qanastek/EMEA-V3 huggingface dataset:
In healthy young adults given a single 500 mg dose of Doribax, 71% and 15% of the dose was recovered in urine as unchanged active substance and ring-opened metabolite, respectively.
F’ adulti żgħażagħ f’ saħħithom li ngħataw doża waħda ta ’ 500 mg ta ’ Doribax, 71% u 15% tad- doża ġiet irkuprata mill- awrina bħala sustanza attiva mhux mibdula u metabolit ċirku miftuħ rispettivament.
Following the administration of a single 500 mg dose of radiolabeled doripenem to healthy young adults, less than 1% of the total radioactivity was recovered in faeces.
Wara l- amministrazzjoni ta ’ doża waħda ta ’ doripenem radjutikkettat lill- adulti żgħażagħ f’ saħħithom, anqas minn 1% tat- total ta ’ radjuattività kien irkuprat mill- ippurgar.
The pharmacokinetics of doripenem are linear over a dose range of 500 mg to 1 g when intravenously infused over either 1 or 4 hours.
Il- farmakokinetika ta ’ doripenem hija lineari fuq medda ta ’ doża bejn 500 mg u 1 g meta mogħti b’ infuzjoni fuq perjodu jew ta ’ siegħa jew ta ’ 4 sigħat.
Renal Insufficiency Following a single 500 mg dose of Doribax, doripenem AUC increased 1.6-fold, 2.8-fold, and 5.1-fold in subjects with mild (CrCl 51-79 ml/min), moderate (CrCl 31-50 ml/min), and severe renal impairment (CrCl ≤ 30 ml/min), respectively, compared to age-matched healthy subjects with normal renal function (CrCl > 80 ml/min).
Insuffiċjenza tal- Kliewi Wara doża waħda ta ’ 500 mg Doribax, l- AUC ta ’ doripenem żdiedet 1. 6 drabi, 2. 8 drabi u 5. 1 drabi aktar f’ individwi b’ indeboliment tal- kliewi ħafif (CrCl 51- 79 ml/ min), moderat (CrCl 31- 50 ml/ min), u qawwi (CrCl ≤ 30 ml/ min), rispettivament, meta mqabbla ma ’ individwi f’ saħħithom li huma ndaqs fl- età b’ funzjoni normali tal- kliewi (CrCl > 80 ml/ min).
AUC of the microbiologically inactive ring-opened metabolite is expected to be considerably increased in patients with severe renal impairment compared with healthy subjects.
L- AUC tal- metabolit ċirku miftuħ li huwa mikrobijoloġikament inattiv hija mistennija li tiżdied b’ mod konsiderevoli f’ pazjenti b’ indeboliment qawwi tal- kliewi meta mqabbla ma ’ individwi b’ saħħithom.
Dosage adjustment is necessary in patients with moderate and severe renal impairment (see section 4.2).
Aġġustament tad- doża huwa meħtieġ f’ pazjenti b’ indeboliment moderat u qawwi tal- kliewi (ara sezzjoni 4. 2).
AUCs of doripenem and of the microbiologically inactive ring-opened metabolite are substantially increased in patients who require haemodialysis compared with healthy subjects.
L- AUCs ta ’ doripenem u tal- metabolit ċirku miftuħ mikrobijoloġikament inattiv jiżdiedu b’ mod sostanzjali f’ pazjenti li għandhom bżonn id- dijalisi tad- demm meta mqabbla ma ’ individwi f’ saħħithom.
In a study where six subjects with end stage renal disease on haemodialysis received a single dose of 500 mg doripenem by i.v. infusion, the amount of doripenem removed during the four-hour haemodialysis session was 231 mg (46% of the dose).
Fi studju fejn sitt individwi b’ indeboliment tal- kliewi ta ’ l- aħħar stadju rċievew doża waħda ta ’ 500 mg doripenem permezz ta ’ infużjoni fil- vina, l- ammont ta ’ doripenem li tneħħa waqt is - sessjoni ta ’ erba ’ sigħat ta ’ dijalisi tad- demm kien ta ’ 231 mg (46% tad- doża).
Hepatic Impairment The pharmacokinetics of doripenem in patients with hepatic impairment have not been established.
Indeboliment tal- Fwied Il- farmakokinetika ta ’ doripenem f’ pazjenti b’ indeboliment tal- fwied ma ġietx stabbilita.
As doripenem does not appear to undergo hepatic metabolism, the pharmacokinetics of Doribax are not expected to be affected by hepatic impairment.
Minħabba li doripenem ma jidhirx li jgħaddi minn metaboliżmu fil- fwied, il- farmakokinetika ta ’ Doribax m’ hijiex mistennija li tiġi affettwata minn indeboliment tal- fwied.
8 Elderly The impact of age on the pharmacokinetics of doripenem was evaluated in healthy elderly male and female subjects (66-84 years of age).
Anzjani L- impatt ta ’ l- età fuq il- farmakokinetika ta ’ doripenem kienet evalwata f’ individwi nisa u rġiel anzjani f’ saħħithom (66- 84 sena).
Doripenem AUC increased 49% in elderly adults relative to young adults.
L- AUC ta ’ doripenem żdiedet 49% f’ adulti anzjani meta mqabbla ma ’ adulti żgħażagħ.
These changes were mainly attributed to age-related changes in renal function.
Dawn il- bidliet kienu l- aktar attribbwibbli għal tibdil fil- funzjoni tal- kliewi li għandha x’ taqsam ma ’ l- età.
No dosage adjustment is necessary in elderly patients, except in cases of moderate to severe renal insufficiency (see section 4.2).
L- ebda aġġustament fid- doża ma hu neċessarju f’ pazjenti anzjani, ħlief f’ każijiet ta ’ insiffiċjenza tal- kliewi moderata jew severa (ara sezzjoni 4. 2).
Gender The effect of gender on the pharmacokinetics of doripenem was evaluated in healthy male and female subjects.
Sess L- effett tas- sess fuq il- farmakokinetika ta ’ doripenem kien evalwat f’ individwi rġiel u nisa f’ saħħithom.
Doripenem AUC was 15% higher in females compared to males.
L- AUC ta ’ doripenem kienet 15% ogħla fin- nisa meta mqabbla ma ’ l- irġiel.
No dose adjustment is recommended based on gender.
L- ebda aġġustament tad- doża ma huwa rakkomandat ibbażat fuq is- sess.
Race The effect of race on doripenem pharmacokinetics was examined through a population pharmacokinetic analysis.
Razza L- effett tar- razza fuq il- farmakokinetika ta ’ doripenem kienet eżaminata permezz ta ’ analiżi ta ’ popolazzjoni.
No significant difference in mean doripenem clearance was observed across race groups and therefore, no dosage adjustment is recommended for race.
L- ebda differenza sinifikanti fit- tneħħija medja ta ’ doripenem ma ġiet osservata fi gruppi ta ’ razez u għalhekk, l- ebda aġġustament tad- doża ma huwa rakkomandat minħabba r- razza.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and genotoxicity.
Madankollu, minħabba kif kienu
However, because of the design of the repeat dose toxicity studies and differences in pharmacokinetics in animals and humans, continuous exposure of animals was not assured in these studies.
9 iddisinjati l- istudji ta ’ tossiċità minn dożi ripetuti u d- differenzi fil- farmakokinetika fl- annimali u l - bnedmin, l- esponiment kontinwu ta ’ l- annimali ma kienx żgurat f’ dawn l- istudji.
No reproductive toxicity was observed in studies performed in rats and rabbits.
L- ebda tossiċità fuq is- sistema riproduttiva ma ġiet osservata fl- istudji magħmula fuq firien u fniek.
However, these studies are of limited relevance because studies were performed with single daily dosing resulting in less than one tenth of daily doripenem exposure duration in animals.
Madankollu, dawn l- istudji huma ta ’ rilevanza limitata minħabba li l- istudji saru b’ doża waħda kuljum li tirriżulta f’ dewmien ta ’ esponiment għal doripenem kuljum ta ’ anqas minn wieħed minn għaxra fl - annimali
None
Xejn
Storage of reconstituted solutions:
Ħażna tas- soluzzjonijiet rikostitwiti:
Upon reconstitution with sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, Doribax suspension in the vial may be held for up to 1 hour below 30°C prior to transfer and dilution in the infusion bag.
Hekk kif jiġi rikostitwit b’ ilma sterili għall- injezzjonijiet jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għall- injezzjoni, is- soluzzjoni ta ’ Doribax fil- kunjett tista ’ tinżamm sa siegħa f’ temperatura anqas minn 30°C qabel ma tiġi trasferita u ddilwita fil- borża ta ’ l- infużjoni.
Following dilution in the infusion bag with sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection, Doribax infusions stored at controlled room temperature or under refrigeration should be completed according to the times in the following table:
Wara id- dilwizzjoni fil- borża ta ’ l- infużjoni f’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għall - injezzjoni jew soluzzjoni ta ’ dextrose 50 mg/ ml (5%) għall- injezzjoni, infużjonijiet ta ’ Doribax maħżuna f’ temperatura tal- kamra kkontrollata jew miżmuma fil- friġġ għandhom jintemmu skond il - ħinijiet fit- tabella li ġejja:
9 Time by which reconstitution, dilution and infusion must complete for Doribax infusion solutions
Il- ħin sa meta r- rikostituzzjoni, id- dilwizzjoni u l- infużjoni għal soluzzjonijiet ta ’ infużjonijiet ta ’ Doribax għandhom jintemmu
Infusion solution
Soluzzjoni għall- infużjoni
Solution stored at
Soluzzjoni maħżuna f’ temperatura tal- kamra
Solution stored in a
Soluzzjoni maħżuna ġewwa friġġ (2 °C- 8 °C)
sodium chloride 9 mg/ml (0.9%) solution for injection +
sodium chloride 9 mg/ ml (0. 9%) soluzzjoni 12- il siegħa għall- injezzjoni +
refrigerator (2°C-8°C) 72 hours*
72 siegħa *
dextrose 50 mg/ml (5%) solution for injection
dextrose 50 mg/ ml (5%) soluzzjoni għall - 4 sigħat injezzjoni
24 hours *
24 siegħa *
* Once removed from the refrigerator, infusions should be completed within the room temperature stability time, provided the total refrigeration time, time to reach room temperature and infusion time does not exceed refrigeration stability time. + Dextrose 50 mg/ml (5%) solution for injection should not be used for infusion durations greater than 1 hour.
* Ladarba mneħħija mill- friġġ, l- infużjonijiet għandhom jintemmu fil- ħinijiet ta ’ stabbiltà tat - temperatura tal- kamra, bil- kundizzjoni li l- ħin totali li jinżammu fil- friġġ, il- ħin li jieħdu biex jilħqu it- temperatura tal- kamra u l- ħin ta ’ l- infużjoni ma jkunux aktar mill- ħin ta ’ stabbilità meta jkunu fil - friġġ. + Dextrose 50 mg/ ml (5%) soluzzjoni għall- injezzjoni m’ għandux jintuża għal infużjonijiet li jdumu aktar minn siegħa.
Chemical and physical in-use stability has been demonstrated for the times and solutions shown in the above Table.
L- istabbiltà kimika u fiżika waqt l- użu ntweriet għall- ħinijiet u s- soluzzjonijiet murija fit- Tabella t’ hawn fuq.
From a microbiological point of view, the product should be used immediately.
Mill- punt mikrobijoloġiku, il- prodott għandu jintuża immedjatament.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, il- kundizzjonijiet u l- ħinijiet tal- ħażna waqt l- użu huma r- responsabbiltà ta ’ min qed 10 jużah u normalment ma jkunux aktar minn 24 siegħa f’ temperatura bejn 2 °C- 8 °C, sakemm ir - rikostituzzjoni/ dilwizzjoni ma tkunx saret f’ kundizzjonjiet asettiċi kkontrollati u validati.
For storage conditions of the reconstituted medicinal product, and infusion solutions see section 6.3.
Għall- kundizzjonijiet tal- ħażna tal- prodott mediċinali rikostitwit, u s- soluzzjonijiet għall- infużjoni ara sezzjoni 6. 3.
Clear 20 ml Type I glass vial.
Kunjett trasparenti tal- ħġieġ tat- Tip I ta ’ 20ml.
The medicinal product is supplied in cartons containing 10 vials.
Il- prodott mediċinali jiġi f’ kaxxi tal- kartun li fihom 10 kunjetti.
Each vial is for single use only.
Kull kunjett qiegħed biex jintuża darba biss.
Doribax is reconstituted and then further diluted prior to infusion.
Doribax jiġi rikostitwit imbagħad dilwit aktar qabel l- infużjoni.
Preparation of 500 mg dose of solution for infusion 1.
Il- preparazzjoni ta ’ soluzzjoni ta ’ doża ta ’ 500 mg għall- infuzjoni 1.
Add 10 ml of sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to the vial and shake it to form a suspension.
Żid 10 ml ta ’ ilma sterili għall- injezzjonijiet jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għall- injezzjoni fil- kunjett u ħawwdu biex tifforma suspensjoni.
Inspect the suspension visually for foreign matter.
Ifli s- suspensjoni viżwalment għal xi frak.
Note: the suspension is not for direct infusion.
Nota: is- suspensjoni m’ hijiex qegħda għal infużjoni diretta.
Withdraw the suspension using a syringe and needle and add it to an infusion bag containing 100 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection and mix to complete dissolution.
Iġbed is- suspensjoni permezz ta ’ siringa u labra u żidha fil- borża ta ’ l- infużjoni li jew ikun fiha 100 ml ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għall- injezzjoni jew inkella soluzzjoni ta ’ dextrose 50 mg/ ml (5%) għall- injezzjoni u ħallat biex tinħall kompletament.
Infuse all of this solution to administer a 500 mg dose of doripenem.
Agħti din is- soluzzjoni kollha fil- vina biex tkun tajt doża ta ’ 500 mg doripenem.
Preparation of 250 mg dose of solution for infusion for patients with moderate or severe renal impairment 1.
Il- preparazzjoni ta ’ soluzzjoni ta ’ doża ta ’ 250 mg għall- infuzjoni għal pazjenti b’ indeboliment moderat jew qawwi tal- kliewi 1.
Withdraw the suspension using a syringe and needle and add it to an infusion bag containing 100 ml either sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection and mix to complete dissolution.
Iġbed is- suspensjoni permezz ta ’ siringa u labra u żidha fil- borża ta ’ l- infużjoni li ikun fiha 100 ml jew ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għall- injezzjoni jew inkella soluzzjoni ta ’ dextrose 50 mg/ ml (5%) għall- injezzjoni u ħallat biex tinħall kompletament.
Remove 55 ml of this solution from the
Neħħi 55 ml minn din is- soluzzjoni mill- borża ta ’ l- infużjoni u armiha.
Infuse all of the remaining solution to administer a 250 mg dose of doripenem.
Agħti is- soluzzjoni kollha li jibqa ’ fil- vina biex tkun tajt doża ta ’ 250 mg doripenem.
Doribax solutions for infusion range from clear, colourless solutions to solutions that are clear and slightly yellow.
Soluzzjonijiet ta ’ Doribax għall- infużjoni jistgħu jkunu minn soluzzjonijiet trasparenti bla kulur sa soluzzjonijiet trasparenti u jagħtu ftit fl- isfar.
Variations in colour within this range do not affect the potency of the product.
Varjazzjonijiet fil- kulur f’ din il- medda ma jaffettwawx il - qawwa tal- prodott.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa mill- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse Belgium
Janssen- Cilag International NV Turnhoutseweg, 30
DD month YYYY
JJ xahar SSSS
{MM/YYYY}
{XX/ SSSS}
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
12 A.
12 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Name and address of the manufacturer responsible for batch release
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Janssen Pharmaceutica N.V.
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott
Turnhoutseweg 30 B-2340 Beerse Belgium
Janssen- Cilag International NV Turnhoutseweg, 30 B- 2340 Beerse Il- Belġju
CONDITIONS OF THE MARKETING AUTH ORISATION
KUNDIZZJONJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in the version dated 10 May 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jaċċerta illi s- sistema ta ’ farmakoviġilanza, kif ġiet deskritta fil- verżjoni ta ’ l- 10 ta ’ Mejju 2007 u ppreżentata ġewwa Modulu 1. 8. 1 ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq, hija fis- seħħ u funzjonanti qabel u waqt li l- prodott qiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- immaniġġar tar- riskju Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq jikkommetti li jagħmel l- istudji u attivitajiet oħra ta ’ farmakoviġilanza kif dettaljat ġo l- pjan ta ’ farmakoviġilanza, kif miftiehem f’ verżjoni 3 ta ’ l- pjan ta ’ l- immaniġġar tar- riskju ppreżentat ġewwa Modulu 1. 8. 2 ta ’ l- applikazzjoni għal- awtorizzazzjoni għat- tqegħid fis- suq u aġġornamenti sussegwenti ta ’ l- pjan ta ’ l- immaniġġar tar- riskju miftiehem mis - CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- linji gwida tas- CHMP fuq sistemi dwar l- immaniġġar tar- riskji għall- prodotti mediċinali għall- użu uman, il- pjan ta ’ l- immaniġġar tar- riskju aġġornat għandu jiġi sottomess fl- istess ħin ta ’ l - PSUR.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Flimkien ma ’ dan, pjan ta ’ l- immaniġġar tar- riskju aġġornat għandu jiġi sottomess • Meta informazzjoni ġdida tinkiseb illi jista jkollha mpatt fuq l- ispeċifikazzjonikiet tas- sigurta ’ kurrenti, fuq il- pjan ta ’ farmakoviġilanza jew f ’ l- attivitajiet ta ’ minimizzazzjoni tar- riskji • Fi żmien 60 ġurnata minn meta tintlaħaq ġrajja importanti (ta ’ farmakoviġilanza jew minimizzazzjoni tar- riskji) • Fuq rikjesta ta ’ l- EMEA
Doribax 500 mg powder for solution for infusion doripenem
Doribax 500 mg trab għal soluzzjoni għall- infużjoni doripenem
Each vial contains doripenem monohydrate equivalent to 500 mg doripenem
Kull kunjett fih doripenem monohydrate ekwivalenti għal 500 mg doripenem
Read the package leaflet before use Intravenous use
Użu għal ġol- vina
For single use only
Biex jintuża darba biss
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Turnhoutseweg 30 B-2340 Beerse Belgium
Turnhoutseweg 30 B- 2340 Beerse Il- Belġju
BN
LOTT
Justification for not using Braille accepted
Il- Ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata
17 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI EWLENIN
Doribax 500 mg powder for infusion doripenem Intravenous use
Doribax 500 mg trab għall- infużjoni doripenem Użu għal ġol- vini
Each vial contains doripenem monohydrate equivalent to 500 mg doripenem
Kull kunjett fih doripenem monohydrate ekwivalenti għal 500 doripenem
OTHER SPECIAL WARNING (S) IF NECESSARY
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA
For single use only
Għal użu ta ’ darba biss
NAME AND ADDRESS OF MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MARKETING AUTHORISATION NUMBER (S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
INFORMATION ON BRAILLE
INFORMAZZJONI BIL- BRAILLE
please tell your doctor or pharmacist.
m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Doribax is and what it is used for 2.
1 X’ inhu Doribax u għalxiex jintuża 2.
Before you use Doribax 3.
Qabel ma tuża Doribax 3.
How to use Doribax 4.
Kif tuża Doribax 4.
How to store Doribax 6.
Kif taħżen Doribax 6.
WHAT DORIBAX IS AND WHAT IT IS USED FOR
X’ INHU DORIBAX U GĦALXIEX JINTUŻA
Doribax works by killing different types of bacteria (germs) that cause infections in various parts of the body.
Doribax jaħdem billi joqtol tipi differenti ta ’ batterji (mikrobi) li jikkawżaw infezzjonijiet f’ diversi partijiet tal- ġisem.
Doribax is used for the following infections:
Doribax jintuża għall- infezzjonijiet li ġejjin:
- Pneumonia (a serious type of chest or lung infection) that you catch in a hospital or similar setting.
- Pulmonite (tip ta ’ infezzjoni serja fis- sider jew fil- pulmun) li inti tista ’ tieħu mill- isptar jew
This includes pneumonia that you catch when on a machine that helps you breathe
Dan jinkludi pulmonite li tieħu meta tkun fuq magna li tgħinek tieħu n - nifs.
- Complicated infections of the area around your stomach (abdominal infections)
- Infezzjonijiet ikkumplikati fil- parti ta ’ madwar l- istonku tieħek (infezzjonijiet addominali)
- Complicated urinary tract infections, including kidney infections and cases that have spread to the
- Infezzjonijiet ikkumplikati fl- apparat ta ’ l- awrina, inkluż infezzjonijiet fil- kliewi u każi li nfirxu
bloodstream.
fid- demm.
BEFORE YOU USE DORIBAX
QABEL MA TUŻA DORIBAX
Do not use Doribax
Tużax Doribax
- If you are allergic (hypersensitive) to doripenem
- Jekk inti allerġiku/ allerġika (tbati minn sensittività eċċessiva) għal doripenem
- If you are allergic to other antibiotics such as penicillins, cephalosporins or carbapenems (which
- Jekk inti allerġiku għal antibijotiċi oħra bħal penicillins, cephalosporins jew carbapenems (li
are used to treat various infections) as you may also be allergic to Doribax.
jintużaw biex jikkuraw infezzjonijiet diversi) minħabba li tista ’ tkun allerġiku/ allerġiku wkoll għal Doribax.
Do not use Doribax if any of the above applies to you.
Tużax Doribax jekk xi waħda minn dawn t’ hawn fuq tapplika għalik.
If you are not sure, talk to your doctor or pharmacist before being given Doribax.
Jekk m’ intix ċert, kellem lit- tabib jew lill- ispiżjar tiegħek qabel ma tingħata Doribax.
Take special care with Doribax If you have:
Oqogħod attent ħafna b’ Doribax Jekk għandek:
- Kidney problems.
- Problemi fil- kliewi.
Your doctor may need to lower your dose of Doribax
It- tabib jista ’ jkollu bżonn inaqqaslek id- doża ta ’ Doribax
- Diarrhoea.
- Dijarea.
It is important that you tell your doctor if you have bloody diarrhoea before, during or
Huwa importanti li inti tgħid lit- tabib tiegħek jekk ikollok dijarea bid- demm qabel,
after your treatment with Doribax.
waqt jew wara kura b’ Doribax.
This is because you may have a condition known as colitis (an inflammation of the bowel).
Dan minħabba li inti jista ’ jkollok kundizzjoni magħrufa bħala kolite (infjammazzjoni tal- musrana).
Do not take any medicine to treat diarrhoea without first checking with your doctor.
Tieħux mediċini biex tikkura d- dijarea mingħajr ma l - ewwel tiċċekkja mat- tabib tiegħek.
Convulsions have infrequently been reported during treatment with closely related antibiotics.
22 Aċċessjonijiet ġew irrappurtati b’ mod mhux frekwenti waqt kura b’ antibijotiċi relatati mill- qrib.
21 While antibiotics including Doribax kill certain bacteria, other bacteria and fungi may continue to grow more than normal.
Filwaqt li l- antibijotiċi inkluż Doribax joqtlu ċerti batterji, batterji oħra u moffa jistgħu jkomplu jikbru aktar minn normal.
This is called overgrowth.
Dan huwa magħruf bħala tkabbir żejjed.
Your doctor will monitor you for overgrowth and treat you if necessary.
It- tabib tiegħek se jimmonitorjak għal dan it- tkabbir żejjed u jikkurak jekk ikun meħtieġ.
Doribax should not be inhaled as it may cause inflammation of the lung (pneumonitis).
Doribax m’ għandux jittieħed man- nifs minħabba li jista ’ jikkawża infjammazzjoni tal- pulmun (pulmonite).
Doribax should not be given to children or adolescents (under 18 years of age) as there is not enough information to be sure that Doribax can be used safely in children or adolescents.
Doribax m’ għandux jingħata lit- tfal jew adoloxxenti (taħt it- 18- il sena) minħabba li m’ hemmx informazzjoni biżżejjed biex ikun żgurat li Doribax jista ’ jintuża mingħajr periklu fit- tfal jew fl - adoloxxenti.
Taking other medicines Always tell your doctor or pharmacist if you are taking or have recently taken any other medicines, This includes medicines you get without a prescription or herbal medicines.
Dawn jinkludu mediċini li inti tikseb mingħajr riċetta jew mediċini tal- ħxejjex.
Tell your doctor if you are taking medicines called valproic acid (used to treat epilepsy, bipolar disorder, migraines or schizophrenia) or probenecid (used to treat gout or high levels of uric acid in the blood) as these medicines may affect Doribax.
Għid lit- tabib tiegħek jekk tkun qed tieħu mediċina imsejjħa valproic acid (jintuża biex jikkura l- epilessija, disturb bipolari, migranji u skizofrenja) jew probenecid (jintuża biex jikkura il- gotta jew livelli għolja ta ’ aċidu uriku fid- demm) minħabba li dawn il- mediċini jistgħu jaffettwaw lil Doribax.
Pregnancy and breast -feeding Tell your doctor or pharmacist before using Doribax if:
Tqala u Treddigħ Għid lit- tabib jew lill- ispiżjar tiegħek qabel tuża Doribax jekk:
- You are pregnant or think you may be pregnant.
- Inti tqila jew taħseb li inti tqila.
Your doctor will decide whether you should use
It- tabib tiegħek jiddeċiedi jekk inti għandekx tuża Doribax.
- You are breast-feeding or if you plan to breast-feed.
- Inti qed tredda ’ jew jekk qed tippjana li se tredda ’.
Small amounts of this medicine may pass into
Ammonti żgħar minn din il- mediċina jistgħu
breast milk and it may affect the baby.
jgħaddu ġol- ħalib tas- sider u tista ’ taffettwa t- tarbija.
Therefore, your doctor will decide whether you should use Doribax while breastfeeding.
Għalhekk, it- tabib tiegħek se jiddeċiedi jekk inti għandekx tuża Doribax waqt li qed tredda ’.
Driving and using machines Doribax is not likely to affect your ability to drive or operate machinery.
Sewqan u tħaddim ta ’ magni Doribax x’ aktarx li ma jaffettwax il- ħila tiegħek biex issuq jew tħaddem magni.
HOW TO USE DORIBAX
KIF GĦANDEK TUŻA DORIBAX
How Doribax is given
Kif jingħata Doribax
- Doribax will be prepared and given to you by a doctor or nurse over one or four hours as an
- Doribax se jiġi ppreparat u jingħatalek minn tabib jew infermier fuq perjodu ta ’ siegħa jew
intravenous infusion into one of your veins (this is sometimes known as a “drip”)
erba ’ sigħat bħala infużjoni fil- vina ġo waħda mill- vini tiegħek (dan xi drabi huwa magħruf bħala “ dripp ”)
How much Doribax is given
Kemm jingħata Doribax
- Your doctor will decide how much Doribax you need and for how long
- It- tabib tiegħek jiddeċiedi kemm inti għandek bżonn Doribax u għal kemm tul ta ’ żmien
Adults (including people over 65 years of age)
Adulti (inkluż persuni ’ l fuq minn 65 sena)
Each dose is given over a period of one or four hours
- Id- doża tas- soltu hija ta ’ 500 mg mogħtija fuq perjodu ta ’ siegħa jew erba ’ sigħat kull tmien sigħat
- The course usually lasts 5 to 14 days
- Il- kors is- soltu jdum bejn 5 u 14- il ġurnata
- If you have kidney problems, your doctor may lower your dose of Doribax to 250 mg given over
- Jekk inti għandek problemi bil- kliewi, it- tabib tiegħek jista ’ jnaqqas id- doża tiegħek ta ’ Doribax
one or four hours every eight or 12 hours
għal 250 mg mogħtija fuq perjodu ta ’ siegħa jew erba ’ sigħat kull tmien sigħat jew kull tnax- il siegħa.
If you use more Dorib ax than you should If you are concerned that you may have been given too much Doribax, talk to your doctor or pharmacist straight away.
Jekk tuża Doribax aktar milli suppost Jekk inti inkwetat/ a li ngħatajt Doribax aktar milli suppost tkellem mat- tabib jew ma ’ l- ispiżjar tiegħek minnufih.
If a Doribax dose has been missed If you are concerned that you may have missed a dose of Doribax, talk to your doctor or pharmacist straight away.
Jekk tkun tlift doża ta ’ Doribax Jekk inti inkwetat/ a li stajt tlift doża ta ’ Doribax, kellem lit- tabib jew lill- ispiżjar tiegħek mill- ewwel.
It is important that you receive treatment with Doribax as long as your doctor feels it is necessary.
Huwa importanti li inti tieħu kura b’ Doribax għat- tul ta ’ żmien li t- tabib iħoss li huwa meħtieġ.
If you have any further questions on the use of Doribax, ask your doctor or pharmacist.
23 Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ Doribax, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Doribax can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Doribax jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The frequency of possible side effects listed below is defined using the following convention: 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 (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Il- frekwenza ta ’ effetti sekondarji possibbli kif imniżżel hawn taħt hija iddefinita fil- konvenjoni kif ġej: komuni ħafna (jaffettwaw aktar minn persuna waħda minn kull 10) komuni (jaffettwaw minn 1 sa 10 persuna minn kull 100) mhux komuni (jaffetwaw minn 1 sa 10 persuna kull 1, 000) rari (jaffetwaw minn 1 sa 10 persuni kull 10, 000) rari ħafna (jaffetwaw inqas minn persuna kull 10, 000) mhux magħruf (il- frekwenza ma ’ tistax tiġi stmat mid- data disponibbli)
- Headache
- Uġigħ ta ’ ras
- Rash, itching or hives
- Raxx, ħakk jew ħorriqija
Tell your doctor straight away if you get bloody diarrhoea before, during or after your
Għid lit- tabib tiegħek mill- ewwel jekk taqbdek dijarea bid- demm qabel, waqt jew wara
treatment with Doribax
l- kura tiegħek b’ Doribax
- Feeling sick (nausea)
- Tħossok se tirremetti (tqalligħ)
- Vein wall inflammation where the intravenous infusion (or “drip”) goes into your vein (phlebitis)
- Infjammazzjoni tal- ħajt tal- vina fejn l- infużjoni fil- vina (jew “ dripp ”) tidħol fil- vina tiegħek
- Fungal infections (thrush) in your mouth or vagina
- Infezzjonijiet bil- moffa f’ ħalqek jew fil- vaġina
- Increase in the level of some liver enzymes in your blood
- Żieda fil- livell ta ’ xi wħud mill- enzimi tal- fwied fid- demm tiegħek
- Inflammation of the bowel with diarrhoea (Clostridium difficile colitis)
- Infjammazzjoni tal- musrana bid- dijarea (kolite bi Clostridium difficile)
These
- Nefħa f’ daqqa waħda f’ xufftejk, wiċċek, griżmejk jew ilsienek, raxx, problemi biex tibla ’ jew biex
may be signs of a severe allergic reaction (anaphylaxis) and may be life-threatening.
Dawn jistgħu jkunu sinjali ta ’ reazzjoni ta ’ allerġija qawwija (anafilassi) u jistgħu jkunu ta ’ periklu għall- ħajja.
Tell your doctor straight away if you get these as you may need urgent medical treatment.
Għid lit- tabib tiegħek mill- ewwel jekk ikollok dawn is- sintomi minħabba li inti jista ’ jkollok bżonn kura medika urġenti.
The following side effect was also seen in a small number of patients:
L- effett sekondarju li ġej deher ukoll f’ numru żgħir ta ’ pazjenti:
- Decrease of white blood cells which may increase your risk of infections.
- Tnaqqis fiċ- ċelloli bojod li jistgħu jżidu r- riskju tiegħek ta ’ infezzjonijiet.
HOW TO STORE DORIBAX
KIF TAĦŻEN DORIBAX
Do not use this medicine after the expiry date stated on the container.
Tużax din il- mediċina wara d- data ta ’ skadenza li tidher fuq il- kunjett.
The first two numbers indicate the month.
L- ewwel żewġ numri jindikaw ix- xahar.
The next four numbers indicate the year.
It- tieni erba ’ numri jindikaw is- sena.
These measures will help to protect the environment.
Dawn il - miżuri jgħinu għall- protezzjoni ta ’ l- ambjent.
What Doribax contains
X’ fih Doribax
- The active substance is doripenem.
- Is- sustanza attiva hija doripenem.
Each vial contains doripenem monohydrate equivalent to
Kull kunjett fih doripenem monohydrate ekwivalenti għal
500 mg doripenem
500 mg ta ’ doripenem
23 What Doribax looks like and contents of the pack Doribax is a white to slightly yellowish off-white crystalline powder in a glass vial.
Id- Dehra ta ’ Doribax u l- kontenuti tal- pakkett Doribax huwa trab kristallin abjad sa abjad jagħti ftit fl- isfar f’ kunjett tal- ħġieġ.
Doribax is supplied in packs of 10 vials.
Doribax jiġi f’ pakketti ta ’ 10 kunjetti.
Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium
Janssen- Cilag International NV Turnhoutseweg 30 B- 2340 Beerse Il- Belġju
Manufacturer Janssen Pharmaceutica Turnhoutseweg 30 B-2340 Beerse Belgium
Turnhoutseweg 30 B- 2340 Beerse Il- Belġju
For any information about this medicinal product, 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:
France JANSSEN-CILAG Tel:
25 France JANSSEN- CILAG Tel:
This leaflet was last approved in MM/YYYY
Dan il- fuljett kien approvat l- aħħar f ’ XX/ SSSS
Detailed information on this medicine is available on the European Medicines Evaluation Agency (EMEA) website: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /
Doribax is reconstituted and then further diluted prior to infusion.
Doribax huwa rikostitwit imbagħad dilwit aktar qabel l- infużjoni.
Preparation of 500 mg dose of solution for infusion
Il- preparazzjoni ta ’ soluzzjoni ta ’ doża ta ’ 500 mg għall- infuzjoni
Add 10 ml of sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to the vial and shake it to form a suspension 2.
Żid 10 ml ta ’ ilma sterili għall- injezzjonijiet jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għall- injezzjoni fil- kunjett u ħawwdu biex tifforma suspensjoni.
Preparation of 250 mg dose of solution for infusion for patients with moderate or severe renal impairment
26 Il- preparazzjoni ta ’ soluzzjoni ta ’ doża ta ’ 250 mg għall- infuzjoni għal pazjenti b’ indeboliment moderat jew qawwi tal- kliewi
Remove 55 ml of this solution from the infusion bag and discard.
Neħħi 55 ml minn din is- soluzzjoni mill- borża ta ’ l- infużjoni u armiha.
25 Doribax solutions for infusion range from clear, colourless solutions to solutions that are clear and slightly yellow.
Soluzzjonijiet ta ’ Doribax għall- infużjoni jistgħu jkunu minn soluzzjonijiet trasparenti bla kulur sa soluzzjonijiet trasparenti u jagħtu ftit fl- isfar.
Storage of reconstituted solutions
Ħażna ta ’ soluzzjonijiet rikostitwiti
Upon reconstitution with sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, Doribax suspension in the vial may be held for up to 1 hour below 30°C prior to transfer and dilution in the infusion bag.
Hekk kif jiġi rikostitwit b’ ilma sterili għall- injezzjonijiet jew soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għall- injezzjoni, is- suspensjoni ta ’ Doribax fil- kunjett tista ’ tinżamm sa siegħa f’ temperatura anqas minn 30°C qabel ma tiġi trasferita u ddilwita fil- borża ta ’ l- infużjoni.
Following dilution in the infusion bag with sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection, Doribax infusions stored at controlled room temperature or under refrigeration should be completed according to the times in the following table:
Wara d- dilwizzjoni fil- borża ta ’ l- infużjoni f’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għall - injezzjoni jew soluzzjoni ta ’ dextrose 50 mg/ ml (5%) għall- injezzjoni, infużjonijiet ta ’ Doribax maħżuna f’ temperatura tal- kamra kkontrollata jew miżmuma fil- friġġ għandhom jintemmu skond il - ħinijiet fit- tabella li ġejja:
Time by which reconstitution, dilution and infusion must complete for Doribax infusions solutions
Il- ħin sa meta r- rikostituzzjoni, id- dilwizzjoni u l- infużjoni għal soluzzjonijiet ta ’ infużjonijiet ta ’ Doribax għandhom jintemmu
Solution stored in a
Soluzzjoni maħżuna fi friġġ (2 °C- 8 °C)
sodium chloride 9 mg/ml (0.9%) solution for injection +
sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni +
temperature 12 hours
12- il siegħa
dextrose 50 mg/ml (5%) solution for injection
dextrose 50 mg/ ml (5%) soluzzjoni għall - injezzjoni
4 hours
4 sigħat
24 hours*
24 siegħa *
*Once removed from the refrigerator, infusions should be completed within the room temperature stability time, provided the total refrigeration time, time to reach room temperature and infusion time does not exceed refrigeration stability time. + Dextrose 50 mg/ml (5%) solution for injection should not be used for infusion durations greater than 1 hour.
* Ladarba mneħħija mill- friġġ, l- infużjonijiet għandhom jintemmu fil- ħinijiet ta ’ stabbiltà tat - temperatura tal- kamra, bil- kundizzjoni li l- ħin totali li jinżammu fil- friġġ, il- ħin li jieħdu biex jilħqu it- temperatura tal- kamra u l- ħin ta ’ l- infużjoni ma jkunux aktar mill- ħin ta ’ stabbilità meta jkunu fil - friġġ. + dextrose 50 mg/ ml (5%) soluzzjoni għall- injezzjoni m’ għandux jintuża għal infużjonijiet li jdumu aktar minn siegħa.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, il- kundizzjonijiet u l- ħinijiet tal- ħażna waqt l- użu huma r- responsabbiltà ta ’ min qed jużah u normalment ma jkunux aktar minn 24 siegħa f’ temperatura bejn 2 °C- 8 °C, sakemm ir - rikostituzzjoni/ dilwizzjoni ma tkunx saret f’ kundizzjonjiet asettiċi kkontrollati u validati.
EMEA/ H/ C/ 476
, EMEA/ H/ C/ 476
What is Dukoral?
X’ inhu Dukoral?
Dukoral is a vaccine, which is available as a suspension in a vial.
Dukoral huwa vaċċin, li jiġi bħala sospensjoni fi fjala.
It contains four different inactivated (killed) strains (types) of the bacterium Vibrio cholerae (V. cholerae) serotype O1, and part of a toxin from one of these strains as active substances.
Huwa magħmul minn erba ’ razez (tipi) inattivati (maqtula) tal- batterju Vibrio cholerae( V. cholerae) serotip O1 u parti minn tossin minn waħda minn dawn ir- razez bħala sustanzi attivi.
Dukoral is supplied with granules in a sachet to help make it up into an oral suspension.
Dukoral jiġi fornut ma ’ granuli f’ qartas li jgħinuh jinħall f’ sospensjoni orali.
What is Dukoral used for?
Għalxiex jintuża Dukoral?
Dukoral is used to protect against cholera (a very serious disease caused by V. cholerae, which is caught from contaminated food or water and causes severe diarrhoea).
Dukoral jintuża bħala protezzjoni kontra l- kolera (marda serja ħafna kkawżata mill- V. cholerae, li tittieħed minn ikel jew ilma kkontaminat u li jikkawża dijarea severa).
Dukoral is used in adults, adolescents and children from two years of age who will be visiting high-risk areas.
Dukoral jintuża fl- adulti, adoloxxenti u fit- tfal li jkunu għalqu s- sentejn li jkunu sejrin f’ postijiet b’ riskju serju.
Dukoral should be given according to official recommendations, taking into account where cholera is found and the risk of contracting the disease.
Dukoral għandu jingħata skond ir- rakkomandazzjonijiet uffiċjali, billi wieħed iqis fejn tinstab il- kolera u r- riskju tat - teħid tal- marda.
Dukoral should not replace standard protective measures against cholera, including paying attention to advice on diet and hygiene.
Dukoral m’ għandux jieħu post il- miżuri ta ’ protezzjoni standard kontra l- kolera, inkluż li wieħed isegwi pariri dwar id- dieta u l- iġjene.
How is Dukoral used?
Kif jintuża Dukoral?
Dukoral is taken by mouth.
Dukoral jittieħed mill- ħalq.
In adults and children from six years of age, Dukoral is given as two doses, one to six weeks apart.
Fl- adulti u fit- tfal minn sitt snin ’ il fuq, Dukoral jingħata f’ żewġ dożi, b’ bejn ġimgħa u sitt ġimgħat.
Children aged between two and six years should receive three doses, with an interval of one to six weeks between each dose.
It- tfal ta ’ bejn sentejn u sitt ġimgħat jingħataw tliet dożi, b’ intervall ta ’ bejn ġimgħa u sitt ġimgħat bejn kull doża.
The course should be completed at least one week before potential exposure to cholera.
Il- kors għandu jitlesta tal- anqas ġimgħa qabel ma l- persuni jkunu potenzjalment esposti għall- kolera.
For continuous protection against cholera, a single booster dose is recommended after two years for adults and children from six years of age, and after six months for children aged between two and six years.
Għall- protezzjoni kontinwa kontra l- kolera, huwa rakkomandat li tingħata doża booster waħdanija wara sentejn għall- adulti u t- tfal li jkollhom iktar minn sitt snin, u wara sitt xhur għal tfal ta ’ bejn sentejn u sitt snin.
The vaccine is made up by dissolving the granules in a glass of water to prepare an effervescent (sparkling) solution, and adding the contents of the vial.
Il- vaċċin jinħall bit- taħlit tal- granuli f’ tazza ilma biex tiġi ppreparata soluzzjoni effervexxenti (tfexfex) u biż- żieda tal- kontenut tal- fjala.
Once prepared, the suspension should be drunk within two hours.
Ladarba tiġi ppreparata, is- soluzzjoni għandha tinxtorob fi żmien sagħtejn.
Food, drink and other medicines taken by mouth should be avoided for one hour before and one hour after each dose of Dukoral.
Għandu jiġi evitat ikel, xorb u mediċini oħra bejn siegħa qabel u siegħa wara kull doża ta ’ Dukoral.
How does Dukoral work?
Kif jaħdem Dukoral?
Dukoral is a vaccine.
Dukoral huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to protect itself against a disease.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id- difiżi naturali tal - ġisem) kif tipproteġi ruħha kontra l- marda.
Dukoral contains small amounts of killed cholera bacteria and a part of the cholera toxin called the ‘ B subunit’.
Dukoral fih ammonti żgħar tal- batterju tal- kolera maqtul u parti mit- tossin tal- kolera magħruf bħala ‘ B subunit ’.
This subunit is not toxic by itself.
Dan is- subunit mhuwiex tossiku fih innifsu.
These antibodies will help to protect against cholera by preventing the bacteria and the toxins from attaching to the walls of the gut and entering the body’ s cells.
Dawn l- antikorpi jgħinu fil- protezzjoni kontra l- kolera billi jipprevjenu lill- batterji u lit- tossini milli jeħlu mal- ħitan tal- imsaren u jidħlu fiċ- ċelloli tal- ġisem.
In Dukoral, the cholera toxin is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce the toxin.
F’ Dukoral, it- tossin prodott mill- kolera jiġi prodott b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: jiġi magħmul minn batterju li jkun irċieva ġene (DNA), li jagħmlu kapaċi jipproduċi t - tossin.
How has Dukoral been studied?
Kif ġie studjat Dukoral?
As Dukoral has been in use in Sweden since 1991, the company presented the results of three main studies that had already been carried out in order to support the use of Dukoral.
Billi Dukoral ilu jintuża fl- Iżvezja sa mill- 1991, il- kumpanija ppreżentat ir- riżultati ta ’ tliet studji ewlenin li diġà kienu saru biex jappoġġjaw l- użu ta ’ Dukoral.
The company also presented data from the published literature.
Il- kumpanija ppreżentat ukoll dejta mil - letteratura ppubblikata.
The three main studies involved a total of almost 113,000 people.
Fit- tliet studji ewlenin b’ kollox ħadu sehem kważi 113, 000 ruħ.
In all three studies, the effectiveness of Dukoral, given as either two or three doses, was compared with that of placebo (a dummy vaccine).
Fit- tliet studji li huma, l- effettività ta ’ Dukoral, mogħti f’ żewġ jew tliet dożi, tqabblet ma ’ dik ta ’ plaċebo (vaċċin finta).
The studies took place in areas where cholera is found.
L- istudji saru f’ postijiet fejn tinstab il- kolera.
The first study involved over 89,000 people in Bangladesh and compared the effects of Dukoral with the effects of the vaccine without the toxin and with the effects of placebo.
Fl- ewwel studju kienu involuti 89, 000 ruħ fil- Bangladexx u ġew imqabbla l- effetti ta ’ Dukoral (magħmul bl- użu ta ’ tossin tal- kolera estratt mill- batterju tal- kolera) mal- effetti tal- plaċebo.
The other two studies compared Dukoral (containing recombinant cholera toxin) with placebo in over 22,000 people in Peru.
F’ dan l- istudju, Dukoral ġie magħmul bl- użu tat- tossin tal- kolera estratt mill - batterja tal- kolera minflok it- tossin rikombinanti li huwa aktar ġdid. Iż- żewġ studji l- oħra qabblu Dukoral (li jkun fih it- tossin tal- kolera rekombinat) mal- plaċebo fi 22, 000 ruħ fil- Perù.
The people in the final study also received a booster dose 10 to 12 months later.
In- nies fl- aħħar studju ngħataw ukoll doża booster bejn 10 u 12- il xahar wara.
In all three studies, the main measure of effectiveness was the ‘ protective effectiveness ’ of the vaccine, calculated by comparing the number of people in the studies who developed cholera after receiving Dukoral and after receiving placebo.
Fit- tliet studji li huma, il- mezz ewlieni tal- kejl tal- effettività kien l- effettività protettiva tal- vaċċin, ikkalkulata mit- tqabbil tan- numru ta ’ nies fl- istudju li żviluppaw il- kolera wara li jkunu ngħataw Dukoral u wara li jkunu ngħataw il- plaċebo.
A further study was carried out to show that Dukoral could produce antibodies in people who do not come from areas where cholera is found.
Sar studju ieħor biex juri li Dukoral ikun jista ’ jipproduċi antikorpi f’ persuni li ma jkunux minn żoni fejn tinstab il- kolera.
The company also presented information on the use of Dukoral for the prevention of a severe type of traveller’ s diarrhoea caused by a bacterium called ‘ enterotoxigenic Escherichia coli’.
Il- kumpanija ppreżentat ukoll dejta dwar l- użu ta ’ Dukoral għall- prevenzjoni ta ’ tip sever ta ’ dijarea tal- vjaġġaturi kkawżata minn batterju magħruf bħala ‘ Escherichia coli enterotossiġeniku ’.
What benefit has Dukoral shown during the studies?
Liema benefiċċju wera Dukoral waqt l- istudji mwettqa?
In the study in Bangladesh, the protective effectiveness of Dukoral was 85% over the first six months of follow-up.
Fl- istudju tal- Bangladexx, l- effettività protettiva ta ’ Dukoral kienet 85% matul l- ewwel sitt xhur ta ’ sorveljanza.
The length of vaccine protection was different for adults and children, lasting for six months in children and for two years in adults.
Kemm idum l- effett tal- protezzjoni mit- tilqima jvarja mill- adulti għat- tfal u jdum sitt xhur fit- tfal u sentejn fl- adulti.
In adults, two vaccine doses were shown to be as effective as three.
Fl- adulti, intwera li d- doża ta ’ żewġ tilqimiet kienet effettiva daqs tlieta.
In the first of the two studies in Peru, the protective effectiveness of Dukoral was 85% for the first five months of follow-up.
Fl - ewwel studju miż- żewġ studji fil- Perù, l- effettività protettiva ta ’ Dukoral kienet 85% għall- ewwel ħames xhur sorveljanza.
The other study in Peru showed that after a booster dose, the protective effectiveness of Dukoral during the second year of follow-up was 61%.
L- studju l- ieħor li sar fil- Perù wera li wara doża booster, l- effettività protettiva ta ’ Dukoral waqt it- tieni sena ta ’ sorveljanza, kienet 61%.
The information presented was not sufficient to support the use of Dukoral in traveller’ s diarrhoea.
L- informazzjoni ppreżentata ma kinitx biżżejjed biex tappoġġja l- użu ta ’ Dukoral fid- dijarea tal - vjaġġatur.
What is the risk associated with Dukoral?
X’ inhu r- riskju assoċjat ma ’ Dukoral?
Side effects with Dukoral are not common.
Mhumiex komuni effetti sekondarji fl- użu ta ’ Dukoral.
However, the following side effects are seen in between 1 and 10 patients in 1,000: headache, diarrhoea, and abdominal (tummy) pain, cramps, gurgling (gas) or discomfort.
Minkejja dan, l- effetti sekondarji li ġejjin jidhru f’ bejn pazjent 1 u 10 minn kull 1, 000: huma l- uġigħ ta ’ ras, id- dijarea, u l- uġigħ ta ’ żaqq, bugħawwieġ, gass jew skumdità.
For the full list of side effects reported with Dukoral, see the Package Leaflet.
Għal- lista sħiħa tal -- effetti sekondarji rrappurtati ma ’ Dukoral, ara l - Fuljett ta ’ Tagħrif.
Dukoral should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to formaldehyde.
Dukoral m’ għandux jintuża fi tfal li jistgħu jkunu ipersensittivi (allerġiċi) għal kwalunkwe mis - sustanzi attivi mal- ingredjenti l- oħra jew ma ’ formaldeyde.