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Ablavar (Vasovist) (gadofosveset trisodium) – Labelling - V08CA

Updated on site: 11-Jul-2017

Medication nameAblavar (Vasovist)
ATC CodeV08CA
Substancegadofosveset trisodium
ManufacturerTMC Pharma Services Ltd.
Medicinal product no longer authorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

OUTER PACKAGING - BOX

1.

NAME OF THE MEDICINAL PRODUCT

 

Ablavar 0.25 mmol/ml solution for injection

 

Gadofosveset

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

 

 

 

authorised

1 ml Ablavar solution for injection contains 244 mg (0.25 mmol) gadofosveset tris dium equivalent to 227 mg gadofosveset..

Each vial of 10 ml solution contains 2.44 g (2.50 mmol) of gadofosveset trisodium equivalent to 2.27g gadofosveset.

Each vial of 15 ml solution contains 3.66 g (3.75 mmol) of gadofosveset trisodi m equivalent to 3.41g

gadofosveset .

longer

Each vial of 20 ml solution contains 4.88 g (5.00 mmol) of gadofosveset odium equivalent to 4.54g gadofosveset.

3. LIST OF EXCIPIENTS

Excipients: fosveset, sodium hydroxide, hydrochl ric acid, water for injections

See the leaflet for further information.

no

4.PHARMACEUTICALproductFORM AND CONTENTSSolution for injection1 vial5 vials10 vials

5.MedicinalMETHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Intrav nous use and diagnostic use only.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

The peel-off tracking label included with the vials should have the dose recorded on it and be stuck onto patient record

8. EXPIRY DATE

EXP

After first opening use immediately.

9. SPECIAL STORAGE CONDITIONS

Keep the injection vial in the outer carton in order to protect from light

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINALauthorisedPRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

12. MARKETING AUTHORISATION NUMBER(S)longer

EU/1/05/313/001 Ablavar-0.25 mmol/ml-Solution for injecti -Intravenous use-Vial (glass)-10 ml-1 vial

EU/1/05/313/002 Ablavar-0.25 mmol/ml-Soluti f r injection-Intravenous use-Vial (glass)-10ml-5

vials

product

EU/1/05/313/003 Ablavar-0.25 mmol/ml-Solu ion for injection-Intravenous use-Vial (glass)-10ml-10

 

 

no

 

vials

 

EU/1/05/313/004 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-15ml-1 vial

EU/1/05/313/005 Ablavar-0.25 mm l/ml-Solution for injection-Intravenous use-Vial (glass)-15ml-5 vials

EU/1/05/313/006 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-15ml-10

vials

EU/1/05/313/007MedicinalAb v r-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-20ml-1 vial

EU/1/05/313/008 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-20ml-5 vials

EU/1/05/313/009 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-20ml-10 vials

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

 

 

 

longer

authorised

 

 

no

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

Vial 15 and 20ml
1. NAME OF THE MEDICINAL PRODUCT
Ablavar 0.25 mmol/ml solution for intravenous use

2. STATEMENT OF ACTIVE SUBSTANCE(S)

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

1 ml Ablavar solution contains 244 mg (0.25 mmol) gadofosveset trisodium equivalent to 227 mg of gadofosveset.

Each vial of 15 ml solution contains 3.66 g (3.75 mmol) of gadofosveset trisodium equivalent to 3.41 g of gadofosveset.

Each vial of 20 ml solution contains 4.88 g (5.00 mmol) of gadofosveset trisodium equivalent to 4.54 g of gadofosveset.

authorised

3.LIST OF EXCIPIENTS

 

Fosveset

 

 

longer

 

Sodium hydroxide

 

 

 

Hydrochloric acid

 

 

 

Water for injection

 

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

Solution for injection.

product

no

 

 

 

 

 

15 ml

 

 

 

 

20 ml

 

 

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

AblavarMedicinalshould be dministered as a single intravenous bolus injection, manually, or by magnetic resonance injector over period of time up to 30 seconds followed by a 25-30 ml normal saline flush.

Keep out of the reach and sight of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

12. MARKETING AUTHORISATION NUMBER(S)
TMC Pharma Services Ltd., Finchampstead, Berkshire, RG40 4LJ, UK
Discard any unused medium after each investigation.

After first opening use immediately

9. SPECIAL STORAGE CONDITIONS

Keep the injection vial in the outer carton in order to protect from light

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATIONauthorisedHOLDER

viallonger

EU/1/05/313/004 Ablavar-0.25 mmol/ml-Solution for injection-Int avenous use-Vial (glass)-15ml-1

EU/1/05/313/005 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-15ml-5 vials

EU/1/05/313/006 Ablavar-0.25 mmol/ml-Solution for injecti -I travenous use-Vial (glass)-15ml-10 vials

EU/1/05/313/007 Ablavar-0.25 mmol/ml-Soluti f r injection-Intravenous use-Vial (glass)-20ml-1

vial

 

product

 

EU/1/05/313/008 Ablavar-0.25 mmol/ml-Solu ion for injection-Intravenous use-Vial (glass)-20ml-5

 

 

no

 

vials

 

EU/1/05/313/009 Ablavar-0.25 mmol/ml-Solution for injection-Intravenous use-Vial (glass)-20ml-10 vials

13. BATCH NUMBER

Lot

15. INSTRUCTIONS ON USE

Medicinal14. GENERAL CLASSIFICATION FOR SUPPLY

produ t subject to medical prescription

16. INFORMATION IN BRAILLE

Medicinal

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

10 ML

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Ablavar 0.25 mmol/ml solution for injection

Gadofosveset

Intravenous use

2. METHOD OF ADMINISTRATION

Read the package leaflet before use

3. EXPIRY DATE

EXP

longer

After first opening: the medicinal product should be used immediately.

4. BATCH NUMBER

Lot

 

 

no

5.

 

 

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml

 

product

 

 

 

 

6.

OTHER

 

 

authorised

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