VIVITONIN 50 TABLETS FOR AGED DOGS

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
PROPENTOFYLLINE
Available from:
Intervet Australia Pty Limited
INN (International Name):
propentofylline(50mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
PROPENTOFYLLINE ALKALOID Active 50.0 mg/Tb
Units in package:
#50 Tabs; #Bottle; 60 Tablets; Foil strip
Class:
VM - Veterinary Medicine
Manufactured by:
INTERVET AUSTRALIA
Therapeutic group:
DOG - OLDER
Therapeutic area:
CARDIOVASCULAR SYSTEM
Therapeutic indications:
ALLEVIATION OF DULLNESS, LETHARGY | LONGEVITY | FOR OLDER DOGS | OLD AGE | PROLONG LIFE
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - OLDER: [ALLEVIATION OF DULLNESS, LETHARGY, LONGEVITY]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG - OLDER: [ALLEVIATION OF DULLNESS, LETHARGY, LONGEVITY]; For the alleviation of dullness, lethargy and improvement in overall demeanour in older dogs. May help in slowing development of hearing/sight defects associated with ageing and also slow the development of cataracts in aged animals.Contraindicated in pregnant or lactating bitches. Allergic skin reactions (e.g. urticaria) may occur rarely after administration.
Authorization status:
Registered
Authorization number:
51394
Authorization date:
2019-07-01

Registered

Product

Name;

Pagelo

ilon

Pack Sizes ; 60 tablets

Oate (Vers ion Control): ORAFT NZ Opt1on 1

1212009

AU reviewed 16112109

ACVM approved 01

April

2010 Warn ings

removed 27 Ma

OeS~~i~tlOn;

Carto n

&

Insert

TeX T

incorpo rati ng dose

APVMA:

Pend ing

chan

e and new ACVM Jabel sta lements

Panel

labels

te xt

above the header and below the fo ot er

included In this labe l

text.

[INSERT]

PRESCRIPTION ANIMAL REMEOY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

VIVITONIN@50

TABLETS FOR AGED DOGS

Eac h film-coated tab let

contains 50mg propentofy

JJine.

MODE

V ivito nin acts primarily by producing a m arked improvement

m icro-ci rcu lat ion

a nd the refore by increasing the oxygen supp ly in the per iphera l and cerebral

may start

to take effect

afte r only a few days , de pend ing on

cl inica l

sig ns .

clinical

signs can be expected to retu rn once treatment has been dis continued.

INDICAT

IONS

C ond it ions

ociate d w ith the ageing process in dogs,

such as let hargy, tiredness ,

. apathy , stiff ga it, difficu lty in stan di ng up and walking , lack

appetite ,

ting ,

alopecia, d ull

coat,

when no specific ca use of th

conditions can be fou nd,

V ivito nin

hel p in slow ing the development

hearing and sight de fects

assoc

iated with agei ng and also slow the develop me nt

cataracts in aged anima ls.

CONTRA

INDICAT

IONS

Co ntraind icated in pregna nt

or lactating bitches, as

compo

und has

been

eva luated for these anima ls .

DOSAGE

INISTRATION

- 10

mg propentofylline/kg bodyweight dai ly divi

into two doses give n am & pm

as fo llows:

Bodywei nht

Tabl ets

Dailv Tota l

Da ily total

Ta ble ts (SOma l

Dos e (mg/kal

<5

6.3 -

10.0

6.3 -

10.0

15 kg

6.7 -

11.1

25 kg

-33k

-7.7

The tab let can be adm inis

ed directly onto the back of the tongue or can be mixed

with a sma ll

ball

foo d.

Administe r the tab let on an em pty stomach at

least 30

minutes before feeding .

Cont inue treatment as required .

SIDE EFFECTS

A llergic sk in reactions (e.g.

urticaria) ,

rare ly after admi nistration

iton

in and these necessitate discontin uatio n

the t reatment.

RLP

APPROVED

Info

pest

Verified

Regist ered Produc t Name:

Page

oni~

Pack Sizes :

tab lets

Oate (Version Con tro l): DRAFT NZ Opt ion 1

11/12/2

1)1)

9 AU revie we d 1611

2/1)

ACVM ap

prov

1 Ap ri l

Warnin gs

D esc ription:

Carton

&

Ins ert

TeXT (new.

Inco rpo rati ng do se

removed 27 Ma

APVMA: Pending

cha n e and new ACVM label

statementsl

Panel

labels, t ext above I he header and below th e

te r are not

Inc luded in t hi s lab

elte

x t.

FI RST A ID

If poisoning occurs contact a doctor or Poisons Information Centre. Phone Australia 13 11

New Zealand

0800

POISON

(0800

764 766).

DISP OS

D ispose of

empty

container by

wrapp

ing in pap er 'and putting in garb age.

STORA GE

St ore bel ow

(Roo m temperatu re).

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Registration No:

A 5114.

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rreg

ist ration cond itio ns.

Approved pursuant to the H SNO Act 1996,

HSR002273.

safety data sheet fo r further information. www. inte rvet.co.nz

A PVMA Approval

NO:5

1Y:)4:

QS2cl

NTER

VET/SCHERIN G-PLOUG H

ANIMAL HEALTH

91 -10.5

Harpin Street

ENDIGO

EAST VIC

3550

Phone

: (03) 5440 9888

[MA IN PANE L - CARTON FRONT]

PR ESCR IPTION ANIMAL REM EDY

K EEP OUT OF REAC H OF CHILDR EN

FOR A NIMAL TREAT MENT

iviton

in®50

LETS FOR AG ED DOGS

Re gistered 10:

Schering- Plough A nimal

Healt h Ltd,

Zealand

Phone: 0800 800

ACTIVE CONSTITUENT: Each tablet contains 50mg propenlofylline.

For the alleviation of dullness, lethargy and improvement in overall

de meanour in older dogs.

Tablets

[ANCILLARY PANEL- CARTON SIDE]

V iv ito n in® 50

TA B LET S FOR AG ED DOGS

[SP/lntervet

loqo]

RegIste red Pr odu c t Nam e:

Page3

Pack Siz

tablel s

Date

(II,r

slon

ontr

ol): DRAFT NZ

Optio

1111212009

161

1210

9

ACVM approv ed 01

Apri'

2010 Warnings

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[ANCILLARY PAN EL -

TON BA CK)

NCLOSED

LEAFLET BEFORE USIN G

THIS

PROD

DIRECTIONS

CONTRAlNDlCATIONS

Conltaindicated

pregnant

lactating bi!d18$.

COfTI?OU"d

not yet

been

evaluat

e<!

for these

rina

DOSA

ANO ADMINIS TRATION:

6-10

rng properItOfyflinelkg

bodyweight

daily

dMded

into

dose,

oiWln

&

:>m

1oIows:

,,,,

<5

Yo

Yo

Yo

5 kg

16 -

34 -SO ka

tablet can

administered directly

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bacIo:.

lhe tOl'lguaor can

mixed

wilh a

smal l

ban 01

Jood.

Administer the tablet

on an empty

stomach at

leas t

minutes

before leedirlg.

COntinue treatment

required.

FIRST

AID:

II poisoning occurs Contact a

doctor

Poisons Information Centre Phone

Austfa~a

13 11

New Zealalld

0800

POISON

(0800 164

766).

[A NCILLARY PANEL- CARTON SIDE]

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iton in

TABLETS FOR AG ED DOGS

DISPOSAl.

DisPose

01

empty container

wrapping in paper

and pul ling

STORAGE

SlQfe

below

3O"C

(Room lempera lure) .

Zuland

Inf orm at

RESTRICTED VETERINARY MEDICINE

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Name:

Vivitoni nf;l 50

Page

<I

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Pack stees: 30 table ts

Date

erslon Con t ro

711212009 NZ

Descri

li o n:

afl et

TEXT new

APVMA:

lJels,

te xt ab ove the header and be

t he foot er are not Inc luded In this label te d ,

[BLISTER LABEL]

FOR ANIM

TREATMENT ONL Y

v lvttonin" 50

TA BLETS FOR AG ED DOGS

Acti

ve Co nsti tuent:

Each t ablet con ta ins 50 m g p rop ento fy lli ne

Product Name: Vivitonin® 50 & 100 Tablets for Aged Dogs

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 1 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Substance:

Propentofylline is a xanthine derivative.

Trade Name:

Vivitonin

®

50 & 100 Tablets for Aged Dogs

Product Code:

176445, 176560

Recommended Use:

For the alleviation of dullness, lethargy and improvement in overall demeanor in older

dogs. Vivitonin widens blood vessels and makes blood less sticky, improving circulation.

APVMA No:

51394, 49892

Creation Date:

November, 2006

This version issued:

July, 2009

and is valid for 5 years from this date.

Statement of Hazardous Nature:

This product is classified as:

Not classified as hazardous according to the criteria of SWA.

Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code.

Risk Phrases:

Not Hazardous - No criteria found.

Safety Phrases:

Not Hazardous - No criteria found.

SUSDP Classification:

ADG Classification:

None allocated. Not a Dangerous Good under the ADG Code.

UN Number:

None allocated

Physical Description & Colour:

Ochre coloured tablets.

Odour:

No odour.

Major Health Hazards:

no significant risk factors have been found for this product.

Inhalation:

Short Term Exposure:

Long term inhalation of high amounts of any nuisance dust may overload lung clearance

mechanism. Available data indicates that this product is not harmful. However product may be mildly irritating, although

unlikely to cause anything more than mild transient discomfort.

Long Term Exposure:

No data for health effects associated with long term inhalation.

Skin Contact:

Short Term Exposure:

Available data indicates that this product is not harmful. It should present no hazards in

normal use. In addition product is unlikely to cause any discomfort in normal use.

Long Term Exposure:

No data for health effects associated with long term skin exposure.

Eye Contact:

Short Term Exposure

: This product may be mildly irritating to eyes, but is unlikely to cause anything more than mild

discomfort which should disappear once product is removed.

Potential Health Effects

Emergency Overview

Section 2 - Hazards Identification

Section 1 - Identification of Chemical Product and Company

Intervet Australia Pty Limited

91-105 Harpin Street

Tel: 1 800 033 461

Bendigo East, Vic 3550, AUSTRALIA

Fax: 1 800 817 414

Company ABN: 79 008 467 034

Product Name: Vivitonin® 50 & 100 Tablets for Aged Dogs

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 2 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Long Term Exposure

: No data for health effects associated with long term eye exposure.

Ingestion:

Short Term Exposure

: Significant oral exposure is considered to be unlikely. However, this product may be irritating

to mucous membranes but is unlikely to cause anything more than transient discomfort.

Long Term Exposure

: No data for health effects associated with long term ingestion.

Carcinogen Status:

SWA:

No significant ingredient is classified as carcinogenic by SWA.

NTP:

No significant ingredient is classified as carcinogenic by NTP.

IARC:

No significant ingredient is classified as carcinogenic by IARC.

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

Propentofylline

55242-55-2

50mg/tablet *

not set

not set

Other non hazardous ingredients

secret

to 100

not set

not set

* and 100mg/tablet

This is a commercial product whose exact ratio of components may vary slightly. Minor quantities of other non hazardous

ingredients are also possible.

The SWA TWA exposure value is the average airborne concentration of a particular substance when calculated over a normal 8 hour working day for a

5 day working week. The STEL (Short Term Exposure Limit) is an exposure value that may be equalled (but should not be exceeded) for no longer than

15 minutes and should not be repeated more than 4 times per day. There should be at least 60 minutes between successive exposures at the STEL.

The term "peak "is used when the TWA limit, because of the rapid action of the substance, should never be exceeded, even briefly.

General Information:

You should call The Poisons Information Centre if you feel that you may have been poisoned, burned or irritated

by this product. The number is 13 11 26 from anywhere in Australia (0800 764 766 in New Zealand) and is

available at all times. Have this MSDS with you when you call.

Inhalation:

First aid is not generally required. If in doubt, contact a Poisons Information Centre or a doctor.

Skin Contact:

Gently brush away excess solids. Irritation is unlikely. However, if irritation does occur, flush with

lukewarm, gently flowing water for 5 minutes or until chemical is removed.

Eye Contact:

Quickly and gently brush particles from eyes. No effects expected. If irritation does occur, flush

contaminated eye(s) with lukewarm, gently flowing water for 5 minutes or until the product is removed. Obtain medical

advice if irritation becomes painful or lasts more than a few minutes. Take special care if exposed person is wearing

contact lenses.

Ingestion:

If product is swallowed or gets in mouth, do NOT induce vomiting; wash mouth with water and give some

water to drink. If symptoms develop, or if in doubt contact a Poisons Information Centre or a doctor.

Fire and Explosion Hazards:

There is no risk of an explosion from this product under normal circumstances if it is

involved in a fire.

Fire decomposition products from this product may be toxic if inhaled. Take appropriate protective measures.

Extinguishing Media

: Preferred extinguishing media are carbon dioxide, dry chemical, foam, water fog.

Fire Fighting

: If a significant quantity of this product is involved in a fire, call the fire brigade.

Flash point

:

Combustible solid.

Upper Flammability Limit:

No data.

Lower Flammability Limit:

No data.

Autoignition temperature:

No data.

Flammability Class:

Combustible solid.

Section 3 - Composition/Information on Ingredients

Section 4 - First Aid Measures

Section 5 - Fire Fighting Measures

Product Name: Vivitonin® 50 & 100 Tablets for Aged Dogs

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 3 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Accidental release

: This product is sold in small packages, and the accidental release from one of these is not

usually a cause for concern. For minor spills, refer to product label for specific instructions. No special protective clothing

is normally necessary because of this product. However it is good practice to wear latex gloves when handling this

product. In the event of a major spill, prevent spillage from entering drains or water courses and call emergency services.

Handling

: Keep exposure to this product to a minimum, and minimise the quantities kept in work areas. Check Section

8 of this MSDS for details of personal protective measures, and make sure that those measures are followed. The

measures detailed below under "Storage" should be followed during handling in order to minimise risks to persons using

the product in the workplace. Also, avoid contact or contamination of product with incompatible materials listed in Section

10.

Storage

: This product is a Scheduled Poison. Observe all relevant regulations regarding sale, transport and storage of

this schedule of poison. Store in the closed original container in a dry, cool, well-ventilated area out of direct sunlight.

Make sure that the product does not come into contact with substances listed under "Incompatibilities" in Section 10.

Check packaging - there may be further storage instructions on the label.

The following Australian Standards will provide general advice regarding safety clothing and equipment:

Respiratory equipment: AS/NZS 1715, Protective Gloves: AS 2161, Industrial Clothing: AS2919, Industrial Eye

Protection: AS1336 and AS/NZS 1337, Occupational Protective Footwear: AS/NZS2210.

SWA Exposure Limits

TWA (mg/m

3

)

STEL (mg/m

3

)

Exposure limits have not been established by SWA for any of the significant ingredients in this product.

No special equipment is usually needed when occasionally handling small quantities. The following instructions are for

bulk handling or where regular exposure in an occupational setting occurs without proper containment systems.

Ventilation:

No special ventilation requirements are normally necessary for this product. However make sure that the

work environment remains clean and that dusts are minimised.

Eye Protection:

Eye protection is not normally necessary when this product is being used. However, if in doubt, wear

suitable protective glasses or goggles.

Skin Protection:

The information at hand indicates that this product is not harmful and that normally no special skin

protection is necessary. However, we suggest that you routinely avoid contact with all chemical products and that you

wear suitable gloves (preferably elbow-length) when skin contact is likely.

Protective Material Types:

We suggest that protective clothing be made from the following materials: rubber, PVC.

Respirator:

If there is a significant chance that dusts are likely to build up in the area where this product is being used,

we recommend that you use a suitable Dust Mask.

Physical Description & Colour

Ochre coloured tablets.

Odour:

No odour.

Boiling Point:

Not applicable.

Freezing/Melting Point:

Decomposes before melting.

Volatiles:

No specific data. Expected to be low at 100°C.

Vapour Pressure:

Negligible at normal ambient temperatures.

Vapour Density:

No data.

Section 9 - Physical and Chemical Properties

Section 8 - Exposure Controls and Personal Protection

Section 7 - Handling and Storage

Section 6 - Accidental Release Measures

Product Name: Vivitonin® 50 & 100 Tablets for Aged Dogs

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 4 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Specific Gravity:

No data.

Water Solubility:

Tablet disintegrates in water.

pH:

No data.

Volatility:

Negligible at normal ambient temperatures.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water Distribution

No data

Autoignition temp:

No data.

Reactivity:

This product is unlikely to react or decompose under normal storage conditions. However, if you have any

doubts, contact the supplier for advice on shelf life properties.

Conditions to Avoid:

Store in the closed original container in a dry, cool, well-ventilated area out of direct sunlight.

Incompatibilities:

water, acids, bases, oxidising agents.

Fire Decomposition:

Carbon dioxide, and if combustion is incomplete, carbon monoxide and smoke. Water. Carbon

monoxide poisoning produces headache, weakness, nausea, dizziness, confusion, dimness of vision, disturbance of

judgment, and unconsciousness followed by coma and death.

Polymerisation:

This product will not undergo polymerisation reactions.

Local Effects:

Target Organs:

none known

Little seems to be known of human side effects of Propentofylline as clinical trials of human medications using this drug

have not been finalised.

Ingredient

Risk Phrases

No ingredient mentioned in the HSIS Database is present in this product at hazardous concentrations.

This product is biodegradable. It will not accumulate in the soil or water or cause long term problems.

Disposal:

There are many pieces of legislation covering waste disposal and they differ in each state and territory, so

each user must refer to laws operating in their area. In some areas, certain wastes must be tracked. The Hierarchy of

Controls seems to be common - the user should investigate: Reduce, Reuse, and Recycle and only if all else fails should

disposal be considered. Note that properties of a product may change in use, so that the following suggestions may not

always be appropriate. The following may help you in properly addressing this matter for this product. This product may

be recycled if unused, or if it has not been contaminated so as to make it unsuitable for its intended use. If it has been

contaminated, it may be possible to reclaim the product by filtration, distillation or some other means. If neither of these

options is suitable, consider controlled incineration, or landfill.

ADG Code:

This product is not classified as a Dangerous Good. No special transport conditions are necessary unless

required by other regulations.

Classification of Hazardous Ingredients

Section 10 - Stability and Reactivity

Section 11 - Toxicological Information

Section 12 - Ecological Information

Section 13 - Disposal Considerations

Section 14 - Transport Information

Product Name: Vivitonin® 50 & 100 Tablets for Aged Dogs

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 5 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

AICS:

All of the significant ingredients in this formulation are compliant with NICNAS regulations.

The following ingredients: Propentofylline, are mentioned in the SUSDP.

This MSDS contains only safety-related information. For other data see product literature.

Acronyms:

ADG Code

Australian Code for the Transport of Dangerous Goods by Road and Rail, 7th Edition

AICS

Australian Inventory of Chemical Substances

SWA

Safe Work Australia, formerly ASCC and NOHSC

CAS Number

Chemical Abstracts Service Registry Number

Hazchem Code

Emergency action code of numbers and letters that provide information to emergency

services especially firefighters

IARC

International Agency for Research on Cancer

NOS

Not otherwise specified

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

SUSDP

Standard for the Uniform Scheduling of Drugs & Poisons

UN Number

United Nations Number

THIS MSDS SUMMARISES OUR BEST KNOWLEDGE OF THE HEALTH AND SAFETY HAZARD INFORMATION OF THE PRODUCT AND HOW TO

SAFELY HANDLE AND USE THE PRODUCT IN THE WORKPLACE. EACH USER MUST REVIEW THIS MSDS IN THE CONTEXT OF HOW THE

PRODUCT WILL BE HANDLED AND USED IN THE WORKPLACE.

IF CLARIFICATION OR FURTHER INFORMATION IS NEEDED TO ENSURE THAT AN APPROPRIATE RISK ASSESSMENT CAN BE MADE, THE

USER SHOULD CONTACT THIS COMPANY SO WE CAN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM OUR SUPPLIERS

OUR RESPONSIBILITY FOR PRODUCTS SOLD IS SUBJECT TO OUR STANDARD TERMS AND CONDITIONS, A COPY OF WHICH IS SENT TO

OUR CUSTOMERS AND IS ALSO AVAILABLE ON REQUEST.

Please read all labels carefully before using product.

This MSDS is prepared in accord with the SWA document “National Code of Practice for the

Preparation of Material Safety Data Sheets” 2nd Edition [NOHSC:2001(2003)]

Section 15 - Regulatory Information

Section 16 - Other Information

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