Annex I : GDF Artwork packaging Labelling
Contents
1. 25 C Stop Purinership GLOBAL DRUG All boxes contain the same elements helpful for the information of the users According to the size of these boxes and the space available the layout needs to be adapted without modifying the guidelines defined on page 5 The top face like the main face if different must to repeat the main information and branding elements One face is reserved for the Manufacturer and distribution information FACILITY FACILITY Reserved zone for batch a a number and date of product manufacturing and expiry This zone must not be vernished Code No Mfg Lic No MHIDRUGS KD 428 Mfg Date Exp Date 29 x 23 mm Manufacturer by Fabriqu par Fabricado no Svizera Labs Pvt Ltd Plot No D 16 6 TTC Ind Area MIDC Turbhe Navi Mumbai 400703 India europe Stop Partnership G2. 25 C B Plot No D 16 6 TTC Ind Area MIDC SVIZERA Turbhe Navi Mumbai 400703 India E Distributed by Distribu par Distribuido Svizera Europe B V 1322 AH Almere PThe Netherlands Stop Partnership Stop Partnership GLOBAL DRUG GLOBAL DRUG FACILITY FACILITY The Helvetica Neue Black is the standardized font for all the names Code No Mfg Lic No MH DRUGS KD 428 Lot Mfg Date Exp Date 29 x 23 mm Manufacturer by Fabriqu par Fabricado no Svizera Labs Pvt Ltd Complementary information m Statement of the active substance B List of excipients known to be a safety concern for some patients m Medical product subject to medical prescription m Cautionary statement Children and any other additional cautionary statement m Storing conditions and special instructions for storage if applicable m Special warnings Stop TB Kit E Ethambutol 400mg Ethambutol tablets BP 400mg For Individual Patient Use 5 months Daily Treatment Continuation Phase Categorie II Comprim s d thambutol BP 400 mg Pour patient individuel E 5 mois de traitement quotidien en phase de prolongation Cat gorie II Tabletas Eta
3. 600 gt ALI 119VJ 104 4 gL eu 94 4 H A 9 nu d Wd 01 0 wxetoduedeu eH 4 190 When Im possibl e to ON siso noJeqn e ONS NES 9 diusiaupnDd D 005 9p e BUSA gL 1 9019 Jed iuuno4 n sert th e 4 lan 9 u ages iuenad ou of the Legal text on redeuedu EE IOS Me j909J uoo opesuedsip 4 sides of the box S BLT WOHLIALOOU 3H SONIN ejeoipeui it IS recommended pn SO13Q3ONVOlV 1 jueureopew 3G A VISIA V1 S1NVAN3 SAG uonduoseud H3N3INVA 331304 Y7 13 INA Jeoipeui 1oe qns to use this version 090 V13G SHOH HIN3L 1onpoud jeuroipejw WOWH9HOWHdU ofeq p 10d rexiesuoo 0 0 sed N3HGHIHO on the back face taday au JO HOV3H ANY 1H9IS oJoHatredodeu 9159 jezi n eun e jeuiesuoo v AHL 40 100 d33 8 ep sejue ojoedsoud Uonesi n 9 08 e101S 4 Je 1997 1 amp 0 OSN e 9Jr
4. 28 E 4 RHZE 150 75 mg 12 28 Stop Partnership GLOBAL DRUG FACILITY The Stop TB kits sometimes contain 2 treatments with 2 routes of administration 2 icons are required with the appropriate GDF colour code see page 8 These icon are standardized Only for these kits can the GDF colour code be used for bullets to distinguish the products information The back face is reserved for the patient s control card and other complementary information Stop TB Kit Control Card Carte de contr le Tarjeta de Control Patient s name Nom du patient Nombre del paciente Please note This card does not replace the patient treatment card in use in your program but can be used to monitor the drug consumption from the kit From the enclosed insert determine how many tablets you should give the patient for each dose based on patient s weight Record patient s weight above and number of tablets in the tables noter Cette carte ne remplace pas la carte de traitement du patient utilis e dans votre programme mais peut tre utilis pour surveiller la consommation de drogue dans le kit Le tableau ci joint d termine combien de comprim s vous devez donner au patient pour chaque dose en fonction du poids du patient
5. 1 Intensive phase RHZE 56 doses red colour Phase intensive RHZE 56 doses couleur rouge Fase intensiva RHZE 56 dosis de color rojo RHZE 56 Number of tablets to give to patient for each dose Nombre de comprim s donner au patient pour chaque dose N mero de comprimidos para dar al paciente para cada dosis Starting date Date de d but Fecha de inicio i Dose Dose Dosis Continuation phase RH 112 doses Green colour Phase de continuation RH 112 doses couleur verte Fase de continuaci n RH 112 dosis de color Verde RH 112 Number of tablets to give to patient for each dose Nombre de comprim s donner au patient pour chaque dose N mero de comprimidos para dar al paciente para cada dosis Starting date Date de d but Fecha de inicio Dose Dose Dosis w 1 2 3 1 2 3 4 5 6 rd 8 9 10 11 12 13 14 8 9 10 15 16 17 18 19 20 21 22 23 24 25 26 27 28 15 16 Xr 29 30 31 32 33 34 35 36 37
6. esn L 1 Luxdotioo esojoe euenuoo esoje esf ILIO Reserved zone fo r et WifOEOHMU ueiquie pijozeui np 1ueuie eBe 1uenuo esojoe surejuoo os v JW 009 1 ep Bui 009 euenuoo epijozeui ep pljozeurq batch num ber and uoo 009 1uenuoo ejnorjed 009 surejuoo EXLALIQRL EHTO anbeyo leiqei payeoo uoe3 date of prod uct 9 2 g 8 manufacturing and o amp e 009 pijozour 8 S expiry This Zone must not be varnished S 9 qe uu OL XZ The front face of the box must contain the main information the 4 languages Stop Partnership GLOBAL DRUG FACILITY Global Drug Facility gt Packaging design guidelines 5 Example Kanamycin primary packing 1000 4 10 ampoules m Manufacturer Fabricante Fabricant ij i Meiji Seika Pharma Co Ltd 4 16 Kyobashi 2 chome Chuo ku Tokyo 104 8002 Japan Kanamycine Kanamicina 1000 9 4 10 ampoules 1000mg am 1000mg 4ml Kanamycin sulfate solution for injection 1g 10 ampoules Kanamicina Sulfato en soluc on inyectable 1g 10 ampolla
7. physician m decin indicaciones del m dico 4 Intruction for use Mode d emploi Instrucciones de uso Adaptation in 4 columns SEE PACKAGE BOOKLET VOIR LE LIVRET CONSULTE EL FOLLETO DEL B the contents in To be taken orally with water Par voie orale avec de l eau PAQUETE Storage Store in a cool dry Conservation Conserver dans Por v a oral con agua 25 4 languages place below 25 protected un endroit frais et sec en Almacenamiento Guarde en from light dessous de 25 l abri de la un lugar fresco y seco a Keep out of the reach and lumi re temperaturas que no exedan los sight of children Garder hors de la port e et 25 Proteger de la luz vue des enfants Mantener fuera del alcance y de la vista de los ni os Sion Partnership Adaptation of the legal text GLOBAL DRUG 6 Supplied through the Global TB Drug Facility Not for Resale Fournis par le Global TB Drug Facility Vente interdite FACILITY Logo of the programme Stop Partnership GLOBAL DRUG FACILITY Global Drug Facility gt Packaging design guidelines 4 The organization of the information by zones B The positio
8. Full name ex Applicable pharmacopoeia standard optional Ethambutol Hydrochloride Ethambutol tablets BP 400mg Comprim s d thambutol BP 400 mg Tabletas Etambutol BP 400 mg Information zone by languages BP 400 Icon of route of administration Logo of manufacturer and distributor if different m English m French SVIZERA m Spanish m Russian ness Stop Parinershi GLOBAL DRUG lt Suministrados trav s del Servicio de Medicamentos contra la tuberculosis No para reventa Legal text FACILITY Product Reference No XX XXX WHO Product reference 1 Quantity per packaging The dosage strength for a medicine should be expressed in an appropriate metric system unit 2 Possibility to have 2 icons for the routes of administration see page 10 3 The font is standardized see page 4 4 According to the quantity of information several implementations are possible see examples 5 This text is standardized in 4 languages and needs to be applied to the 4 faces of a box or on 1 face if the space is insufficient see examples Logo of the programme Stop Purinership GLOBAL DRUG CILIT Y Global Drug Facility gt Packaging design guidelines 4 The organization
9. partnership GLOBAL DRUG Stop Partnership GLOBAL DRUG Suministrados trav s del Servicio de Medicamentos contra la tuberculosis No para reventa FA CILITY ee nes FACILITY ERE Stop Partnership GLOBAL DRUG FACILITY Global Drug Facility gt Packaging design guidelines 5 Example small packaging JN 009 eiaLiad iou x Z 1 1 4 1 Sojieiqnoo4 sopiuiduioo 009 04919H pijozeur1 x 009 epijozeur Sje qe OF XZ 009 prjozeur1 ijoz 009 pijozeur P OF X Z 9 4 6002 dW NIN OS 211 oN Ge 217 uu aN ON HA eipu dV LOE 609 eben qooqeyen eueuoper Aljede og 235 A savi OYSLAH 4 4 194n32ejnue pijoz 009 pijozeur 39192 up OL XZ 2 x 10 Film coated tablets Linezolid 600 mg Zolid Linezolid Hetero 600 mg 2 x 10 film coated tablets Lin zolide Hetero 600 mg Repetition of the main elements
10. 38 39 40 41 42 22 23 24 43 44 45 46 47 48 49 50 51 52 53 54 55 56 29 30 31 57 58 59 60 61 62 63 64 65 66 67 68 69 70 36 37 38 71 72 73 74 75 76 78 79 80 81 82 83 84 43 44 45 85 86 87 88 89 90 91 92 93 94 95 96 97 98 50 51 52 Stop Partnership GLOBAL DRUG FACILITY the Manufacturer and distribution information 99 100 101 103 104 105 106 107 108 110 11 112 Completion date Date de fin Fecha de finalizaci n Suministrados trav s del Servicio de Medicamentos contra la tuberculosis para reventa Completion date Date de fin Fecha de finalizaci n Stop Partnership eae GLOBAL DRUG FACILITY Stop Partnership GLOBAL DRUG FACILITY Global Drug Facility gt Packaging design guidelines 5 Example product used for kits NENNEN A LUI V nud 179019 diysiaupind T dors Each film cated tablet contains Ethambutol Hydrochloride BP 4
11. DRUG FACILITY EE Form information _ ANN of the product Brandname or Secondary name of the product E9 E Gus Stop TB Kit Kanamycin Linezolid 600 mg Ethambutol 400 mg Stop Purinership GLOBAL DRUG FACILITY Global Drug Facility gt Packaging design guidelines e Typography B The font used for all the GDF packaging is the the Helvetica family Helvetica Neue Black ABCDEFGHIJKLMNOPQRSTUVWXYZ abcdefghijkimnopqrstuvwxyz 0123456789 Bold ABCDEFGHIJKLMNOPQRSTUVWXYZ abcdefghijklmnopqrstuvwxyz 0123456789 Homan ABCDEFGHIJKLMNOPQRSTUVWXYZ abcdefghijklmnopqrstuvwxyz 0123456789 Light ABCDEFGHIJKLMNOPQRSTUVWXYZ abcdefghijklmnoparstuvwxyz 0123456789 Helvetica Cyrillic Bold PCTYOXLLIM Li ll b bi b 93 IO H 0123456789 Plain 0123456789 Stop Purinership GLOBAL DRUG FACILITY Global Drug Facility gt Packaging design guidelines 4 The organization of the information by zones B The face of the packaging is built according to predetermined zones The definition of a value a is the unit of measurement for a grid to fit the different zones and provide breathing space Each packaging has different
12. Noter le poids du patient ci dessus et le nombre de comprim s dans les tables Mfg Ltc No 489 Nota Esta tarjeta no reemplaza la tarjeta de tratamiento de los pacientes en uso en su programa pero se puede utilizar para controlar el consumo del medicamento en el kit De la nota incluida se puede determinar la cantidad de tabletas que debe dar al paciente para cada dosis seg n el peso del paciente Name Anotar cada vez el peso del paciente y el n mero de tabletas en Address la tabla of the Manufacturer Tick v the appropriate box after the drugs have been administred beginning with dose 1 on the 1st day of treatment Cochez v la case appropri e apr s que le traitement soit administr en commen ant avec la dose 1 au premier jour de traitement Marque la casilla apropiada despu s de que los medicamentos se han administrado comenzando con dosis 1 en el primer d a de tratamiento v c 1
13. One face is reserved for the Manufacturer information Form information in the main language English A colour can be used for the proprietary name of the product according to the manufacturer The place and the organization of the logo block must follow the guidelines defined page 5 Complementary information zone by languages m English m French m Spanish m Russian per column or rows according to the content Some boxes contain a small quantity of medicine The layout and the place of various elements must be adapted but always following the guidelines defined on page 5 It is also important to repeat on 5 faces of the packaging the following names form info in the 4 languages and the icon 2 x 10 comprim s pellicul s Linezolid Hetero 600 mg HETERO 2 x 10 comprimidos recubiertos 4 Logo of manufacturer Xerepo _ and distributor 2 x 10 600 if different Stop Partnership FACILITY INNEN WHO Product Reference No XX XXX 2 10 Film coated tablets 1 Linezolid 600 mg Zolid 4 Linezolid Hetero 600 mg 2 10 film coated tablets Lin zolide Hetero 600 mg 2 x 10 comprim s pellicul s Linezolid Hetero 600 mg 2 x 10 comprimidos recubiertos 2 x 10
14. form info in the 4 languages and the icon All the texts need to be oriented in the same direction to help the user to discover the different contents present on each package faces It is recommended to reserve one face for the patient s card Form information in the main language English Patient s TB treatment register number Num ro de registre du traitement TB du patient TB n mero de registro del tratamiento del paciente Patient s name Nom du patient Nombre del paciente Age Age Edad Bek Weight Poids Peso Bec Sex Sexe Sexo ceke Patient s address Adresse du patient Direcci n del Paciente Anpec Nber of tablet per day Nbre de comprim s par jour N mero de comprimidos al d a B er europe Supervisor s name Nom du superviseur Nombre del supervisor rtr Ston partnership Stop Partnership GLOBAL DRUG GLOBAL DRUG Stop Purinership GLOBAL DRUG FACILITY Global Drug Facility gt Packaging design guidelines 5 Example Stop TB kits Stop TB Kit Pour patient individuel Cat gories 2 mois de traitement quotidien en phase intensive 4 mois de traitement quotidien en phase de prolongation Patient s TB treatm
15. 00 mg Methylparaben used as preservative Approved colours used Dosage As directed by the physician Intruction for use SEE PACKAGE BOOKLET To be taken orally with water Storage Store in a cool dry place below 25 protected from light Keep out of the reach and sight of children WHO Product Reference No XX XXX wiieuger SONI 391423 Stop TB Kit Ethambutol 400mg Chaque comprim pellicul contient L Ethambutol chlorhydrate BP 400 mg Methylparaben utilis comme conservateur Couleurs utilis es approuv es Posologie Comme dirig par le m decin Mode d emploi VOIR LE LIVRET Par voie orale avec de l eau Conservation Conserver dans un endroit frais et sec en dessous de 25 l abri de la lumi re Garder hors de la port e et de vue des enfants uoneBuojo4d ep eseud ue ueipnonb ep siou G 210699 uonenunuo jueuneeJ syJUOW G E jo3nquieui3 4 91 dois Film coated tablets Comprim s pellicul s Comprimidos recubiertos I8Z X OF 10 x 28 Cada comprimido recubierto contiene Clorhidrato de Ethambutol BP 400 mg Metilparabeno utilisa como conservante Aprobado colores utilizados Posolog a seg n las indicac
16. Digitally signed by Nigorsulton IN Ig rS u Ito Muzafarova DN cn Nigorsulton Muzafarova o WHO TBP STBP ou GDF M uzafa rova email muzafarovan who int c lt n Date 2014 12 16 15 08 12 01 00 Global Drug Facility Packaging Guidelines Packing identification and markings of anti IB medicines and kits Stop Partnership GLOBAL DRUG FACILITY Global Drug Facility gt Packaging design guidelines These guidelines have been drawn up for the purpose of clarifying a corporate identity for Global Drug Facility GDF packaging The purpose of this document is to provide a consistent identification for all the products managed by the programme of the GDF It is important to follow these guidelines for overall uniformity and for ease of management through the standardization of the product catalogue B The key elements page 3 B Typography page 4 B The organization of the layout by zones page 5 B Examples page 9 Contact information page 14 Note packaging texts are provided for information purposes only and are not legally binding Stop Partnership GLOBAL DRUG FACILITY Global Drug Facility gt Packaging design guidelines 2 The key elements B The logo and its red line The logo of the GDF is inseparable from its red line No modification of proportions can be made No modification of design and the associated legal text can be made The red line has no hor
17. I Water for injection Light blue 2985C 77 0 7 0 ZZ H100 diagonally striped 2736 C 90 81 0 blue amp white 7 RH 60 30 diagonally striped 802C 94 0100 0 green amp white RH 60 60 diagonally striped 394C 0 090 0 yellow amp white ZZ RAZ 60 30 150 diagonally striped Rhodamine 0 9 purple amp white Red Stop Partnership GLOBAL DRUG Global Drug Facility gt Packaging design guidelines 5 Example product anti TB medicine A LUI V 9nud 178015 diusraupDg T dois e Each film cated tablet contains Ethambutol Hydrochloride BP 400 mg Methylparaben used as preservative Approved colours used Dosage As directed by the physician P Intruction for use SEE PACKAGE BOOKLET To be taken orally with water Storage Store in a cool dry place below 25 protected from light Keep out of the reach and sight of children WHO Product Reference No XX XXX T FEL Te Te 1 3 14 3 14 Ethambutol 400 Ethambutol Hydrochloride XXX XX ON JONPAd OHM BNA AL 12900 ej zed iuunog 104 JON 4 Brag 91 124019 eus 1 QOP 1ougei LoLAQNeLE dg Jo1nquie33 se1ojqer 24 Chaque comprim pellicul contient L Ethamb
18. LOBAL DRUG Distributed by Distribu par Distribuido Svizera Europe B V 1322 AH Almere PThe Netherlands and distributor if different Complementary information zone by languages m English m French m Spanish m Russian per column or rows according to the content Translation of the Legal text on 2 faces The place and the organization of the logo block must follow the guidelines defined on page 5 Ethambutol 400 mg Ethambutol Hydrochloride Ethambutol tablets BP 400mg Logo and information about the manufacturer Comprim s d thambutol BP 400 mg The main information in the 4 languages must to be present on the main face Logo of the manufacturer and distributor if different Tabletas Etambutol BP 400 mg BP 400 Suministrados trav s del Servicio de Medicamentos contra la tuberculosis No para reventa FACILITY FACILITY z Each face of a box can be used to deliver specific information Manufacturing Patient s card details of the dosage and administration instructions and the special warnings The front face of the box must to contain the main information in the 4 languages The main information must to be put int he same field of vision on a least three non opposite faces names
19. al de instrucciones Categor a 111 2 meses de tratamiento diario fase intensiva RHZE 150 75 400 275 mg Comprimidos 6 blisters cada blister 28 comprimidos 4 meses de tratamiento diario fase de continuaci n RH 150 75 mg Comprimidos 12 blisters cada blister 28 comprimidos 111 2 RHZE 150 75 400 275 mg 6 28 4 RHZE 150 75 mg 12 28 Stop f Partnership GLOBAL DRUG FACILITY WHO Product Reference No XX XXX 2 icons are required according to the appropriate GDF colour code Only for kits the GDF colour code can be used for bullets to distinguish the products information See the table below Adaptation in 2 columns 2 rows of the contents in 4 languages GDF colour code Product Colour Pantone RHZE red 185C 95 100 0 RHE peach 148C 0 28 47 0 RH150 75 green 802C 94 0 100 0 RH150 150 yellow 394 C 0 090 0 EH400 150 brown 140C 10 63 97 40 7400 grey Cool Gray 9C 46 38 37 31 E400 orange 716C 0 67 100 0 H300 blue 2736 C 90 81 Streptomycin 1g Violet 253C 45 97 0 0
20. ent register number Num ro de registre du traitement TB du patient TB n mero de registro del tratamiento del paciente Patient s name Nom du patient Nombre del paciente Supervisor s name Nom du superviseur Nombre del supervisor Patient s address Adresse du patient Direcci n del Paciente Age Age Edad BO3PACT Stop Q Partnership GLOBAL DRUG FACILITY Sex Sexe Sexo CEKC It is recommended to reserve one face for the patient s card This face is sometimes the only visible one when several boxes are stored in a cupboard Stop TB Kit For Individual Patient Use Categories Ill 2 months Daily Treatment Intensive Phase 4 months Daily Treatment Continuation Phase Content W Instruction book Instruction Stop TB KIT for Individual User Categorie III B 2 Months DAILY treatment Intensive Phase RHZE 150 75 400 275 mg Tablets 6 blister sheets of 28 tablets each 4 Months DAILY treatment Continuation Phase RH 150 75 mg Tablets 12 blister sheets of 28 tablets each Contenu W Instruction book Instruction Stop TB KIT for Individual User Categorie III B 2 Months DAILY treatment Intensive Phase RHZE 150 75 400 275 mg Tablets 6 blister sheets of 28 tablets each 4 Mon
21. iones del m dico Instrucciones de uso CONSULTE EL FOLLETO DEL PAQUETE Por v a oral con agua Almacenamiento Guarde en un lugar fresco y seco a temperaturas que no exedan los 25 Proteger de la luz Mantener fuera del alcance y de la vista de los ni os Supplied through the Global TB Drug Facility Not for Resale Fournis par le Global TB Drug Facility Vente interdite XXX XX ON 92u819jeH 19npo4d OHM Brag AL 129010 1 Jed 104 ION Ayed 91 19010 eus seed ndu ewewdu m j 1 Burt edoaLoed repari ep oep ep e3uoeroed Jap OSN Jenpiupur nod 1uaned jenprupuj 404 The BP 400 B
22. izontal limit It only follows the alignment designed by the organization of the zones See page 5 to discover how to position the logo and the line in the layout B The organization of the information by zones See page 5 to discover the guidelines for organizing the zones and the space on the main face of a packaging B The organization of the 4 languages Each packaging needs to be developed in 4 languages See the following examples to discover how to position the languages in the layout It is the responsibility of the Manufacturer to provide the relevant information and correct translation in 4 required languages B The name of the product The names of all the products follow very clear rules and guidelines See page 5 and examples to discover how to manage the names for each face of the packaging See page 4 for the font B Theicons To animate the layout and help to understand the information the packaging uses a range of icons according to the dosage form See page 5 and examples to discover how to manage these icons for each face of the packaging B The GDF colour code The Global Drug Facility programme has decided to allow colours for all first line products To keep a simple look and feel and not overcrowd the layout it was decided not to capitalize upper case these colours See page 8 and examples to discover how to use the colours in the context of the kits packagings Stop Partnership GLOBAL
23. logie v ase el prospecto adjunto Store below 30 voir notice jointe Cons rvese a menos de 30 Conserver au dessous de 30 30 Fourni par le Global TB Drug Facility Vente interdite Suministrados a trav s del Servicio de Medicamentos contra la tuberculosis No para reventa Stop Partnershin He G LO BAL DRU G FACILITY Stop Partnership GLOBAL DRUG FACILIT Y Global Drug Facility gt Packaging design guidelines 6 Contact information B This document was designed by Stop TB Partnership Global Drug Facility Date of the version 1 December 2014 Postal address Stop TB Partnership TCS Building Floor 1 Chemin de Blandonnet 2 1214 Vernier Switzerland Email gdf stoptb org Phone 41 22 791 26 90 Fax 41 22 791 48 86 Website htto www stoptb org gdt Design by Comstone Geneva Switzerland Stop Partnership GLOBAL DRUG FACILITY
24. mbutol BP 400 mg Para uso individual del paciente E 5 meses de tratamiento diario fase de continuaci n Categor a II 400 Il This kind of kit follows the same guidelines as for other packaging Only the order of the names is different E 5 To better distinguish this is a kit this information is larger than the name of the product but is highlighted by the addition of a coloured bullet in line with the GDF colour code see page 8 Patient s TB treatment register number Num ro de registre du traitement TB du patient TB n mero de registro del tratamiento del paciente Patient s name Nom du patient Nombre del paciente Age Age Edad sex Weight Poids Peso Bec 0 Patient s address Adresse du patient Direcci n del Paciente Anpec Nber of tablet per day Nbre de comprim s par jour N mero de comprimidos al d a 0 Supervisor s name Nom du superviseur Nombre del supervisor
25. n of the elements on a Stop TB Kit enclosing 2 products This type of big box has a cover The information on each face should be adapted according to the 4 languages Each face of the box needs to present specific translated information The layout needs to be adapted to the available space see examples Stop TB Kit For Individual Patient Use Categories 2 months Daily Treatment Intensive Phase 4 months Daily Treatment Continuation Phase Content W Instruction book Instruction Stop TB KIT for Individual User Categorie 111 E 2 Months DAILY treatment Intensive Phase RHZE 150 75 400 275 mg Tablets 6 blister sheets of 28 tablets each E 4 Months DAILY treatment Continuation Phase RH 150 75 mg Tablets 12 blister sheets of 28 tablets each Contenu W Instruction book Instruction Stop TB KIT for Individual User Categorie III 2 Months DAILY treatment Intensive Phase RHZE 150 75 400 275 mg Tablets 6 blister sheets of 28 tablets each E 4 Months DAILY treatment Continuation Phase RH 150 75 mg Tablets 12 blister sheets of 28 tablets each CILIT Y 2 4 Contenido Manual de instrucciones Manu
26. of the information by zones B The position of the elements on a secondary face Some elements names form info icon and logo need to be positioned on each face of the packaging The layout needs to be adapted to the size of the face or the available space Duplication of the form info and the icon of dosage form If possible in the 4 languages Film coated tablets Comprim s pellicul s Comprimidos recubiertos 24 x 28 Duplication of the names Ethambutol 400 mg Ethambutol Hydrochloride Each film cated tablet Chaque comprim pellicul Cada comprimido recubierto contains Ethambutol contient L Ethambutol contiene Clorhidrato de The BP 400 Hydrochloride BP 400 mg chlorhydrate BP 400 mg Ethambutol BP 400 mg B Methylparaben used as Methylparaben utilis comme Metilparabeno utilisa como preservative conservateur conservante Approved colours used Couleurs utilis es approuv es Aprobado colores utilizados B i Ap Dosage As directed the Posologie Comme dirig par le Posolog a seg n las
27. s cA n e po d S Kanamycine 1000mg m 1000 4 Sulfate de Kanamycine solution pour 19 10 ampoules 1r 10 a o Li n E Stop Partnership 2 GLOBAL DRUG Supplied through the Global TB Drug Facility Not for Resale FACILITY WHO Product Reference No XX XXX 1000 9 4 10 ampoules Kanamycin Kanamycine Kanamicina 1000 9 4 10 ampoules Kanamicina Sulfate de Kanamycine Sulfate de Kanamycine Kanamicina sulfato solution for injection 1g solution for injection 1g soluci n inyectable 1g ir Each ampoule contains 4ml Chaque ampoule renferme 4ml Cada ampolla contiene 4ml de 4 solution ready for i m injection de solution pr te l emploi solucion lista para i m Indications Dosages see pour injection IM Indicac ones y posolog a enclosed leaflet Indications Poso
28. sizes and each face has a role and contains some information This item a might be to define the place to be dedicated to each element Each element Name form info product info secondary info manufacturing branding coloured band are positioned in a zone These zones are standardized in the layout Define a with an appropriate unit of measurement relative to the size of the face or the size of the name s font the height of the upper red band and the size of the GDF logo Form information zone vameszore of the product Brandname or Secondary name of the product Product information zone Stop Partnership M O GLOBAL DRUG T Supplied through the Global TB Drug Facility Not for Resale FACILITY S 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Brand zone Stop Partnership GLOBAL DRUG FACILITY Global Drug Facility gt Packaging design guidelines The international non proprietary name of the product Strength Concentration 4 The organization of the information by zones B The position of the elements on a front face Form information 24 x 28 Film coated tablets Comprim s pellicul s Comprimidos recubiertos Ethambutol 400 mg Secondary name or info ex Proprietry name ex Name of the medicinal product ex
29. ths DAILY treatment Continuation Phase RH 150 75 mg Tablets 12 blister sheets of 28 tablets each Supplied through the Global TB Drug Facility Not for Resale WHO Product Reference No XX XXX Stop TB Kit Para uso individual del paciente Categorias Ill 2 meses de tratamiento diario fase intensiva 4 meses de tratamiento diario fase de continuaci n Fourni par le Global TB Drug Facility Vente interdite Do not worry about blank One face is reserved for space These zones can be used by the health workers or to write in special information OJO 1 III Bi 2 4 Contenido Manual de instrucciones Manual de instrucciones Categor a 111 Bi 2 meses de tratamiento diario fase intensiva RHZE 150 75 400 275 mg Comprimidos 6 blisters cada blister 28 comprimidos 4 meses de tratamiento diario fase de continuaci n RH 150 75 mg Comprimidos 12 blisters cada blister 28 comprimidos B Ill 2 RHZE 150 75 400 275 mg 6
30. utol chlorhydrate BP 400 mg Methylparaben utilis comme conservateur Couleurs utilis es approuv es Posologie Comme dirig par le m decin Mode d emploi VOIR LE LIVRET Par voie orale avec de l eau Conservation Conserver dans un endroit frais et sec en dessous de 25 C l abri de la lumi re Garder hors de la port e et de vue des enfants OOP 32142 jo1nquieu13 x 28 mg Cada comprimido recubierto contiene Clorhidrato de Ethambutol BP 400 mg Metilparabeno utilisa como conservante Aprobado colores utilizados Posolog a seg n las indicaciones del m dico Instrucciones de uso CONSULTE EL FOLLETO DEL PAQUETE Por v a oral con agua Almacenamiento Guarde en un lugar fresco y seco a temperaturas que no exedan los 25 C Proteger de la luz Mantener fuera del alcance y de la vista de los ni os Supplied through the Global TB Drug Facility Not for Resale Fournis par le Global TB Drug Facility Vente interdite Film coated tablets Comprim s pellicul s Comprimidos recubiertos jo3nquieu13 pS 400
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