qanastek/EMEA-V3 huggingface dataset:
PRE-FILLED SYRINGE OF SOLVENT
SIRINGA MIMLIJA GĦAL- LEST BIS- SOLVENT
Valtropin 5 mg/ 1.5 ml Solvent for solution for injection
Valtropin 5 mg/ 1. 5 ml Solvent għal soluzzjoni għall- injezzjoni
1.5 ml (water for injections with metacresol)
1. 5 ml (ilma għall- injezzjonijiet b' metacresol)
Contains 4.5 mg metacresol.
Fih 4. 5 mg metacresol.
18 PACKAGE LEAFLET:
20 FULJETT TA 'TAGĦRIF:
What Valtropin is and what it is used for 2.
X’ inhu Valtropin u għalxiex jintuża 2.
Before you use Valtropin 3.
Qabel ma tuża Valtropin 3.
How to use Valtropin 4.
Kif għandek tuża Valtropin 4.
How to store Valtropin 6.
Kif taħżen Valtropin 6.
WHAT Valtropin IS AND WHAT IT IS USED FOR
X’ INHU Valtropin U GĦALXIEX JINTUŻA
Your medicine is called Valtropin.
Il- mediċina tiegħek jisimha Valtropin.
It is a brand of human growth hormone, also called somatropin.
Dan huwa tip ta 'ormon tat- tkabbir uman, imsejjaħ ukoll somatropin.
Valtropin is made in the laboratory by a special process known as a ‘ recombinant DNA technology’ process in yeast cells (Saccharomyces cerevisiae).
Valtropin huwa magħmul fil- laboratorju bi proċess speċjali magħruf bħala proċess ta '‘ teknoloġija ta' DNA rikombinanti ’ f' ċelloli tal- ħmira (Saccharomyces cerevisiae).
It has the same structure as the growth hormone that the body produces in the pituitary glands.
Huwa għandu l- istess struttura bħall- ormon tat- tkabbir li l- ġisem jipproduċi fil- glandoli pitwitarji.
Growth hormone regulates the growth and development of cells.
L- ormon tat- tkabbir jirregola t- tkabbir u l- iżvilupp taċ- ċelloli.
When it stimulates growth of cells in the long bones of the legs and spine, it causes an increase in height.
Meta jistimula tkabbir taċ- ċelloli fl- għadmiet twal tas- saqajn u s- sinsla, huwa jikkawża żieda fit- tul.
Valtropin is used
Valtropin jintuża
- to treat children who do not develop to their normal height because of poor bone growth caused
- sabiex jiġu kkurati tfal li ma jiżviluppawx għat- tul normali tagħhom minħabba kobor inadegwat
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).
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).
- to treat adults with severe growth hormone deficiency who already had growth hormone
- sabiex jiġu kkurati adulti b' defiċjenza severa ta 'l- ormon tat- tkabbir li diġà kellhom defiċjenza ta'
deficiency when they were children or who do not have enough growth hormone during their adult years for some other reason.
l- ormon tat- tkabbir meta kienu tfal jew li ma jkollhomx biżżejjed ormon tat- tkabbir waqt li huma adulti għal xi raġuni oħra.
In this leaflet the patient is addressed as ‘ you’.
F' dan il- fuljett il- pazjent huwa indirizzat bħala ‘ int ’.
Caregivers administering Valtropin to their children should consider that ‘ you’ refers to the child.
Il- persuni li jagħtu Valtropin lit- tfal tagħhom għandhom iqisu li ‘ int ’ tirreferi għat- tifel/ tifla.
BEFORE YOU USE Valtropin
QABEL MA TUŻA Valtropin
⊗ Do not use Valtropin:
⊗ Tużax Valtropin:
- if you are allergic (hypersensitive) to somatropin or any of the other ingredients of the
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal somatropin jew xi sustanza oħra
powder or solvent of Valtropin, e. g. metacresol (see section 2, ‘ Take special care with Valtropin – Occurrence of certain side effects’)
tat- trab jew solvent ta 'Valtropin, ngħidu aħna metacresol (ara sezzjoni 2, ‘ Oqgħod attent ħafna b' Valtropin – Okkorrenza ta' ċerti effetti sekondarji ’)
- to promote growth if you have already stopped growing
- biex jippromwovi t- tkabbir jekk diġà tkun waqaft tikber
- if you have had a serious heart or abdominal operation
- jekk għamilt operazzjoni serja tal- qalb jew addominali
- if you are being treated for more than one injury following a serious accident
- jekk qed tiġi kkurat għal aktar minn ferita waħda wara aċċident serju
- if you have sudden serious breathing problems
21
19
- jekk għandek problemi serji għall- għarrieda tan- nifs
- if you have an active brain tumour or any other tumour (cancer), since growth hormone will
- jekk għandek tumur attiv f' moħħok jew xi tumur ieħor (kanċer), billi l- ormon tat- tkabbir
make it worse.
jagħmlu agħar.
Tumours must be inactive and anti-tumour therapy complete before growth hormone can be prescribed.
It- tumuri jridu jkunu inattivi u t- terapija kontra t- tumuri mitmuma qabel ma jkun jista 'jiġi ordnat l- ormon tat- tkabbir.
If there is evidence of tumour growth, treatment with Valtropin should be discontinued.
Jekk ikun hemm evidenza ta 'tkabbir ta' tumur, il- kura b' Valtropin m' għandhiex tissokta.
/!\ Take special care with Valtropin Examinations before starting treatment:
/!\ Oqgħod attent ħafna b' Valtropin Testijiet qabel tibda l- kura
- A specialist doctor trained in hormone disorders must examine you to decide if it is safe to use
- Tabib speċjalista mħarreġ fil- mard ta 'l- ormoni jrid jeżaminak biex jiddeċiedi jekk hux bla
Valtropin.
periklu li tuża Valtropin.
- If adults have been treated with growth hormone during childhood, they should be re-evaluated
- Jekk persuni adulti jkunu ġew ikkurati bl- ormon tat- tkabbir fit- tfulija, dawn għandhom jiġu
for growth hormone deficiency before starting any further treatment with growth hormones.
evalwati mill- ġdid għad- defiċjenza ta 'l- ormon tat- tkabbir qabel ma tinbeda xi kura oħra bl- ormoni tat- tkabbir.
- Patients with Prader-Willi syndrome should not be treated with Valtropin unless they are also
- Pazjenti bis- sindrome ta ’ Prader- Willi m’ għandhomx ikunu kkurati b’ Valtropin ħlief jekk ikunu
suffering from growth hormone failure.
qed ibatu wkoll minn insuffiċjenza ta ’ l- ormon tat- tkabbir.
During or after serious illness:
Waqt u wara marda serja:
- If you have had a brain tumour, you should be re-examined frequently to make sure that the
- Jekk kellek tumur f' moħħok, inti għandek tiġi eżaminat mill- ġdid ta 'spiss biex jiġi żgurat li t -
tumour has not come back.
tumur ma reġax tfaċċa.
- If children have had a kidney transplant, growth hormone treatment will be stopped.
- Jekk it- tfal ikunu għamlu trapjant tal- kliewi, il- kura bl- ormon tat- tkabbir tiġi mwaqqfa.
- If the child has Turner syndrome, the child’ s doctor should carefully check for ear infections
- Jekk it- tifel/ tifla jkollhom is- sindrome ta 'Turner, it- tabib tat- tifel/ tifla għandu jiċċekkja sewwa
such as otitis media, because Turner syndrome patients have an increased risk of ear or other hearing disorders.
għal infezzjonijiet tal- widnejn bħal otite tal- parti tan- nofs tal- widna, billi l- pazjenti bis- sindrome ta 'Turner għandhom riskju akbar ta' mard tal- widnejn u mard ieħor tas- smigħ.
Occurrence of certain side effects:
Okkorrenza ta 'ċerti effetti sekondarji:
- If symptoms like headache (severe and recurrent), visual changes, nausea and/ or vomiting
- Jekk jitfaċċaw sintomi bħal uġigħ ta 'ras (qawwi u rikorrenti), bidliet fil- vista, nawsja u/ jew
occur, please ask your doctor for advice.
rimettar, jekk jogħġbok staqsi lit- tabib tiegħek għal parir.
- If you have injected Valtropin by mistake into the muscle instead of under the skin, your blood
- Jekk bi żball injettajt Valtropin fil- muskolu minflok taħt il- ġilda, iz- zokkor fid- demm tiegħek
sugar may become too low (hypoglycaemia).
jista 'jitbaxxa żżejjed (ipogliċemija).
- If the child begins to limp under treatment with Valtropin, please ask your doctor for advice.
- Jekk it- tifel/ tifla jibdew izappu meta jkunu taħt kura b' Valtropin, jekk jogħġbok staqsi lit- tabib
- Too much growth hormone can cause greater than normal growth of ears, nose, lips, tongue and
- Ħafna ormon tat- tkabbir jista 'jikkawża tkabbir akbar min- normal tal- widnejn, l- imnieħer,
cheekbone (acromegaly), high blood sugar (hyperglycaemia) and presence of sugar in the urine (glucosuria).
ix- xufftejn, l- ilsien u l- għadma tal- ħaddejn (akromegalija), livell għoli ta 'zokkor fid- demm (ipergliċemija) u preżenza ta' zokkor fl- awrina (glukosurja).
Always use Valtropin as recommended by your doctor.
Dejjem uża Valtropin kif rakkomandat mit- tabib tiegħek.
- If sensitivity to solvent occurs, the vials should be reconstituted with water for injections
- Jekk ikun hemm sensittività għas- solvent, il- kunjetti għandhom jiġu rikostitwiti b' ilma
without preservative and used as a single use vial (see section 5 ‘ How to store Valtropin’).
għall- injezzjonijiet mingħajr preservattiv u jintużaw bħala kunjett ta 'użu ta' darba (ara sezzjoni 5 ‘ Kif taħżen Valtropin ’).
Do not use the supplied solvent if you have a known sensitivity to metacresol preservative.
Tużax is- solvent ipprovdut jekk għandek sensittività magħrufa għal preservattiv ta 'metacresol.
Monitoring during treatment by your doctor:
Sorveljanza mit- tabib tiegħek waqt il- kura
Your doctor may
- Valtropin jista 'jaffettwa l- mod kif il- ġisem tiegħek jipproċessa z- zokkor mill- ikel u x- xorb.
check the amount of sugar in your urine or blood.
It- tabib tiegħek jista 'jiċċekkja l- ammont taz- zokkor fl- awrina jew id- demm tiegħek.
- Valtropin can affect the amount of thyroid hormone in the blood, so you must have thyroid
- Valtropin jista 'jaffettwa l- ammont ta' ormon tat- tirojde fid- demm, għalhekk trid tagħmel
function tests from time to time.
testijiet tal- funzjoni tat- tirojde minn żmien għall- ieħor.
If the thyroid is not working properly, Valtropin may not work as well as it should.
Jekk it- tirojde ma tkunx qed taħdem sewwa, Valtropin jista 'ma jaħdimx tajjeb kemm suppost.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines:
22 Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi waħda mill - mediċini li ġejjin:
- adrenal steroid hormone such as cortisone or prednisolone
- ormon ta 'l- isterojd adrenali bħal cortisone jew prednisolone
- oral oestrogen
- estroġenu orali
- other prescription medicines (e. g. sex steroids, corticosteroids, anticonvulsants or cyclosporine),
- mediċini oħra bir- riċetta (ngħidu aħna sterojdi tas- sess, kortikosterojdi, antikonvulsivi jew
or non-prescription medicines.
cyclosporine), jew mediċini li jinxtraw mingħajr riċetta.
Your doctor may need to adjust the dose of Valtropin or of the other medicine.
It- tabib tiegħek jista 'jkollu bżonn jaġġusta d- doża ta' Valtropin jew tal- mediċina l- oħra.
20 Pregnancy Valtropin should not be used during pregnancy unless clearly necessary.
Tqala Valtropin m' għandux jintuża waqt it- tqala sakemm ma jkunx meħtieġ b' mod evidenti.
If you become pregnant, tell your doctor immediately.
Avża lit- tabib tiegħek minnufih jekk tinqabad tqila.
Breast-feeding If you are breast-feeding or intend to breast-feed, please ask your doctor for advice before using Valtropin.
Treddigħ Jekk qiegħda tredda 'jew għandek f' moħħok li tredda', jekk jogħġbok staqsi lit- tabib tiegħek qabel ma tuża Valtropin.
Driving and using machines Valtropin has no or negligible effect on the ability to drive and use machines.
Sewqan u tħaddim ta 'magni Valtropin m' għandu l- ebda jew effett żgħir fuq il- ħila ta' sewqan u l- użu ta 'magni.
Important information about some of the ingredients of Valtropin The accompanying solvent of Valtropin contains metacresol.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'Valtropin Is- solvent li jakkumpanja Valtropin fih - metacresol.
Do not use this solvent if you are allergic (hypersensitive) to metacresol (see section 2, ‘ Do not use Valtropin’).
Tużax dan is- solvent jekk int allerġiku (tbati minn sensittività eċċessiva) għal metacresol (ara sezzjoni 2, ‘ Tużax Valtropin ’).
If sensitivity to the solvent occurs, the vials should be reconstituted with water for injections and used as a single use vial (see section 5 ‘ How to store Valtropin’).
Jekk ikun hemm sensittività għas- solvent, il- kunjetti għandhom jiġu rikostitwiti b' ilma għall- injezzjonijiet u jintużaw bħala kunjett b' użu ta 'darba (ara sezzjoni 5 ‘ Kif taħżen Valtropin ’).
HOW TO USE Valtropin
KIF GĦANDEK TUŻA Valtropin
Always use Valtropin exactly as your doctor has told you.
Dejjem għandek tuża Valtropin skond il- parir tat- tabib.
Do not inject Valtropin yourself if you are not sure about the dose.
Tinjettax Valtropin inti stess jekk ma tkunx ċert/ a dwar id- doża.
Dosage Your doctor will tell you how much to use.
Dożaġġ It- tabib tiegħek jgħidlek kemm tuża.
This will vary according to your disease.
Dan ivarja skond il- marda tiegħek.
Please do not change the dosage without consulting your doctor.
Jekk jogħġbok tibdilx id- dożaġġ mingħajr ma tikkonsulta mat- tabib tiegħek.
The accuracy of the Valtropin dose should be checked every 6 months by your doctor.
L- eżattezza tad- doża ta 'Valtropin għandha tiġi ċċekkjata mit- tabib tiegħek kull 6 xhur.
In general the dosage will be calculated as described below.
Ġeneralment id- dożaġġ jiġi kkalkulat kif deskritt hawn taħt.
However, individual doses may vary, and the doctor may change your dose based on your specific need.
Madankollu, id- dożi individwali jistgħu jvarjaw, u t- tabib tiegħek jista 'jbiddel id- doża tiegħek fuq bażi tal- bżonn speċifiku tiegħek.
Growth hormone deficiency in children Inject 0.025 - 0.035 milligrams (mg) for each kilogramme of body weight once daily under the skin (subcutaneously).
Defiċjenza ta 'l- ormon tat- tkabbir fit- tfal Injetta 0. 025 - 0. 035 milligramma (mg) għal kull kilogramma ta' piż tal- ġisem darba kuljum taħt il- ġilda (b' mod subkutanju).
Children with Turner syndrome Inject 0.045 - 0.050 milligrams (mg) for each kilogramme of body weight once daily under the skin (subcutaneously).
Tfal bis- sindrome ta 'Turner Injetta 0. 045 - 0. 050 milligramma (mg) għal kull kilogramma ta' piż tal- ġisem darba kuljum taħt il- ġilda (b' mod subkutanju).
Pre-pubertal children with chronic renal insufficiency Inject 0.045 - 0.050 milligrams (mg) for each kilogramme of body weight once daily under the skin (subcutaneously).
23 Tfal ta 'qabel il- pubertà b' insuffiċjenza renali kronika Injetta 0. 045 - 0. 050 milligramma (mg) għal kull kilogramma ta' piż tal- ġisem darba kuljum taħt il- ġilda (b' mod subkutanju).
Growth hormone deficiency in adults Inject 0.15 - 0.30 milligrams (mg) once daily under the skin (subcutaneously).
Defiċjenza ta 'l- ormon tat- tkabbir fl- adulti Injetta 0. 15 - 0. 30 milligramma (mg) darba kuljum taħt il- ġilda (b' mod subkutanju).
A lower starting dose may be necessary if you are older or overweight.
Tista 'tkun meħtieġa doża inizjali aktar baxxa jekk int akbar fl- età jew għandek piż żejjed.
The total daily dose usually does not exceed 1 mg.
Jekk ikun meħtieġ, it- tabib tiegħek għandu jżid b' mod gradwali din id- doża skond il- ħtiġijiet individwali tiegħek imsejsa fuq ir- riżultat kliniku u l- kejl tal- livelli fid- demm tiegħek ta 'hekk imsejjaħ “ fattur tat- tkabbir ” (magħruf bħala IGF- 1).
IGF-1 concentrations need to be
Id- doża totali ta 'kuljum ġeneralment ma taqbiżx 1 mg.
21 regularly measured and should be maintained below the upper limit of the normal range for your age and sex.
Il- konċentrazzjonijiet ta 'IGF- 1 jeħtieġ li jiġu mkejla b' mod regolari u għandhom jinżammu taħt il- limitu ta' fuq tal- medda normali għall- età u s- sess tiegħek.
Your doctor will always prescribe the minimum effective dose to be used.
It- tabib tiegħek dejjem se jiktiblek id- doża effettiva minima li trid tintuża.
Dosage adjustment In elderly patients a dose reduction may be necessary.
Aġġustament tad- dożaġġ Fl- anzjani jista 'jkun meħtieġ tnaqqis fid- doża.
The dosage of somatropin should be reduced in cases of long lasting swelling (oedema) or severe abnormal sensation (paraesthesia), in order to avoid the development of a rare side effect called carpal tunnel syndrome (hand numbness and pain).
Id- dożaġġ ta 'somatropin għandu jitnaqqas f' każijiet ta' nefħa fit- tul (edima) jew sensazzjoni anormali severa (parasteżija), sabiex jiġi evitat l- iżvilupp ta 'effett sekondarju rari msejjaħ is- sindrome tal- carpal tunnel (tirżiħ u wġigħ fl- idejn).
Following use of the medicine for some time, it may be necessary to reduce the dose, particularly in men.
Wara li l- mediċina tkun intużat għal xi żmien, jista 'jkun meħtieġ li d- doża titnaqas, b' mod partikolari fl- irġiel.
When using other medicines the dose of Valtropin or of the other medicine may need to be adjusted (see section 2, ‘ Using other medicines’).
Meta jkunu qegħdin jintużaw mediċini oħra, id- doża ta 'Valtropin jew tal- mediċina l- oħra jista' jkun hemm bżonn li tiġi aġġustata (ara sezzjoni 2, ‘ Meta tieħu mediċini oħra ’).
Administration Valtropin is intended for subcutaneous use after reconstitution.
Kif jingħata Valtropin huwa maħsub għal użu għal taħt il- ġilda wara rikostituzzjoni.
This means that after reconstitution of the powder with the solvent provided the solution is injected with a short needle into the fatty tissue just under the skin.
Dan ifisser li wara rikostituzzjoni tat- trab bis- solvent ipprovdut, is- soluzzjoni tiġi injettata b' labra qasira fit- tessut tax- xaħam eżatt taħt il- ġilda.
If you are injecting this medicine yourself you will be instructed how to prepare and give the injection.
Jekk se tinjetta din il- mediċina inti stess, inti għandek tiġi mgħallem kif tħejji u tagħti l- injezzjoni.
Do not inject Valtropin yourself unless you have received training.
Tinjettax Valtropin inti stess jekk ma tkunx irċevejt taħriġ.
Detailed instructions for subcutaneous administration are provided with this leaflet (see section ‘ Information on how to self-inject Valtropin’ at the end of this leaflet).
Struzzjonijiet dettaljati għal għoti taħt ġilda huma pprovduti ma 'dan il- fuljett (ara s- sezzjoni ‘ Tagħrif dwar kif tinjetta Valtropin inti stess ’ fl- aħħar ta' dan il- fuljett).
If you use more Valtropin than you should In case more Valtropin was used than recommended, please consult your doctor.
Jekk tuża Valtropin aktar milli suppost F' każ li tieħu aktar Valtropin milli rakkomandat, jekk jogħġbok ikkonsulta mat- tabib tiegħek.
If you have used too much Valtropin, initially your blood sugar may decrease and become too low (hypoglycaemia) and subsequently increase and become too high (hyperglycaemia).
Jekk tieħu żżejjed Valtropin, għall- ewwel iz- zokkor fid- demm tiegħek jista 'jonqos u jsir baxx wisq (ipogliċemija) u wara jiżdied u jsir għoli żżejjed (ipergliċemija).
If you have used too much Valtropin over a longer period, this may result in a greater than normal growth of ears, nose, lips, tongue and cheekbone (acromegaly).
Jekk tieħu żżejjed Valtropin għal perijodu itwal, dan jista 'jirriżulta fi tkabbir aktar min- normal tal- widnejn, l- imnieħer, ix- xufftejn, l- ilsien u l- għadma tal- ħaddejn (akromegalija).
If you forget to use Valtropin Do not take a double dose to make up for forgotten doses.
Jekk tinsa tuża Valtropin M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Continue with the prescribed dosage regimen.
Kompli bil- kors ta 'dożaġġ ordnat.
If you have any doubts, please contact your doctor.
Jekk għandek xi dubji, jekk jogħġbok ikkuntattja lit- tabib tiegħek.
If you stop using Valtropin Please ask your doctor for advice before stopping treatment.
24 Jekk tieqaf tuża Valtropin Jekk jogħġbok staqsi lit- tabib tiegħek għal parir qabel twaqqaf il- kura.
Interruption or early stopping of treatment with Valtropin may impair the success of the growth hormone therapy.
L- interruzzjoni jew twaqqif kmieni tal- kura b' Valtropin tista 'ttellef is- suċċess tat- terapija bl- ormon tat- tkabbir.
Like all medicines, Valtropin can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Valtropin jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The side effects of medicines are classified as follows:
L- effetti sekondarji tal- mediċini huma kklassifikati kif ġej:
uncommon rare very rare
komuni ħafna komuni mhux komuni rari rari ħafna
happening in 1 in 1,000 to 1 in 100 patients happening in 1 in 10,000 to 1 in 1,000 patients happening in less than 1 in 10,000 patients, including isolated reports
iseħħu f' aktar minn 1 minn kull 10 pazjenti iseħħu f' 1 minn kull 100 sa 1 minn kull 10 pazjenti iseħħu f' 1 minn kull 1, 000 sa 1 minn kull 100 pazjent iseħħu f' 1 minn kull 10, 000 sa 1 minn kull 1, 000 pazjent iseħħu f' anqas minn 1 minn kull 10, 000 pazjent, inklużi rapporti iżolati.
You may experience any of the following side effects after administration of Valtropin:
Inti tista 'tesperjenza kull wieħed minn dawn l- effetti sekondarji wara li tieħu Valtropin:
General and local effects • Weakness: uncommon • Pain or reaction at the injection site: common • Swelling (local or generalised oedema): common (more common in adults than in children)
Effetti ġenerali u lokali • Indeboliment: mhux komuni • Uġigħ jew reazzjoni fil- post ta 'l- injezzjoni: komuni • Nefħa (edima lokali jew ġeneralizzata): komuni (aktar komuni fl- adulti milli fit- tfal)
Hormone effects • Subnormal activity of the thyroid gland (hypothyroidism): common • Breast enlargement (gynaecomastia): very rare (children); uncommon (adults)
Effetti ormonali • Attività anqas min- normali tal- glandola tat- tirojde (ipotirojdiżmu): komuni • Tkabbir tas- sider (ġinekomastja): rari ħafna (tfal); mhux komuni (adulti)
Insulin resistance means that the normal effect of insulin on muscle, fat, and liver cells is reduced.
Effetti fuq il- metaboliżmu • Żieda ħafifa taz- zokkor fid- demm (ipergliċemija ħafifa): komuni • Reżistenza għall- insulina Reżistenza għall- insulina tfisser li l- effett normali ta 'l- insulina fuq iċ- ċelloli tal- muskoli, tax- xaħam u tal- fwied jonqos.
Nerve effects • Symptoms of benign increased brain pressure (benign intracranial hypertension): rare • Headache: very common (adults) • Insomnia: very rare (children); common (adults) • Abnormal sensation (paraesthesia): rare (children); very common (adults)
Effetti fuq in- nervituri • Sintomi ta 'pressjoni akbar beninnja fuq il- moħħ (pressjoni għolja beninnja ġol- kranju): rari • Uġigħ ta' ras: komuni ħafna (adulti) • Nuqqas ta 'rqad: rari ħafna (tfal); komuni (adulti) • Sensazzjoni anormali (parasteżija): rari (tfal); komuni ħafna (adulti)
Vascular effects • High blood pressure (hypertension): rare (children); common (adults)
Effetti vaskulari • Pressjoni tad- demm għolja (pressjoni għolja): rari (tfal); komuni (adulti)
Joint and muscle effects • Joint pain and disorder (arthralgia): very common (adults) • Localised muscle pain (myalgia): common (adults)
Effetti fuq il- ġogi u l- muskoli • Uġigħ u mard tal- ġogi (artralġja): komuni ħafna (adulti) • Uġigħ lokalizzat fil- muskoli (majalġja): komuni (adulti)
As with all medicines containing growth hormone a small percentage of patients may develop blocking chemicals called antibodies to growth hormone.
Bħal kull mediċina oħra li fiha l- ormon ta ’ tkabbir, perċentwal żgħir ta 'pazjenti jistgħu jiżviluppaw kimiċi ta' imblokk imsejħa antikorpi għall- ormon tat- tkabbir.
In a clinical study with Valtropin 3% of children with growth hormone deficiency developed such antibodies.
Fi studju kliniku b' Valtropin, 3% tat- tfal b' defiċjenza ta 'l- ormon tat- tkabbir żviluppaw antikorpi bħal dawn.
However, these antibodies did not have an effect on the growth response to Valtropin.
Madankollu, dawn l- antikorpi ma kellhomx effett fuq ir- respons tat- tkabbir għal Valtropin.
If you are failing to respond to therapy with Valtropin, your doctor will test for antibodies.
Jekk m' intix tirrispondi għat- terapija b' Valtropin, it- tabib tiegħek għandu jittestja għall- antikorpi.
There was one patient (< 1%) who experienced acute hypersensitivity reactions involving hives (urticaria) and itching (pruritus) after administration of Valtropin.
25 Kien hemm pazjent wieħed (< 1%) li esperjenza reazzjonijiet ta 'sensittività eċċessiva akuta li kienu jinvolvu ħorriqija (urtikarja) u tekil tal- ġilda (ħakk) wara li ngħata Valtropin.
Children Leukaemia has been reported in a small number of children treated with somatropin.
Tfal Kienet irrapportata lewkimja f' numru żgħir ta 'tfal ikkurati b' somatropin.
However, there is no evidence that somatropin causes leukaemia when there are no other risk factors.
Madankollu, m' hemmx evidenza li somatropin jikkawża lewkimja meta ma jkunx hemm fatturi oħra ta 'riskju.
Adults Swelling, muscle pain, joint pain and disorders have been reported early in therapy with somatropin but these effects tended to be transient (short-lived).
Adulti Nefħa, uġigħ fil- muskoli, uġigħ u mard fil- ġogi kienu rrapportati bikri fit- terapija b' somatropin iżda dawn l- effetti kellhom tendenza li jkunu temporanja (ma jdumux).
HOW TO STORE Valtropin
KIF TAĦŻEN Valtropin
• Keep out of the reach and sight of children. • Do not use Valtropin after the expiry date which is stated on the labels and the carton.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Tużax Valtropin wara d- data ta 'skadenza li tidher fuq it- tikketti u l- kaxxa.
The expiry date refers to the last day of that month.
Id- Data ta 'skadenza tirreferi għal l- aħħar ġurnata ta' dak ix- xahar.
Storage conditions of the unopened product: • Store in a refrigerator (2°C - 8°C).
Kondizzjonijiet għall- ħażna tal- prodott mhux miftuħ: • Aħżen fi friġġ (2°C - 8°C).
Do not freeze. • The non-reconstituted product can be kept at room temperature (not above 25°C) for one single period of up to 4 weeks before use.
Tagħmlux fil- friża. • Il- prodott mhux rikostitwit jista 'jinżamm f' temperatura tal- kamra (mhux ogħla minn 25°C) għal perijodu wieħed li ma jaqbiżx l- erba ’ ġimgħat qabel l- użu.
Shelf-life after reconstitution with solvent: • After reconstitution with the solvent provided the product may be stored in the refrigerator (2°C - 8°C) for a maximum of 21 days.
Kemm idum tajjeb il- prodott wara rikostituzzjoni bis- solvent: • Wara rikostituzzjoni bis- solvent ipprovdut, il- prodott jista 'jinżamm fil- friġġ (2°C - 8°C) sa massimu ta' 21 ġurnata.
Shelf-life after reconstitution with water for injections (NOT tap water): • After reconstitution with water for injections the product must be used immediately and as a single use vial.
Kemm idum tajjeb il- prodott wara rikostituzzjoni b' ilma għall- injezzjonijiet (MHUX ilma tal- vit): • Wara rikostituzzjoni b' ilma għall- injezzjonijiet, il- prodott irid jintuża immedjatament u bħala kunjett b' użu ta 'darba biss.
Do not use Valtropin if you notice that the solvent or the reconstituted solution is cloudy or discoloured.
Tużax Valtropin jekk tinnota li s- solvent jew is- soluzzjoni rikostitwita huma mdardra jew lewnhom mitfi.
Medicines should not be disposed of via waste water or household waste.
Il- mediċini m' għandhomx jintremew ma 'l- ilma tad- dranaġġ jew ma' l- iskart domestiku.
Ask your pharmacist how to dispose of medicines that are no longer required.
Staqsi lill- ispiżjar tiegħek dwar kif għandek tarmi mediċini li m' għandekx bżonnhom aktar.
What Valtropin contains
X' fih Valtropin
- The active substance is somatropin.
- Is- sustanza attiva hija somatropin.
One vial of powder contains 5 mg somatropin
Kunjett wieħed tat- trab fih 5 mg somatropin (li jikkorrispondi
(corresponding to 15 IU).
għal 15 IU).
After reconstitution with 1.5 ml solvent, 1 ml contains 3.33 mg somatropin (corresponding to 10 IU).
Wara rikostituzzjoni b' 1. 5 ml solvent, 1 ml ikun fih 3. 33 mg somatropin (li jikkorrispondi għal 10 IU).
- The other ingredients are glycine, mannitol, sodium phosphate monobasic, sodium phosphate
- Is- sustanzi l- oħra huma glycine, mannitol, sodium phosphate monobasic, sodium phosphate
dibasic and for pH adjustment sodium hydroxide and hydrochloric acid.
dibasic u għall- aġġustament tal- pH sodium hydroxide u hydrochloric acid.
- The pre-filled syringe contains water for injections and metacresol (see section 2, ‘ Important
- Is- siringa mimlija għal- lest fiha ilma għall- injezzjonijiet u metacresol (ara sezzjoni 2, ‘ Tagħrif
information about some of the ingredients of Valtropin’).
importanti dwar xi wħud mis- sustanzi ta 'Valtropin ’).
What Valtropin looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett:
Valtropin is presented as a powder and solvent for solution for injection.
Valtropin huwa ppreżentat bħala trab u solvent għal soluzzjoni għall- injezzjoni.
A single pack contains:
Pakkett wieħed fih:
- 1 vial with white to almost white powder
- kunjett bi trab abjad għal kważi abjad
- 1 pre-filled syringe with 1.5 ml of solvent for reconstitution as a clear solution.
- siringa mimlija għal- lest b' 1. 5 ml ta 'solvent għal rikostituzzjoni bħala soluzzjoni ċara.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
BioPartners GmbH Eisenstrasse 3 D-65428 Rüsselsheim Germany Tel: +49 (0) 6142 70 8000 Fax: +49 (0) 6142 70 80 060
BioPartners GmbH Eisenstrasse 3 D- 65428 Rüsselsheim Il- Ġermanja Tel: + 49 (0) 6142 70 8000 Fax: +49 (0) 6142 70 80060
24 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq:
Deutschland BioPartners GmbH Eisenstrasse 3 D-65428 Rüsselsheim Tel: + 49(0) 6142 70 8000
27 Deutschland BioPartners GmbH Eisenstrasse 3 D- 65428 Rüsselsheim Tel: +49 (0) 6142 70 8000
Eesti Nycomed SEFA AS Pirita tee 20T EE-10127 Tallinn Tel: + 372 6112 569
Eesti Nycomed SEFA AS Pirita tee 20T EE- 10127 Tallinn Tel: + 372 6112 569 00
Κύπρος BioPartners GmbH Eisenstrasse 3 D-65428 Rüsselsheim Γερμανία Τηλ: + 49(0) 6142 70 8000
28 Κύπρος BioPartners GmbH Eisenstrasse 3 D- 65428 Rüsselsheim Γερμανία Τηλ: +49 (0) 6142 70 8000
United Kingdom Cambridge Laboratories Deltic House Kingfisher Way Silverlink Business Park Wallsend Tyne & Wear NE28 9NX - UK Tel: +44 (0) 191 296 9369
Renju Unit Cambridge Laboratories Deltic House Kingfisher Way Silverlink Business Park Wallsend Tyne & Wear NE28 9NX - UK Tel: + 44 0 191 296
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu
INFORMATION ON HOW TO SELF-INJECT Valtropin
INFORMAZZJONI DWAR KIF TINJETTA LILEK INNFISEK B' Valtropin
Please read the following instructions carefully before using Valtropin.
Jekk jogħġbok aqra sewwa l- istruzzjonijiet li ġejjin qabel tuża Valtropin.
Introduction The following instructions explain how to inject Valtropin yourself.
Introduzzjoni L- istruzzjonijiet li ġejjin jispjegaw kif tinjetta Valtropin inti nnifsek.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra l- istruzzjonijiet sewwa u segwihom pass pass.
Your doctor or his/ her assistant will instruct you how to self-inject Valtropin.
It- tabib tiegħek jew l- assistant/ a tiegħu ser jgħallmuk kif tinjetta lilek innifsek b' Valtropin..
Do not attempt to inject yourself unless you are sure you understand the procedure and requirements of self-injection.
Tippruvax tinjetta lilek innifsek jekk m' intix żgur li tifhem il- proċedura u l- ħtiġijiet biex tinjetta lilek innifsek.
General notes For patients with a known sensitivity to metacresol, Valtropin should not be reconstituted with the supplied solvent (see section 2, ‘ Do not use Valtropin’).
Noti ġenerali Għal pazjenti b' sensittività magħrufa għall- metacresol, Valtropin m' għandux jiġi rikostitwit bis- solvent ipprovdut (ara sezzjoni 2, 'Tużax Valtropin').
If sensitivity to the accompanying solvent occurs, the vials should be reconstituted with water for injections (see section 5 ‘ How to store Valtropin’).
Jekk ikun hemm sensittività għas- solvent li jakkumpanjah, il- kunjetti għandhom jiġu rikostitwiti b' ilma għall- injezzjonijiet (ara sezzjoni 5 ‘ Kif taħżen Valtropin ’).
Do not use tap water.
Tużax ilma tal- vit.
Collect the necessary items before you begin.
Iġbor l- affarijiet li għandek bżonn qabel tibda.
These are:
Dawn huma:
Supplied in the pack
Ipprovduti fil- pakkett
the Valtropin vial with powder for solution for injection the pre-filled syringe with 1.5 ml solvent for solution for injection
il- kunjett ta 'Valtropin bit- trab għal soluzzjoni għall- injezzjoni is- siringa mimlija għal- lest b' 1. 5 ml solvent għal soluzzjoni għall- injezzjoni
NOT supplied in the pack
MHUX ipprovduti fil- pakkett
sterile injection syringe and needles alcohol swabs dry gauze or cotton pad an adhesive plaster disposal box for used syringes and needles.
siringa għall- injezzjoni u labar sterilizzati biċċiet tat- tajjar imxarrbin bl- alkolħol garża xotta jew biċċa tajjar stikk kaxxa għar- rimi ta 'siringi u labar użati.
Preparing the solution
Preparazzjoni tas- soluzzjoni
Wash your hands thoroughly with soap and water before preparing the medicine.
Aħsel idejk sewwa bis- sapun u l- ilma qabel tipprepara l- mediċina.
Take the Valtropin carton out of the refrigerator and take the powder vial and pre-filled syringe with solvent out of the box.
Oħroġ il- kaxxa ta 'Valtropin mill- friġġ u oħroġ il- kunjett tat- trab u s- siringa mimlija għal- lest bis - solvent minn ġol- kaxxa.
Check that the medicine is within the expiry date.
Iċċekkja li l- mediċina ma skadietx.
Remove the protective plastic cap from the powder vial.
Neħħi l- għatu protettiv tal- plastik mill- kunjett tat- trab.
Clean the rubber stopper on the top of the powder vial with an alcohol swab.
Naddaf it- tapp tal- gomma fil- parti ta ’ fuq tal- kunjett tat- trab b’ biċċa tajjara mxarrba bl- alkoħol.
After cleaning do not touch the top of the vial.
Wara t- tindif tmissx il- parti ta 'fuq tal- kunjett.
Vial containing the powder of your medicine
Kunjett li fih it- trab tal- mediċina tiegħek
Take the pre-filled syringe with solvent supplied in the pack to prepare your medicine.
Ħu s- siringa mimlija għal- lest bis- solvent ipprovdut fil- pakkett biex tipprepara l- mediċina.
Remove the rubber tip cap and firmly attach a needle to the syringe.
Neħħi l- għatu tal- gomma li jipproteġi l- ponta u mas- siringa waħħal sewwa labra.
Your doctor or his/her assistant will tell you what size of needle to use.
It- tabib tiegħek jew l- assistent/ a tiegħu/ tagħha jgħidulek liema qies ta 'labra għandek tuża.
Remove the needle guard without touching the needle.
Neħħi t- tapp ta ’ protezzjoni tal- labra mingħajr ma tmiss il- labra.
Slowly insert the needle straight through the centre of the rubber stopper of the vial.
Bil- mod il- mod daħħal il- labra dritt fiċ- ċentru tal- għatu tal- gomma tal- kunjett.
Slowly inject all of the solvent (1.5 ml) into the powder vial aiming the stream of liquid against the side of the vial.
Bil- mod il- mod injetta s- solvent kollu (1. 5 ml) fil- kunjett tat- trab billi timmira l- fluss tal- likwidu fuq il- ġenb tal- kunjett.
DO NOT aim it at the white powder at the bottom of the vial.
TIMMIRAHX lejn it- trab abjad fil- qiegħ tal- kunjett.
Before taking the syringe out of the vial, draw in the same amount of air (1.5 ml) as the solvent you injected to reduce the pressure in the vial.
Qabel toħroġ is- siringa mill- kunjett, daħħal l- istess ammont ta 'arja (1. 5 ml) daqs is- solvent li injettajt biex tnaqqas il- pressjoni fil- kunjett.
Withdraw the syringe and replace the needle guard.
Oħroġ is- siringa u poġġi t- tapp ta 'protezzjoni tal- labra.
Swirl the vial GENTLY to completely dissolve the contents.
Dawwar il- kunjett BIL- MOD biex iddewweb il- kontenut għal kollox.
Dissolving up your medicine
Kif iddewweb il- mediċina tiegħek
The resulting solution should be clear, without particles.
Is- soluzzjoni li tirriżulta għandha tkun ċara, mingħajr frak.
Label the vial with the date on which you prepared the solution.
Immarka l- kunjett b' tikketta bid- data li fiha inti ppreparajt is- soluzzjoni.
28 Preparing the injection
Preparzzjoni ta 'l- injezzjoni
Clean the rubber stopper on the top of the vial with an alcohol swab again.
Naddaf mill- ġdid it- tapp tal- gomma fil- parti ta 'fuq tal- kunjett b’ biċċa tajjara mxarrba bl- alkolħol.
Vial containing the solution of your medicine
Kunjett li fih is- soluzzjoni bil- mediċina tiegħek
Take the injection syringe and the needle supplied by your pharmacy or hospital, to withdraw the solution of medicine.
Aqbad is- siringa ta 'l- injezzjoni u l- labra pprovduti mill- ispiżerija jew l- isptar tiegħek, biex tiġbed is- soluzzjoni tal- mediċina.
Remove the injection syringe from its sterile packaging and attach the needle to the syringe.
Neħħi s- siringa ta 'l- injezzjoni mill- ippakkjar sterili tagħha u waħħal il- labra mas- siringa.
Fill the syringe with air by pulling the plunger back to the level that represents your dose as prescribed by your doctor.
Imla s- siringa bl- arja billi tiġbed tarf is- siringa fejn mhemmx il- labra sal- livell li jirrappreżenta d- doża tiegħek kif preskritta mit- tabib tiegħek.
Slowly insert the needle straight through the centre of the rubber stopper of the vial.
Bil- mod, il- mod daħħal il- labra dritt fiċ- ċentru tat- tapp tal- gomma tal- kunjett.
Gently push the plunger to discharge the air in the syringe into the vial.
Bil- mod iġbed it- tarf tas- siringa fejn m' hemmx il- labra biex iddaħħal l- arja fis- siringa għal ġewwa l- kunjett.
29 18.
32 18.
Turn the vial upside down with the needle still in it and hold the vial in one hand.
Dawwar il- kunjett rasu l- isfel bil- labra tkun għadha fih u żomm il- kunjett b' id waħda.
Hold the syringe with the needle in the vial pointing up.
Żomm is- siringa bil- labra fil- kunjett tipponta 'l fuq.
Ensure that the tip of the needle is in the solution.
Kun żgur li t- tarf tal- labra jkun fis- soluzzjoni.
Using your other hand slowly pull back the plunger in a continuous motion to draw the correct dose into the syringe ensuring that the needle tip remains in the solution.
Bl- użu ta 'l- id l- oħra bil- mod, il- mod iġbed il- planġer b' ġibda waħda kontinwa biex tiġbed id- doża korretta fis- siringa filwaqt li tiżgura li tarf il- labra jibqa' fis- soluzzjoni.
Withdrawing the right volume of your medicine with the help of the syringe markings
Tiġbed il- volum korrett tal- mediċina tiegħek bl- għajnuna tal- marki fuq is- siringa
Remove the syringe from the needle leaving the needle in the vial without touching the tip of the syringe.
Neħħi s- siringa mil- labra billi tħalli l- labra fil- kunjett mingħajr ma tmiss it- tarf tas- siringa.
Withdraw the needle, replace the needle guard and dispose in a closed container.
Neħħi l- labra, poġġi t- tapp protettiv tal- labra f' postu u armiha f' kontenitur magħluq.
For handling the vial see ‘Injecting the solution’, step 32.
Biex tieħu ħsieb il- kunjett ara 'Injezzjoni tas- soluzzjoni', numru 32.
Take a new needle (one that is suitable for subcutaneous injection) and place it firmly onto the tip of the syringe.
Ħu labra ġdida (waħda li hija adattata għal injezzjoni taħt il- ġilda) u waħħalha sewwa fin- naħa ta 'fuq tas- siringa.
Syringe containing your medicine being attached to a new needle
Siringa li fiha l- mediċina tiegħek li qegħda titwaħħlilha labra ġdida
Remove the needle guard from the syringe needle and check for air bubbles in the syringe.
Neħħi t- tapp ta ’ protezzjoni mil- labra tas- siringa u ara li fis- siringa m' hemmx bżieżaq ta 'l- arja.
If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing up, until the bubbles disappear.
Jekk tara xi bżieżaq, iġbed tarf is- siringa fejn m' hemmx il- labra ftit lura; agħti daqqa ħafifa b' subgħajk il- werrej lis- siringa, bil- labra tipponta 'l fuq, sakemm il- bżieżaq jitilqu.
Push the plunger slowly back up to the correct dose.
Iġbed tarf is- siringa fejn m' hemmx il- labra bil- mod lura biex tikkoreġi d- doża.
Replace the needle guard and place the syringe with the needle on a flat surface.
Erġa 'poġġi t- tapp ta ’ protezzjoni tal- labra u poġġi s- siringa bil- labra fuq wiċċ ċatt.
30 Injecting the solution
33 Injezzjoni tas- soluzzjoni
Ensure the solution is at room temperature.
Kun żgur li s- soluzzjoni hija f' temperatura tal- kamra.
If the solution is cold, warm the syringe between your palms.
Jekk is- soluzzjoni hija kiesħa, saħħan is- siringa bejn l- uċuh ta 'idejk.
Inspect the solution prior to administration: if the solution is discoloured or if you can see any solid particles in the liquid the solution MUST NOT be injected.
Spezzjona s- soluzzjoni qabel ma tagħtiha: jekk is- soluzzjoni tilfet lewnha jew tista 'tara xi frak solidu fil- likwidu, is- soluzzjoni M' GĦANDHIEX tiġi injettata.
Select the injection site according to the recommendation of your doctor.
Agħżel is- sit għall- injezzjoni skond ir- rakkomandazzjoni tat- tabib tiegħek.
It is very important that you vary the injection site each time you give the medicine.
Huwa importanti ħafna li tvarja s- sit ta 'l- injezzjoni kull darba li tagħti l- mediċina.
Cleanse the injection site with an alcohol swab and wait for the area to dry.
Naddaf is- sit ta 'l- injezzjoni b’ biċċa tajjara mxarrba bl- alkoħol u stennih jinxef.
Check that the correct dose of Valtropin solution is in the syringe.
Iċċekkja li fis- siringa hemm id- doża korretta ta 'Valtropin.
Hold the syringe in your hand as you would hold a pencil.
Żomm is- siringa f' idek bħalma żżomm lapes.
Squeeze a big skin fold between your thumb and index finger.
Agħfas biċċa ġilda kbira bejn subgħajk il- kbir u subgħajk il- werrej.
Insert the needle into the pinched skin at a 45° to 90° angle with a quick, firm motion.
Daħħal il- labra fil- ġilda maqrusa f' angolu ta '45° sa 90° b' moviment veloċi u sod.
This hurts less than pushing the needle in slowly.
Hekk tħoss inqas uġigħ milli kieku ddaħħal il- labra bil- mod.
31.
Bil- mod (fi ftit sekondi) injetta s- soluzzjoni billi bil- mod timbotta l- planġer sakemm is- siringa tkun vojta.
EU-Numbers
Isem ivvintat
Packaging
Tubu (HDPE)
Cream Cream Cream
Krema
Cutaneous use Cutaneous use Cutaneous use
ilda G all- u u fuq il - ilda
Tube (HDPE) Tube (HDPE) Tube (HDPE)
Tubu (HDPE)
15 g (11.5% w/ w) 30 g (11.5% w/ w) 60 g (11.5% w/ w)
60 g (11. 5% w/ w)
1 tube 1 tube 1 tube
tubu 1
Vaniqa 11.5% cream
Vaniqa 11. 5% krema
Each gram of Vaniqa 11.5% w/ w cream contains 115 mg eflornithine (as hydrochloride monohydrate).
Kull gramma ta ’ Vaniqa 11. 5% w/ w krema fiha 115 mg eflornithine (b ala hydrochloride monohydrate).
Cetostearyl alcohol Stearyl alcohol.
Cetostearyl alcohol Stearyl alcohol.
Cream.
Krema
White to off white cream
Krema bajda sa bajda tag ti fil- gri
4.1 Therapeutic indication
4. 1 Indikazzjonijiet terapewti i
Treatment of facial hirsutism in women.
u l - isem fin- nisa.
A thin layer of the cream should be applied to clean and dry affected areas twice daily, at least eight hours apart.
Saff irqiq tal- krema g andu jindilek darbtejn kuljum, ta ’ l- inqas wara intervall ta ’ tmien sig at. fuq il- partijiet affettwati li jkunu nodfa u xotti.
The cream should be rubbed in thoroughly.
Il- krema g andha ting orok sewwa fil - ilda.
Hands should be washed after applying this medicine.
L- idejn g andhom jin aslu wara li tindilek din il- medi ina.
For maximal efficacy, the treated area should not be cleansed within four hours of application.
G al effi jenza massima, il- parti kkurata m’ g andhiex titnaddaf sa erba ’ sig at wara l- applikazzjoni tal- krema.
Cosmetics (including sunscreens) can be applied over the treated areas, but no sooner than five minutes after application.
Prodotti kosmeti i (inklu i kremi g al protezzjoni mix- xemx) jistg u jintu aw fuq il- partijiet kkurati, i da mhux qabel ames minuti wara l- applikazzjoni tal- krema.
Efficacy has only been demonstrated for affected areas of the face and under the chin.
L- effika ja intweriet biss fuq il- partijiet affettwati tal- wi u ta t l- il it.
Application should be limited to these areas.
L- u u tal- krema g andu jkun limitat g al dawn il- partijiet.
The product should be applied such that no visual residual product remains on the treated areas after rub-in.
Il- prodott g andu jintu a b’ mod li l- ebda residwu vi ibbli tal- prodott ma jibqa ’ fuq il- partijiet ikkurati wara li tkun g orokt il - ilda.
Maximal applied doses used safely in clinical trials were up to 30 grams per month.
Id- do i massimi u ati b’ mod sigur fi provi klini i kienu sa 30 gramma fix- xahar.
Improvement in the condition may be noticed within eight weeks of starting treatment.
Titjib fil- kundizzjoni kien innutat wara tmien img at mill- bidu tal- kura.
Continued treatment may result in further improvement and is necessary to maintain beneficial effects.
It- tkomplija tal- kura tista ’ tirri ulta f’ titjib ulterjuri u hi me tie a biex jin ammu l- effetti ta ’ benefi ju.
The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment.
Il- kundizzjoni tista ’ ter a ’ lura g al- livelli ta ’ qabel il- kura fi mien tmien img at wara t- twaqqif tal- kura.
Use should be discontinued if no beneficial effects are noticed within four months of commencing therapy.
L- u u g andu jitwaqqaf jekk l- ebda effetti ta ’ benefi ju ma jkunu osservati fi mien erba ’ xhur wara l- bidu tat- terapija.
Patients may need to continue to use a hair removal method (e. g. shaving or plucking) in conjunction with Vaniqa.
Il- pazjenti jista ’ jkollhom b onn li jkomplu ju aw metodu tat- tne ija tax- xag ar (e. li x - xag ar jitqaxxar jew jin ibed) flimkien ma ’ Vaniqa.
In that case, the cream should be applied no sooner than five minutes after shaving or use of other hair removal methods, as increased stinging or burning may otherwise occur.
F’ dak il- ka, il- krema m’ g andhiex tintu a qabel ames minuti wara t- tqaxxir jew l- u u ta ’ metodi o ra tat- tne ija tax- xag ar, g aliex inkella jista ’ jkun hemm ieda fit- tingi jew ruq.
(> 65 years) no dosage adjustment is necessary.
(> 65 sena) l- ebda a ustament fid- do a mhu me tie.
(< 12 years) safety and efficacy of Vaniqa have not been established.
(< 12- il sena) is- sigurtà u l- effika ja ta ’ Vaniqa ma kienux stabbiliti.
2 Hepatic/ renal impairment: the safety and efficacy of Vaniqa in women with hepatic or renal impairment have not been established.
2 Indeboliment tal- fwied/ kliewi: is- sigurtà u l- effika ja ta ’ Vaniqa ma kinux stabbiliti f’ nisa b’ indeboliment tal- fwied jew tal- kliewi.
Hypersensitivity to eflornithine or to any of the excipients (see section 6.1).
Sensittività e essiva g al eflornithine jew g al xi sustanzi mhux attivi (ara sezzjoni 6. 1).
Excessive hair growth can result from serious underlying disorders (e. g. polycystic ovary syndrome, androgen secreting neoplasm) or certain medications (e. g. cyclosporin, glucocorticoids, minoxidil, phenobarbitone, phenytoin, combined oestrogen-androgen hormone replacement therapy).
It- tkabbir e essiv tax- xag ar jista ’ jirri ulta minn mard serju li ma jidhirx (e. sindromu poli istiku ta ’ l- ovarji, neopla ma li tnixxi l- androgen) jew erti medi ini (e. cyclosporin, glukokortikojdi, minoxidil, phenobarbitone, phenytoin, ormon kombinat ta ’ oestrogen - androgen, terapija tas- sostituzzjoni ta ’ l- ormoni).
These factors should be considered in the overall medical treatment of patients who might be prescribed Vaniqa.
Dawn il- fatturi g andhom ikunu kkunsidrati fil- kura medika enerali ta ’ pazjenti li jistg u jing ataw ri etta g al Vaniqa.
Vaniqa is for cutaneous use only.
Vaniqa g andha tintu a fuq il - ilda biss.
Contact with eyes or mucous membranes (e. g. nose or mouth) should be avoided.
Kuntatt ma ’ l- g ajnejn jew mal- membrani muku i (e. l- imnie er jew il - alq) g andu jkun evitat.
Transient stinging or burning may occur when the cream is applied to abraded or broken skin.
Tingi jew ruq temporanju jista ’ jse meta l- krema tintu a fuq ilda mislu a jew maqsuma.
If skin irritation or intolerance develops, the frequency of application should be reduced temporarily to once a day.
Jekk ti viluppa irritazzjoni jew intolleranza tal - ilda, il- frekwenza ta ’ l- u u g andha titnaqqas temporanjament g al darba kuljum.
If irritation continues, treatment should be discontinued and the physician consulted.
Jekk l- irritazzjoni tkompli, il- kura g andha titwaqqaf u g andu ji i kkonsultat tabib.