Zermex 1% w/v Solution for Injection for Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Moxidectin

Available from:

Zoetis UK Limited

ATC code:

QP54AB02

INN (International Name):

Moxidectin

Pharmaceutical form:

Solution for injection

Prescription type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Sheep

Therapeutic area:

Endectocide

Authorization status:

Authorized

Authorization date:

2000-06-07

Summary of Product characteristics

Revised: November 2020
AN: 01080/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zermex 1% w/v Solution for Injection for Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Ingredient
Moxidectin
10 mg
Excipients
Benzyl Alcohol
40 mg
Butylated Hydroxytoluene
2.5 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A sterile clear to pale yellow aqueous solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for:
Prevention and treatment of Psoroptic mange (_Psoroptes _ovis):
Clinical cure:
2 injections 10 days apart.
Preventive efficacy: 1 injection.
Treatment and control of infestations caused by moxidectin sensitive
strains of:
Gastro-intestinal nematodes:
•
_Haemonchus contortus_
•
_Teladorsagia circumcincta _(including inhibited larvae)
•
_Trichostrongylus axei _(adults)
•
_Trichostrongylus colubriformis_ (adults and L3)
•
_Nematodirus spathiger_ (adults)
•
_Cooperia curticei _(adults)
•
_Cooperia punctata _(adults)
Revised: November 2020
AN: 01080/2020
Page 2 of 7
•
_Gaigeria pachyscelis_ (L3)
•
_Oesophagostomum columbianum _(L3)
•
_Chabertia ovina _(adults)
Respiratory tract nematode:
•
_Dictyocaulus filaria _(adults)
Larvae of Diptera:
•
Oestrus ovis : L1, L2, L3
Has a persistent effect in preventing infestation or reinfestation
for:
-
at least 4 weeks against _Psoroptes ovis_
-
5 weeks against_ Teladorsagia circumcincta_ and _Haemonchus contortus_
-
4 weeks against _Gaigeria pachyscelis _and _Oesophagostomum
columbianum_
-
2 weeks against _Trichostrongylus colubriformis_
Trials
have
shown
that
the
product
may
be
effective
against
strains
of
_Haemonchus contortus _resistant to benzimidazoles, ivermectin and
doramectin.
4.3
CONTRAINDICATIONS
Do not use in animals vaccinated against footrot.
4.4
SPECIAL WARNINGS
A single injection will protect against scab for at least 28 days, but
contact with
infected s