FORTUM 2 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION, FORTUM 2 G POWDER FOR SOLUTION FOR INFUSION (MONOVIAL) - Patient leaflet, side effects, dosage

2 g powder for solution for injection or infusion

ceftazidime

Intravenous use after reconstitution/d i I ution.

1 vial

Glaxo Operations UK Ltd 980 Great West Road Brentford

Middlesex TW8 9GS

Trade marks are owned by or licensed to the GSK group of companies.

© 2020 GSK group of companies or its licensor.

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F5380936

fortum

2 g powder for solution for injection or infusion ceftazidime

Version:

Artwork copyright Is the property of the GSK Group of Companies. All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork. The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers. The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.

Harmony AMS

Artwork Information Panel

Manufacturing Site Number:

F5380936 _____________­__________

Manufacturing Site(s):

ACS Dobfar Verona ITALY

Product Market Trade Name:

Fortum _____________­______________

Approving Market(s):

United Kingdom-GBR

Print Process:

N/A _____________­_______________

Colour Standard Reference:

N/A _____________­_______________

Technical Drawing (Do NOT Include version number):

D15083CAR _________________

Material Spec. (Do NOT Include version number):

N/A _____________­______________

Material Type: …

N/A N/A

Body Text Size:

8.0pt

Smallest Text Size:

7.0pt _____________­___________

Leading:

9.0pt _____________­___________

Horizontal Scale:

100%

Microtext:

Y____________­______

Additional Info (1):

N/A _____________­________

Additional Info (2):

N/A _____________­________

Additional Info (3):

N/A

IMPORTANT

GSK LOC is responsible to approve the change documentation, artwork brief and final artwork, ensuring that it is accurate, consistent and complete.

GSK SDC is responsible for site technical requirements and pre-press suitability.

GSK Market is responsible to advise SDC when changes required impact the following: Formulation Tablet embossing Storage conditions Shelf Life

NOTE TO MARKET

AIP_Production_V_IL­L – 04_2017 – Harmony – Version 2

Local approvers must ensure that trade mark and copyright statements included in the brief comply with guidance provided by Legal: Global Trade Marks.

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PDF is both PDF/X-4 compliant and GSK compliant for the workflow PRODUCTION Cartons_backin­g cards

AIP_Disclaimers_AI ■ NOV.2013 Version 2

Artwork copyright is the property of the GlaxoSmithKline Group of Companies

All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork. The distribution and use of fonts/software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers. The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.

• ATTENTION ATTENTION ATTENTION ATTENTION ATTENTION ATTENTION ATTENTION ATTENTION

To Ensure Accurate PDF Viewing and Printing: FOR SCREEN VIEWING: Use Adobe Acrobat 7 Professional or Adobe Acrobat Reader, Standard or Professional (higher than 7). Overprint Preview must be activated for accurate on screen viewing. FOR PRINTING: Use only Acrobat Professional version 7 or higher. „Apply Overprint Preview“ or „Simulate Overprinting“ must be activated in the print settings for printing accurate hard copies.

180 mm Measuring Bar

If a status identification banner DOES NOT appear on this document, THEN this document has NOT been printed from the Global Pack Management system.

IMPORTANT

TEXT SIZE CONTAINED IN THIS ARTWORK

GSK Market is responsible for this product, its design and content. Ensure the artwork is thoroughly checked, all the text proof-read and approved. RSC GSK is responsible for site technical requirements and pre-press suitability.

GSK Market is responsible to advise RSC in case changes required impact the followings: Formulation, Tablet embossing. Storage conditions. Shelf Life

Intravenous use.

1000000

0140506

2 g powder for solution for injection or infusion ceftazidime

Body text size: 7.0pt

Smallest text size: 7.0pt Microtext: No

Each vial contains 2 g ceftazidime (as pentahydrate) with sodium carbonate (118 mg per gram of ceftazidime).

Also contains sodium carbonate (anhydrous sterile). See leaflet for further information.

Read the package leaflet before use.

Keep vials in the outer carton to protect from light. Store below 25°C.

Read the leaflet for the shelf life of the reconstituted product.

Keep out of the sight and reach of children.

PL 00004/0424 [POM]

This PDF has been verified using Pitstop 12

8 Page 1 of 2

AIP_Disclaimers_AI ■ NOV.2013 Version 2

Artwork copyright is the property of the GlaxoSmithKline Group of Companies

All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork. The distribution and use of fonts/software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers. The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.

• ATTENTION ATTENTION ATTENTION ATTENTION ATTENTION ATTENTION ATTENTION ATTENTION

To Ensure Accurate PDF Viewing and Printing: FOR SCREEN VIEWING: Use Adobe Acrobat 7 Professional or Adobe Acrobat Reader, Standard or Professional (higher than 7). Overprint Preview must be activated for accurate on screen viewing. FOR PRINTING: Use only Acrobat Professional version 7 or higher. „Apply Overprint Preview“ or „Simulate Overprinting“ must be activated in the print settings for printing accurate hard copies.

180 mm Measuring Bar

If a status identification banner DOES NOT appear on this document, THEN this document has NOT been printed from the Global Pack Management system.

IMPORTANT

TEXT SIZE CONTAINED IN THIS ARTWORK

GSK Market is responsible for this product, its design and content. Ensure the artwork is thoroughly checked, all the text proof-read and approved. RSC GSK is responsible for site technical requirements and pre-press suitability.

GSK Market is responsible to advise RSC in case changes required impact the followings: Formulation, Tablet embossing. Storage conditions. Shelf Life

2 g powder for solution for injection or infusion ceftazidime

Intravenous use.

Body text size: 7.0pt

Smallest text size: 7.0pt Microtext: No

Each vial contains 2 g ceftazidime (as pentahydrate) with sodium carbonate (118 mg per gram of ceftazidime).

Also contains sodium carbonate (anhydrous sterile). See leaflet for further information.

Read the package leaflet before use.

Keep vials in the outer carton to protect from light. Store below 25°C.

Read the leaflet for the shelf life of the reconstituted product.

Keep out of the sight and reach of children.

PL 00004/0424 jPOM]

FOR TECHNICAL AND ADVANCED CHECK

This PDF has been verified using Pitstop 12

8 Page 2 of 2