qanastek/EMEA-V3 huggingface dataset:
If you have been told by your doctor that you or your child has an intolerance to some sugars, inform your doctor before you or your child takes this vaccine.
Jekk it- tabib tiegħek ikun qallek li inti jew it- tifel/ tifla tiegħek għandkom intolleranza għal xi zokkrijiet, għid lit- tabib tiegħek qabel ma inti jew it- tifel/ tifla tiegħek tieħdu din it - tilqima.
HOW TO USE ProQuad
KIF JINTUŻA ProQuad
ProQuad should be injected under the skin in the upper arm or in the outer thigh.
ProQuad għandu jiġi injettat taħt il- ġilda, preferibbilment fil- parti ta 'fuq tad- dirgħajn jew fil- parti ta' barra tal- koxxa.
ProQuad is not to be injected directly into any blood vessel.
ProQuad ma għandux jiġi injettat direttament f' xi vina.
ProQuad is given by injection to persons from 12 months of age.
ProQuad jingħata b' injezzjoni lil persuni minn 12- il xahar 'il fuq.
The appropriate time and number of injections will be determined by your doctor using appropriate official recommendations.
Il- ħin meta għandu jingħata u n - numru ta 'injezzjonijiet jiġu stabbiliti mit- tabib tiegħek permezz ta' rakkomandazzjonijiet uffiċjali xierqa.
Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet
L- istruzzjonijiet dwar ir- rikonstituzzjoni maħsubin għall- professjonisti fil- qasam mediku huma nklużi fil- parti ta 'l- aħħar tal- fuljett
If you forget to take ProQuad
Jekk tinsa tieħu ProQuad
Your doctor will decide when to give the missed dose.
It- tabib tiegħek jiddeċiedi meta għandha tingħata d- doża li tkun inqabżet.
Like all medicines, ProQuad can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ProQuad jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most common side effects reported with the use of ProQuad were: injection site complaints including pain/ tenderness/ soreness, redness, swelling or bruising; fever (38.9°C or higher); irritability; rash (including measles-like rash, varicella-like rash, viral exanthema, and injection site rash); upper respiratory infection; vomiting and diarrhoea.
L- aktar effetti sekondarji komuni rrapportati bl- użu ta 'ProQuad kienu: ilmenti fis- sit ta' l- injezzjoni inkluż uġigħ/ tenerezza/ ħruxija, ħmurija, nefħa jew tbenġil; deni (38. 9°C jew ogħla); irritabilità; raxx (inkluż raxx simili għall- ħosba, raxx simili għall- ġidri r- riħ, eksantema virali, u raxx fis- sit ta 'l - injezzjoni); infezzjoni fil- parti ta' fuq ta 'l- apparat respiratorju; rimettar u dijarea.
Other less common side effects have been reported following administration of ProQuad and some of these were serious.
Effetti sekondarji oħra inqas komuni ġew irrapportati wara għoti ta 'ProQuad u xi wħud minn dawn kienu serji.
These included: allergic reactions (hives); seizures with a fever; cough and bronchiolitis (difficulty breathing with or without cough); and unsteadiness with walking.
Dawn jinkludu: reazzjonijiet allerġiċi (ħorriqija); attakk ta 'puplesija b' deni; sogħla u bronkite (diffikultà fit- teħid tan- nifs bi jew mingħajr sogħla); u nuqqas ta' fermezza waqt il- mixi.
Other side effects have been reported with the use of either measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., the monovalent components of the measles, mumps, and rubella vaccine produced by Merck & Co., Inc., or Varicella Vaccine live (Oka/ Merck): unusual bleeding or bruising under the skin, swelling of the testicles; tingling of the skin, herpes zoster (shingles); inflammation of the brain (encephalitis); severe skin disorders; skin infection; stroke; seizures without a fever; joint pain and/ or swelling (which could be transient or chronic); and inflammation of the lung (pneumonia/ pneumonitis).
Effetti sekondarji oħra ġew irrapportati bl- użu ta 'jew it- tilqima tal- ħosba, gattone, u rubella mmanifatturata minn Merck & Co., Inc., il- komponenti monovalenti tat- tilqima tal- ħosba, gattone, u rubella prodotta minn Merck & Co., Inc., jew Varicella Vaccine live (Oka/ Merck): fsad jew tbenġil taħt il- ġilda mhux normali, nefħa fit- testikoli; ħakk fil- ġilda, herpes zoster (ħruq ta' Sant' Antnin); infjammazzjoni tal- moħħ (enċefalite); mard sever tal- ġilda; infezzjoni tal- ġilda; puplesija; aċċessjonijiet mingħajr deni; uġigħ u/ jew nefħa fil- ġogi (li jistgħu jgħaddu jew jkunu kroniċi); u infjammazzjoni tal- pulmun (pnewmonja/ pulmonite).
The doctor has a more complete list of side effects for ProQuad and for the vaccine components for ProQuad (the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. and Varicella Vaccine live (Oka/ Merck)).
48 It- tabib għandu lista ta 'effetti sekondarji aktar kompleta għal ProQuad u għall- komponenti tat- tilqima għal ProQuad (it- tilqima tal- ħosba, gattone, u rubella mmanifatturata minn Merck & Co., Inc. u l - Vaċċin tal- Varicella live (Oka/ Merck)).
HOW TO STORE ProQuad
KIF TAĦŻEN ProQuad
Keep the vial in the outer carton in order to protect from light.
Żomm il- kunjett fil- kaxxa tal- kartun biex tipproteġih mid- dawl.
Do not use ProQuad after the expiry date which is stated on the outer carton after EXP.
Tużax ProQuad wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna ta ’ barra wara JIS.
FURTHER INFORMATION
GĦALL - AKTAR TAGĦRIF
What ProQuad contains
Wara rikonstituzzjoni, doża waħda (0. 5 ml) fiha:
After reconstitution, one dose (0.5 ml) contains:
Virus tal- gattone1 razza Jeryl Lynn™ (Livell B) (ħaj, attenwat)........... mhux CCID50 *
The active substances are:
inqas minn 3. 00 log10
Measles virus1 Enders’ Edmonston strain (live, attenuated).................. not less than 3.00 log10 CCID50* Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated)............. not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated)......................... not less than 3.00 log10 CCID50* Varicella virus3 Oka/ Merck strain (live, attenuated).............................. not less than 3.99 log10 PFU**
Virus tal- ġidri r- riħ1, razza Oka/ Merck (ħaj, attenwat).......................... mhux log10 PFU **
*50% cell culture infectious dose ** plaque-forming units
* 50% doża infettuża tal- kultura taċ- ċelloli ** unitajiet li jiffurmaw plakek
(2) Produced in human diploid lung (WI-38) fibroblasts.
(2) Prodott f 'fibroblasti diplojdi tal- pulmun uman (WI- 38) i.
(3) Produced in human diploid cells (MRC-5).
(3) Prodott f' ċelloli diplojdi umani (MRC- 5).
The other ingredients are:
L- ingredjenti l- oħra huma:
Powder Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks’ Salts, MEM, neomycin, phenol red, hydrochloric acid and sodium hydroxide.
Trab Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 b' Hanks ’ Salts, MEM, neomycin, phenol red, hydrochloric acid u sodium hydroxide.
The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be mixed with solvent provided with the vial of powder.
49 Id- dehra ta 'ProQuad u l- kontenut tal- pakkett It- tilqima hija f' għamla ta' trab għal sospensjoni għall- injezzjoni f' kunjett ta 'doża waħda, li għandha tiġi mħallta bis- solvent mogħti mal- kunjett tat- trab.
ProQuad is available in pack of 1 and pack of 10.
ProQuad huwa disponibbli f' pakkett ta '1 u f' pakkett ta' 10.
Marketing Authorisation Holder and Manufacturer
Id- detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
Marketing Authorisation Holder:
Id- Detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq:
Merck Sharp and Dohme, B. V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Merck Sharp and Dohme, B. V., Waarderweg, 39, NL- 2003 PC2031 BN Haarlem, L- Olanda
48 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.
SIA Merck Sharp & Dohme Latvija, Tel: +371.67364.224 Lietuva:
SIA Merck Sharp & Dohme Latvija, Tel: +371. 67364 224 Lietuva:
---------------------------------------------------------------------------------------------------------------------
Dan il- fuljett kien approvat l- aħħar fi: --------------------------------------------------------------------------------------------------------------------- Dan it- tagħrif huwa maħsub għal professjonisti tal- mediċina jew tal- kura tas- saħħa biss:
Reconstitution instructions
Struzzjonijiet ta 'rikostituzzjoni
Before mixing with the solvent, the powder vaccine is a white to pale yellow compact crystalline cake.
Qabel tħallat is- solvent, il- vaċċin f' għamla ta 'trab huwa kejk kristallin kumpatt abjad għal isfar ċar.
When completely mixed, the vaccine is a clear pale yellow to light pink liquid.
Meta mħallat għal kollox, il- vaċċin huwa likwidu isfar ċar għal roża ċar.
Withdraw the entire volume of solvent into a syringe.
50 Iġbed il- volum kollu f' siringa ta 'solvent f' siringa.
It is recommended that the vaccine be administered immediately after reconstitution to minimize loss of potency.
Huwa rrakkomandat li l- vaċċin jingħata minnufih wara rikostituzzjoni, sabiex tnaqqas it- telf tas- saħħa.
Discard if reconstituted vaccine is not used within 30 minutes.
Armi l- vaċċin rikonstitwit jekk ma jintużax fi żmien 30 minuta.
Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the vaccine differs from that described above.
Tużax il- vaċċin rikonstitwit jekk tinnota xi materja ta 'partikulati jew jekk id- dehra tal- vaċċin tkun differenti minn dik deskritta fuq.
49 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
See also section 3 HOW TO USE ProQuad.
Ara wkoll sezzjoni 3 KIF TUŻA ProQuad
50 PACKAGE LEAFLET:
51 FULJETT TA ’ TAGĦRIF:
ProQuad Powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live)
ProQuad Trab u solvent għal sospensjoni għall- injezzjoni f' siringa mimlija għal- lest Vaċċin (ħaj) tal- ħosba, gattone, rubella u ġidri r- riħ
ProQuad is a vaccine containing measles, mumps, rubella, and varicella (chickenpox) viruses that have been weakened.
ProQuad huwa tilqima li fiha l- virus tal- ħosba, tal- gattone, tar- rubella, u tal- ġidri r- riħ (chickenpox) li ġew imdgħajjfa.
When a person is given the vaccine, the immune system (the body’ s natural defences) will make antibodies against the measles, mumps, rubella, and varicella viruses.
Meta persuna tingħata l- vaċċin, is- sistema ta 'l- immunità (id- difiża naturali tal- ġisem) tagħmel antikorpi kontra l- virus tal- ħosba, tal- gattone, tar- rubella, u tal- ġidri r- riħ.
• If your child is allergic (hypersensitive) to any of the components of ProQuad (including neomycin or any of the ingredients listed under “ other ingredients” -see section 6, Further information). • If your child has a blood disorder or any type of cancer that affects the immune system. • If your child is receiving treatment or taking medications that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy). • If your child has a weakened immune system because of a disease (including AIDS). • If your child has a family history of congenital or hereditary immunodeficiency, unless the immune competence of your child is demonstrated. • If your child has active untreated tuberculosis. • If your child has any illness with fever higher than 38.5°C; however, low-grade fever itself is not a reason to delay vaccination. • If your child is pregnant (in addition, pregnancy should be avoided for 3 months after vaccination, see Pregnancy and breast-feeding).
• Jekk it- tifel/ tifla tiegħek huwa/ hija allerġiku/ a (ibati/ tbati minn sensittività eċċessiva) għal xi sustanza ta 'ProQuad (inkluż neomycin jew xi ingredjent elenkat taħt “ ingredjenti oħra ” - ara sezzjoni 6, Aktar informazzjoni). • Jekk it- tifel/ tifla tiegħek ibati/ tbati minn xi disturbi tad- demm jew minn xi tip ta' kanċer li jaffettwa s- sistema ta 'l- immunità. • Jekk it- tifel/ tifla tiegħek qed jirċievi/ tirċievi trattament jew qed jieħu/ tieħu mediċini li jistgħu jdgħajjfu s- sistema ta' l- immunità (għajr terapija ta 'doża baxxa ta' kortikosterojdi għall- ażżma jew terapija ta 'sostituzzjoni). • Jekk it- tifel/ tifla tiegħek għandha sistema ta' immunità mdgħajjfa minħabba marda (inkluż AIDS). • Jekk it- tifel/ tifla tiegħek għandha storja familjari ta 'immunodefiċjenza konġenitali jew ereditarja, sakemm ma tintweriex il- kompetenza ta' l- immunità tat- tifel/ tifla tiegħek. • Jekk it- tifel/ tifla tiegħek għandu/ għandha tuberkolożi attiva mhux trattata. • Jekk it- tifel/ tifla tiegħek għandu/ għandha marda b' deni ogħla minn 38. 5°C; madankollu, deni baxxa m' huwiex raġuni l- għala t- tilqima għandha ddum biex tingħata. • Jekk tifla tiegħek hija tqila (barra minn hekk, it- tqala għandha tiġi evitata għal 3 xhur wara t - tilqima, ara Tqala u Treddigħ).
51 Take special care with ProQuad
52 Oqgħod attent ħafna b' ProQuad
The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulin (IG), or varicella zoster immune globulin (VZIG).
It- tabib jista 'jdewwem it- tilqima għal mill- inqas 3 xhur wara t- trasfużjonijiet ta- demm jew plażma, jew l- għoti ta' globulin immun (IG), jew ġidri r- riħ globulin taz- zoster immune( VZIG).
ProQuad should not be given to pregnant females.
53 ProQuad ma għandux jingħata lil nisa tqal.
52 Persons who are breast-feeding or who intend to breast-feed should tell the doctor.
Persuni li qegħdin ireddgħu jew li għandhom l- intenzjoni li jreddgħu għandhom javżaw lit- tabib.
The doctor has a more complete list of side effects for ProQuad and for the vaccine components for ProQuad (the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. and Varicella Vaccine live (Oka/ Merck)).
54 It- tabib għandu lista ta 'effetti sekondarji aktar kompleta għal ProQuad u għall- komponenti tat- tilqima għal ProQuad (it- tilqima tal- ħosba, gattone, u rubella mmanifatturata minn Merck & Co., Inc. u l - Vaċċin tal- Varicella live (Oka/ Merck)).
The active substances are:
inqas minn 4. 30 log10
Measles virus1 Enders’ Edmonston strain (live, attenuated)........ not less than 3.00 log10 CCID50* Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated)... not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated)............... not less than 3.00 log10 CCID50* Varicella virus3 Oka/ Merck strain (live, attenuated).................... not less than 3.99 log10 PFU**
Virus tar- rubella2 razza Wistar RA 27/ 3 (ħaj, attenwat)........................ mhux CCID50 *
(2) Produced in human diploid lung (WI-38) fibroblasts.
(2) Prodott f 'fibroblasti diplojdi tal- pulmun uman (WI- 38).
What ProQuad looks like and contents of the pack The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be mixed with solvent provided with the vial of powder.
55 Id- dehra ta 'ProQuad u l- kontenut tal- pakkett It- tilqima hija f' għamla ta' trab għal sospensjoni għall- injezzjoni f' kunjett ta 'doża waħda, li għandha tiġi mħallta bis- solvent mogħti mal- kunjett tat- trab.
ProQuad is available in pack of 1, 10 and 20.
ProQuad huwa disponibbli f' pakketti ta '1, 10 u 20 bi jew mingħajr labar.
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal - pakketti jistgħu jiġu kkumerċjalizzati.
54 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.
Sanofi Pasteur MSD, Tlf: +45 23 32 69 29 Deutschland:
Sanofi Pasteur MSD, Tlf: +45 23 32 69 2945 Deutschland:
This leaflet was last approved in:
Dan il- fuljett kien approvat l- aħħar fi:
Reconstitution instructions
Struzzjonijiet ta 'rikonstituzzjoni
Before mixing with the solvent, the powder vaccine is a white to pale yellow compact crystalline cake.
56 Qabel tħallat is- solvent, il- vaċċin f' għamla ta 'trab huwa kejk kristallin kumpatt abjad għal isfar ċar.
. Inject the entire content of the syringe into the vial containing the powder.
Injetta l- kontenut kollu tas- siringa mimlija għal- lest tas- solvent fil- kunjett li fih it- trab.
Gently agitate to dissolve completely.
Ħawwad bil - mod sabiex iddewwbu għal kollox.
55 See also section 3 HOW TO USE ProQuad.
Ara wkoll sezzjoni 3 KIF TUŻA ProQuad
What is Protaphane?
X’ inhu Protaphane?
Protaphane is a range of insulin suspensions for injection.
Protaphane huwa medda ta ’ sospensjonijiet ta ’ l- insulina għall- injezzjoni.
Protaphane is supplied in vials, cartridges (Penfill), or pre-filled pens (InnoLet, NovoLet and FlexPen).
Protaphane huwa pprovdut fi fjali, cartridges (Penfill), jew pinnen mimlija minn qabel (InnoLet, NovoLet u FlexPen).
Protaphane contains the active substance insulin human (rDNA).
Protaphane fih is- sustanza attiva insulina umana (rDNA).
What is Protaphane used for?
Għal xiex jintuża Protaphane?
Protaphane is used in patients with diabetes.
Protaphane jintuża f’ pazjenti bid- dijabete.
How is Protaphane used?
Kif jintuża Protaphane?
Protaphane is given subcutaneously (under the skin) by injection, usually in the thigh.
Protaphane jingħata b’ injezzjoni taħt il- ġilda, ġeneralment fil- koxxa.
If convenient it may also be given in the abdominal wall (tummy), the gluteal region (buttocks) or the deltoid region (shoulder).
Jekk ikun konvenjenti, jista ’ jingħata wkoll fil- ħajt addominali (iż- żaqq), fir- reġjun gluteali (fil- warrani) jew fir- reġjun tad- deltoid (fl- ispalla).
Protaphane is a long-acting insulin, it can be given as a once- or twice-daily injection, with or without a fast-acting insulin (at meal times), according to the doctor’ s recommendation.
Protaphane huwa insulina li taħdem fit- tul, jista ’ jingħata b’ injezzjoni darba jew darbtejn kuljum, ma insulina li taħdem malajr (f’ ħin l- ikel) jew mingħajr, skond ir- rakkomandazzjoni tat- tabib.
How does Protaphane work?
Kif jaħdem Protaphane?
Protaphane is a replacement insulin which identical to the insulin made by the pancreas.
Protaphane hu insulina li tissostitwixxi u hi identika għall- insulina magħmula mill- frixa.
The insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Is - sustanza attiva f’ Protaphane, l- insulina tal- bniedem (rDNA), hi prodotta b’ metodu magħruf bħala ‘ teknoloġija rekombinanti ’: l- insulina hi magħmula minn ħmira li tkun irċeviet ġene (DNA), li b’ hekk tkun tista ’ tipproduċi l- insulina.
Protaphane contains insulin mixed with another substance, protamine, in an ‘ isophane’ form which is absorbed much more slowly during the day.
Protaphane fih insulina mħallta ma ’ sustanza oħra, il- protamina, f’ forma ‘ isophane ’ li hija assorbita ħafna aktar bil- mod matul il- ġurnata.
This gives Protaphane a longer duration of action.
Din tagħti lil Protaphane azzjoni għal żmien itwal.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
L- insulina ta ’ sostituzzjoni taġixxi bl- istess mod bħall- insulina prodotta b’ mod naturali u tgħin lill- glukożju jidħol fiċ- ċelloli mid- demm.
By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Bil- kontroll tal- glukożju fid- demm, is- sintomi u l- kumplikazzjonijiet tad- dijabete jitnaqqsu.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Protaphane been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Protaphane?
Protaphane has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Protaphane ġie studjat f’ erba ’ provi kliniċi ewlenin, li inkludew total ta ’ 557 pazjent bid- dijabete ta ’ l - ewwel tip, li fiha l- frixa ma tkunx tista ’ tipproduċi insulina (żewġ studji bil- parteċipazzjoni ta ’ 81 pazjent), jew dijabete tat- tieni tip, meta l- ġisem ma jkunx jista ’ juża l- insulina b’ mod effettiv (żewġ studji li involvew 476 pazjent).
In most patients, Protaphane was compared with other types of human insulin or insulin analogues.
Fil- biċċa l- kbira tal- pazjenti, Protaphane ġie mqabbel ma ’ tipi oħrajn ta ’ insulina umani jew ma ’ sustanzi analogi għall- insulina.
The studies measured the level of fasting blood glucose or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
L- istudji kejlu l- livell ta ’ glukożju fid - demm waqt sawm jew sustanza fid- demm magħrufa bħala emoglobina glikosalata (glycosylated haemoblobin) (HbA1c), li tagħti indikazzjoni ta ’ kemm il- glukożju fid- demm ikun ikkontrollat sew.
Further studies were also carried out in 225 patients comparing injecting Protaphane using a syringe, or using a pre-filled pen (InnoLet, NovoPen or FlexPen).
Saru studji ulterjuri fuq 225 pazjent li qabblu l- injezzjoni ta ’ Protaphane bl- użu ta ’ siringa, jew b’ pinna mimlija minn qabel (InnoLet, NovoPen jew FlexPen).
What benefit has Protaphane shown during the studies?
X’ inhuma l- benefiċċji ta ’ Protaphane li ntwerew f’ dawn l- istudji?
Protaphane led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Protaphane wassal għal tnaqqis fil- livell ta ’ HbA1c, u b’ hekk indika li l- livelli ta ’ zokkor fid- demm kienu ġew ikkontrollati għal livell simili bħal dak b’ insulina oħra umana.
Protaphane was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pens.
Protaphane kien effettiv għad- dijabete kemm ta ’ l- ewwel tip kif ukoll tat- tieni tip, u meta tintuża injezzjoni standard jew waħda mill- pinen.
What is the risk associated with Protaphane?
X’ inhu r- riskju assoċjat ma ’ Protaphane?
As with all insulins, Protaphane may cause hypoglycaemia (low blood glucose).
Bħal kull insulina oħra, Protaphane jista ’ jikkawża ipogliċemija (livell baxx ta ’ glukożju fid- demm).
For the full list of all side effects reported with Protaphane, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Protaphane, ara l- Fuljett ta ’ Tagħrif.
Protaphane should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Protaphane m’ għandux jingħata lil persuni allerġiċi għall- insulina umana (rDNA) jew għal kwalunkwe ingredjent ieħor.
Protaphane doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose.
Id- dożi ta ’ Protaphane jista ’ wkoll ikollhom jiġu aġġustati meta jingħata ma ’ għadd ta ’ mediċini oħra li jistgħu jaffettwaw il- glukożju fid- demm.
Why has Protaphane been approved?
Għaliex ġie approvat Protaphane?
The Committee for Medicinal products for Human Use (CHMP) decided that Protaphane’ s benefits are greater than its risks for the treatment of diabetes.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Protaphane fit- trattament tad- dijabete huma ikbar mir- riskji tiegħu.
The Committee recommended that Protaphane be given marketing authorisation.
Il- Kumitat irrakkomanda li Protaphane jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Protaphane:
Tagħrif ieħor dwar Protaphane:
The European Commission granted a marketing authorisation valid throughout the European Union for Protaphane to Novo Nordisk A/ S on 7 October 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Protaphane valida fl- Unjoni Ewropea kollha lil Novo Nordisk A/ S fis- 7 ta ’ Ottubru 2002.
The full EPAR for Protaphane is available here.
L- EPAR sħiħ għal Protaphane jinsab hawnhekk.
Protaphane 40 IU/ ml suspension for injection in a vial.
Protaphane 40 UI/ ml suspensjoni g all- injezzjoni f' kunjett
Protaphane is a suspension of isophane (NPH) insulin.
Protaphane huwa suspensjoni ta ’ insulina isophane (NPH).
Protaphane is a long-acting insulin.
Protaphane huwa insulina li ta dem fit- tul.
Protaphane may be used alone or mixed with fast-acting insulin.
Protaphane jista ’ jintu a wa du jew jit allat ma ’ insulina li ta dem malajr.
Protaphane is administered subcutaneously in the thigh.
Protaphane jing ata minn ta t il - ilda fil- koxxa.
Protaphane is accompanied by a package leaflet with detailed instruction for use to be followed.
Protaphane ji i b’ fuljett ta ’ tag rif mieg u, bi struzzjonijiet dettaljati g all- u u li g andhom ji u segwiti.
If an adjustment is needed when switching the patients to Protaphane, it may occur with the first dose or during the first several weeks or months.
Jekk ikun hemm b onn ta ’ xi a ustament meta l- pazjenti jaqilbu g al Protaphane, dan jista ’ jsir ma ’ l- ewwel do a jew matul l - ewwel img at jew xhur.
On rare occasions, injection site reactions may require discontinuation of Protaphane.
F’ okka jonijiet rari, min abba r- reazzjonijiet fil- post ta ’ l- injezzjoni ikun hemm b onn li Protaphane jitwaqqaf.
Protaphane contains metacresol, which may cause allergic reactions.
Protaphane fih metacresol, li jista ’ jikkaw a reazzjonijiet aller i i.
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Konta ettivi orali, tija idi, glukokortikojdi, ormoni tat- tirojde u beta- simpatomimeti i, ormon tat - tikbir u danazol.
However, the Protaphane dosage may need to be adjusted.
Madankollu, jista ’ jkun hemm b onn li d- do a ta ’ Protaphane ji i a ustat.
Frequencies of adverse drug reactions from clinical trials that are considered related to Protaphane are listed below.
Minn studji klini i l- frekwenzi tar- reazzjonijiet avversi tal- medi ina, li huma kkunsidrati li huma konnessi ma ’ Protaphane, huma mni lin hawn ta t.
The frequencies are defined as: uncommon (1/ 1,000 to < 1/ 100).
Il- frekwenzi huma definiti kif ej: mhux komuni (1/ 1, 000, sa < 1/ 100).
5 4.9 Overdose
4. 9 Do a e essiva
6 Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Eliminazzjoni Il- half- life terminali hi stabbilita mir- rata ta ’ l- assorbiment mit- tessuti ta 'ta t il - ilda.
6.4 Special precautions for storage
7 6. 4 Prekawzjonijiet spe jali g all - a na
7 6.6 Special precautions for disposal and other handling
Prekawzjonijiet spe jali li g andhom jittie du meta jintrema u g al immani
After removing Protaphane vial from the refrigerator it is recommended to allow the vial to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tne i l- kunjett ta ’ Protaphane mill- fri, huwa rakkomandat li t alli l- kunjett jil aq it - temperatura ambjentali tal- kamra (mhux i jed minn 25°C) qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni skond l- istruzzjonijiet g all- ewwel u u.
Protaphane 100 IU/ ml suspension for injection in a vial.
Protaphane 100 UI/ ml suspensjoni g all- injezzjoni f' kunjett
On rare occasions, injection site reactions may require discontinuation of Protaphane.
F’ okka jonijiet rari, min abba ir- reazzjonijiet fil- post ta ’ l- injezzjoni ikun hemm b onn li Protaphane jitwaqqaf.
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
13 Assorbiment Il- kon entrazzjoni massima ta ’ l- insulina fil- pla ma tintla aq fi mien 2- 18- il sieg a wara l- g oti minn ta t il - ilda.
13 Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Eliminazzjoni Il- half- life terminali hi stabbilita mir- rata ta ’ l- assorbiment mit- tessuti ta 'ta t il - ilda.
Do not freeze.
14 Tag milhomx fil- fri a.
14 6.6 Special precautions for disposal and other handling
Prekawzjonijiet spe jali li g andhom jittie du meta jintrema u g al immani
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge.
Protaphane Penfill 100 UI/ ml Suspensjoni g all- injezzjoni fi skarto
20 Elimination The terminal half-life is determined by the rate of absorption from the subcutaneous tissue.
Eliminazzjoni Il- half- life terminali hi stabbilita mir- rata ta ’ l- assorbiment mit- tessuti ta 'ta t il - ilda.
6.4 Special precautions for storage
21 6. 4 Prekawzjonijiet spe jali g all - a na
21 6.6 Special precautions for disposal and other handling
Prekawzjonijiet spe jali li g andhom jittie du meta jintrema u g al immani
Cartridges should only be used in combination with products that are compatible with them and allow the cartridge to function safely and effectively.
L- iskarto i g andhom jintu aw biss ma ’ prodotti li jkunu kompatibbli mag hom u li jippermettu li l - iskarto ja dem b’ mod sikur u b’ mod effettiv.
Protaphane Penfill is for single person use only.
Protaphane Penfill hu g all- u u ta ’ persuna wa da biss.
After removing Protaphane Penfill from the refrigerator it is recommended to allow the Penfill to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tne i Protaphane Penfill mill- fri, huwa rakkomandat li t alli l- Penfill jil aq it- temperatura ambjentali tal- kamra (mhux i jed minn 25°C) qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni skond l- istruzzjonijiet g all- ewwel u u.
Date of latest renewal:
22 Data ta ’ l- a
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Protaphane NovoLet 100 UI/ ml Suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest
Protaphane NovoLet is designed to be used with NovoFine needles.
Protaphane NovoLet hi mag mula biex tintu a mal- labar NovoFine.
25 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il - ila biex issuq u t addem magni
26 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari afna - Reazzjonijiet anafilatti i Is- sintomi ta ’ sensittività e essiva eneralizzata jistg u jinkludu raxx eneralizzat tal - ilda, akk, g araq, disturbi gastrointestinali, edima an jonewrotika, diffikultà biex tie u n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ass a in/ tintilef minn sensik.
28 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm o fih
The cartridge is made of glass (type 1), containing a bromobutyl rubber plunger and a bromobutyl/ polyisoprene rubber stopper.
L- iskarto hu tal - ie (tip 1), li fih plan er tal- gomma tal- bromobutyl u tapp tal - gomma tal- bromobutyl/ polyisoprene.
Protaphane NovoLet is for single person use only.
Protaphane NovoLet hi g all- u u minn persuna wa da biss.
After removing Protaphane NovoLet from the refrigerator it is recommended to allow the NovoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tne i Protaphane NovoLet mill- fri, huwa rakkomandat li t alli n- NovoLet til aq it - temperatura ambjentali tal- kamra qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni skond l - istruzzjonijiet g all- ewwel u u.
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Protaphane InnoLet 100 IU/ ml Suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest
Protaphane InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Protaphane InnoLet hi mag mula biex tintu a ma 'labar NovoFine bl- g atu qasir ta' 8 mm jew iqsar.
The needle box is marked with an S.
Il- kaxxa tal- labar hi mmarkata b' S.
32 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il - ila biex issuq u t addem magni
33 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari afna - Reazzjonijiet anafilatti i Is- sintomi ta ’ sensittività e essiva eneralizzata jistg u jinkludu raxx eneralizzat tal - ilda, akk, g araq, disturbi gastrointestinali, edima an jonewrotika, diffikultà biex tie u n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ass a in/ tintilef minn sensik.
35 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm o fih
Protaphane InnoLet is for single person use only.
Protaphane InnoLet hi mag mula biex tintu a minn persuna wa da biss.
After removing Protaphane InnoLet from the refrigerator it is recommended to allow the InnoLet to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tne i Protaphane InnoLet mill- fri, huwa rakkomandat li t alli l- InnoLet til aq it - temperatura ambjentali tal- kamra (mhux i jed minn 25°C) qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni skond l- istruzzjonijiet g all- ewwel u u.
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
Protaphane FlexPen 100 UI/ ml Suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest
Protaphane FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Protaphane FlexPen hi mag mula biex tintu a ma ’ labar NovoFine S ta '8 mm jew iqsar.
39 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il - ila biex issuq u t addem magni
40 Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/ loss of consciousness.
Disturbi fis- sistema immuni Mhux komuni - Urtikarja, raxx Rari afna - Reazzjonijiet anafilatti i Is- sintomi ta ’ sensittività e essiva eneralizzata jistg u jinkludu raxx eneralizzat tal - ilda, akk, g araq, disturbi gastrointestinali, edima an jonewrotika, diffikultà biex tie u n- nifs, palpitazzjonijiet, tnaqqis fil- pressjoni tad- demm u ass a in/ tintilef minn sensik.
42 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm o fih
Protaphane FlexPen is for single person use only.
Protaphane FlexPen hi mag mula biex tintu a minn persuna wa da biss.
After removing Protaphane FlexPen from the refrigerator it is recommended to allow the FlexPen to reach room temperature (not above 25°C) before resuspending the insulin as instructed for first time use.
Wara li tne i Protaphane FlexPen mill- fri, huwa rakkomandat li t alli l- FlexPen til aq it - temperatura ambjentali tal- kamra (mhux i jed minn 25°C) qabel ma l- insulina ter a ’ ti i mag mula f’ suspensjoni skond l- istruzzjonijiet g all- ewwel u u.
Protaphane Penfill and FlexPen
Protaphane Penfill u FlexPen
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 40 UI/ ml suspensjoni g all- injezzjoni f' kunjett Insulina umana (rDNA)
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light During use: do not refrigerate or store above 25°C
A en fi fri (2°C - 8°C) Tag mlux fil- fri a omm il- kunjett fil- kartuna ta ’ barra sabiex tilqa 'mid- dawl Waqt l- u u: tag mlux fil- fri jew ta en f’ temperatura ’ l fuq minn 25°C
Protaphane vial 40 IU/ ml
Protaphane kunjett 40 UI/ ml
Protaphane 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane 40 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 100 UI/ ml suspensjoni g all- injezzjoni f' kunjett Insulina umana (rDNA)
Protaphane vial 100 IU/ ml
Protaphane kunjett 100 UI/ ml
Protaphane 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane 100 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
Protaphane Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Protaphane Penfill 100 UI/ ml suspensjoni g all- injezzjoni fi skarto Insulina umana (rDNA)
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Protaphane Penfill is for use by one person only
U u g al ta t il - ilda L- iskarto i Penfill huma g all- u u ma ’ sistemi ta ’ l- g oti ta ’ insulina Novo Nordisk Er a ’ ifforma suspensjoni skond l- istruzzjonijiet Aqra l- fuljett ta 'tag rif qabel l- u u.
Protaphane Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane Penfill 100 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
Protaphane NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane NovoLet 100 UI/ ml suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest Insulina umana (rDNA)
Subcutaneous use Protaphane NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Protaphane NovoLet is for use by one person only
Protaphane NovoLet huwa g all- u u minn persuna wa da biss.
Store in a refrigerator (2°C - 8°C) Do not freeze Protect from light During use: do not refrigerate or store above 30°C
A en fi fri (2°C - 8°C) Tag mlux fil- fri a Tag mlux fid- dawl Waqt l- u u: tag mlux fil- fri
Protaphane NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane NovoLet 100 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
Protaphane InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane InnoLet 100 UI/ ml uspensjoni g all- injezzjoni f’ pinna mimlija g al- lest Insulina umana (rDNA)
Subcutaneous use Protaphane InnoLet is designed to be used with NovoFine S needles Resuspend according to instructions Read the package leaflet before use Protaphane InnoLet is for use by one person only
Protaphane InnoLet hi g all- u u minn persuna wa da biss
Protaphane InnoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane InnoLet 100 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
Protaphane FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Protaphane FlexPen 100 UI/ ml suspensjoni g all- injezzjoni f’ pinna mimlija g al- lest Insulina umana (rDNA)
Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm Needles are not included Resuspend according to instructions Read the package leaflet before use Protaphane FlexPen is for use by one person only
Protaphane FlexPen huwa g all- u u minn persuna wa da biss.
Protaphane FlexPen 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Protaphane FlexPen 100 UI/ ml suspensjoni g all- injezzjoni Insulina umana (rDNA) G all- u u minn ta t il - ilda
Protaphane 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 40 UI/ ml suspensjoni g all- injezzjoni f 'kunjett Insulina umana (rDNA)
Protaphane Read all of this leaflet carefully before you start using your insulin. – Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tu a din il- medi ina. – omm dan il- fuljett.
WHAT PROTAPHANE IS AND WHAT IT IS USED FOR
X’ INHU PROTAPHANE U G ALXIEX JINTU A
Protaphane is human insulin to treat diabetes.
Protaphane hu insulina umana g all- kura tad- dijabete.
Protaphane is often given in combination with fast-acting insulin products.
Dan ifisser li jibda jbaxxilek il- livell taz- zokkor fid- demm madwar sieg a u nofs wara li tie du, u l- effett idum g al madwar 24 sieg a. afna drabi Protaphane jing ata flimkien ma ’ prodotti ta ’ l- insulina li ja dmu b’ mod malajr.
BEFORE YOU USE PROTAPHANE
QABEL MA TU A PROTAPHANE
Do not use Protaphane
Tu ax Protaphane
If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information).
Jekk inti aller iku/ a (tbati minn sensittività e essiva) g al dan il- prodott ta ’ l- insulina, metacresol jew g al xi wie ed mill- ingredjenti l- o ra (ara 7 Aktar tag rif).
Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
Oqg od attent g as - sinjali ta ’ l- aller ija f' 5 Effetti sekondarji li jista ’ jkollu Jekk t oss li ejja ipo (ipo hi taqsira ta ’ reazzjoni ipogli emika u hija abra ta ’ sintomi li jindikaw livell baxx ta 'zokkor fid- demm).
Take special care with Protaphane
Oqg od attent afna b’ Protaphane
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections.
Jekk g andek problemi tal- kliewi jew tal- fwied, jew tal- glandola adrenali, pitwitarja jew tat - tirojde Jekk qed tixrob l- alko ol: oqg od attent/ a g as- sinjali ta ’ xi ipo u qatt m' g andek tixrob l - alko ol fuq stonku vojt Jekk tag mel e er izzju fi iku aktar mis- soltu jew jekk trid tibdel id- dieta normali tieg ek Jekk inti marid/ a: kompli u l- insulina tieg ek Jekk ser issiefer: li tivvja a bejn oni tal - in differenti, jista 'jaffettwa l - ti ijiet tieg ek g all- insulina u l - in meta tie u l- injezzjonijiet.
75 Pregnancy and breast-feeding
Tqala u treddig
HOW TO USE PROTAPHANE
KIF G ANDEK TU A PROTAPHANE
Before using Protaphane
Qabel tu a Protaphane
Check the label to make sure it is the right type of insulin Disinfect the rubber membrane with a medicinal swab.
Iddi infetta l- membrana tal- gomma b’ tajjara medi inali
In insulin infusion pumps If the protective cap is loose or missing.
F’ pompi ta ’ l- infu joni ta ’ l- insulina Jekk l- g atu prottetiv ma jkunx issikkat jew ikun nieqes.
If it isn’ t in perfect condition when you get the vial, return the vial to your supplier If it hasn’ t been stored correctly or been frozen (see 6 How to store Protaphane) If it’ s not uniformly white and cloudy when it’ s resuspended.
Jekk ma jkunx in a en kif suppost jew jekk kien iffri at (see 6 Kif ta en Protaphane)
Protaphane is for injection under the skin (subcutaneously).
mod uniformi meta jer a ’ ji i mag mul f’ suspensjoni.
Protaphane vials are for use with insulin syringes with the corresponding unit scale.
Il- kunjetti ta 'Protaphane huma g all- u u ma' siringi ta ’ l- insulina bi skala korrispondenti ta ’ unitajiet.
To inject Protaphane on its own
Meta tinjetta Protaphane wa du
To mix Protaphane with fast-acting insulin
Biex t allat Protaphane ma ’ insulina li ta dem b’ mod malajr
Roll the vial of Protaphane between your hands.
Irrombla l- kunjett ta 'Protaphane bejn idejk.
Draw as much air into the syringe as the dose of Protaphane you need.
Injetta l- arja ol- kunjett ta 'Protaphane, u mbag ad i bed il- labra' l barra.
Now push the needle into the vial of Protaphane.
Issa imbotta l- labra ol- kunjett ta 'Protaphane.
Draw the right dose of Protaphane into the syringe.
I bed id- do a korretta ta 'Protaphane os- siringa.
Use the injection technique advised by your doctor or diabetes nurse Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.
U a t- teknika ta ’ l- injezzjoni kif tak parir it- tabib jew l - infermier/ a tad- dijabete tieg ek omm il- labra ta t il - ilda tieg ek g al mill- anqas 6 sekondi biex ti gura li d- do a s i a tkun ing atat.
They must not give you any food or drink as it could choke you.
Jekk ipogli emija severa ma tkunx ikkurata, din tista ’ tikkaw a sara fil- mo (temporanja jew permanenti) u anki l- mewt
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
81 Jekk ikollok ipo li ieg lek tintilef minn sensik, jew afna ipos, kellem lit- tabib tieg ek.
77 Causes of a hypo
Il- kaw i ta' ipo
Like all medicines, Protaphane can cause side effects, although not everybody gets them.
B al kull medi ina o ra, Protaphane jista ’ jkollu effetti sekondarji, g alkemm ma jidhrux fuq kul add.
Protaphane may cause hypoglycaemia (low blood sugar).
Protaphane jista 'jikkaw a l- ipogli emija (livell baxx ta' zokkor fid- demm).
You may have a very rare serious allergic reaction to Protaphane or one of its ingredients (called a systemic allergic reaction).
Inti jista ’ jkollok reazzjoni aller ika serja rari afna g al Protaphane jew g al xi wie ed mill - ingredjenti tieg u (imsej a reazzjoni aller ika sistemika).
See also warning in 2 Before you use Protaphane.
Ara wkoll it- twissija f' 2 Qabel ma tu a Protaphane.
78 Side effects reported very rarely (in less than 1 patient in 10,000)
Effetti sekondarji rrappurtati b 'mod rari afna (f’ inqas minn pazjent 1 minn kull 10, 000)
HOW TO STORE PROTAPHANE
EN PROTAPHANE
Do not use Protaphane after the expiry date which is stated on the label and the carton.
Tu ax Protaphane wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kartuna.
See 3 How to use Protaphane.
Ara 3 Kif tu a Protaphane.
Protaphane must be protected from excessive heat and sunlight.
Protaphane g andu jkun protett minn s ana e essiva u mid- dawl tax- xemx.
Protaphane should not be disposed of via wastewater or household waste.
83 Protaphane m’ g andux jintrema ma ’ l- ilma tad- drana jew ma ’ l- iskart domestiku.
What Protaphane contains
X’ fih Protaphane
1 ml contains 40 IU of insulin human.
Protaphane huwa suspensjoni ta ’ insulina isophane (NPH) Millilitru fih 40 UI ta ’ insulina umana.
What Protaphane looks like and contents of the pack
Id- Dehra ta ’ Protaphane u l- kontenuti tal- pakkett:
79 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni g at- tqeg id fis- Suq u l- Manifattur
80 PACKAGE LEAFLET:
84 FULJETT TA' TAG RIF:
Protaphane 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Protaphane 100 UI/ ml suspensjoni g all- injezzjoni f 'kunjett Insulina umana (rDNA)
Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is asymptom of low blood sugar).
Oqg od attent g as - sinjali ta ’ l- aller ija f' 5 Effetti sekondarji li jista ’ jkollu Jekk t oss li ejja ipo (ipo hi taqsira ta ’ reazzjoni ipogli emika u hija abra ta ’ sintomi li jindikaw livell baxx ta 'zokkor fid- demm).
Draw as much air into the syringe as the dose of Protaphane you need.
I bed ammont ta 'arja os- siringa daqs id- do a ta' Protaphane li te tie.
Inject the air into the Protaphane vial, then pull out the needle 3.
Injetta l- arja ol- kunjett ta 'Protaphane, imbag ad i bed il- labra' l barra 3.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
87 Jekk ikollok ipo li ieg lek tintilef minn sensik, jew afna ipos, kellem lit- tabib tieg ek.