LOTAGEN - CONCENTRATE

Main information

  • Trade name:
  • LOTAGEN ASTRINGENT/ANTISEPTIC CONCENTRATE
  • Pharmaceutical form:
  • TOPICAL SOLUTION/SUSPENSION
  • Units in package:
  • 100mL,1L
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • INTERVET AUSTRALIA

Documents

Localization

  • Available in:
  • LOTAGEN ASTRINGENT/ANTISEPTIC CONCENTRATE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ANIMAL | CAT | COW | DOG | HORSE MARE (FEMALE) | PIG SOW (FEMALE) | SHEEP EWE (FEMALE) | BITCH | BOVINE | CASTRATE | CAT - QUEEN
  • Therapeutic area:
  • topical,wound treatment
  • Therapeutic indications:
  • AGENT ACTING ON UTERUS | CRACKS, SORES, WOUNDS (ASSIST HEALING) | ABRASIONS | AGALACTIA | BITES | CONTRACTION | CUTS | ENDOMETRITIS | HAEMORRHAGE POST-PARTUM | HEALING PROMOTANT | LABOUR | LET DOWN | OBSTETRICAL | PARTURITION | PLACENTA REMOVAL | POST-PARTUM HAEMORRHAGE | UTERINE
  • Product summary:
  • For the treatment of fresh or old wounds, to promote healing and prevent excessive granulation in all species.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 35967/0702
  • Authorization date:
  • 30-07-2002
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

File Name:

35967_0702c.doc

Prepared By:

L. Wirth

Preparation Date:

9/7/2002

Last Revised:

14/2/2001

Schering-Plough Label & Printer

Specifications:

CCP 02/023

Version:

Page 1 of 9

PRIMARY PACK

LOTAGEN CONCENTRATE

100mL CARTON – MAIN PANEL

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

LOTAGEN®

Astringent/Antiseptic Concentrate

ACTIVE CONSTITUENTS PER mL:

METACRESOLSULPHONIC ACID AND

FORMALDEHYDE CONDENSATION PRODUCT

414 mg

For the treatment of fresh or old wounds, to promote

healing and prevent excessive granulation in all species.

100mL

Schering-Plough Animal Health

PRIMARY PACK

LOTAGEN CONCENTRATE

100mL CARTON – SIDE PANEL

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

Directions for use:

Precaution: Do not bring Lotagen into contact with textiles or leather.

For new and old wounds, excessive bleeding, prevention of “proud flesh” paint with Lotagen

Concentrate daily. The best methods are to bandage swabs soaked in Lotagen to the wound, or

preferably to apply with a spraying bottle.

PUERPERAL DISORDERS: IRRIGATE WITH A 4% SOLUTION.

ENDOMETRITIS IN COWS, SOWS AND EWES: INSTIL 4% SOLUTION TO STIMULATE UTERINE

TONE.

INTRAUTERINE USE IN MARES: 1-2% SOLUTION.

INTRAUTERINE USE IN SOWS: 2% SOLUTION.

WITHHOLDING PERIOD:

MEAT: DO NOT USE less than 28 days before slaughter for human consumption.

Info

pest

Verified

File Name:

35967_0702c.doc

Prepared By:

L. Wirth

Preparation Date:

9/7/2002

Last Revised:

14/2/2001

Schering-Plough Label & Printer

Specifications:

CCP 02/023

Version:

Page 2 of 9

PRIMARY PACK

LOTAGEN CONCENTRATE

100mL CARTON – SIDE PANEL

SAFETY DIRECTIONS

Will irritate the eyes. May irritate the skin. Avoid contact with eyes and skin. If product on

skin, immediately wash area with soap and water. If product in eyes, wash it out immediately

with water. Wash hands after use.

FIRST AID

If poisoning occurs contact a doctor or Poisons Information Centre (Phone 131126). If

swallowed DO NOT induce vomiting. Give a glass of water.

Warranty

Schering-Plough Pty Ltd [SPPL] warrant that this product is of merchantable quality and fit for its

intended purpose. SPPL’s liability for any loss, including consequential losses or injury caused by any

act or omission, including negligent acts or omissions, by SPPL or its agent, is limited to replacing or

repairing the product at the option of SPPL. If possible, a sample of any product causing concern

should be retained or delivered to SPPL within 30 days for a scientific examination.

PRIMARY PACK

LOTAGEN CONCENTRATE

100mL CARTON – SIDE PANEL

Schering-Plough Customer Service & Emergency Phone No. 1 800 226 511

(Australia only).

BATCH

FOR BATCH AND EXPIRY REFER TO BOTTOM PANEL

EXPIRY

Dispose of empty container by wrapping with paper and putting in garbage.

Store below 25

C (Air Conditioning).

NRA 35967/0702

Schering-Plough Animal Health

A Division of Schering-Plough Pty Ltd

11 Gibbon Road, Baulkham Hills NSW 2153

® Registered Trademark

© Copyright 2001

PRIMARY PACK

LOTAGEN CONCENTRATE

100mL CARTON – TOP PANEL

LOTAGEN®

Astringent/Antiseptic Concentrate

100mL

PRIMARY PACK

LOTAGEN CONCENTRATE

100mL CARTON – BOTTOM PANEL

BATCH

EXPIRY

File Name:

35967_0702c.doc

Prepared By:

L. Wirth

Preparation Date:

9/7/2002

Last Revised:

14/2/2001

Schering-Plough Label & Printer

Specifications:

CCP 02/023

Version:

Page 3 of 9

IMMEDIATE CONTAINER

LOTAGEN CONCENTRATE

100mL LABEL – MAIN PANEL

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

LOTAGEN®

Astringent/Antiseptic Concentre

ACTIVE CONSTITUENTS PER mL:

METACRESOLSULPHONIC ACID AND

FORMALDEHYDE CONDENSATION PRODUCT

414 mg

For the treatment of fresh or old wounds, to promote

healing and prevent excessive granulation in all species.

100mL

Schering-Plough Animal Health

File Name:

35967_0702c.doc

Prepared By:

L. Wirth

Preparation Date:

9/7/2002

Last Revised:

14/2/2001

Schering-Plough Label & Printer

Specifications:

CCP 02/023

Version:

Page 4 of 9

IMMEDIATE CONTAINER

LOTAGEN CONCENTRATE

100mL LABEL – SIDE PANELS

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

Directions for Use:

Precaution: Do not bring Lotagen into contact with textiles or leather.

For new and old wounds, excessive bleeding, prevention of “proud flesh” paint with Lotagen

Concentrate daily. The best methods are to bandage swabs soaked in Lotagen to the wound, or

preferably apply with a spraying bottle.

WITHHOLDING PERIOD: MEAT: DO NOT USE less than 28 days before slaughter for human

consumption.

SAFETY DIRECTIONS

Will irritate the eyes. May irritate the skin. Avoid contact with eyes and skin. If product on

skin, immediately wash area with soap and water. If product in eyes, wash it out immediately

with water. Wash hands after use.

FIRST AID

If poisoning occurs contact a doctor or Poisons Information Centre (Phone 131126). If

swallowed DO NOT induce vomiting. Give a glass of water.

Schering-Plough Animal Health

A Division of Schering-Plough Pty Ltd

11 Gibbon Road, Baulkham Hills NSW 2153

Dispose of empty container by wrapping with paper and putting in garbage.

Store below 25

C (Air Conditioning).

NRA 35967/0702

(B)

EXP

File Name:

35967_0702c.doc

Prepared By:

L. Wirth

Preparation Date:

9/7/2002

Last Revised:

14/2/2001

Schering-Plough Label & Printer

Specifications:

CCP 02/023

Version:

Page 5 of 9

IMMEDIATE CONTAINER

LOTAGEN CONCENTRATE

1000mL LABEL – MAIN PANEL

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

LOTAGEN®

Astringent/Antiseptic Concentrate

ACTIVE CONSTITUENTS PER mL:

METACRESOLSULPHONIC ACID

AND FORMALDEHYDE CONDENSATION PRODUCT 414 mg

For the treatment of fresh or old wounds,

to promote healing and prevent excessive

granulation in all species.

1000mL

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

Directions for Use:

Precaution: Do not bring Lotagen into contact with textiles or leather.

Fresh wounds should be treated initially to reduce bleeding. The best

methods are to bandage swabs soaked in Lotagen to the wound, or

preferably apply with a spraying bottle.

WITHHOLDING PERIOD:

MEAT: DO NOT USE less than 28 days before slaughter for human

consumption.

Schering-Plough Animal Health

File Name:

35967_0702c.doc

Prepared By:

L. Wirth

Preparation Date:

9/7/2002

Last Revised:

14/2/2001

Schering-Plough Label & Printer

Specifications:

CCP 02/023

Version:

Page 6 of 9

IMMEDIATE CONTAINER

LOTAGEN CONCENTRATE

1000mL LABEL – OTHER PANEL

SAFETY DIRECTIONS

Will irritate the eyes. May irritate the skin. Avoid contact with eyes and skin. If product on

skin, immediately wash area with soap and water. If product in eyes, wash it out immediately

with water. Wash hands after use.

FIRST AID

If poisoning occurs contact a doctor or Poisons Information Centre (Phone 131126). If

swallowed DO NOT induce vomiting. Give a glass of water.

Dispose of empty container by wrapping with paper and putting in garbage.

Store below 25

C (Air Conditioning).

NRA 35967/0702

Batch:

Expiry:

Schering-Plough Animal Health

A Division of Schering-Plough Pty Ltd

11 Gibbon Road, Baulkham Hills NSW 2153

Schering-Plough Customer Service & Emergency Phone No.

1 800 226 511 (Australia only).

® Registered Trademark

© Copyright 2001

File Name:

35967_0702c.doc

Prepared By:

L. Wirth

Preparation Date:

9/7/2002

Last Revised:

14/2/2001

Schering-Plough Label & Printer

Specifications:

CCP 02/023

Version:

Page 7 of 9

PACKAGE INSERT

LOTAGEN CONCENTRATE

LEAFLET (100mL and 1000mL)

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

Lotagen®

Astringent/Antiseptic Concentrate

ACTIVE CONSTITUENTS PER mL: METACRESOLSULPHONIC ACID AND FORMALDEHYDE

CONDENSATION PRODUCT 414mg

Chemistry

Lotagen concentrate contains 36% by weight of the condensation product of metacresolsulphonic acid

and formaldehyde. It is reddish-brown highly acidic (pH 0.6) liquid soluble in water. A 4% solution of

Lotagen Concentrate has a pH of 1.62.

Pharmacology

Lotagen selectively singles out diseased tissue without affecting healthy tissue. Pathologically

changed and necrotic tissue, secretions and mucus are coagulated thereby aiding and accelerating

the healing processes of demarcation and regeneration. Lotagen has an astringent action on healthy

mucous membrane but does not affect viability. Lotagen increases uterine tone during the puerperal

period and with its coagulating properties, assists in eliminating retained foetal membranes. Similarly

the product produces vasoconstriction and through this, cessation of capillary oozing. Granulation

and epithelization are promoted. The bacterial and fungicidal properties of Lotagen make it ideal for

the treatment of wounds and of infertility resulting from endometritis.

Lotagen in action

Bactericidal and fungicidal activity against pathogens. Lotagen kills bacteria and fungi on contact.

Capillary bleeding is controlled. Lotagen exerts haemostatic action through constriction of small

blood vessels.

Wound healing is promoted by Lotagen; the astringent action constricts wounds, healthy tissue

growth is promoted through reactive hyperaemia, together with epithelization (new tissue growth)

of the wound.

Lotagen prevents granular hyperplasia (proud flesh) during wound healing.

Lotagen increases uterine tone.

Indications

Treatment of wounds, ulcers, abscesses, eczema, furunculosis, otitis externa, navel infection.

To stop bleeding and oozing; wounds castration, mulesing, marking, dehorning, navel bleeding,

during and after surgery.

Foot abscesses, greasy heel.

Acute and chronic endometritis.

Uterine prolapse.

Treatment of uterine infections.

DIRECTIONS FOR USE:

Precaution: Do not bring Lotagen into contact with textiles or leather.

For use in animals, including dogs and cats. Lotagen is available in a number of presentations for

wound treatment. As a guide, the following treatment regimes are recommended:

File Name:

35967_0702c.doc

Prepared By:

L. Wirth

Preparation Date:

9/7/2002

Last Revised:

14/2/2001

Schering-Plough Label & Printer

Specifications:

CCP 02/023

Version:

Page 8 of 9

PACKAGE INSERT

LOTAGEN CONCENTRATE

LEAFLET (100mL and 1000mL) - continued

Indications

Treatment

Wounds (new or old)

Paint with Lotagen Concentrate daily or irrigate with Lotagen Concentrate

Surgical wounds,

at 10-20% dilution daily and continue treatment with Lotagen Gel under

abscesses, eczema

bandage where necessary daily.

furunculosis, hoof

wounds

Haemorrhage/wound

Apply Lotagen Concentrate or irrigate with Lotagen Concentrate at 20%

Dilution.

Prevention of “Proud

Paint with Lotagen Concentrate daily or apply Lotagen Gel under pressure

Flesh” during wound

bandage.

Healing – horse

Hoof Treatment

After surgical cleaning of the involved part paint with Concentrate 2-3 times.

Puerperal Disorders

(Retained Foetal Membranes, Uterine Prolapse) irrigation with Lotagen solution coagulates the

placenta, stimulates uterine tone and reduces haemorrhage. Depending on the state of involution, 1-

2 litres of solution may be required. Treatment can be repeated depending on the clinical

assessment. Lotagen is useful in the treatment of uterine prolapse.

Endometritis

Solution may be instilled in cows/sows/mares as a bactericide and to stimulate uterine tone.

Treatment may be administered prior to insemination or service (the pH of the uterus returns to

normal within 24 hours) or after insemination or service (allowing sufficient time for sperm to reach the

oviducts). The number of treatments required may vary from case to case but usually one treatment

is sufficient.

Intrauterine in mares:

1-2% solution of Lotagen Concentrate in a volume of 200-400 mL.

Intrauterine use in sows:

2% solution of Lotagen Concentrate in a volume of 50-150 mL.

Intrauterine use in cows:

4% solution of Lotagen Concentrate in a volume of 100-200 mL.

WITHHOLDING PERIOD:

MEAT: DO NOT USE less than 28 days before slaughter for human consumption.

Note

Lotagen is stable indefinitely in aqueous solution. Antibiotics and sulphonamides may be used

concurrently.

File Name:

35967_0702c.doc

Prepared By:

L. Wirth

Preparation Date:

9/7/2002

Last Revised:

14/2/2001

Schering-Plough Label & Printer

Specifications:

CCP 02/023

Version:

Page 9 of 9

PACKAGE INSERT

LOTAGEN CONCENTRATE

LEAFLET (100mL and 1000mL) - continued

SAFETY DIRECTIONS

Will irritate the eyes. May irritate the skin. Avoid contact with eyes and skin. If product on

skin, immediately wash area with soap and water. If product in eyes, wash it out immediately

with water. Wash hands after use.

FIRST AID

If poisoning occurs contact a doctor or Poisons Information Centre (Phone 131126). If

swallowed DO NOT induce vomiting. Give a glass of water.

Lotagen should not be used after the expiry date.

Dilution

To obtain desired concentration of solution of Lotagen Concentrate:

20mL of Lotagen Concentrate made up to 100 mL with water

4 mL of Lotagen Concentrate made up to 100 mL with water

2 mL of Lotagen Concentrate made up to 100 mL with water

1 mL of Lotagen Concentrate made up to 100 mL with water

Dispose of empty container by wrapping with paper and putting in garbage.

Store below 25

C (Air Conditioning).

Presentation

Bottle of 100mL, 1000mL

Schering-Plough Animal Health

A Division of Schering-Plough Pty Ltd

11 Gibbon Road, Baulkham Hills NSW 2153

Schering-Plough Customer Service & Emergency Phone No.

1 800 226 511 (Australia only).

NRA 35967/0702

® Registered Trademark

© Copyright 2001

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