Curacef Duo

New Zealand - English - Ministry for Primary Industries

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Active ingredient:
ketoprofen; ceftiofur present as ceftiofur hydrochloride
Available from:
Virbac New Zealand Ltd
Composition:
ketoprofen 150 g/litre; ceftiofur present as ceftiofur hydrochloride 50 g/litre
Authorization number:
A011611
Authorization date:
2019-08-30

Curacef Duo

Virbac

August 2019

Page 1 of 5

Bottle label

FOR ANIMAL TREATMENT ONLY

RESTRICTED VETERINARY MEDICINE

Ceftiofur (as hydrochloride) 50.0 mg/ml and ketoprofen 150.0 mg/ml injection for cattle

50 ml/100 ml/250 ml

1ml/50kg BW by IM route

Read leaflet before use.

Withholding periods

Milk: Nil

Meat: 3 days

Registered to and Distributed by:

Virbac New Zealand Limited. 26 – 30 Maui St, Pukete, Hamilton

Visit us at nz.virbac.com or contact us on 0800 VIRBAC (0800 847 222)

Registered pursuant to the ACVM Act 1997, No. A11611. See www.foodsafety.govt.nz for registration conditions.

Batch:

Expiry:

Curacef Duo

Virbac

August 2019

Page 2 of 5

Carton label

FOR ANIMAL TREATMENT ONLY

RESTRICTED VETERINARY MEDICINE

Ceftiofur (as hydrochloride) 50.0 mg/ml and ketoprofen 150.0 mg/ml injection for cattle

50 ml/100 ml/250 ml

Indications

Treatment of bovine respiratory disease associated with Histophilus somni (formerly Haemophilus somnus),

Mannheimia haemolytica (formerly Pasteurella haemolytica) and Pasteurella multocida.

Treatment of acute interdigital necrobacillosis (panaritium, foot rot) associated with Fusobacterium

necrophorum and Bacteroides melaninogenicus.

Reduction of associated clinical signs of inflammation or pyrexia.

Directions for use

Shake the bottle vigorously for 20 seconds before use to ensure a homogeneous suspension.

Administer 1 ml per 50 kg daily by intramuscular injection into the anterior half of the neck for:

Foot rot – 3 days

Respiratory disease – 3 to 5 days

If inflammation / pyrexia resolves, the full treatment course is to be completed using a product containing ceftiofur

only.

Not for use in bobby calves. Do not use in animals known to be hypersensitive to ketoprofen, ceftiofur or other β-

lactam antibiotics. Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of

increased renal toxicity. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or

within 24 hours of each other.

Prudent Use:

Third generation cephalosporins such as ceftiofur should be reserved for the treatment of clinical conditions, which

have responded poorly, or are expected to respond poorly, to other classes of antimicrobials including first

generation cephalosporins. Use of product should be based on susceptibility testing.

Withholding periods

It is an offence for users of this product to cause residues exceeding the relevant MRL in the Food Notice:

Maximum Residue Levels for Agricultural Compounds.

Milk: Curacef Duo has no milk withholding period when used as directed.

Meat: Cattle producing meat and offal for human consumption must not be sold for slaughter either during

treatment or within 3 days of the last treatment.

Curacef Duo

Virbac

August 2019

Page 3 of 5

Warning

Harmful if swallowed. Toxic if inhaled. Causes skin irritation and serious eye irritation. May cause damage to blood

and haemopoietic system through prolonged or repeated oral exposure. Harmful to terrestrial vertebrates.

Keep out of reach of children. Read label before use. Wash hands thoroughly after handling. Do not eat, drink or

smoke when using this product. Avoid breathing mist. Use only outdoors or in a well-ventilated area. Wear

protective gloves and eye protection. Avoid release to the environment.

If medical advice is needed, have product container or label at hand.

IF SWALLOWED: Call a POISON CENTER or doctor if you feel unwell. Rinse mouth.

IF INHALED: Remove to fresh air and keep at rest in a position comfortable for breathing.

IF ON SKIN: Wash with plenty of soap and water. Take off contaminated clothing and wash before re-use.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.

Continue rinsing.

IN CASES OF ACCIDENTAL SELF-INJECTION seek medical advice immediately and show the leaflet or carton the the

doctor.

Get medical advice if you feel unwell.

Storage and disposal

Store below 25°C. Do not freeze. (Glass vial only: Keep the vial in the outer packaging to protect from light.)

Use within 28 days after the first dose is removed.

Preferably, dispose of product by use. Otherwise dispose of product and packaging at an approved landfill or other

approved facility.

Registered to and Distributed by:

Virbac New Zealand Limited. 26 – 30 Maui St, Pukete, Hamilton

Visit us at nz.virbac.com or contact us on 0800 VIRBAC (0800 847 222)

Registered pursuant to the ACVM Act 1997, No. A11611. See www.foodsafety.govt.nz for registration conditions.

Batch:

Expiry:

Curacef Duo

Virbac

August 2019

Page 4 of 5

Leaflet

FOR ANIMAL TREATMENT ONLY

RESTRICTED VETERINARY MEDICINE

Ceftiofur (as hydrochloride) 50.0 mg/ml and ketoprofen 150.0 mg/ml injection for cattle

50 ml/100 ml/250 ml

Indications

Treatment of bovine respiratory disease associated with Histophilus somni (formerly Haemophilus somnus),

Mannheimia haemolytica (formerly Pasteurella haemolytica) and Pasteurella multocida.

Treatment of acute interdigital necrobacillosis (panaritium, foot rot) associated with Fusobacterium

necrophorum and Bacteroides melaninogenicus.

Reduction of associated clinical signs of inflammation or pyrexia.

Directions for use

Shake the bottle vigorously for 20 seconds before use to ensure a homogeneous suspension.

Administer 1 ml per 50 kg daily by intramuscular injection into the anterior half of the neck for:

Foot rot – 3 days

Respiratory disease – 3 to 5 days

If inflammation / pyrexia resolves, the full treatment course is to be completed using a product containing ceftiofur

only.

Not for use in bobby calves. Do not use in animals known to be hypersensitive to ketoprofen, ceftiofur or other β-

lactam antibiotics. Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of

increased renal toxicity. Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or

within 24 hours of each other.

Prudent Use:

Third generation cephalosporins such as ceftiofur should be reserved for the treatment of clinical conditions, which

have responded poorly, or are expected to respond poorly, to other classes of antimicrobials including first

generation cephalosporins. Use of product should be based on susceptibility testing.

Withholding periods

It is an offence for users of this product to cause residues exceeding the relevant MRL in the Food Notice:

Maximum Residue Levels for Agricultural Compounds.

Milk: Curacef Duo has no milk withholding period when used as directed.

Meat: Cattle producing meat and offal for human consumption must not be sold for slaughter either during

treatment or within 3 days of the last treatment.

Curacef Duo

Virbac

August 2019

Page 5 of 5

Target Animal Safety:

Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of

gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia.

Mild inflammatory reactions at the injection site, such as tissue oedema, without pain in most cases, may be

observed.

In common with all NSAIDs, due to their action of inhibition of prostaglandin synthesis, there can be the possibility in

certain individuals of gastric intolerance such as ulceration or bleeding.

Warning

Harmful if swallowed. Toxic if inhaled. Causes skin irritation and serious eye irritation. May cause damage to blood

and haemopoietic system through prolonged or repeated oral exposure. Harmful to terrestrial vertebrates.

Keep out of reach of children. Read label before use. Wash hands thoroughly after handling. Do not eat, drink or

smoke when using this product. Avoid breathing mist. Use only outdoors or in a well-ventilated area. Wear

protective gloves and eye protection. Avoid release to the environment.

If medical advice is needed, have product container or label at hand.

IF SWALLOWED: Call a POISON CENTER or doctor if you feel unwell. Rinse mouth.

IF INHALED: Remove to fresh air and keep at rest in a position comfortable for breathing.

IF ON SKIN: Wash with plenty of soap and water. Take off contaminated clothing and wash before re-use.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.

Continue rinsing.

IN CASES OF ACCIDENTAL SELF-INJECTION seek medical advice immediately and show the leaflet or carton the the

doctor.

Get medical advice if you feel unwell.

Storage and disposal

Store below 25°C. Do not freeze. (Glass vial only: Keep the vial in the outer packaging to protect from light.)

Use within 28 days after the first dose is removed.

Preferably, dispose of product by use. Otherwise dispose of product and packaging at an approved landfill or other

approved facility.

Registered to and Distributed by:

Virbac New Zealand Limited. 26 – 30 Maui St, Pukete, Hamilton

Visit us at nz.virbac.com or contact us on 0800 VIRBAC (0800 847 222)

Registered pursuant to the ACVM Act 1997, No. A11611. See www.foodsafety.govt.nz for registration conditions.

Batch:

Expiry:

Ref No A011611-01

Public Record of Delegate Decision

For granting an application for registration under section 21 of the Agricultural Compounds and Veterinary

Medicines Act 1997

Product details

Trade name

Curacef Duo

Ref No

A011611-01

Applicant

Virbac New Zealand Limited

Application type

NEW PRODUCT

Date of Delegate

Decision

27 August 2019

Registration

Expiry Period

This registration will expire 5 years from the date of this Delegate’s Decision.

Protected

Confidential

Information

Status

Protected CI - New Registration - Non-innovative Trade Name Product

Summary of reasons for the Decision to grant the Application

Chemistry/Manufacturing: Chemistry and manufacturing information conformed to MPI requirements and was

sufficient to confirm the identity and quality of the product.

The product data sheet is complete, accurate and current.

The manufacturer has the appropriate approval. Manufacturing specifications conformed to MPI requirements and

were sufficient to show that the product could be consistently manufactured to those specifications.

Stability trials and data conformed to MPI requirements and were sufficient to assess.

Efficacy: Efficacy trials and data conformed to MPI requirements and were sufficient to assess.

Safety: Safety trials and data conformed to MPI requirements and were sufficient to assess.

Residues: Residue trials and data conformed to MPI requirements and were sufficient to assess.

Trade: The product has been assessed in regard to the impact its use may have on trade in primary produce.

Public health: Due to the nature of the product and how it is intended to be used there were no additional public

health matters that needed to be addressed over and above those covered under the Hazardous Substances and

New Organisms Act 1996.

Recommendation to Register

On the basis of the above information, the product as approved, and when imported, manufactured, sold or used

in accordance with the conditions listed below, is not likely to cause unacceptable risks to:

public health

trade in primary produce

animal welfare or

Ref No A011611-01

agricultural security.

In balance, there are sufficient benefits to warrant this product to be registered.

When used in accordance with this approval, the product is not likely to cause residues in primary produce, food

or food-related products that would breach domestic food residue standards.

The assessed label content is adequate to provide sufficient consumer information to allow the product to be used

appropriately and safely and meets labelling requirements.

Delegate’s decision

Being satisfied of the matters above, and under delegated authority pursuant to the Agricultural Compounds and

Veterinary Medicines Act 1997, this application for registration is granted, under section 21(1)(d) under the

conditions as listed on the Register.

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