Zycortal (desoxycortone pivalate) – Labelling - QH02AA03

Updated on site: 21-Sep-2017

Medication name: Zycortal
ATC: QH02AA03
Substance: desoxycortone pivalate
Manufacturer: Dechra Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

CARDBOARD CARTON

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Zycortal 25 mg/ml prolonged-release suspension for injection for dogs desoxycortone pivalate

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

desoxycortone pivalate 25 mg/ml

3.PHARMACEUTICAL FORM

Prolonged-release suspension for injection

4.PACKAGE SIZE

4 ml

5.TARGET SPECIES

Dogs

6.INDICATION(S)

Read the package leaflet before use.

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP {month/year}

Once broached, use by…

11.SPECIAL STORAGE CONDITIONS

Do not store above 30 °C.

Do not freeze.

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Disposal: Read package leaflet.

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE

For animal treatment only. To be supplied only on veterinary prescription.

14.THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Dechra Limited

Snaygill Industrial Estate

Skipton

BD23 2RW

UNITED KINGDOM

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/15/189/001

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Zycortal 25 mg/ml prolonged-release suspension for injection desoxycortone pivalate

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Desoxycortone pivalate 25 mg/ml

3.CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

4 ml

4.ROUTE(S) OF ADMINISTRATION

SC

5.WITHDRAWAL PERIOD

6.BATCH NUMBER

Lot {number}

7.EXPIRY DATE

EXP {month/year}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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