CALIERMUTIN 162 mg/ml solution for injection for pigs

Main information

  • Trade name:
  • CALIERMUTIN 162 mg/ml solution for injection for pigs
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALIERMUTIN 162 mg/ml solution for injection for pigs
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Tiamulin
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • PT/V/0102/001
  • Authorization date:
  • 24-02-2010
  • EU code:
  • PT/V/0102/001
  • Last update:
  • 09-08-2016

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

PACKAGELEAFLET

CALIERMUTIN 162 mg/ml SOLUTIONFOR INJECTIONFOR PIGS (PT)

1. NAME ANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE, IFDIFFERENT

<Marketingauthorisation holder<and manufacturer>>:

LABORATORIOS CALIER, S.A.

C/Barcelonès, 26. PladelRamassà.

08520 LES FRANQUESESDELVALLÈS.

BARCELONA.SPAIN

2. NAME OFTHEVETERINARYMEDICINALPRODUCT

CALIERMUTIN 162 mg/ml SOLUTIONFOR INJECTIONFOR PIGS (PT)

MACROMUTIN 162mg/ml SOLUTIONFOR INJECTIONFOR PIGS (ES)

3. STATEMENTOFTHEACTIVESUBSTANCE(S) ANDOTHERINGREDIENT(S)

Each mlcontains:

ActiveSubstances

Tiamulin base.............................................................................................162,0mg

(Equivalent to tiamulin hydrogen fumarate)..............................................200,0 mg

Excipients

Butylparahydroxybenzoate...........................................................................0.32 mg

Propylgallate (E310)...................................................................................0.162 mg

4. INDICATION(S)

Swinedysentery:ForthetreatmentofswinedysenterycausedbyBrachyspirahyodysenteriae

and complicated byBacteroidesspp andFusobacteriumspp.

Enzooticpneumoniacomplexofpigs:Forthetreatmentofenzooticpneumoniacomplex,

causedbyM. hyopneumoniaeand wherethe secondarybacteria aresensitiveto tiamulin.

Mycoplasmalarthritis:ForthetreatmentofarthritiscausedbyMycoplasmahyosynoviae,to

reducelameness and restoregrowth performance.

5. CONTRAINDICATIONS

Animalsshouldnotreceiveproductscontainingmonensin,narasinorsalinomycinduringor

foratleastsevendaysbeforeandaftertreatmentwithMacromutin162mg/mlsolutionfor

injection for pigs. Severegrowth depression ordeath mayresult.

Donotuseinanimalswithknownhypersensitivitytotheactiveingredientoranyofthe

excipients.

Do not usein cases of known resistanceto tiamulin.

6. ADVERSEREACTIONS

On rare occasions erythema ormild oedema ofthe skinmayoccurin pigs followingthe use ofthis

product.

Ifyou noticeanyserious effects orothereffects notmentioned in this leaflet, pleaseinformyour

veterinarysurgeon.

7. TARGETSPECIES

Porcine

8. DOSAGEFOREACHSPECIES, ROUTE(S) ANDMETHODOFADMINISTRATION

Treatmentofswinedesintery:1ml/20kgbodyweight(equivalentto10mgtiamulinhydrogen

fumarate/kgbodyweight)intramuscularlyadministeredasasingletreatmenttopigsshowing

clinical signs of thedisease.

Treatmentofenzooticpneumoniacomplexandmycoplasmalarthritis:1.5ml/20kg

bodyweight(equivalentto15mgtiamulinhydrogenfumarate/kgbodyweight)administered

intramuscularlyforaperiodof3consecutivedays(1injection/24hoursfor3consecutive

days)

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibleto

avoid underdosing.

9. ADVICEONCORRECTADMINISTRATION

Tobeadministeredbyintramuscularinjection.Swabtherubberseptumbeforeremovingeach

dose.Useadry, sterile, needle and syringe.

10. WITHDRAWALPERIOD

Swine:

Meat and offal:14 days

11. SPECIALSTORAGEPRECAUTIONS

Do not storeabove25°C. Do not refrigerate.

Followingwithdrawal of thefirst dose, usethe product within 28 days. Discard unused

material.

Keep outofthe reach and sightofchildren.

12. SPECIALWARNING(S)

Forintramuscular useonlyin pigs.

AsMacromutin162mg/mlsolutionforinjectionforpigsisformulatedwithsesameoil,itis

importanttoensurethatthesyringeusedisdry.Themixtureofoilandwatermaycausethe

plunger to stick.

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeintoaccountofficialand

local antimicrobial policies.

Inappropriateuseoftheproductmayincreasetheprevalenceofbacteriaresistanttotiamulin

and maydecreasethe effectiveness of treatment with tiamulin related substances.

Longtermorrepeateduseshouldbeavoidedbyimprovingmanagementpracticeand

thorough cleansingand disinfection.

In the absenceof asatisfactoryresponse totreatment, thediagnosis should bereconsidered.

Inflammation/scarringmayoccuratthesiteofinjection.Forthisreason,itisrecommended

that the product should be administered into the muscle ofthe neck.

Incaseofskincontactwiththeproduct,washimmediatelywithrunningwaterinorderto

minimise absorption through the skin.

Incaseofeyecontactwiththeproduct,washimmediatelywithrunningwaterandseek

medical advice.

People with known hypersensitivityto tiamulin should handle theproduct carefully.

Wash hands after use.

Thisproductcontainssesameoil.Accidentalselfinjectionmayresultinseverelocalised

reactions,particularlyifinjectedintoajointorfinger.Incaseofaccidentalinjection,seek

medical adviceimmediately. Show thepackageleaflet or thelabel to the physician.

13. SPECIALPRECAUTIONS FORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS, IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinal products should bedisposed of in accordancewith local requirements.

14. DATEONWHICH THE PACKAGELEAFLETWAS LASTAPPROVED

--

<15.OTHERINFORMATION>

For anyinformation aboutthis veterinarymedicinalproduct, pleasecontactthe localrepresentative of

the marketingauthorisation holder.

Batch number

EXP

Do notuseafterthe expirydate which is stated on the label.

For animaltreatmentonly.To besupplied onlyon veterinaryprescription

Reg. nº.: