Dectomax 10 mg/ml Solution for Injection for Pigs

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Doramectin

MAH:

Elanco Europe Ltd

ATC_code:

QP54AA

INN:

Doramectin

pharmaceutical_form:

Solution for injection

prescription_type:

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

therapeutic_group:

Pigs

therapeutic_area:

Endectocide

authorization_status:

Authorized

authorization_date:

1997-10-30

SPC

Revised: December 2020
AN: 01355/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dectomax 10 mg/ml Solution for Injection for Pigs (UK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml Dectomax 10 mg/ml Solution for Injection contains the following:
ACTIVE SUBSTANCE:
Doramectin
10 mg
(1)
EXCIPIENT(S):
Butylhydroxyanisole (E320)
0.1 mg
(1)
Contains no overage and assumes a potency of 100 percent. The
actual amount of doramectin added will depend on the potency of the
ingoing drug substance.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Colourless to pale yellow sterile oily solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
Revised: December 2020
AN: 01355/2020
Page 2 of 6
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of mange mites, gastrointestinal roundworms, lungworms,
kidney worms and sucking lice in pigs.
Gastrointestinal nematodes (adults and fourth stage larvae)
_Hyostrongylus rubidus_
_Ascaris suum_
_Strongyloides ransomi (adults only)_
_Oesophagostomum dentatum_
_Oesophagostomum quadrispinulatum_
Lungworms
_Metastrongylus spp. (adults only)_
Kidney worms
_Stephanurus dentatus (adults only)_
Sucking Lice
_Haematopinus suis_
Mange Mites
_Sarcoptes scabiei_
Dectomax injection for pigs protects pigs against infection or
reinfection
with _Sarcoptes scabiei_ for 18 days.
4.3
CONTRAINDICATIONS
The product has been formulated specifically for pigs. It should not
be
administered
to
other
species
as
severe
adverse
reactions,
including
fatalities in dogs, may occur. Do not use in case of hypersensitivity
to the
active substance or any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care
should
be
taken
to
avoid
the
following
practices
because
they
increase the risk of development of resistance and could ultimately
result in
ineffective therapy:
- too frequent and repeated use of anthelmintics from the same class,
over
an extended period of time.
- under dosing, which may be