Sunday afternoon, the whole family together. What

Sunday afternoon, the whole
family together.
What could be better?
The
broad
e
spect st
ru
worme m
for d r
ogs
New additional claims: now prevents Angiostrongylosis and treats Thelazia (eye worm)*
* Milbemax is now indicated for the prevention of Angiostrongylosis caused by Angiostrongylus
vasorum (lungworm) in dogs and for the treatment of Thelazia callipaeda (eye worm) in dogs
where concomitant treatment against cestodes is indicated.
People, pets and parasites
Many people are close to their pet.
How many of them worry that
this means they’re close to
parasites too?
Not that many.
…but not so easy to diagnose
• S
ome roundworm-infected adult dogs will be asymptomatic; in younger dogs, clinical
signs are more common and in some cases can be serious1
• T apeworms often don’t cause significant clinical signs in dogs2 and diagnosis is
probably underestimated3,4
• L ungworm infection can present in many different forms and diagnosis can be difficult,
requiring repeated sampling
Worms are a health risk to people
• T
oxocara canis and Toxocara leonina are both zoonotic. In the UK, visceral larva migrans
is rare but a number of cases of ocular larva migrans occur each year, with children
most likely to be affected2
Why aren’t more people
worried about parasites
such as worms?
• H
umans can become infected with tapeworm through accidently ingesting eggs in their
environment or even fleas2, 7
• E
chinococcus can cause a clinically serious hydatid disease in humans
• T hey can’t see the problem
• T hey don’t know how easily dogs can pick
up worms
• T hey don’t understand the health risks
to themselves and their family
80%
of children kiss their pet6
which may have just
ingested worm eggs
• T hey presume their vet will tell them how
to protect their pet
Worms are easy to pick up…
Younger dogs and those that hunt are particularly vulnerable,
but there are many routes of infection.
• R
oundworms are transmitted by ingestion of a paratenic host, bitch’s milk, embryonated
eggs and by transplacental transmission
• T apeworms can be transmitted through a range of intermediate hosts including fleas,
lice, rabbits, ruminants and rodents
• S
lugs and snails are intermediate hosts for lungworm (Angiostrongylus vasorum)1
*BSAVA Guidelines
25%
of dogs carry worm eggs
on their coats5 which
people may pick up
when stroking their pet
What can you do to help protect
pets and people?
Recommend the broadest spectrum
wormer, so owners can relax with their
pet without worrying about worms.
Milbemax has the broadest spectrum
protection of any wormer
Milbemax prevents lungworm
NEW
INDICATION
Milbemax is now indicated for the prevention of angiostrongylosis
caused by Angiostrongylus vasorum (lungworm) in dogs.
Lungworm
• The risk of dogs picking up A. vasorum infection is increasing across Europe9
Internal parasites’ spectrum of activity
• Some infected dogs will be asymptomatic10
• It can cause heart failure and sudden death in severe cases10
Milbemax
for dogs
Drontal for dogs
Advocate for dogs*
Toxocara canis
4
4
4
Toxascaris leonina
4
4
4
Ancylostoma caninum
4
4
4
How do the experts recommend A. vasorum infection
is prevented?14, 15
Trichuris vulpis
4
4
4
Minimise environmental risk:
Dirofilaria immitis
4
4
Angiostrongylus vasorum
4
4
Crenosoma vulpis
4
4
• Vets in endemic areas should advise their clients of the common clinical signs to
look for and also encourage daily disposal of faeces to prevent environmental build
up of larvae
Thelazia callipaeda
4
Dipylidium caninum
4
4
Taenia spp.
4
4
Echinococcus spp.
4
4
Mesocestoides spp.
4
4
††
**
†
Uncinaria stenocephala
4
Preventative treatment:
• R
ecommendations for preventive treatment should also take into account the local
epidemiological situation
• I n endemic areas, regular, monthly anthelmintic treatment is probably the main form
of defence
4
Dirofilaria repens
4
Spirocerca lupi
4
Milbemax treats eye worm
Milbemax is now indicated for the treatment of Thelazia callipaeda
(eye worm) in dogs. It is the only product labelled for this specific
purpose.
The market-leader
Eye worm
• M
ilbemax is the no. 1 vet-preferred
wormer in Europe8
• Eye worm is present throughout continental Europe11
• We’re continuing to broaden its spectrum
NEW
INDICATION
• I n dogs it can cause minor clinical signs such as lacrimation,
to the more severe keratitis12
• Human cases of thelaziasis have already been recorded in Italy, France and Spain11
* Also effective on some external parasites, please see SPC
** Reduction in level of infection plus prevention of angiostrongylosis.
†
Reduction in level of infection.
††
Prevention of heartworm disease and treatment of circulating microfilaria.
The many benefits of Milbemax
Proven safety profile for dogs and owners
Milbemax Chewable tablets are designed to treat
Specially developed by Novartis Animal Health to help make worming more enjoyable:
Milbemax
Chewable tablets
Can be given to puppies
4
Milbemax
tablets
4
(From >1.0kg)
(From 2 weeks of age and/or >0.5kg)
Can be given to breeding dogs, including
pregnant and lactating bitches
4
4
No need to separate other pets during
and after treatment
4
Safe post-treatment contact for owners
and their families
• Soft, palatable formulation
• Unique chicken flavour Easychew Technology™
Milbemax Chewable tablets are easy to give
The palatable formulation makes it easier for owners to regularly worm their pet:
4
• 94% of dogs accept it from their owner’s hand, helping with compliance12
• Milbemax should be given by oral administration with or after some food
4
4
Milbemax Chewable tablets improve owner compliance
• R
esearch shows that 8 out of 10 pets and owners now enjoy worming more, thanks
to Milbemax Chewable tablets13
Accurate oral dose
Milbemax
Chewable tablets
Milbemax
tablets
Delivers the right dose straight to the
gastrointestinal tract
4
4
A direct and mess-free option for
owners and pets
4
4
Just one tablet for the majority of dogs
4
4
• 5
8% say they will increase their worming frequency thanks to Milbemax
Chewable tablets13
You can help protect pets and people
Recommend Milbemax as the
broadest spectrum wormer
available and help dog owners
relax with their pet, without
worrying about worms.
Milbemax chewable tablets for small dogs and puppies
Milbemax chewable tablets for dogs
INTRODUCTION
Company name: Novartis Animal Health UK Ltd
Address: Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Telephone: 01276 694403
PRESENTATION
Milbemax chewable tablets for small dogs and puppies: oval-shaped, dark brown, chewable tablet,
containing milbemycin oxime 2.5 mg and praziquantel 25.0 mg.
Milbemax chewable tablets for dogs: oval-shaped, dark brown, chewable tablet, containing
milbemycin oxime 12.5 mg and praziquantel 125.0 mg.
USES
In dogs: treatment of mixed infections by adult cestodes and nematodes of the following species:
Cestodes: Dipylidium caninum, Taenia spp., Echinococcus spp., Mesocestoides spp.
Nematodes: Ancyclostoma caninum, Toxocara canis, Toxascaris leonina, Trichuris vulpis.
Crenosoma vulpis (reduction of the level of infection), Angiostrongylus vasorum – prevention and
treatment (reduction of the level of infection by immature adult (L5) and adult parasite stages – see
specific treatment and disease prevention schedules under Dosage and administration).
Thelazia callipaeda (see specific treatment schedule under Dosage and administration).
The product can also be used in the prevention of heartworm disease (Dirofilaria immitis), if
concomitant treatment against cestodes is indicated.
DOSAGE AND ADMINISTRATION
Minimum recommended dose rate: 0.5 mg of milbemycin oxime and 5 mg of praziquantel per kg are
given once orally.
The product should be administered with or after some food.
Depending on the bodyweight of the dog, the practical dosing is as follows:
Weight
Milbemax chewable tablets for small dogs and puppies
1-5 kg
1 tablet
Weight
Milbemax chewable tablets for dogs
5-25 kg
1 tablet
> 25-50 kg
2 tablets
> 50-75 kg
3 tablets
In cases where heartworm disease prevention is used and at the same time treatment against
tapeworm is required, the product can replace the monovalent product for the prevention of
heartworm disease.
For treatment of Angiostrongylus vasorum infections, milbemycin oxime should be given four times at
weekly intervals. It is recommended, where concomitant treatment against cestodes is indicated, to
treat once with the product and continue with the monovalent product containing milbemycin oxime
alone, for the remaining three weekly treatments.
In endemic areas administration of the product every four weeks will prevent angiostrongylosis
by reducing immature adult (L5) and adult parasite burden, where concomitant treatment against
cestodes is indicated.
For the treatment of Thelazia callipaeda, milbemcyin oxime should be given in two treatments, seven
days apart. Where concomitant treatment against cestodes is indicated, MILBEMAX can replace the
monovalent product containing milbemycin oxime alone.
CONTRA-INDICATIONS, WARNINGS, ETC.
Do not use either strength of tablet in dogs weighing less than 1 kg. Do not use Milbemax chewable
tablets for dogs in dogs weighing less than 5 kg.
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Studies with milbemycin oxime indicate that the margin of safety in certain dogs of Collie, or related
breeds, is less than in other breeds. In these dogs, the recommended dose should be strictly
observed.
The tolerance of the product in young puppies from these breeds has not been investigated.
Clinical signs in Collies are similar to those seen in the general dog population when overdosed.
heartworm risk regions, before using Milbemax, a veterinary consultation is advised to exclude the
presence of any concurrent infestation of Dirofilaria immitis. In the case of a positive diagnosis,
adulticidal therapy is indicated before administering the product.
Echinococcosis represents a hazard for humans. In case of Echinococcosis, specific guidelines on the
treatment and follow-up and on the safeguard of persons have to be followed. Experts or institutes of
parasitology should be consulted.
No studies have been performed with severely debilitated dogs or individuals with seriously
compromised kidney or liver function. The product is not recommended for such animals or only
according to a benefit/risk assessment by the responsible veterinary surgeon.
In dogs less than 4 weeks old, tapeworm infection is unusual. Treatment of animals less than 4 weeks
old with a combination product may therefore not be necessary.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated
use of an anthelmintic of that class.
In very rare occasions, systemic signs (such as lethargy), neurological signs (such as muscle tremors
and ataxia) and/or gastrointestinal signs (such as emesis, drooling, diarrhoea and anorexia) have
been observed in dogs after administration of Milbemax.
The adverse reactions observed following an overdose are the same as those observed at the
recommended dose but more pronounced.
Interaction with other medicinal products and other forms of interaction
The concurrent use of the product with selamectin is well tolerated. No interactions were observed
when the recommended dose of the macrocyclic lactone selamectin was administered during
treatment with the product at the recommended dose. In the absence of further studies, caution
should be taken in the case of concurrent use of the product and other macrocyclic lactones. Also, no
such studies have been performed with reproducing animals.
User warnings
Wash hands after use.
In the event of accidental ingestion of the tablets, particularly by a child, seek medical advice
immediately and show the package leaflet or the label to the doctor.
Pregnancy and lactation
Milbemax can be used in pregnant and lactating bitches and in breeding animals.
Environmental warnings
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.
Milbemax chewable tablets should not enter water courses as this may be dangerous for fish and
other aquatic organisms.
Pharmaceutical precautions
Do not store above 25°C.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Keep out of the reach and sight of children.
LEGAL CATEGORY
POM-V
PACKAGING QUANTITIES
Box with 1 blister or strip of 2 tablets
Box with 1 or 12 blisters of 4 tablets
Not all pack sizes may be marketed.
FURTHER INFORMATION
Milbemycin oxime belongs to the group of macrocyclic lactones and is active against mites, against
larval and adult stages of nematodes as well as against larvae of Dirofilaria immitis.
Praziquantel is an acylated pyrazino-isoquinoline derivative active against cestodes and trematodes.
Milbemax is effective against Dirofilaria immitis, which is endemic in the USA and some parts of
continental Europe. The product is also effective against Echinococcus multilocularis which is endemic
in some parts of continental Europe and prophylactic treatment is required in all pets entering the UK
under the PETS scheme or under quarantine conditions.
MARKETING AUTHORISATION NUMBERS
Milbemax chewable tablets for small dogs and puppies Vm 12501/4170
Milbemax chewable tablets for dogs Vm 12501/4169
SIGNIFICANT CHANGES
PRECAUTIONS FOR USE
Treatment of dogs with a high number of circulating microfilariae can sometimes lead to the
appearance of hypersensitivity reactions, such as pale mucous membranes, vomiting, trembling,
laboured breathing or excessive salivation. These reactions are associated with the release of proteins
from dead or dying microfilariae and are not a direct toxic effect of the product. The use in dogs
suffering from microfilaremia is thus not recommended.
In heartworm risk-areas, or in cases where it is known that a dog has been travelling to and from
SKU
GTIN
MILBEMAX CHEWY 2.5/25 MG TAB PK ST
05037694053239
MILBEMAX CHEWY 12.5/125 MG TAB 4 PK ST
05037694053246
MILBEMAX CHEWY 2.5/25 MG TAB 4 X 12 ST
05037694053215
MILBEMAX CHEWY 12.5/125 MG TAB 4 X 12 ST
05037694053222
References: 1. Worm Control in Dogs and Cats. European Scientific Counsel Companion Animal Parasites (ESCCAP) Guideline 01 Second Edition, September 2010. 2. Fisher, M. BSAVA Worming Guidelines,
2006. 3. Current Advice on Parasite Control: Intestinal Parasites – Cyclophyllidean Tapeworm. Companion Animal Parasite Control (CAPC), April 2011. 4. Conboy G. (2009) Cestodes of dogs and cats in North
America. Vet Clin Small Anim 39;1075-1090. 5. Wolfe A and Wright IP. (2003) Human toxocariasis and direct contact with dogs. Vet Record 152;419-427. 6. McNicholas J. (2002) Effect of pet ownership on immune
functioning in children and nature of the relationship between children and pets. Department of Psychology, University of Warwick. 7. Parasites and Health: Dipylidium caninum infection (2009) www.dpd.cdc.
gov 8. Pan-European survey (Switzerland, France, Germany, Italy, UK, Spain) carried out on behalf of Novartis Animal Health, April 2010 (n=1108). 9. Morgan E and Shaw S. (2010) Angiostrongylus vasorum
infection in dogs: continuing spread and developments in diagnosis and treatment. J Small Animal Pract 51: 616-621. 10. Otranto D et al. (2013) Vector-borne helminths of dogs and humans in Europe. Parasites
& Vectors 6:16. 11. Motta B et al. (2012) Therapeutic efficacy of milbemycin oxime/praziquantel oral formulation (Milbemax®) against Thelazia callipaeda in naturally infested dogs and cats. Parasites & Vectors
5:85. 12. Palatability/acceptability trial. Data on file, study number NAH-02-0054. 13. Research data June 2011 (France, n=1100). 14. Morgan E and Shaw S. Journal of Small Animal Practice (2010) 51, 616-621.
15. Helm J R et al. J Vet Emerg Crit Care 2010; 20(1): 98-109.
Advice on the use of this medicine must be sought from the medicine prescriber.
Use medicines responsibly (www.noah.co.uk/responsible).
For further information call the practice support line in the UK on 01276 694402 or in Ireland on 05137 7201,
or write to Novartis Animal Health UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, UK.
Milbemax POM-V in the UK and Milbemax POM in Ireland contains milbemycin oxime and praziquantel.
Milbemax® is a registered trademark of Novartis AG, Basel, Switzerland. © 2013 Novartis Animal Health Inc,
Basel, Switzerland. UK/MIL/13/0292 10/13