NAQUASONE BOLUS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TRICHLORMETHIAZIDE; DEXAMETHASONE

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

trichlormethiazide(200mg/Bs)+dexamethasone(5mg/Bs)

Pharmaceutical form:

ORAL BOLUS, CHEWABLE

Composition:

TRICHLORMETHIAZIDE UNGROUPED Active 200.0 mg/PB; DEXAMETHASONE STEROID-GLUCOCORTICOID Active 5.0 mg/PB

Units in package:

24 Boluses; Unit=1 Bol

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER

Therapeutic area:

GENITOURINARY SYSTEM

Therapeutic indications:

OEDEMA | PHYSIOLOGICAL OF THE MAMMARY G

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat: Do not use less than 28 days before slaughter for human consumption . WHP: Milk: Milk collected from cows within 48 hours [4 milkings] following treatment MUST NOT BE USED for human co nsumption or processing. This milk sho uld not be fed to boddy calves.; Host/pest details: CATTLE: [OEDEMA]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [OEDEMA]; For treatment of physiological parturient oedema of the mammary gland and associated structures in cattle. For oral use only.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

File Name:
36998_0803c.doc
Prepared By:
L. Wirth
Preparation Date:
25/7/2003
Last Revised:
7/9/2000
Schering-Plough Label & Printer
Specifications:
CCP 03/014
Version:
1
(25/7/2003)
Page 1 of 3
NAQUASONE BOLUS – PRIMARY PACK
CARTON LABEL (MAIN PANEL)
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
NAQUASONE®
BOLUS
ACTIVE CONSTITUENTS:
200MG TRICHLORMETHIAZIDE
5MG DEXAMETHASONE
PER BOLUS
PACK OF 24
SCHERING-PLOUGH
Schering-Plough Animal Health
ANIMAL HEALTH
(A Division of Schering-Plough Pty Ltd)
11 Gibbon Road, Baulkham Hills NSW 2153
Enquiries: Phone [phone]
Schering-Plough Animal Health Limited
33 Whakatiki Street, Upper Hutt, New Zealand
Phone: [phone]
Registered pursuant to the ACVM Act 1997, No. A1903.
See www.nzfsa.govt.nz/acvm/ for registration conditions.
PRESCRIPTION ANIMAL REMEDY (P.A.R) CLASS I
FOR USE ONLY UNDER THE AUTHORITY OR PRESCRIPTION OF A VETERINARIAN.
Info
PEST
!
Verified
File Name:
36998_0803c.doc
Prepared By:
L. Wirth
Preparation Date:
25/7/2003
Last Revised:
7/9/2000
Schering-Plough Label & Printer
Specifications:
CCP 03/014
Version:
1
(25/7/2003)
Page 2 of 3
NAQUASONE BOLUS – PRIMARY PACK
CARTON LABEL (OTHER PANEL)
INDICATIONS: Treatment of physiological parturient oedema of the
mammary gland and
associated structures in cattle. For oral use only.
DIRECTIONS FOR USE
DOSAGE GUIDE: 1 or 2 boluses initially followed by ½ to one bolus
daily. Do not treat
beyond 3 days.
WITHHOLDING PERIODS:
MEAT: DO NOT USE LESS THAN 28 DAYS BEFORE SLAUGHTER FOR HUMAN
CONSUMPTION.
MILK: MILK COLLECTED FROM COWS WITHIN 48 HOURS [4 MILKINGS] FOLLOWING
TREATMENT
MUST NOT BE USED FOR HUMAN CONSUMPTION OR PROCESSING. THIS MILK SHOULD
NOT BE
FED TO BOBBY CALVES.
DISPOSE of empty container by wrapping with paper and putting in
garbage.
STORE below 30
o
C (Room Temperature).
NRA 36998/0803
® Registered Trademark
(B)
EXPIRY:
To be inserted on final printed labels:
LABEL ITEM CODE
BARCODE
File Name:
36998_0803c.doc
Prepared By:
L. Wirth
Preparation Date:
25/7/2003
Las

Summary of Product characteristics

________________________________________________________________________
Schering-Plough Corporation
Global Supply Chain
1095 Morris Avenue
Union, New Jersey 07083-7143
Telephone [phone]
NAQUASONE
 BOLUS (EX000027)
This product is exempt from [Material] Safety Data Sheet requirements.
The following regional exemptions apply:
United States:
According to the OSHA Hazard Communication Standard [29 CFR §
1910.1200 (b) (6) (vii)], an MSDS is
not required for any drug when it is in the solid, final form (_e.g_.
tablets or pills).
European Union:
According to the European Union Commission Directive 2001/58/EC of 27
July 2001, as it relates to
Directive 1999/45/EC [Article 1.5.a], an SDS is not required for
medicinal products in the finished state,
intended for the final user.
Canada:
According to the WHMIS Hazardous Product Act [Part II Controlled
Products 12.b], an MSDS is not
required for any drug within the meaning of the _Food and Drugs Act._
If you have any questions or need assistance, please call
Schering-Plough Animal Health
Corporation at 800- 932-0473. Many Schering-Plough Animal Health
[Material] Safety Data
Sheets may be obtained through the MSDS HelpLine at 800-770-8878 or
from the S-P MSDS
website at www.schering-ploughmsds.com.
Technical inquiries for adverse events in animals for Schering-Plough
Animal Health Products may
be addressed to Schering-Plough Animal Health Technical Services:
For Small Animals and Horses [phone]
For Livestock [phone]
For Poultry [phone]
Sincerely,
Global Safety & Environmental Affairs
Schering-Plough Corporation
Schering-Plough
Global Safety & Environmental Affairs