natgillin/translations-raw huggingface dataset:
26 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.
Tulbur ri ale sistemului imunitar Mai pu in frecvente – urticarie, erup ii cutanate tranzitorii Foarte rare – reac ii anafilactice Simptomele hipersensibilit ii generalizate pot include erup ii cutanate generalizate, prurit, transpira ii, tulbur ri gastro- intestinale, edem angioneurotic, dificult i de respira ie, palpita ii, sc derea tensiunii arteriale i le in/ pierderea con tien ei.
Metabolism
Distribu ie
27 Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
27 Nu s- a observat formarea de leg turi puternice cu proteinele plasmatice, cu excep ia anticorpilor insulinici circulan i (dac sunt prezen i).
Keep the pen cap on in order to protect from light.
Stiloul injector (pen- ul) preumplut se ine acoperit cu capacul, pentru a fi protejat de lumin.
6.5 Nature and contents of container
28 6. 5 Natura i con inutul ambalajului
Pre-filled pen (multidose disposable pen) comprising a pen injector with a cartridge (3 ml).
Stilou injector (pen) preumplut cu doze multiple este format dintr- un sistem de injectare i un cartu (3 ml).
The cartridge is made of glass (type 1), containing a bromobutyl rubber plunger and a
Cartu ul este confec ionat din sticl (tip I), cu piston din cauciuc bromobutilic i cu dop de cauciuc bromobutilic/ poliizoprenic.
The cartridge contains a glass ball to facilitate the re- suspension.
Cartu ul con ine o bil din sticl care faciliteaz omogenizarea suspensiei.
The pen injector is made of plastic.
Sistemul de injectare este confec ionat din plastic.
Pens should only be used in combination with products that are compatible with them and allow the pens to function safely and effectively.
Stilourile injectoare (pen- urile) preumplute trebuie folosite numai în combina ie cu produse cu care sunt compatibile i care permit func ionarea lor sigur i eficace.
Insulatard NovoLet is for single person use only.
Insulatard NovoLet este de folosin individual.
After removing Insulatard 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.
Dup scoaterea din frigider a Insulatard NovoLet, este recomandat s l sa i NovoLet s ajung la temperatura camerei (nu peste 25°C) înainte de a omogeniza insulina, conform instruc iunilor pentru prima utilizare.
Insulatard InnoLet 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard InnoLet 100 UI/ ml suspensie injectabil în stilou injector (pen) preumplut
1 pre-filled pen contains 3 ml equivalent to 300 IU.
1 ml suspensie injectabil con ine insulin uman 100 UI 1 stilou injector (pen) preumplut con ine 3 ml echivalent cu 300 UI
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
30 De asemenea, ajustarea dozei poate fi necesar dac pacien ii î i intensific activitatea fizic sau î i modific dieta obi nuit.
30 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
4. 4).
Administration For subcutaneous use.
Administrare Pentru administrare subcutanat..
Insulatard InnoLet is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Insulatard InnoLet este destinat utiliz rii împreun cu acele NovoFine de 8 mm sau mai scurte.
The needle box is marked with an S.
Pe cutia cu ace exist marcajul S.
InnoLet delivers 1-50 units in increments of 1 unit.
Cu stiloul injector (pen) preumplut InnoLet se pot administra 1- 50 unit i, în trepte de câte 1 unitate.
The pens should be primed before injection so that the dose selector returns to zero and a drop of insulin appears at the needle top.
Stiloul injector (pen- ul) preumplut trebuie preg tit înainte de injectare, astfel încât selectorul dozei s fie în pozi ia zero i o pic tur de insulin s apar la vârful acului.
The dose is set by turning the selector, which returns to zero during the injection.
Doza este fixat prin rotirea selectorului, care revine la pozi ia zero în timpul inject rii.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
31 Trecerea unui pacient pe un alt produs sau alt tip de insulin trebuie f cut numai sub supraveghere medical strict.
Changes in strength, brand (manufacturer), type (fast-, dual-, long-acting insulin etc.), origin (animal, human or analogue insulin) and/ or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dosage.
Schimb rile survenite în concentra ie, marc (produc tor), tip (insulin cu ac iune rapid, cu ac iune intermediar, cu ac iune prelungit, etc.), specie (animal, uman sau analog de insulin) i/ sau metod de fabrica ie (tehnologie ADN recombinant fa de insulina de origine animal) pot duce la modific ri ale dozei.
31 As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Ca în orice tratament cu insulin, pot ap rea reac ii la locul de injectare, care includ: durere, prurit, urticarie, tumefac ie i inflama ie.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimesters.
32 Necesarul de insulin scade, de obicei, în timpul primului trimestru de sarcin i cre te în al doilea i al treilea trimestru.
32 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Capacitatea de concentrare i de reac ie a pacientului poate fi afectat ca urmare a hipoglicemiei.
General disorders and administration site conditions Uncommon - Injection site reactions Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with insulin.
Tulbur ri generale i la locul administr rii Mai pu in frecvente – reac ii la locul inject rii
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
33 Reac ii la locul inject rii (ro ea, tumefac ie, prurit, durere i hematom la locul inject rii) pot s apar în timpul tratamentului cu insulin.
These symptoms are usually of transitory nature.
Obi nuit, aceste reac ii sunt tranzitorii i dispar pe parcursul tratamentului.
Immune system disorders Uncommon - Urticaria, rash Very rare - Anaphylactic reactions
Obi nuit, aceste simptome sunt tranzitorii.
33 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.
Tulbur ri ale sistemului imunitar Mai pu in frecvente – urticarie, erup ii cutanate tranzitorii Foarte rare – reac ii anafilactice Simptomele hipersensibilit ii generalizate pot include erup ii cutanate generalizate, prurit, transpira ii, tulbur ri gastro- intestinale, edem angioneurotic, dificult i de respira ie, palpita ii, sc derea tensiunii arteriale i le in/ pierderea con tien ei.
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
34 Concentra ia plasmatic maxim a insulinei este atins în 2- 18 ore de la administrarea subcutanat.
34 Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolism S- a raportat c insulina uman este degradat de insulin- proteaz sau enzime de degradare a insulinei i posibil de izomeraza protein- disulfit.
Keep the pen cap on in order to protect from light.
35 Stiloul injector (pen- ul) preumplut se ine acoperit cu capacul, pentru a fi protejat de lumin.
1, 5 and 10 pre-filled pens x 3 ml.
1, 5 sau 10 stilouri injectoare (pen- uri) preumplute a câte 3 ml.
Insulatard InnoLet is for single person use only.
Insulatard InnoLet este de folosin individual.
After removing Insulatard 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.
Dup scoaterea din frigider a Insulatard InnoLet, este recomandat s l sa i InnoLet s ajung la temperatura camerei (nu peste 25°C) înainte de a omogeniza insulina, conform instruc iunilor pentru prima utilizare.
Insulatard FlexPen 100 IU/ ml suspension for injection in a pre-filled pen.
Insulatard FlexPen 100 UI/ ml suspensie injectabil în stilou injector (pen) preumplut
Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
37 De asemenea, ajustarea dozei poate fi necesar dac pacien ii î i intensific activitatea fizic sau î i modific dieta obi nuit.
37 Dosage adjustment may be necessary when transferring patients from one insulin preparation to another (see section 4.4).
4. 4).
Insulatard FlexPen is designed to be used with NovoFine short cap needles of 8 mm or shorter in length.
Insulatard FlexPen este destinat utiliz rii împreun cu acele NovoFine de 8 mm sau mai scurte.
FlexPen delivers 1-60 units in increments of 1 unit.
Cu stiloul injector (pen) preumplut FlexPen se pot administra 1- 60 unit i, în trepte de câte 1 unitate.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
38 Trecerea unui pacient pe un alt produs sau alt tip de insulin trebuie f cut numai sub supraveghere medical strict.
38 As with any insulin therapy, injection site reactions may occur and include pain, itching, hives, swelling and inflammation.
Ca în orice tratament cu insulin, pot ap rea reac ii la locul de injectare, care includ: durere, prurit, urticarie, tumefac ie i inflama ie.
Insulin requirements usually fall in the first trimester and subsequently increase during the second and third trimesters.
39 Necesarul de insulin scade, de obicei, în timpul primului trimestru de sarcin i cre te în al doilea i al treilea trimestru.
39 The patient’ s ability to concentrate and react may be impaired as a result of hypoglycaemia.
Capacitatea de concentrare i de reac ie a pacientului poate fi afectat ca urmare a hipoglicemiei.
Uncommon - Oedema Oedema may occur upon initiation of insulin therapy.
40 Reac ii la locul inject rii (ro ea, tumefac ie, prurit, durere i hematom la locul inject rii) pot s apar în timpul tratamentului cu insulin.
40 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.
Tulbur ri ale sistemului imunitar Mai pu in frecvente – urticarie, erup ii cutanate tranzitorii Foarte rare – reac ii anafilactice Simptomele hipersensibilit ii generalizate pot include erup ii cutanate generalizate, prurit, transpira ii, tulbur ri gastro- intestinale, edem angioneurotic, dificult i de respira ie, palpita ii, sc derea tensiunii arteriale i le in/ pierderea con tien ei.
Absorption The maximum plasma concentration of the insulin is reached within 2-18 hours after subcutaneous administration.
41 Concentra ia plasmatic maxim a insulinei este atins în 2- 18 ore de la administrarea subcutanat.
41 Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Metabolism S- a raportat c insulina uman este degradat de insulin- proteaz sau enzime de degradare a insulinei i posibil de izomeraza protein- disulfit.
Keep the pen cap on in order to protect from light.
42 Stiloul injector (pen- ul) preumplut se ine acoperit cu capacul, pentru a fi protejat de lumin.
Insulatard FlexPen is for single person use only.
Insulatard FlexPen este de folosin individual.
After removing Insulatard 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.
Dup scoaterea din frigider a Insulatard FlexPen, este recomandat s l sa i FlexPen s ajung la temperatura camerei (nu peste 25°C) înainte de a omogeniza insulina, conform instruc iunilor pentru prima utilizare.
43 ANNEX II
43 ANEXA II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
PRODUC TORUL SUBSTAN EI( LOR) BIOLOGIC ACTIVE I DE IN TORUL AUTORIZA IEI DE FABRICA IE RESPONSABIL( I) PENTRU ELIBERAREA SERIEI
CONDITIONS OF THE MARKETING AUTHORISATION
CONDI IILE EMITERII AUTORIZA IEI DE PUNERE PE PIA
Name and address of the manufacturer of the biological active substance
Numele i adresa produc torului substan ei( lor) biologic active
Name and address of the manufacturers responsible for batch release
Numele i adresa produc torului
Insulatard Penfill and FlexPen
Insulatard Penfill i FlexPen
Novo Nordisk Production SAS 45, Avenue d’ Orléans F-28002 Chartres France
Novo Nordisk Production SAS 45, Avenue d’ Orléans F- 28002 Chartres Fran a
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Prospectul tip rit al medicamentului trebuie s men ioneze numele i adresa produc torului responsabil pentru eliberarea seriei respective.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• CONDI II SAU RESTRIC II PRIVIND FURNIZAREA I UTILIZAREA IMPUSE DE IN TORULUI AUTORIZA IEI DE PUNERE PE PIA
Medicinal product subject to medical prescription
Medicament cu eliberare pe baz de prescrip ie medical.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• CONDI II SAU RESTRIC II CU PRIVIRE LA SIGURAN A I EFICACITATEA UTILIZ RII MEDICAMENTULUI
45 ANNEX III
45 ANEXA III
LABELLING AND PACKAGE LEAFLET
ETICHETAREA I PROSPECTUL
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
47 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
Insulatard 40 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Insulatard 40 UI/ ml suspensie injectabil în flacon Insulin uman (ADNr)
STATEMENT OF ACTIVE SUBSTANCE
DECLARAREA SUBSTAN EI ACTIVE
1 ml suspension contains 40 IU (1.4 mg) of insulin human (rDNA).
1 ml suspensie con ine 40 UI (1, 4 mg) insulin uman (ADNr)
zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.
clorur de zinc, glicerol, metacrezol, fenol, hidrogenofosfat de disodiu dihidrat, hidroxid de sodiu, acid clorhidric, sulfat de protamin i ap pentru preparate injectabile
PHARMACEUTICAL FORM AND CONTENTS
FORMA FARMACEUTIC
Suspension for injection 1 x 10 ml 5 x 10 ml
Suspensie injectabil 1 x 10 ml 5 x 10 ml
METHOD AND ROUTE OF ADMINISTRATION
MODUL I CALEA DE ADMINISTRARE
Subcutaneous use Resuspend according to instructions Read the package leaflet before use
Administrare subcutanat Omogeniza i suspensia injectabil conform instruc iunilor A se citi prospectul înainte de utilizare
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
ATEN IONARE SPECIAL PRIVIND FAPTUL C MEDICAMENTUL NU TREBUIE P STRAT LA ÎNDEMÂNA I VEDEREA COPIILOR
OTHER SPECIAL WARNING(S), IF NECESSARY
ALT (E) ATEN IONARE (RI) SPECIAL (E), DAC ESTE( SUNT) NECESAR (E)
EXP/ During use: use within 4 weeks
EXP / În timpul utiliz rii: a se utiliza în decurs de 4 s pt mâni
SPECIAL STORAGE CONDITIONS 48 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 se p stra la temperaturi sub 25°C
GENERAL CLASSIFICATION FOR SUPPLY
CLASIFICARE GENERAL PRIVIND MODUL DE ELIBERARE
Medicinal product subject to medical prescription
Medicament eliberat pe baz de prescrip ie medical
Insulatard vial 40 IU/ ml
Insulatard flacon 40 UI/ ml
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
49 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
DENUMIREA COMERCIAL A MEDICAMENTULUI I CALEA DE ADMINISTRARE
Insulatard 40 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard 40 UI/ ml suspensie injectabil Insulin uman (ADNr) Administrare s. c.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
CON INUTUL PE MAS, VOLUM SAU UNITATEA DE DOZ
OTHER
ALTE INFORMA II
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
50 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
Insulatard 100 IU/ ml suspension for injection in a vial Insulin human (rDNA)
Insulatard 100 UI/ ml suspensie injectabil în flacon Insulin uman (ADNr)
1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA).
1 ml suspensie con ine 100 UI (3, 5 mg) insulin uman (ADNr)
EXP/ During use: use within 6 weeks
EXP / În timpul utiliz rii: a se utiliza în decurs de 6 s pt mâni
SPECIAL STORAGE CONDITIONS 51 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 se p stra la temperaturi sub 25°C
Insulatard vial 100 IU/ ml
Insulatard flacon 100 IU/ ml
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
52 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
Insulatard 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard 100 UI/ ml suspensie injectabil Insulin uman (ADNr) Administrare s. c.
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
53 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
Suspension for injection 1 x 10 ml This is part of a multipack and not for sale of individual vials
Suspensie injectabil 1 x 10 ml Aceast form de ambalare este parte integranta dintr- un ambalaj multiplu i nu se comercializeaz separat
SPECIAL STORAGE CONDITIONS 54 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 se p stra la temperaturi sub 25°C
Insulatard vial 40 IU/ ml
Insulatard flacon 40 IU/ ml
55 PARTICULARS TO APPEAR ON THE PACKAGING
55 INFORMA II CARE TREBUIE S APAR PE AMBALAJ
OUTER WRAPPER LABELON MULTIPACKS
ETICHETA COLECTIV A AMBALAJELOR MULTIPLE
Suspension for injection 5 x (1 x 10 ml) This is a multipack and not for sale of individual vials
Suspensie injectabil 5 x (1 x 10 ml) Aceast form de ambalare este parte integranta dintr- un ambalaj multiplu i nu se comercializeaz separat
SPECIAL STORAGE CONDITIONS
CONDI II SPECIALE DE P STRARE
56 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 se p stra la temperaturi sub 25°C
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
57 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
SPECIAL STORAGE CONDITIONS 58 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 se p stra la temperaturi sub 25°C
59 PARTICULARS TO APPEAR ON THE PACKAGING
59 INFORMA II CARE TREBUIE S APAR PE AMBALAJ
60 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 se p stra la temperaturi sub 25°C
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
61 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR SI PE AMBALAJUL PRIMAR
Insulatard Penfill 100 IU/ ml suspension for injection in a cartridge Insulin human (rDNA)
Insulatard Penfill 100 UI/ mlsuspensie injectabil în cartu Insulin uman (ADNr)
Suspension for injection 1 x 3 ml 5 x 3 ml 10 x 3 ml
Suspensie injectabil 1 x 3 ml 5 x 3 ml 10 x 3 ml
Subcutaneous use Penfill cartridges for use with Novo Nordisk insulin devices Resuspend according to instructions Read the package leaflet before use Insulatard Penfill is for use by one person only
Administrare subcutanat Cartu ele Penfill sunt destinate utiliz rii împreun cu dispozitivele Novo Nordisk de administrare a insulinei Omogeniza i suspensia injectabil conform instruc iunilor A se citi prospectul înainte de utilizare Insulatard Penfill este de folosin individual
EXP/ During use: use within 6 weeks
62 EXP / În timpul utiliz rii: a se utiliza în decurs de 6 s pt mâni
Store in a refrigerator (2°C - 8°C) Do not freeze Keep the cartridge in the outer carton in order to protect from light During use: do not refrigerate or store above 30°C
A se p stra la temperaturi sub 30°C
63 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
63 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
Insulatard Penfill 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard Penfill 100 UI/ ml suspensie injectabil Insulin uman (ADNr) Administrare s. c.
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
64 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
Insulatard NovoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Insulatard NovoLet 100 UI/ ml suspensie injectabil în stilou injector (pen) preumplut Insulin uman (ADNr)
Suspension for injection 5 x 3 ml 10 x 3 ml
Suspensie injectabil 5 x 3 ml 10 x 3 ml
Subcutaneous use Insulatard NovoLet is designed to be used with NovoFine needles Resuspend according to instructions Read the package leaflet before use Insulatard NovoLet is for use by one person only
Administrare subcutanat Insulatard NovoLet este destinat utiliz rii împreun cu acele NovoFine Omogeniza i suspensia injectabil conform instruc iunilor A se citi prospectul înainte de utilizare Insulatard NovoLet este de folosin individual
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 se p stra la temperaturi sub 30°C
66 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
66 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
Insulatard NovoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard NovoLet 100 UI/ ml suspensie injectabil Insulin uman (ADNr) Administrare s. c.
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
67 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
Insulatard InnoLet 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Insulatard InnoLet 100 UI/ ml suspensie injectabil în stilou injector (pen) preumplut Insulin uman (ADNr)
Subcutaneous use Insulatard InnoLet is designed to be used with NovoFine S needles Resuspend according to instructions Read the package leaflet before use Insulatard InnoLet is for use by one person only
Administrare subcutanat Insulatard InnoLet este destinat utiliz rii împreun cu acele NovoFine Omogeniza i suspensia injectabil conform instruc iunilor A se citi prospectul înainte de utilizare Insulatard InnoLet este de folosin individual
EU/ 1/ 02/ 233/ 010 1 x 3 ml EU/ 1/ 02/ 233/ 011 5 x 3 ml EU/ 1/ 02/ 233/ 012 10 X 3 ml
EU/ 1/ 02/ 233/ 010 1 x 3 ml EU/ 1/ 02/ 233/ 011 5 x 3 ml EU/ 1/ 02/ 233/ 012 10 X 3 m
69 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
69 MINIMUM DE INFORMA II CARE TREBUIE S APAR PE AMBALAJELE PRIMARE MICI
INNOLET LABEL
ETICHET DE INNOLET
Insulatard InnoLet 100 IU/ ml suspension for injection Insulin human (rDNA) SC use
Insulatard InnoLet 100 UI/ ml suspensie injectabil Insulin uman (ADNr)
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
70 INFORMA II CARE TREBUIE S APAR PE AMBALAJUL SECUNDAR I PE AMBALAJUL PRIMAR
Insulatard FlexPen 100 IU/ ml suspension for injection in a pre-filled pen Insulin human (rDNA)
Insulatard FlexPen 100 UI/ ml suspensie injectabil în stilou injector (pen) preumplut Insulin uman (ADNr)
Subcutaneous use
Administrare subcutanat