Halagon (halofuginone lactate) – Package leaflet - QP51AX08

Updated on site: 21-Sep-2017

Lääkkeen nimi: Halagon
ATC: QP51AX08
Lääkeaine: halofuginone lactate
Valmistaja: Emdoka BVBA

PACKAGE LEAFLET FOR:

HALAGON 0.5 mg/ml oral solution for calves

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing Authorisation Holder:

EMDOKA bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Manufacturer responsible for batch release: Divasa-Farmavic, S.A.

Ctra. Sant Hipolit, Km. 71

08503 Gurb-Vic, Barcelona Spain

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

HALAGON 0.5 mg/ml oral solution for calves

Halofuginone (as lactate salt)

3.STATEMENT OF ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS

Each ml contains:

Active substance:

Halofuginone (as lactate salt) 0.50 mg

Equivalent to 0.6086 mg of halofuginone lactate

Excipients:

 

Benzoic acid (E210)

1 mg

Tartrazine (E102)

0.03 mg

Clear yellow oral solution.

 

4.

INDICATION(S)

 

In new-born calves:

Prevention of diarrhoea due to diagnosed Cryptosporidium parvum infection, in farms with history of cryptosporidiosis.

Administration should start in the first 24 to 48 hours of age.

Reduction of diarrhoea due to diagnosed Cryptosporidium parvum infection. Administration should start within 24 hours after the onset of diarrhoea.

In both cases, the reduction of oocysts excretion has been demonstrated.

5.CONTRAINDICATIONS

Do not use on an empty stomach.

Do not use in case of diarrhoea established for more than 24 hours and in weak animals. Do not use in case of hypersensitivity to the active substance or to any of the excipients.

6.ADVERSE REACTIONS

In very rare cases, an increase in the level of diarrhoea has been observed in treated animals.

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

-very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

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

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

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

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

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

7.TARGET SPECIES

Cattle (newborn calves)

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

For oral use in calves after feeding.

The dosage is: 100 μg of halofuginone / kg bw / once a day for 7 consecutive days, i.e. 4 ml of

HALAGON / 20 kg bw / once a day for 7 consecutive days.

However, in order to make the HALAGON treatment easier, a simplified dosage scheme is proposed:

35 kg < calves ≤ 45 kg: 8 ml of HALAGON once a day during 7 consecutive days

45 kg < calves < 60 kg: 12 ml of HALAGON once a day during 7 consecutive days

For smaller or higher weights, a precise calculation should be performed (4 ml/20 kg).

To ensure a correct dosage, an appropriate doser for administration of ‘HALAGON’ is included.

The consecutive treatment should be done at the same time each day.

Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists.

9.ADVICE ON CORRECT ADMINISTRATION

To ensure a correct dosage, an appropriate doser for administration of ‘HALAGON’ is included.

1)Screw the metering pump on the bottle.

2)Remove the protector cap from the nozzle.

3)If the metering pump is used for the first time (or hasn’t been used for a few days), carefully pump till a drop of solution is formed on top of the nozzle.

4)Restrain the calf and insert the nozzle of the metering pump into the calves mouth.

5)Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution. Pull twice or three times, respectively, for administration of the desired volume (8 ml for calves of 35 – 45 kg and 12 ml for calves of 45 – 60 kg, respectively).

6)Put the protector cap back on the nozzle.

10.WITHDRAWAL PERIOD

Meat and offal: 13 days.

11.SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Keep the bottle in the outer carton in order to protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

Shelf-life after first opening the immediate packaging: 6 months.

12.SPECIAL WARNING(S)

Special precautions for use in animals:

Administer after colostrum feeding, or after milk or milk replacer feeding only. An appropriate device for oral administration is included. For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution. The animals should receive enough colostrum according to good breeding practice.

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

People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.

Repetitive contact with the product may lead to skin allergies.

Avoid skin, eye or mucosal contact with the product. Wear protective gloves while handling the product.

In case of skin and eye contact wash the exposed area thoroughly with clean water. If eye irritation persists, seek medical advice.

Wash hands after use.

Overdose (symptoms, emergency procedures, antidotes):

As symptoms of toxicity may occur at twice the therapeutic dose, it is necessary to apply the recommended dosage strictly. Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration. Should clinical signs of overdosing occur, the treatment must be stopped immediately and the animal fed unmedicated milk or milk replacer. Rehydration may be necessary.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

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 thes veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.

15.OTHER INFORMATION

Cardboard box with high density polyethylene bottles of 290 ml, 490 and 980 ml. Not all pack sizes may be marketed.

To be supplied only on veterinary prescription.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien

Lietuva

Ecuphar nv

UAB Vetma

Legeweg 157 I

Birželio 23 sios, 23 G

BE-8020 Oostkamp

LT-50220, Kaunas

Tél/Tel: +32 (0)50 314 269

Tel: + 370 37 711276

Република България

Luxembourg/Luxemburg

БИОСФЕРА ФАРМ ЕООД

Ecuphar nv

ул.Юрий Гагарин № 50

Legeweg 157 I

BG гр. Костинброд 2230

BE-8020 Oostkamp

Teл: + 359 885917017

Tél/Tel: +32 (0)50 314 269

Česká republika

Magyarország

BIOPHARM, Výzkumný ústav biofarmacie

Panon VetPharma Kft.

a veterinárních léčiv, a.s

Hankóczy Jenõ utca 21/A

Pohoří – Chotouň 90

HU-1022 Budapest

CZ-254 49 Jílové u Prahy

Tel.: +36 30 650 0 650

Tel: +420 241 950 383

 

Danmark

Nederland

Dechra Veterinary Products A/S

AST Farma B.V.

Mekuvej 9

Wilgenweg 7

DK- 7171 Uldum

NL-3421 TV Oudewater

Tlf: +45 7690 1100

Tel: +31 (0) 0348 56 34 34

Deutschland

Österreich

WDT eG

Richter Pharma AG

Siemensstr. 14

Feldgasse 19, A

DE-30827 Garbsen

A-4600 Wels

Tel: +49 5131 705 0

Tel: +43 7242 490 0

Eesti

Polska

OÜ Zoovetvaru

Fatro Polska Sp. z o.o.

Uusaru 5

ul. Bolońska 1

EE-Saue 76505

PL-55 040 Kobierzyce

Tel: +372 6 709 006

Tel.: +48 71 311 11 11

Ελλάδα

Portugal

FATRO-HELLAS SPLTD

Divasa Farmavic de Portugal, Produtos e

2ο χιλ. ΠΑΙΑΝΙΑΣ-ΣΠΑΤΩΝ

Equipamentos Veterinários, Lda.

GR-190 02 ΠΑΙΑΝΙΑ

Praceta Jaime Corteção

Τηλ: + 30 210 6644331

Nº 1 – R/C Loja Esq.

 

2625-170 Povoa de Santa Iria

 

Tel: +351 219 739 130

España

Republika Hrvatska

Divasa-Farmavic S.A.

Vet Consulting d.o.o.

Ctra. Sant Hipòlit, km 71

Matije Gupca 42

ES-08503 Gurb-Vic, Barcelona

43500 Daruvar

Tel: +34 93 886 01 00

Tel: +385 43 440 527

France

România

Axience SAS

SC Altius SRL

Tour Essor - 14, rue Scandicci

Str Iancu Capitanu nr 38 Ap 1

F-93500 Pantin

Sector 2, Bucuresti – RO

Tél. +33 1 41 83 23 17

Tel: + 40 021 310 88 80

Ireland

Slovenská republika

Duggan Veterinary Supplies Ltd.,

BIOPHARM, Výzkumný ústav biofarmacie

Holycross,

a veterinárních léčiv, a.s

Thurles,

Pohoří – Chotouň 90

Co Tipperary

CZ-254 49 Jílové u Prahy

Ireland

Tel: +420 241 950 383

Tel: +353 (0) 504 43169

 

Italia

Suomi/Finland

Azienda Terapeutica Italiana A.T.I. s.r.l.

FaunaPharma Oy

Via Emilia 285

C/O Oriola Oy

I-40064 Ozzano dell’Emilia – Bologna

P.O. box 8

Tel: +39 051 6512711

FI- 02101 Espoo

 

Puh/Tel: +358 45 1896144

Latvija

United Kingdom

OÜ Zoovetvaru

Duggan Veterinary Supplies Ltd.,

Uusaru 5

Holycross,

EE-Saue 76505

Thurles,

Tel: +372 6 709 006

Co Tipperary

 

Ireland

 

Tel: +353 (0) 504 43169

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