Novaquin

Основна информация

  • Търговско наименование:
  • Novaquin
  • Използвай за:
  • Животни
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Novaquin
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Horses
  • Терапевтична област:
  • Anti inflammatory and antirheumatic products, non steroids (oxicams)
  • Терапевтични показания:
  • Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.
  • Каталог на резюме:
  • Revision: 2

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/V/C/003866
  • Дата Оторизация:
  • 07-09-2015
  • EMEA код:
  • EMEA/V/C/003866
  • Последна актуализация:
  • 25-12-2019

Доклад обществена оценка

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Canary Wharf

London E14 5EU

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

EMA/463262/2015

EMEA/V/C/003866

EPAR summary for the public

Novaquin

Meloxicam

This is a summary of the European public assessment report (EPAR) for Novaquin. It explains how the

Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU)

and its conditions of use. It is not intended to provide practical advice on how to use Novaquin.

For practical information about using Novaquin, animal owners or keepers should read the package

leaflet or contact their veterinarian or pharmacist.

What is Novaquin and what is it used for?

Novaquin is a veterinary medicine used for the alleviation of inflammation and relief of pain and

chronic musculoskeletal disorders (disorders affecting the muscle and bones) in horses. It contains the

active substance meloxicam.

Novaquin is a ‘generic medicine’. This means that Novaquin is similar to a ‘reference medicine’ already

authorised in the European Union (EU) called Metacam.

For further information, see the package leaflet.

How is Novaquin used?

Novaquin is available as a 15 mg/ml oral suspension and can only be obtained with a prescription. It is

given once daily for up to two weeks. It is either given with food or directly into the mouth at a dosage

of 0.6 mg/kg bodyweight.

For further information, see the package leaflet.

Novaquin

EMA/463262/2015

Page 2/3

How does Novaquin work?

Novaquin contains meloxicam, which belongs to a class of medicines called non-steroidal anti-

inflammatory drugs (NSAIDs). Meloxicam acts by blocking an enzyme called cyclooxygenase which is

involved in the production of prostaglandins. As prostaglandins are substances that trigger

inflammation, pain, exudation (fluid that leaks out of blood vessels during inflammation) and fever,

meloxicam reduces these signs of disease.

How has Novaquin been studied?

Because Novaquin is a generic medicine, studies in animals have been limited to tests to determine

that it is bioequivalent to the reference medicine, Metacam. Two medicines are bioequivalent when

they produce the same levels of the active substance in the body.

What are the benefits and risks of Novaquin?

Because Novaquin is a generic medicine and is bioequivalent to the reference medicine, its benefits

and risks are taken as being the same as the reference medicine’s.

What are the precautions for the person who gives the medicine or comes

into contact with the animal?

Safety information has been included in the summary of product characteristics and the package leaflet

for Novaquin, including the precautions to be followed by healthcare professionals and animal owners

or keepers. The precautions are the same as for the reference medicine since Novaquin is a generic

medicine.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be

slaughtered and the meat used for human consumption. It is also the time required after

administration of a medicine before milk or eggs may be used for human consumption.

The withdrawal period for meat from horses treated with Novaquin is three days.

The medicine is not authorised for use in horses producing milk for human consumption.

Why is Novaquin approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in

accordance with EU requirements, Novaquin has been shown to have comparable quality and to be

bioequivalent to Metacam. Therefore, the CVMP’s view was that, as for Metacam, the benefits outweigh

the identified risks. The Committee recommended that Novaquin be approved for use in the EU.

Other information about Novaquin

The European Commission granted a marketing authorisation valid throughout the EU for Novaquin on

8 September 2015.

The full EPAR for Novaquin can be found on the Agency’s website: ema.europa.eu/Find

medicine/Veterinary medicines/European public assessment reports. For more information about

treatment with Novaquin, read the package leaflet (also part of the EPAR) or contact your veterinarian

or pharmacist.

Novaquin

EMA/463262/2015

Page 3/3

The full EPAR for the reference medicine can also be found on the Agency’s website.

This summary was last updated in July 2015.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Novaquin 15 mg/ml oral suspension for horses

1.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF

THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH

RELEASE, IF DIFFERENT

Marketing authorisation holder:

Le Vet Pharma B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

Manufacturer responsible for batch release:

Produlab Pharma B.V.

Forellenweg 16

4941 SJ Raamsdonksveer

The Netherlands

2.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Novaquin 15 mg/ml oral suspension for horses

Meloxicam

3.

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

One ml contains:

Active substance

Meloxicam

15 mg.

Excipients

Sodium benzoate

1.75

Yellowish-green viscous oral suspension.

4.

INDICATION(S)

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in

horses.

5.

CONTRAINDICATIONS

Do not use in pregnant or lactating mares.

Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage,

impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Do not use in horses less than 6 weeks of age.

6.

ADVERSE REACTIONS

Isolated cases of adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs

(NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible.

In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and

should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals, including isolated reports treated).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform

your veterinary surgeon.

7.

TARGET SPECIES

Horses.

8.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Dosage

Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.

Method and route of administration

Shake vigorously at least 20 times before use. To be administered either mixed with a small quantity

of food, prior to feeding, or directly into the mouth.

The suspension should be given using the measuring syringe provided in the package. The syringe fits

onto the bottle and has a kg-body weight scale.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash

the measuring syringe with warm water and let it dry.

9.

ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

10.

WITHDRAWAL PERIOD(S)

Meat and offal: 3 days.

Not authorised for use in horses producing milk for human consumption.

11.

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Shelf-life after first opening of the container: 5 months.

Do not use after the expiry date stated on the carton and the bottle after EXP.

12.

SPECIAL WARNING(S)

Special precautions for use in animals:

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal

toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to

animals:

People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal

product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the

label to the physician.

Pregnancy and lactation:

See section “Contraindications”.

Interaction with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or

with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose symptomatic treatment should be initiated.

13.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR

WASTE MATERIALS, IF ANY

Any unused medicines or waste materials should not be disposed of via wastewater or household

waste but in accordance with local requirements. Ask your veterinary surgeon how to dispose of

medicines no longer required

.

These measures should help to protect the environment.

14.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency http://www.ema.europa.eu/.

15.

OTHER INFORMATION

Cardboard box containing one high density polyethylene (HDPE) bottle of 125 ml or 336 ml with a

HDPE screw cap and a polypropylene measuring syringe.

Not all pack sizes may be marketed.For any information about this veterinary medicinal product,

please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien

Dechra Veterinary Products NV

Achterstenhoek 48

2275 Lille

Tel. : +32 14 44 36 70

Luxembourg/Luxemburg

Dechra Veterinary Products NV

Achterstenhoek 48

2275 Lille

Belgium

Tel. : +32 14 44 36 70

Република България

Vetpro Komers Ltd

JK Trakia, bl 189, ent v, ap 2

4000 Plovdiv

Tel. +359 (0) 897 843918

Magyarország

Dopharma

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Tel. +31 162 582000

Česká republika

Sevaron ltd

Palackeho trida 163 a

61200 Brno

Tel. +420 541 426 370

Malta

Le Vet B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

Tel. +31 348 565858

Danmark

Dechra Veterinary Products A/S

Mekuvej 9

7171 Uldum

Tel. +45 7690 1100

Nederland

Dechra Veterinary Products BV

Wilgenweg 7

NL 3421 TV Oudewater

Tel. +31 348 565858

Deutschland

Dechra Veterinary Products/Albrecht GmbH

Hauptstr. 6-8

D-88326 Aulendor

fTel. +49 7525 205 71

Norge

Dechra Veterinary Products AS

Henrik Ibsens Gate 90

0255 Oslo

Tel. +47 48 02 07 98

Eesti

AS Dimedium

Emajõe 1a

51008 Tartu

Tel. +372 739 0660

Österreich

Dechra Veterinary Products GmbH

FN 439005x

Hintere Achmühlerstraße 1A

A - 6850 Dornbirn

Tel. +55 72 402 42 55

Ελλάδα

Le Vet B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

Tel. +31 348 565858

Polska

Dechra Veterinary Products Sp. z o.o.

ul. Modlińska 61

03-199 Warszawa

Tel: +48 22 431 28 91

España

Dechra Veterinary Products S.L.U.

Balmes 202, 6ª

08006 Barcelona

Tel: +34 93 544 85 07

Portugal

Dechra Veterinary Products S.L.U.

Balmes 202, 6ª

08006 Barcelona

Spain

Tel: +34 93 544 85 07

France

Dechra Veterinary Products SAS

60 avenue du centre

78180 Montigny le Bretonneux

Tel: +33 (0)1 30 48 71 40

România

Dopharma

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Tel. +31 162 582000

Ireland

Slovenija

Dechra Veterinary Products Ltd

Sansaw Business Park

Hadnall

Shrewsbury

Shropshire

SY4 4AS

United Kingdom

Tel: +44 (0)1939 211200

Genera

Podjetje

zastopanje

trgovino

d.o.o.

Parmova Ulica 53

1000 Ljubljana

Tel. + 386 1 46 44 66

Ísland

Icevet

Krokhalsi 14

110 Reykjavik

Sími: +354-820 2240

Slovenská republika

Sevaron ltd

Palackeho trida 163 a

61200 Brno

Tel. +420 541 426 370

Italia

Dechra Veterinary Products Srl

Via Agostino da Montefetro 2

10134 Torino

Tel: +39 0113 157 437

Suomi/Finland

Dechra Veterinary Products Oy

Stora Wäsby Orangeriet 3

194 37 Upplands Väsby

Sweden

Puh/Tel: +358 2 2510 500

Κύπρος

Le Vet B.V.

Wilgenweg 7

NL 3421 TV Oudewater

The Netherlands

Tel. +31 348 565858

Sverige

Dechra Veterinary Products AB

Stora Wäsby Orangeriet 3

194 37 Upplands Väsby

Tel. +46 8 325355

Latvija

AS Dimedium

Emajõe 1a

51008 Tartu

Tel. +372 739 0660

United Kingdom

Dechra Veterinary Products Ltd

Sansaw Business Park

Hadnall

Shrewsbury

Shropshire

SY4 4AS

Tel: +44 (0)1939 211200

Lietuva

AS Dimedium

Emajõe 1a

51008 Tartu

Tel. +372 739 0660

Republika Hrvatska

Genera Inc.

Svetonedeljska cesta 2

Kalinovica

HR 10436 Rakov Potok

Tel. +385 1 3388602