żgħir ta' pazjenti jistgħu jiżviluppaw antikorpi għall-proteina somatropin.
English: Part IV: Commonly Asked Questions
Maltese: Parti IV: Mistoqsijiet Komuni
English: < PC: {number} SN: {number} NN: {number}
Maltese: X'nagħmel jekk inwaqqa' l-Pinna NutropinAq tiegħi?
English: Patients under 11 years of age were also randomised to receive oestrogen therapy, either in late (aged 15 years) or early (aged 12 years) adolescence.
Maltese: Pazjenti b'età inqas minn 11-il sena kienu randomised ukoll biex jirċievu terapija ta' estroġeni, fl-aħħar tal-adolexxenza (età ta' 15-il sena) jew fil-bidu tal-adolexxenza (età ta' 12-il sena).
English: In vitro and in vivo preclinical and clinical tests have demonstrated that somatropin is therapeutically equivalent to human growth hormone of pituitary origin.
Maltese: Testijiet prekliniċi u kliniċi in vitro u in vivo wrew li somatropin huwa ekwivalenti terapewtikament għall-ormon tat-tkabbir uman li ġej mill-pitwitarja.
English: NutropininAq is a registered trademark of Genentech, Inc.
Maltese: Dan il-fuljett kien approvat l-aħħar f' <{XX/SSSS}> NutropininAq huwa trademark irreġistrata ta' Genentech, Inc.
English: There was also a significant increase in height SDS in somatropin-treated patients, from -2.9 to -2.7 at baseline to -1.6 to -1.4 at 24 months.
Maltese: Kien hemm ukoll żieda sinifikanti fl-SDS tat-tul f'pazjenti kkurati b'somatropin, minn -2.9 sa -2.7 fil-linja bażi għal -1.6 sa -1.4 wara 24 xahar.
English: Part III: Needles for the NutropinAq Pen
Maltese: III: Labar għall-Pinna NutropinAq
English: Injection site reactions may be avoided by using the correct injection technique and rotation of injection sites.
Maltese: Dawn lavvenimenti jistgħu jiġu evitati permezz ta' teknika ta' injezzjoni korretta u rotazzjoni tas-siti talinjezzjoni.
English: The average treatment time was 4.7 years in the somatropin three times a week group and 4.6 years in the somatropin daily group.
Maltese: Iż-żmien medju ta' kura kien ta' 4.7 snin fil-grupp ta' somatropin tliet darbiet fil-ġimgħa u ta' 4.6 snin fil-grupp ta' somatropin kuljum.
English: Rare: Diabetes mellitus, hyperglycaemia, hypoglycaemia, glucose tolerance impaired
Maltese: Dijabete mellitus, ipergliċemija, ipogliċemija, indeboliment fit-tolleranza għallglucose
English: Use with oral oestrogen therapy
Maltese: Użu ma' terapija ta' estroġeni orali
English: Respiratory thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Somatropin therapy is not indicated in diabetic patients with active proliferative or severe non-proliferative retinopathy.
Maltese: Terapija b'somatropin mhijiex indikata f'pazjenti dijabetiċi b'retinopatija attiva proliferattiva, jew retinopatija severa mhux proliferattiva.
English: The height standard deviation score (SDS) improved each year, increasing from -3.0 to -2.7 at baseline to -1.0 to -0.8 at Month 36.
Maltese: Il-punteġġ ta' devjazzjoni standard (SDS - standard deviation score) tat-tul tjieb kull sena, u żdied minn -3.0 sa -2.7 fil-linja bażi għal -1.0 sa -0.8 f'Xahar 36.
English: Psychiatric disorders Uncommon: Personality disorder
Maltese: Mhux komuni: Disturb filpersonalità
English: Very common in adults, common in children: Peripheral oedema, oedema Common: Asthenia, injection site reaction
Maltese: Komuni ħafna f'persuni adulti, komuni fit-tfal: Edima periferali, edima
English: OTHER
Maltese: Algés
English: - Long-term treatment of girls from 2 years old with growth failure associated with Turner syndrome.
Maltese: - Kura fit-tul ta' bniet b'età minn sentejn 'il fuq b'falliment tat-tkabbir assoċjat mas-sindrome ta' Turner.
English: In adults NutropinAq is used for:
Maltese: Fl-adulti NutropinAq jintuża għal:
English: The most frequently reported AEs in the two pivotal studies were headache, oedema, arthralgia/arthrosis, tenosynovitis, paraesthesia and allergic reaction/rash.
Maltese: L-aktar AEs irrappurtati b'mod frekwenti fiż-żewġ studji pivitali kienu wġigħ ta' ras, edima, artralġja/ artrosi, tenosinovite, parasteżija u reazzjoni allerġika/raxx.
English: - Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology.
Maltese: - Sostituzzjoni tal-ormon tat-tkabbir endoġenu f'adulti b'defiċjenza tal-ormon tat-tkabbir li tibda fit-tfulija jew f'età adulta.
English: 2 ml of solution in a cartridge (Type I glass) closed with a stopper (butyl rubber) and a seal (rubber).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 2 ml ta' soluzzjoni fi skartoċċ (ħġieġ Tip I) magħluq b'tapp (lasktu butyl) u siġill (lasktu).
English: Serum concentration of inorganic phosphorus are increased in patients with growth hormone deficiency after NutropinAq therapy due to metabolic activity associated with bone growth and increased tubular reabsorption in the kidney.
Maltese: Konċentrazzjoni fis-serum ta' fosforu inorganiku tiżdied f'pazjenti b'defiċjenza tal-ormon tat-tkabbir wara terapija b'NutropinAq minħabba attività metabolika assoċjata ma' tkabbir tal-għadam u żieda fl-assorbiment tubulari mill-ġdid filkliewi.
English: NutropinAq 10 mg/2 ml (30 IU), solution for injection Somatropin
Maltese: NutropinAq 10 mg/2 ml (30 IU), soluzzjoni għall-injezzjoni Somatropin
English: Rare: Abnormal behaviour, depression, insomnia
Maltese: Imġiba mhux normali, depressjoni, nuqqas ta' rqad
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: NutropinAq reduces insulin sensitivity; glucose tolerance impairment was reported in both the pivotal and supportive clinical trials and the post-marketing surveillance survey.
Maltese: NutropinAq inaqqas is-sensittività għall-insulina; indeboliment fit-tolleranza għall-glucose kien irrappurtat kemm fil-provi kliniċi pivitali kif ukoll f'dawk ta' appoġġ u fis-servej ta' sorveljanza ta' wara t-tqegħid fis-suq.
English: NutropinAq Pen Components:
Maltese: Komponenti tal-Pinna NutropinAq:
English: This medicinal product contains less than 1 mmol sodium (23 mg) per cartridge, i.e. essentially “sodium- free‟.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) f'kull skartoċc, jiġifieri huwa essenzjalment “mingħajr sodium”.
English: NutropinAq Pen Instruction for use with NutropinAq
Maltese: Jekk tinsa tieħu NutropinAq
English: The dose was 0.05 mg/kg/day s.c. in both studies.
Maltese: Id-doża kienet ta' 0.05 mg/kg/jum s.c. fiżżewġ studji.
English: Tabulated summary of adverse reactions
Maltese: Sommarju ta' reazzjonijiet avversi f'tabella
English: A statistically significant increase in mean PAH SDS was observed, from -1.6 or -1.7 at baseline to -0.7 or -0.9 at Month 24.
Maltese: Kienet osservata żieda statistikament sinifikanti fil-medja ta' SDS ta' PAH, minn -1.6 jew -1.7 fil-linja bażi għal -0.7 jew -0.9 f'Xahar 24.
English: There is no antidote for somatropin overdose.
Maltese: M'hemmx antidotu għal doża eċċessiva ta' somatropin.
English: Indication specific side effects seen during clinical trials
Maltese: Effetti sekondarji speċifiċi għall-indikazzjoni osservati waqt provi kliniċi
English: NutropinAq 10 mg/2 ml (30 IU) solution for injection.
Maltese: IL-PRODOTT MEDIĊINALI NutropinAq 10 mg/2 ml (30 IU) soluzzjoni għall-injezzjoni.
English: Mortality was higher (41.9 % vs. 19.3 %) among growth hormone treated patients (doses 5.38 mg/day) compared to those receiving placebo.
Maltese: 19.3 %) fost il-pazjenti kkurati bl-ormon tat-tkabbir (dożi ta' 5.3 - 8 mg/kuljum) meta mqabbla ma' dawk li kienu qed jirċievu l-plaċebo.
English: NutropinAq 10 mg/2 ml (30 IU) solution for injection Somatropin
Maltese: NutropinAq 10 mg/2 ml (30 IU) soluzzjoni għall-injezzjoni Somatropin
English: Neoplasms (malignant and benign) were reported in both the pivotal and supportive clinical trials and in the post-marketing surveillance survey (see sections 4.3 and 4.4).
Maltese: Neoplażmi (malinni u beninni) kienu rrappurtati kemm fil-provi kliniċi pivitali kif ukoll f'dawk ta' appoġġ u fis-servej ta' sorveljanza ta' wara t-tqegħid fis-suq (ara sezzjonijiet 4.3 u 4.4).
English: Treatment with NutropinAq is a long-term therapy.
Maltese: Kura b'NutropinAq hija terapija fit-tul.
English: Uncommon: Headache Rare: Benign intracranial hypertension, intracranial pressure increased, migraine, carpal tunnel syndrome, paraesthesia, dizziness
Maltese: Pressjoni għolja beninna fil-kranju, żieda fil-pressjoni filkranju, emigranja, sindrome carpal tunnel, parasteżija, sturdament
English: Other rare side effects seen with NutropinAq treatment include itching over the whole body, rash, blurred vision, increased weight, dizziness, diarrhoea, swelling of the face, fatigue, pain, fever, breast enlargement (gynaecomastia), depression and difficulty to sleep (insomnia).
Maltese: Effetti sekondarji rari oħra osservati b'kura ta' NutropinAq jinkludu ħakk mal-ġisem kollu, raxx, vista mċajpra, żieda fil-piż, sturdament, dijarea, nefħa fil-wiċċ, għeja, uġigħ, deni, tkabbir tas-sider (ġinekomastija), depressjoni u diffikultà biex torqod (insomnja).
English: Test for growth hormone deficiency should not be performed until adequate replacement therapy for other hormone deficiencies have been instituted.
Maltese: M'għandux isir test għal defiċjenza tal-ormon tat-tkabbir qabel tinbeda terapija adegwata ta' sostituzzjoni għal defiċjenza tal-ormoni l-oħra.
English: The pharmacokinetic properties of NutropinAq have only been investigated in healthy adult males.
Maltese: Il-kwalitajiet farmakokinetiċi ta' NutropinAq ġew investigati biss f'irġiel adulti f'saħħithom.
English: • There may be an increased risk of developing an inflammation of the pancreas (pancreatitis) in children compared to adults treated with growth hormone.
Maltese: • Jista' jkun hemm riskju akbar li tiżviluppa infjammazzjoni tal-frixa (pankreatite) fit-tfal meta mqabbel ma' adulti kkurati bl-ormon tat-tkabbir.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Maltese: L-MAH irid jiżgura li s-sistema ta' farmakoviġilanza, ippreżentata fil-Modulu 1.8.1 talAwtorizzazzjoni għat-Tqegħid fis-Suq, tkun fis-seħħ u tiffunzjona qabel u waqt li l-prodott mediċinali jkun fis-suq.
English: Limited published data for exogenously-administered somatropin suggest absorption and elimination half-lives and time of maximum concentration tmax in Turner patients are similar to those observed in both normal and growth hormone deficient populations.
Maltese: Data limitata ppubblikata dwar somatropin mogħti b'mod esoġenu tissuġġerixxi half-lives ta' assorbiment u eliminazzjoni u ħin sakemm tintlaħaq konċentrazzjoni massima tmax f'pazjenti b'Turner simili għal dawk osservati kemm f'popolazzjoni normali kif ukoll f'dik b'defiċjenza talormon tat-tkabbir.
English: Q: Can I use my NutropinAq Pen without the shields?
Maltese: M: Nista' nuża l-Pinna NutropinAq tiegħi mingħajr il-protezzjonijiet?
English: A: No.
Maltese: T: Le.
English: Feeling of weakness (asthenia) and increased muscle tension (hypertonia)
Maltese: Sensazzjoni ta' dgħjufija (astenja) u żieda fit-tensjoni tal-muskoli (ipertonija).
English: Now turn the black dose knob clockwise (See illustration) by one click (0.1mg).
Maltese: Jekk bi żball iddawwarha wisq, mur lura b'ċekċika waħda (0.1 mg).
English: Use a damp cloth to wipe away dirt.
Maltese: Għandek tieqaf tieħu NutropinAq jekk inti tqila.
English: • At the request of the European Medicines Agency;
Maltese: • Sistema ta' Farmakoviġilanza
English: For 51 patients who achieved near-adult height after an average duration of treatment of 6 years in males and 5 years in females, the mean near-adult height SDS was -0.7 in males and -1.2 in females.
Maltese: Għal 51 pazjent li kisbu tul viċin dak ta' adult wara tul medju ta' kura ta' 6 snin fl-irġiel u 5 snin finnisa, l-SDS medja tat-tul viċin dak ta' adult kienet ta' -0.7 fl-irġiel u ta' -1.2 fin-nisa.
English: Ipsen Pharma.
Maltese: FIS-SUQ Ipsen Pharma.
English: See also section “warning and precautions”.
Maltese: Ara wkoll sezzjoni “twissijiet u prekawzjonijiet”.
English: Decrease in the number of red blood cells in the blood (anaemia), decrease in blood sugar level (hypoglycaemia) and increase in phosphate levels (hyperphosphatemia).
Maltese: Tnaqqis fin-numru ta' ċelluli ħomor tad-demm fid-demm (anemija), tnaqqis fil-livell taz-zokkor fiddemm (ipogliċemija) u żieda fil-livelli tal-fosfat (iperfosfatemija).
English: Because somatropin may reduce insulin sensitivity, patients should be monitored for evidence of glucose intolerance.
Maltese: Peress li somatropin jista' jnaqqas is-sensittività għall-insulina, il-pazjenti għandhom jiġu ssorveljati għall-evidenza ta' intolleranza għall-glucose.
English: NutropinAq contains somatropin which is a recombinant growth hormone similar to the human's natural growth hormone made by your body.
Maltese: NutropinAq fih somatropin li huwa ormon rikombinanti tat-tkabbir simili għall-ormon naturali tattkabbir tal-bniedem magħmul mill-ġisem tiegħek.
English: NutropinAq is supplied as a multi-dose solution.
Maltese: NutropinAq huwa disponibbli bħala soluzzjoni għal ħafna dożi.
English: Treatment is symptomatic and supportive.
Maltese: Kura hija sintomatika u ta' appoġġ.
English: Of the 3 patients with a central nervous system tumour, 2 patients experienced a recurrent medulloblastoma and 1 patient experienced a histiocytoma.
Maltese: Mit-3 pazjenti b'tumur fis-sistema nervuża ċentrali, żewġ pazjenti kellhom medulloblastoma rikorrenti u pazjent wieħed kellu istjoċitoma.
English: To inject NutropinAq you should use the NutropinAq Pen.
Maltese: Biex tinjetta NutropinAq għandek tuża l-Pinna NutropinAq.
English: For in-use storage conditions of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali waqt l-użu, ara sezzjoni 6.3. 6.5
English: Clearance and mean terminal half-life t½ of somatropin in adult and paediatric growth hormone deficient patients are similar to those observed in healthy subjects.
Maltese: It-tneħħija u l-half-life terminali medja t½ ta' somatropin f'pazjenti adulti u pedjatriċi b'defiċjenza talormon tat-tkabbir huma simili għal dawk osservati f'individwi f'saħħithom.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodiumfree”.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) f'kull kunjett, jiġifieri, huwa essenzjalment “mingħajr sodium”.
English: Q: Can I store my NutropinAq Pen in the freezer?
Maltese: M: Nista' naħżen il-Pinna NutropinAq tiegħi fil-friża?
English: • If you have complications after major surgery (open-heart or abdominal surgery), multiple trauma, acute respiratory failure, or similar conditions, your doctor should decide whether it is safe to continue NutropinAq treatment.
Maltese: • Jekk għandek komplikazzjonijiet wara kirurġija maġġuri (kirurġija open-heart jew addominali), trawma multipla, insuffiċjenza respiratorja akuta, jew kondizzjonijiet simili, it-tabib tiegħek għandu jiddeċiedi jekk huwiex perikoluż li titkompla l-kura b'NutropinAq.
English: Rare: Gynaecomastia
Maltese: Konklużjonijiet xjentifiċi
English: In both studies there was a significant improvement in growth rate in the naïve patients, increasing from 4.2 to 10.9 cm/year in one study and from 4.8 to 11.2 cm/year in the other at 12 months.
Maltese: 9 ċm/sena fi studju wieħed u minn 4.8 għal 11.2 ċm/sena fl-ieħor wara 12-il xahar.
English: Remove the green pen cap and unscrew the cartridge holder from the pen.
Maltese: Il-maġġoranza ta' neoplażmi rrappurtati kienu rikorrenza ta' neoplażmi preċedenti u t-tieni neoplażma.
English: Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy.
Maltese: Pazjenti bid-dijabete jew intolleranza għall-glucose għandhom jiġu ssorveljati mill-viċin waqt terapija b'somatropin.
English: The dose should be adjusted stepwise, controlled by serum Insulin-like Growth Factor-1 (IGF-I) values.
Maltese: Id-doża għandha tiġi aġġustata pass pass, ikkontrollata minn valuri tal-Fattur tat-Tkabbir-1 li jixbah lill-Insulina (IGF-I - Insulin-like Growth Factor-1) fis-serum.
English: - Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion.
Maltese: - Kura fit-tul ta' tfal b'falliment tat-tkabbir ikkawżat minn sekrezzjoni inadegwata tal-ormon tattkabbir endoġenu.
English: There have been reports of sleep apnoea and sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Maltese: Kien hemm rapporti ta' apnea waqt l-irqad u mewt f'daqqa wara bidu ta' terapija bl-ormon tat-tkabbir f'pazjenti pedjatriċi bis-sindrome ta' Prader-Willi li kellhom wieħed jew aktar mill-fatturi ta' riskju li ġejjin: ħxuna severa, passat ta' sadd tal-parti ta' fuq tal-passaġġ tal-arja jew apnea waqt l-irqad, jew infezzjoni respiratorja mhux identifikata.
English: Childhood-onset: Patients who have had growth hormone deficiency as a child should be retested to confirm growth hormone deficiency in adulthood before replacement therapy with NutropinAq is started.
Maltese: Pazjenti li kellhom defiċjenza tal-ormon tat-tkabbir meta kienu għadhom tfal għandhom jerġgħu jiġu ttestjati biex tkun ikkonfermata defiċjenza tal-ormon tat-tkabbir f'età adulta qabel tinbeda terapija ta' sostituzzjoni b'NutropinAq.
English: Part II: Storage and Maintenance
Maltese: Parti II: Ħażna u Manutenzjoni