PHENOMAV 100 MG ANTICONVULSANT TABLETS FOR DOGS

País: Australia

Idioma: inglés

Fuente: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredientes activos:

PHENOBARBITONE

Disponible desde:

MAVLAB PTY. LTD.

Designación común internacional (DCI):

phenobarbitone(100mg/Tb)

formulario farmacéutico:

ORAL TABLET

Composición:

PHENOBARBITONE BARBITURATE Active 100.0 mg/Tb

Unidades en paquete:

100 Tablets

clase:

VM - Veterinary Medicine

Grupo terapéutico:

DOG | BITCH | CASTRATE | PUPPY

Área terapéutica:

CENTRAL NERVOUS SYSTEM

indicaciones terapéuticas:

CONVULSIONS | IDIOPATHIC EPILEPSY | SEIZURES | STATUS EPILEPTICUS

Resumen del producto:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [CONVULSIONS, IDIOPATHIC EPILEPSY, SEIZURES, STATUS EPILEPTICUS]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CONVULSIONS, IDIOPATHIC EPILEPSY, SEIZURES, STATUS EPILEPTICUS]; For the treatment of seizures, convulsions, idiopathic epilepsy and status epilepticus in dogs.

Estado de Autorización:

Registered

Fecha de autorización:

2023-07-01

Información para el usuario

PHENOMAV 100 MG ANTICONVULSANT TABLETS FOR DOGS
52997/137262
Product Name:
APVMA Approval No:
Label Name:
PHENOMAV 100 MG ANTICONVULSANT TABLETS FOR DOGS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each tablet contains 100 mg PHENOBARBITONE
Claims:
For the treatment of seizures, convulsions, idiopathic epilepsy and
status epilepticus in
dogs
Net Contents:
100 Tablets
Directions for Use:
Restraints:
Contraindications:
Contraindicated in severe hepatic and renal impairment.
Precautions:
Use cautiously during pregnancy. Pregnant animals are more
sensitive/responsive to
depressant effects than nonpregnant animals
Exposure during prenatal growth can induce permanent changes in sexual
development
Use reduced dose rates in geriatric patients with severe respiratory
insufficiency
Drug interactions may occur with other anti-convulsants. Interactions
also may be
encountered with antibiotics, antacids, cardiac medications,
theophylline and its derivatives,
and steroids. Phenobarbitone reduces the availability of most drugs
administered
concurrently due to hepatic enzyme induction.
Side Effects:
At the initiation of treatment, high therapeutic range of drug levels
may be manifested as
sedation and ataxia which disappears rapidly.
Less severe side effects include fatigue, listlessness, polyphagia,
polydipsia, and polyuria.
These effects are more prominent in larger and older dogs then smaller
animals. RLP APPROVED
When given orally for long periods, hepatotoxicity may occur due to
the high concentration
of phenobarbitone present in portal circulation. Test liver function
every 6 months by serum
analysis.
Dosage and
Administration:
¼ - 1 tablet per 12.5kg BW (2 - 8 mg/kg)
Administer once daily or in divided doses every 12 hours. Medication
should be given at
the same time each day consistently. Divide the tablet to obtain the
required dose. Use the
minimum dose necessary to control the condition
After initial treatment continue dosing unchanged fo

Ficha técnica

MAVLAB PTY LTD
Date of Issue:
August 2008
MATERIAL SAFETY DATA SHEET
PHENOMAV 100
Page 1 of 5
MSDS version:
2
Date of Revision:
August 2008
Update of section:
All sections
SECTION 1 IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Product (material) name:
Phenomav 100 mg Anticonvulsant Tablets For Dogs
Other names:
Manufacturer’s codes: P8000
Recommended use:
For the treatment of seizures, convulsions, idiopathic epilepsy and
status
epilepticus in dogs.
Supplier Details:
Mavlab Pty Ltd ACN 068 507 148
33 Rowland Street
SLACKS CREEK QLD 4127
Contact Person:
Dr Paul Ross
Emergency Telephone:
[phone]
Facsimile:
[phone]
SECTION 2 HAZARDS IDENTIFICATION
This product is not dangerous goods under the Australian Dangerous
Goods Code but is classified as hazardous
according to the classification criteria of NOHSC:1008(2004), Approved
Criteria For Classifying Hazardous
Substances and the National Code of Practice for the Preparation of
Material Safety Data Sheets 2
nd
Edition
[NOHSC:2011(2003)]
Although this material could be classified as dangerous goods on the
basis of its toxicity, the capacities of the
packages in which the material is shipped are less than the minimum
pack sizes that would result in this material
being classified as dangerous goods.
Health Effects:
This material is presented in tablet form and it is therefore not
expected to pose inhalational or dermal health
hazards. However, if tablet integrity is compromised and dust is
generated, both dermal and inhalational hazard
could result. In this case all the following could apply:
Risk Phrases:
R23
Toxic by inhalation
R24
Toxic if in contact with skin
R25
Toxic if swallowed.
R43
May cause sensitization by skin contact.
R60
May impair fertility.
R61
May cause harm to the unborn child
Safety Phrases:
S45
In case of accident or if you feel unwell, seek medical advice
immediately (show the label where possible).
S36/37/39
Wear suitable protective clothing, gloves, and eye/face protection.
S22
Do not breathe dust.
SECTION 3 COMPOSITION/INFORMATION ON