Milbemax 2.5 mg/25 mg tablets for small dogs and puppies

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Milbemycin Oxime (A3 and A4), Praziquantel

Available from:

Elanco Europe Ltd

ATC code:

QP54AB51

INN (International Name):

Milbemycin Oxime (A3 and A4), Praziquantel

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Anthelmintic

Authorization status:

Authorized

Authorization date:

2003-04-17

Summary of Product characteristics

Revised: May 2024
AN: 03391/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Milbemax 2.5 mg/25 mg tablets for small dogs and puppies
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains :
ACTIVE SUBSTANCES:
Milbemycin oxime
2.5 mg
Praziquantel
25.0 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
Cellulose, microcristalline
Croscarmellose sodium
Povidone
Lactose monohydrate
Silica, colloidal anhydrous
Magnesium stearate
Oblong shaped, white tablet, with a score on both sides. One side
bears the imprint
“AA”, the other side “NA”.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs (≥ 0.5 kg).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For
dogs
with,
or
at
risk
from
mixed
infections
of
cestodes,
gastrointestinal
nematodes,
eyeworm,
lungworms
and/or
heartworm.
This
veterinary
medicinal
product is only indicated when use against cestodes and nematodes or
prevention of
heartworm disease/angiostrongylosis is indicated at the same time.
Cestodes:
Treatment of_ _tapeworms: _Dipylidium caninum, Taenia _spp_.,
Echinococcus _spp_., _
_Mesocestoides _spp_._
Gastrointestinal nematodes
Treatment of:
Hookworm: _Ancylostoma caninum, _
Roundworms:_ Toxocara canis, Toxascaris leonina,_
Whipworm:_ Trichuris vulpis_.
Revised: May 2024
AN: 03391/2022
Page 2 of 7
Eyeworm
Treatment of _Thelazia callipaeda_ (see specific treatment schedule
under section 3.9
“Administration routes and dosage”).
Lungworms
Treatment of:_ _
_Angiostrongylus vasorum_ (Reduction of the level of infection by
immature adult (L5)
and adult parasite stages; see specific treatment and prevention
disease schedules
under section 3.9 “Administration routes and dosage”),
_Crenosoma vulpis_ (Reduction of the level of infection).
Heartworm
Prevention of heartworm disease (_Dirofilaria immitis_) if concomitant
treatment against
cestodes is indicated.
3.3
CONTRAINDICATIONS
Do not use in puppies of less than 2 weeks of age and/or weighing less
than 0.5 kg.
Do not use i