FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data), including isolated reports
Maltese: Komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari ≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli), inkluż rapporti iżolati
English: Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment).
Maltese: Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH).
English: During clinical studies 128 children (98 children with growth hormone deficiency and 30 with Turner syndrome) were exposed to Valtropin.
Maltese: Waqt studji kliniċi 128 tifel/tifla (98 tifel/tifla b'defiċjenza ta' l-ormon tat-tkabbir u 30 bis-sindrome ta' Turner) kienu esposti għal Valtropin.
English: Anti-host cell protein (anti-S. cerevisiae) antibodies were uncommon in patients treated with Valtropin.
Maltese: L-anti-host cell protein (anti-S cerevisiae) antibodies ma kinux komuni f'pazjenti kkurati b'Valtropin.
English: Turner syndrome
Maltese: Sindrome ta' Turner
English: Slipped capital epiphyse
Maltese: Epiphyses kapitali mqabbża
English: In a clinical study with Valtropin, 3% of children with growth hormone deficiency developed antibodies to somatropin.
Maltese: Fi studju kliniku b'Valtropin, 3% tat-tfal b'defiċjenza ta' l-ormon tat-tkabbir żviluppaw antikorpi għal somatropin.
English: Valtropin is synthesised in yeast cells (Saccharomyces cerevisiae).
Maltese: Valtropin huwa sintetizzat f'ċelloli tal-ħmira (Saccharomyces cerevisiae).
English: Somatropin stimulates lipid metabolism; it increases plasma fatty acids and high-density lipoprotein (HDL)-cholesterols, and decreases total plasma cholesterol.
Maltese: Somatropin jistimula l-metaboliżmu tal-lipidi; huwa jżid l-aċidi grassi tal-plasma u l-kolesteroli tal-lipoproteini b'densità għolja (HLD) u jnaqqas il-kolesterol totali fil-plasma.
English: Headache in adults
Maltese: Dożaġġ f'pazjenti adulti
English: Growth hormone deficiency in adults
Maltese: Defiċjenza ta' l-ormon tat-tkabbir fl-adulti
English: Uncommon: Personality disorder
Maltese: Mhux komuni: Disturbi fil-personalità
English: The recommended starting dose is 0.15 - 0.30 mg/day, given as a subcutaneous injection.
Maltese: Id-doża inizjali rakkomandata hija 0.15 - 0.30 mg/kuljum, mogħtija bħala injezzjoni taħt ġilda.
English: A double-blind, randomised, single dose, crossover study in 24 healthy volunteers showed that the pharmacokinetic profile of Valtropin was comparable to that of the reference medicinal product.
Maltese: Studju tat-tip cross-over ta' doża waħda, double blind, fejn 24 voluntiera b'saħħithom ntgħażlu b'mod każwali wera li l-profil farmakokinetiku ta' Valtropin kien komparabbli ma' dak tal-prodott mediċinali ta' referenza.
English: - Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis.
Maltese: - Kura ta' l-istatura qasira fi tfal bis-sindrome ta' Turner, ikkonfermata b'analiżi tal-kromosomi.
English: After reconstitution with 1.5 ml solvent, 1 ml contains: somatropin* 3.33 mg (corresponding to 10 IU) * produced in Saccharomyces cerevisiae cells by recombinant DNA technology.
Maltese: Wara rikostituzzjoni b'1.5 ml solvent, 1 ml ikun fih: somatropin* 3.33 mg (li jikkorrispondu għal 10 IU) * magħmul f'ċelloli Saccharomyces cerevisiae permezz ta' teknoloġija tad-DNA rikombinanti.
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists; ATC code: H01AC01
Maltese: Ormoni u analogi pitwitarji u ipotalamiċi, somatropin u agonisti ta' somatropin; Kodiċi ATC:
English: 1 vial of powder contains 5 mg (15 IU) somatropin (3.33 mg/ml somatropin after reconstitution with 1.5 ml solvent).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett 1 ta' trab fih 5 mg (15 IU) somatropin (3.33 mg/ml somatropin wara rikostituzzjoni b'1.5 ml solvent).
English: Somatropin may induce insulin resistance.
Maltese: Somatropin jista' jikkawża reżistenza għall-insulina.
English: After reconstitution with the solvent provided, Valtropin has a pH of approximately 7.5 and an osmolality of approximately 320 mOsm/kg.
Maltese: Wara li jiġi rikostitwit bis-solvent ipprovdut Valtropin ikollu pH ta' madwar 7.5 u osmolalità ta' madwar 320 mOsm/kg.
English: The clearance of compounds metabolised by cytochrome P 450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be especially increased resulting in lower plasma levels of these compounds.
Maltese: It-tneħħija ta' komposti metabolizzati miċ-ċitokromu P450 3A4 (pereżempju sterojdi tas-sess, kortikosterojdi, antikonvulsivi u cyclosporine) tista' tiżdied b'mod partikolari li jwassal għal livelli aktar baxxi ta' dawn il-komposti fil-plażma.
English: The minimum effective dose should be used.
Maltese: Għandha tintuża d-doża minima effettiva.
English: Dizziness (vertigo)
Maltese: Sturdament (mejt)
English: Tumour control
Maltese: Kontroll tat-tumuri
English: - The other ingredients are glycine, mannitol, sodium phosphate monobasic, sodium phosphate dibasic and for pH (acidity) adjustment sodium hydroxide and hydrochloric acid.
Maltese: - Is-sustanzi l-oħra huma glycine, mannitol, sodium phosphate monobasic, sodium phosphate dibasic u għall-aġġustament tal-pH (aċidità) sodium hydroxide u hydrochloric acid.
English: Common: Glucose tolerance impaired Common: Mild hyperglycaemia (1% in children;
Maltese: Indeboliment fit-tolleranza għal glucose Komuni: Ipergliċemija ħafifa (1% fit-tfal; 1% - 10% f'persuni adulti)
English: Very rare
Maltese: Rari:
English: After reconstitution with the solvent provided, chemical and physical in-use stability has been demonstrated for 21 days at 2°C - 8°C (refrigerator).
Maltese: Wara rikostituzzjoni bis-solvent ipprovdut, stabbiltà kimika u fiżika waqt li jkun qed jintuża ntweriet għal 21 ġurnata f'temperatura ta' 2°C - 8°C (friġġ).
English: Adult patients - Replacement therapy in adults with pronounced growth hormone deficiency of either childhood or adult-onset aetiology.
Maltese: Pazjenti adulti - Terapija ta' sostituzzjoni f'persuni adulti b'defiċjenza evidenti ta' l-ormon tat-tkabbir li bdiet fit-tfulija jew f'età adulta.
English: • sterile injection syringe and needles
Maltese: • siringa għall-injezzjoni u labar sterilizzati
English: After reconstitution with 1.5 ml solvent, 1 ml contains 3.33 mg somatropin (corresponding to 10 IU).
Maltese: Wara rikostituzzjoni b'1.5 ml solvent, 1 ml ikun fih 3.33 mg somatropin (li jikkorrispondi għal 10 IU).
English: Underactive thyroid gland (hypothyroidism) Impaired ability to reduce sugar levels (glucose tolerance) Mild increase of blood sugar levels (mild hyperglycaemia) (1% in children; 1% - 10% in adults) Abnormal increase of muscle tone (hypertonia) Sleeplessness (insomnia) in adults Increased blood pressure (hypertension) in adults Shortness of breath (dyspnoea) in adults Temporary interruption of breathing during sleep (sleep apnoea) in adults
Maltese: Żieda ħafifa tal-livelli ta' zokkor fid-demm (ipergliċemija ħafifa) (1% fit-tfal; 1% - 10% f'persuni adulti) Żieda mhux normali ta' sodizza tal-muskoli (ipertonija)
English: For further information on reconstitution and administration see section 6.6.
Maltese: Għal aktar informazzjoni dwar ir-rikostituzzjoni u kif jingħata ara sezzjoni 6.6.
English: 1 pre-filled syringe of 1.5 ml solvent.
Maltese: Siringa 1 mimlija għal-lest b'1.5 ml ta' solvent.
English: One vial of powder contains 5 mg somatropin (corresponding to 15 IU).
Maltese: Kunjett wieħed tat-trab fih 5 mg somatropin (li jikkorrispondi għal 15 IU).
English: Solvent: metacresol (see leaflet for further information) and water for injections.
Maltese: Solvent: metacresol (ara l-fuljett għal aktar informazzjoni) u ilma għall-injezzjonijiet.
English: Common: Insomnia in adults Common: Carpal tunnel syndrome in adults Uncommon: Carpal tunnel syndrome in children Uncommon: Nystagmus
Maltese: Mhux komuni: Sindrome tal-carpal tunnel fit-tfal Mhux komuni: Nystagmus
English: Ensure the solution is at room temperature.
Maltese: Kun żgur li s-soluzzjoni hija f'temperatura tal-kamra.
English: Paediatric population - Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone.
Maltese: Popolazzjoni pedjatrika - Kura fuq perijodu fit-tul ta' tfal (minn sentejn sa 11-il sena) u adolexxenti (minn 12 sa 18-il sena) b'nuqqas ta' tkabbir minħabba tnixxija inadegwata ta' l-ormon endoġenu normali tat tkabbir.
English: The safety profile of Valtropin observed in these clinical studies was consistent with that reported with the reference medicinal product used in these studies and other somatropin containing medicinal products.
Maltese: Il-profil tas-sigurtà ta' Valtropin osservat f'dawn l-istudji kliniċi kien konsistenti ma' dak irrapportat bil-prodott mediċinali ta' referenza użat f'dawn l-istudji kliniċi u prodotti mediċinali oħra li fihom somatropin.
English: Intracranial hypertension
Maltese: Injezzjoni tas-soluzzjoni
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilMediċini http://www.ema.europa.eu/
English: Powder: glycine, mannitol, sodium phosphate monobasic, sodium phosphate dibasic.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Trab: glycine, mannitol, sodium phosphate monobasic, sodium phosphate dibasic. aġġustament tal-pH: sodium hydroxide u hydrochloric acid.
English: 5 mg of powder in a vial (Type I glass) closed with a stopper (butyl rubber) and a flip-off cap (aluminium plastic).
Maltese: 5 mg ta' trab f'kunjett (ħġieġ tat-Tip I) magħluq b'tapp (gomma tal-butyl) u għatu li jinfetaħ b'daqqa ta' saba' (aluminju u plastik).
English: Very common: Oedema, peripheral oedema in adults Common: Oedema, peripheral oedema in children Common: Injection site reactions, asthenia Uncommon: Injection site atrophy, injection site haemorrhage, injection site mass, hypertrophy, weakness in children
Maltese: Komuni ħafna: Edema, edema periferali f'persuni adulti Komuni: Edema, edema periferali fit-tfal Komuni: Reazzjonijiet fis-sit tal-injezzjoni, astenja Mhux komuni: Atrofija fis-sit tal-injezzjoni, emorraġija fis-sit tal-injezzjoni, massa fis-sit tal-injezzjoni, ipertrofija, dgħufija fit-tfal
English: In contrast to bacteria (E. coli), yeast has not been described to elicit adjuvant effects modifying the immunological response.
Maltese: B'kuntrast mal-batterji (E. coli), il-ħmira ma ġietx deskritta li tislet effetti oħra li jimmodifikaw ir-reazzjoni immunoloġika.
English: Inject 0.15 - 0.30 milligrams (mg) once daily under the skin (subcutaneously).
Maltese: Injetta 0.15 - 0.30 milligramma (mg) darba kuljum taħt il-ġilda (b'mod subkutanju).
English: From reproductive toxicity studies performed with other somatropin medicinal products there is no evidence of an increased risk of adverse reactions for the embryo or foetus.
Maltese: Minn studji dwar it-tossiċità riproduttiva li saru bi prodotti mediċinali oħra ta' somatropin, m'hemmx evidenza ta' riskju akbar ta' reazzjonijiet avversi għall-embriju jew il-fetu.
English: Patients with endocrine disorders, including growth hormone deficiency, may develop slipped capital epiphyses more frequently.
Maltese: Pazjenti b'mard endokrinali, fosthom defiċjenza ta' l-ormon tat-tkabbir, jistgħu jiżviluppaw epiphyses kapitali mqabbża aktar ta' spiss.
English: The generation of such antibodies with low binding capacity is unlikely to be clinically relevant.
Maltese: Il-produzzjoni ta' antikorpi bħal dawn b'kapaċità ta' rbit baxxa mhix probabbli li tkun klinikament rilevanti.
English: Insert the needle into the pinched skin at a 45° to 90° angle with a quick, firm motion.
Maltese: Daħħal il-labra fil-ġilda maqrusa f'angolu ta' 45° sa 90° b'moviment veloċi u sod.
English: Valtropin 5 mg/1.5 ml powder and solvent for solution for injection Somatropin
Maltese: Valtropin 5 mg/1.5 ml trab u solvent għal soluzzjoni għall-injezzjoni Somatropin
English: The dosage of somatropin should be decreased in cases of persistent oedema or severe paresthesia, in order to avoid the development of carpal tunnel syndrome.
Maltese: Id-dożaġġ ta' somatropin għandu jitnaqqas f'każijiet ta' edima persistenti jew parasteżija severa, sabiex jiġi evitat l-iżvilupp tas-sindrome tal-carpal tunnel.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER BioPartners GmbH, Kaiserpassage 11, D-72764 Reutlingen, Germany
Maltese: BioPartners GmbH, Kaiserpassage 11, D-72764
English: There were no relevant differences between Valtropin and the reference medicinal product with regard to height velocity and height velocity SDS.
Maltese: Ma kienx hemm differenzi rilevanti bejn Valtropin u l-prodott mediċinali ta' referenza fir-rigward tal-veloċità tat-tul u l-SDS talveloċità tat-tul.
English: In patients with hypopituitarism, standard replacement therapy must be closely monitored when somatropin therapy is administered.
Maltese: F'pazjenti li jkollhom ipopitwitariżmu, it-terapija standard ta' sostituzzjoni trid tiġi mmonitorjata mill-qrib meta tingħata terapija b'somatropin.
English: Fertility No data on fertility are available.
Maltese: L-ebda dejta mhi disponibbli dwar il-fertilità.
English: Experience of prolonged treatment (over 5 years) with somatropin in adults is limited.
Maltese: L-esperjenza ta' kura fit-tul (iktar minn 5 snin) b'somatropin f'persuni adulti hi limitata.
English: Inject 0.045 - 0.050 milligrams (mg) for each kilogramme of body weight once daily under the skin (subcutaneously).
Maltese: Injetta 0.045 - 0.050 milligramma (mg) għal kull kilogramma ta' piż tal-ġisem darba kuljum taħt il-ġilda (b'mod subkutanju).
English: Inject 0.025 - 0.035 milligrams (mg) for each kilogramme of body weight once daily under the skin (subcutaneously).
Maltese: Injetta 0.025 - 0.035 milligramma (mg) għal kull kilogramma ta' piż tal-ġisem darba kuljum taħt il-ġilda (b'mod subkutanju).
English: In this leaflet:
Maltese: Rari ħafna:
English: Uncommon: Urinary incontinence, haematuria, polyuria, urine frequency/pollakiuria, urine abnormality Reproductive system and breast disorders Uncommon: Genital discharge Uncommon: Gynaecomastia in adults
Maltese: Mhux komuni: Inkontinenza fl-awrina, ematurja, tagħmel ammont eċċessiv ta' awrina, frekwenza flawrina/pollakijurija, anormalità fl-awrina
English: In adult patients with adult-onset growth hormone deficiency, oedema, muscle pain, joint pain and disorders were reported early in therapy and tended to be transient.
Maltese: F'pazjenti adulti b'defiċjenza ta' l-ormon tat-tkabbir li bdiet f'età adulta, edima, uġigħ fil-muskoli, uġigħ u mard tal-ġogi kienu rrapportati kmieni fit-terapija u kellhom tendenza li jkunu temporanji.
English: Valtropin should not be reconstituted with the supplied solvent for patients with a known sensitivity to metacresol (see section 4.3).
Maltese: Valtropin m'għandux jiġi rikostitwit bis-solvent ipprovdut fil-każ ta' pazjenti b'sensittività magħrufa għal metacresol (ara sezzjoni 4.3).
English: HOW TO STORE Valtropin
Maltese: QABEL MA TUŻA Valtropin
English: Joint pain (arthralgia) in children Muscle pain (myalgia)
Maltese: Uġigħ fil-ġogi (artralġja) fit-tfal Uġigħ fil-muskoli (mijalġja)
English: One pack contains: - 5 mg of white to almost white powder in a glass vial closed with a rubber stopper and a cap - 1.5 ml of solvent in a pre-filled syringe closed with a tip cap, for reconstitution as a clear solution.
Maltese: Pakkett wieħed ikun fih: - 5 mg ta' trab abjad sa kważi abjad trab f'kunjett tal-ħġieġ magħluq b'tapp tal-lastku u għatu - 1.5 ml ta' solvent f'siringa mimlija għal-lest magħluqa b'għatu fit-tarf, għar-rikostituzzjoni bħala soluzzjoni ċara.
English: - Patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or patients having acute respiratory failure.
Maltese: - Pazjenti b'mard kritiku akut minħabba kumplikazzjonijiet wara kirurġija miftuħa tal-qalb jew addominali, trawmi aċċidentali multipli, jew pazjenti li jkollhom difett respiratorju akut.
English: Uncommon: Papilloedema, diplopia
Maltese: Mhux komuni: Ipogliċemija, iperfosfatemija
English: Syringe containing your medicine being attached to a new needle 21.
Maltese: Siringa li fiha l-mediċina tiegħek li qegħda titwaħħlilha labra ġdida 21.
English: Rapid uncontrollable movement of the eyes (nystagmus) Swelling of the optic nerve head (papilloedema) Double vision (diplopia)
Maltese: Nefħa tat-tarf tan-nerv ottiku (papilloedema) Tara doppju (diplopja)
English: It is advisable not to exceed the recommended dosage in view of the potential risks of acromegaly, hyperglycaemia, and glucosuria.
Maltese: Huwa rakkomandabbli li ma jinqabiżx id-dożaġġ rakkomandat minħabba r-riskji potenzjali ta' akromegalija, ipergliċemija, u glukosurja.
English: Children with Turner syndrome
Maltese: Tfal bis-sindrome ta' Turner
English: Currently available data on renal insufficiency are described in section 4.4, but no recommendation on a posology can be made.
Maltese: Dejta disponibbli dwar insuffiċjenza tal-kliewi hi deskritta f'sezzjoni 4.4, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: Children before puberty, who suffer from long-term kidney problems Inject 0.045 - 0.050 milligrams (mg) for each kilogramme of body weight once daily under the skin (subcutaneously).
Maltese: Tfal qabel il-pubertà, li jbatu minn problemi tal-kliewi fit-tul Injetta 0.045 - 0.050 milligramma (mg) għal kull kilogramma ta' piż tal-ġisem darba kuljum taħt il-ġilda (b'mod subkutanju).
English: - Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency.
Maltese: - Kura ta' dewmien fit-tkabbir fi tfal ta' qabel il-pubertà li jkollhom insuffiċjenza renali kronika.
English: Not known: Insulin resistance
Maltese: Reżistenza għall-insulina
English: The side effects of medicines are classified as follows: very common affects more than 1 user in 10 common affects 1 to 10 users in 100 uncommon affects 1 to 10 users in 1,000 rare very rare not known
Maltese: L-effetti sekondarji tal-mediċini huma kklassifikati kif ġej: komuni ħafna jaffettwaw iktar minn utent 1 minn kull 10 komuni jaffettwaw minn 1 sa 10 utenti minn kull 100 mhux komuni jaffettwaw minn 1 sa 10 utenti minn kull 1,000 rari jaffettwaw minn 1 sa 10 utenti minn kull 10,000
English: Abnormal results in kidney function tests
Maltese: Riżultati mhux normali tat-testijiet tal-funzjoni fil-kliewi
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.5 ml (water for injections with metacresol)
Maltese: INDIVIDWALI 1.5 ml (ilma għall-injezzjonijiet b'metacresol)
English: Uncommon: Vomiting, abdominal pain, flatulence, nausea Rare: Diarrhoea
Maltese: Mhux komuni: Rimettar, uġigħ addominali, gass, nawseja Rari:
English: Valtropin is used - to treat children (2 to 11 years old) and teenagers (12 to 18 years old) who do not develop to their normal height because of poor bone growth caused by growth hormone deficiency (relative lack of growth hormone), Turner syndrome, or ‘chronic renal insufficiency' (a condition in which the kidneys gradually lose their ability to perform their normal functions, such as the removal of wastes and extra fluid from the body).
Maltese: Valtropin jintuża - sabiex jiġu kkurati tfal (minn sentejn sa 11-il sena) u adolexxenti (minn 12 sa 18-il sena) li ma jiżviluppawx għat-tul normali tagħhom minħabba kobor inadegwat ta' l-għadam ikkawżat minn defiċjenza ta' l-ormon tat-tkabbir (nuqqas relattiv ta' ormon għat-tkabbir), is-sindrome ta' Turner, jew ‘insuffiċjenza renali kronika' (kondizzjoni li fiha l-kliewi gradwalment jitilfu l-kapaċità tagħhom li jwettqu l-funzjonijiet normali tagħhom, bħat-tneħħija ta' ħmieġ u fluwidi żejda mill-ġisem). - sabiex jiġu kkurati adulti b'defiċjenza severa ta' l-ormon tat-tkabbir li diġà kellhom defiċjenza ta' l-ormon tat-tkabbir meta kienu tfal jew li ma jkollhomx biżżejjed ormon tat-tkabbir waqt li huma adulti għal xi raġuni oħra.
English: For handling the vial see ‘Injecting the solution', step 32.
Maltese: Biex tieħu ħsieb il-kunjett ara ‘Injezzjoni tas-soluzzjoni', numru 32.
English: Do not use this solvent if you are allergic to metacresol (see section 2, ‘Do not use Valtropin').
Maltese: Tużax dan is-solvent jekk int allerġiku għal metacresol (ara sezzjoni 2, ‘Tużax Valtropin').
English: Uncommon: Anaemia
Maltese: Mhux komuni: Anemija Disturbi fis-sistema immuni
English: There is no evidence to suspect that growth hormone replacement influences the recurrence rate or regrowth of intracranial neoplasms, but standard clinical practice requires regular pituitary imaging in patients with a history of pituitary pathology.
Maltese: M'hemmx evidenza biex wieħed jissuspetta li s-sostituzzjoni ta' l-ormon tat-tkabbir tinfluwenza r-rata ta' rikorrenza jew l-iżvilupp mill-ġdid ta' neoplażmi ġol-kranju, iżda prattika klinika standard titlob immaġni pitwitarja regolari f'pazjenti bi storja ta' patoloġija pitwitarja.
English: Common: Dyspnoea in adults Common: Sleep apnoea in adults
Maltese: Komuni: Pressjoni għolja f'persuni adulti
English: Involuntary loss of urine (urinary incontinence), blood in the urine (haematuria), passing more urine than normal (polyuria, pollakiuria), abnormal urine Genital discharge
Maltese: Telf involontarju ta' awrina (inkontinenza urinarja), demm fl-awrina (ematurja), tagħmel iktar awrina min-normal, (poliurija, pollakijurija), awrina mhux normali Tnixxija mill-partijiet ġenitali Tkabbir tal-glandola tas-sider fl-irġiel (ġinekomastija) f'persuni adulti
English: Uncommon: Muscle atrophy, bone pain
Maltese: Mhux komuni: Atrofija fil-muskoli, uġigħ fl-għadam
English: Additionally, it promotes cellular protein synthesis and nitrogen retention.
Maltese: Barra minn hekk, huwa jippromwovi s-sintesi ċellulari tal-proteini u ż-żamma ta' nitrogen.
English: Rare: Renal function test abnormal
Maltese: Test tal-funzjoni tal-kliewi b'riżultat mhux normali
English: Single case of acute allergic reaction involving itching and swelling similar to insect stings and itching Severe reduction of insulin effects (insulin resistance)
Maltese: Każijiet waħidhom ta' reazzjoni allerġika akuta li tinvolvi ħakk u nefħa simili għal tingiż tal-insetti u ħakk Tnaqqis sever tal-effetti tal-insulina (reżistenza għallinsulina)
English: The biological effects of somatropin are equivalent to those of human growth hormone of pituitary origin.
Maltese: L-effetti bijoloġiċi ta' somatropin huma ekwivalenti għal dawk ta' l-ormon tat-tkabbir uman ta' oriġini pitwitarja.
English: Paediatric population Mild and transient oedema was observed early during the course of treatment with somatropin.
Maltese: Popolazzjoni pedjatrika Kienet osservata edima ħafifa u temporanja kmieni matul il-kors tal-kura b'somatropin.
English: There have been reports of sleep apnoea and sudden death after initiating growth hormone therapy in 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 għal għarrieda wara l-bidu tat-terapija bl-ormon tat-tkabbir f'pazjenti bis-sindrome ta' Prader-Willi, li kellhom wieħed jew iktar mill-fatturi ta' riskju li ġejjin: obesita' severa, storja medika ta' ostruzzjoni fin-naħa ta' fuq tal-pajp tan-nifs jew apnea waqt l-irqad, jew infezzjoni respiratorja mhux identifikata.
English: In cases of severe or recurrent headache, visual problems, nausea, and/or vomiting, a fundoscopy for papilloedema is recommended.
Maltese: F'każijiet ta' uġigħ ta' ras qawwi jew rikorrenti, problemi viżwali, nawsja, u/jew rimettar, hija rakkomandata fundoskopija għal papilloedima.
English: Musculoskeletal and connective tissue disorders
Maltese: Injezzjoni aċċidentali ġol-muskoli