English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Natpar (parathyroid hormone) – Labelling - H05AA03

Updated on site: 08-Oct-2017

Medication nameNatpar
ATC CodeH05AA03
Substanceparathyroid hormone
ManufacturerShire Pharmaceuticals Ireland Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Natpar 25 micrograms/dose powder and solvent for solution for injection

Natpar 50 micrograms/dose powder and solvent for solution for injection

Natpar 75 micrograms/dose powder and solvent for solution for injection

Natpar 100 micrograms/dose powder and solvent for solution for injection

Parathyroid hormone (rDNA)

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each dose contains 25 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.

Each cartridge contains 350 micrograms parathyroid hormone (rDNA).

Each dose contains 50 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.

Each cartridge contains 700 micrograms parathyroid hormone (rDNA).

Each dose contains 75 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.

Each cartridge contains 1050 micrograms parathyroid hormone (rDNA).

Each dose contains 100 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.

Each cartridge contains 1400 micrograms parathyroid hormone (rDNA).

3.LIST OF EXCIPIENTS

Sodium chloride, mannitol, citric acid monohydrate, metacresol, sodium hydroxide (for pH adjustment), water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Powder and solvent for solution for injection

2 cartridges in their cartridge holders

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Subcutaneous use.

Use with mixing device, Natpar pen, pen needles

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

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

Discard mixed cartridge after 14 days.

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

Do not freeze.

Keep the cartridge within its cartridge holder 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 AUTHORISATION HOLDER

Shire Pharmaceuticals Ireland Limited, 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1078/001

EU/1/15/1078/002

EU/1/15/1078/003

EU/1/15/1078/004

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Natpar 25

Natpar 50

Natpar 75

Natpar 100

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

CARTRIDGE HOLDER LABEL

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

Natpar 25 mcg/dose powder for solution for injection

Natpar 50 mcg/dose powder for solution for injection

Natpar 75 mcg/dose powder for solution for injection

Natpar 100 mcg/dose powder for solution for injection

Parathyroid hormone (rDNA)

SC

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6.OTHER

REMINDER TAB TEXT (included in the pack)

Attach needle before mixing

See Instructions for Use

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed