Septotryl II Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trimethoprim; Sulfadiazine

Available from:

Vetoquinol Ireland Limited

ATC code:

QJ01EW10

INN (International Name):

Trimethoprim; Sulfadiazine

Dosage:

40, 200 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Cattle, Dogs, Horses, Pigs

Therapeutic area:

sulfadiazine and trimethoprim

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1994-03-23

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Septotryl II Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, Cattle, Pigs, Dogs, Cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Septotryl II Injection is indicated for the treatment of systemic
infections caused by or associated with organisms sensitive
to Trimethoprim:Sulphadiazine combination.
The spectrum of activity includes both Gram positive and Gram negative
organisms including:
_Actinobacilli_
_Bordetella_ spp_._
_Corynebacteria_
_Escherichia coli_
_Haemophilus_ spp_._
_Klebsiella_ spp_._
_Pasteurella_ spp_._
_Salmonella_ spp_._
_Staphylococci_
_Streptococci_
Each ml contains:
ACTIVE SUBSTANCES
Trimethoprim
40
mg
Sulfadiazine
200 mg
EXCIPIENTS
Chlorocresol
1
mg
Sodium Formaldehyde Sulfoxylate
1
mg
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_4_
_/_
_0_
_8_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_1_
_6_
_0_
_0_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.3 CONTRAINDICATIONS
Septotryl II Injection should not be given by routes other than those
recommended.
Do not use in cases of hypersensitivity to the active ingredients.
Do not use in animals with severe liver parenchymal
damage or blood dyscrasias.
Do not use in horses exhibiting drug induced cardiac arrhythmias, such
arr