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Ultratard (insulin human) – Labelling - A10AE01

Updated on site: 10-Oct-2017

Medication nameUltratard
ATC CodeA10AE01
Substanceinsulin human
ManufacturerNovo Nordisk A/S
1 vial of 10 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING

OUTER CARTON

1.

NAME OF THE MEDICINAL PRODUCT

 

Ultratard 40 IU/ml

 

Suspension for injection in a vial

 

Insulin human, rDNA

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

authorised

1 ml suspension contains 40 IU (1.4 mg) of insulin human, rDNA

3.

LIST OF EXCIPIENTS

 

 

 

 

 

longer

zinc chloride, sodium chloride, methyl parahydroxybenzoate, sodium acetate, sodium hydroxide,

hydrochloric acid and water for injections

 

 

 

 

no

 

4. PHARMACEUTICAL FORM AND CONTENTS

5.METHOD AND ROUTE(S)ProductOF ADMINISTRATION

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

7.MedicinalOTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS

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 NUMBERSlonger

13.MANUFACTURER’S BATCH NUMBER

 

 

 

 

Batch:

 

no

 

 

 

 

 

 

14.

 

Product

 

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.

INSTRUCTIONS ON USE

 

Medicinal

 

 

 

 

 

5 vials of 10 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING

OUTER CARTON

1.

NAME OF THE MEDICINAL PRODUCT

 

Ultratard 40 IU/ml

 

Suspension for injection in a vial

 

Insulin human, rDNA

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

authorised

1 ml suspension contains 40 IU (1.4 mg) of insulin human, rDNA

3.

LIST OF EXCIPIENTS

 

 

 

 

 

longer

zinc chloride, sodium chloride, methyl parahydroxybenzoate, sodium acetate, sodium hydroxide,

hydrochloric acid and water for injections

 

 

 

 

no

 

4. PHARMACEUTICAL FORM AND CONTENTS

5.METHOD AND ROUTE(S)ProductOF ADMINISTRATION

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

7.MedicinalOTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS

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 NUMBERSlonger

13.MANUFACTURER’S BATCH NUMBER

 

 

 

 

Batch:

 

no

 

 

 

 

 

 

14.

 

Product

 

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.

INSTRUCTIONS ON USE

 

Medicinal

 

 

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL

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

Ultratard 40 IU/ml

Suspension for injection

Insulin human, rDNA

authorised

2.METHOD OF ADMINISTRATION

SC use

 

 

 

 

 

3.

EXPIRY DATE

 

 

longer

 

 

 

Expiry

 

 

 

 

 

 

 

 

4.

BATCH NUMBER

 

 

 

Batch:

 

no

 

 

 

 

 

 

5.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml

Product

 

 

 

 

 

 

Medicinal

 

 

 

 

 

 

 

1 vial of 10 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING

OUTER CARTON

1.

NAME OF THE MEDICINAL PRODUCT

 

Ultratard 100 IU/ml

 

Suspension for injection in a vial

 

Insulin human, rDNA

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

authorised

1 ml suspension contains 100 IU (3.5 mg) of insulin human, rDNA

3.

LIST OF EXCIPIENTS

 

 

 

 

 

longer

zinc chloride, sodium chloride, methyl parahydroxybenzoate, sodium acetate, sodium hydroxide,

hydrochloric acid and water for injections

 

 

 

 

no

 

4. PHARMACEUTICAL FORM AND CONTENTS

5.METHOD AND ROUTE(S)ProductOF ADMINISTRATION

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

7.MedicinalOTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS

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 NUMBERSlonger

13.MANUFACTURER’S BATCH NUMBERStore at 2°C - 8°C (in a refrigerator)

Batch:

 

no

 

 

 

 

 

 

Product

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

 

Medicinal

 

 

5 vials of 10 ml

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING

OUTER CARTON

1.

NAME OF THE MEDICINAL PRODUCT

 

Ultratard 100 IU/ml

 

Suspension for injection in a vial

 

Insulin human, rDNA

 

 

 

 

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

authorised

1 ml suspension contains 100 IU (3.5 mg) of insulin human, rDNA

3.

LIST OF EXCIPIENTS

 

 

 

 

 

longer

zinc chloride, sodium chloride, methyl parahydroxybenzoate, sodium acetate, sodium hydroxide,

hydrochloric acid and water for injections

 

 

 

 

no

 

4. PHARMACEUTICAL FORM AND CONTENTS

5.METHOD AND ROUTE(S)ProductOF ADMINISTRATION

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

7.MedicinalOTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS

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 NUMBERSlonger

13.MANUFACTURER’S BATCH NUMBER

 

 

 

 

Batch:

 

no

 

 

 

 

 

 

14.

 

Product

 

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.

INSTRUCTIONS ON USE

 

Medicinal

 

 

 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL

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

Ultratard 100 IU/ml

Suspension for injection

Insulin human, rDNA

authorised

2.METHOD OF ADMINISTRATION

SC use

 

 

 

 

 

3.

EXPIRY DATE

 

 

longer

 

 

 

Expiry

 

 

 

 

 

 

 

 

4.

BATCH NUMBER

 

 

 

Batch:

 

no

 

 

 

 

 

 

5.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

10 ml

Product

 

 

 

 

 

 

Medicinal

 

 

 

 

 

 

 

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