AMACIN

Main information

  • Trade name:
  • AMACIN EYE & EAR OINTMENT
  • Pharmaceutical form:
  • MISC. AURAL, OPHTHALMIC, ORO/NASO PHARYNGEAL
  • Units in package:
  • 4g
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMACIN EYE & EAR OINTMENT
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH
  • Therapeutic area:
  • antibiotic,corticosteroid
  • Therapeutic indications:
  • EAR INFECTIONS | INFECTION - OCULAR | EYE INFECTIONS | OCULAR INFECTIONS
  • Product summary:
  • Topical treatment of ocular and aural infections in dogs, cats and horses.Not to be used in food producing species of animals.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 36293/53222
  • Authorization date:
  • 17-05-2011
  • Last update:
  • 15-06-2017

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

Amacin Eye & Ear Ointment (Draft)

Labelling

21APR11

Jurox Pty Limited

Tube (for use with and without a carton)

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

AMACIN EYE & EAR OINTMENT

5 mg/g NEOMYCIN SULFATE

5,000 I.U./g POLYMYXIN B SULFATE

50 mg/g SULFACETAMIDE SODIUM

2.5 mg/g PREDNISOLONE

4 g NET

[

jurox logo]

Topical treatment of ocular & aural infections in dogs, cats and horses.

DIRECTIONS FOR USE:

Restraint: NOT TO BE USED in food producing species of animals.

Apply once or twice daily as required.

MEAT WITHHOLDING PERIOD (HORSES): NOT TO BE USED in horses

intended for human consumption

DISPOSE of container by wrapping in paper and putting in garbage.

Jurox Pty Limited, 85 Gardiner Road RUTHERFORD NSW 2320 AUSTRALIA

STORE below 30°C (RoomTemperature).

See crimp for batch and expiry.

[Item code]

APVMA 36293/53222

Carton (for optional use)

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

AMACIN EYE & EAR OINTMENT

5 mg/g NEOMYCIN SULFATE

4g NET

5,000 I.U./g POLYMYXIN B SULFATE

50 mg/g SULFACETAMIDE SODIUM

2.5 mg/g PREDNISOLONE

[

jurox logo]

RLP

APPROVED

Info

pest

Verified

Amacin Eye & Ear Ointment (Draft)

Labelling

21APR11

Jurox Pty Limited

Carton (ANZ) (for optional use) (continued)

Topical treatment of ocular & aural infections in dogs, cats and horses.

DIRECTIONS FOR USE:

Restraint: NOT TO BE USED in food producing species of animals.

Apply once or twice daily as required.

MEAT WITHHOLDING PERIOD (HORSES): NOT TO BE USED in horses

intended for human consumption

FIRST AID

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone

Australia 131 126, New Zealand 0800 764 766.

DISPOSE of container by wrapping with paper and putting in garbage.

STORE below 30 C (Room Temperature).

Jurox Pty Limited

85 Gardiner Rd

RUTHERFORD NSW 2320 AUSTRALIA

Infoline 1800 023 312

APVMA 36293/53222

EXP.

[Item code] [Bar code]

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

2-7-2018

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

FDA - U.S. Food and Drug Administration

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-12-2018

Ziagen (ViiV Healthcare BV)

Ziagen (ViiV Healthcare BV)

Ziagen (Active substance: abacavir sulfate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8685 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/252/T/104

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

14-5-2018

Girolan and its associated name Apralan

Girolan and its associated name Apralan

Girolan and its associated name Apralan (Active substance: Apramycin sulfate) - Community Referrals - Art 34 - Commission Decision (2018)2989 of Mon, 14 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/A/122

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)-paromamine sulfate) - Transfer of orphan designation - Commission Decision (2018)1823 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/16/T/01

Europe -DG Health and Food Safety