Zactran

1 x 50 ml
Liquid for injection, solution
IM
SC

Species

Cattle, sheep and pigs.

Indications

Cattle:

Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. The presence of the disease in the herd should be established before metaphylactic use.

Pigs:

Treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Bordetella bronchiseptica.

Sheep:

Treatment of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment.

Dose to be administered and administration route

A single dose of 6 mg gamithromycin/kg body weight (equivalent to 1 ml/25 kg body weight) into the neck (cattle and pigs) or anterior to the shoulder (sheep). To ensure correct dose, body weight should be determined as accurately as possible to avoid underdosing.

Cattle and sheep

Subcutaneous injection. For treatment of cattle over 250 kg and sheep over 125 kg body weight, divide the dose so that no more than 10 ml (cattle) or 5 ml (sheep) are injected at a single site.

Pigs

Intramuscular injection. The injection volume should not exceed 5 ml per injection site.

The cap may be safely punctured up to 50 times with a 16G needle and up to 80 times with a 18G needle. For multiple vial entry, an automatic dosing device is recommended to avoid excessive broaching of the stopper.

Adverse reactions

During clinical trials transient injection site swellings were observed.

• Visible injection site swellings associated with occasional slight pain may develop very commonly in cattle for one day. The swellings typically resolve within 3 to 14 days but may persist in some animals for up to 35 days after treatment.

• Mild to moderate injection site swelling has been reported commonly in sheep and pigs in clinical trials, with occasional slight pain evident for one day in sheep. These local reactions are transient, and typically resolve within 2 (pigs) to 4 (sheep) days.

The frequency of adverse reactions is defined using the following convention:

• Very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• Common (more than 1 but less than 10 animals in 100 animals treated)

• Uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• Rare (more than 1 but less than 10 animals in 10,000 animals treated)

• Very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

EMA Categorisation

C
Pig
Sheep
Cattle
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Art. Nr. 04491/5061
EAN 4028691567929
PACKAGES
Zactran
Boehringer Ingelheim Animal Health
1 x 50 ml
04491/5061
Zactran
Boehringer Ingelheim Animal Health
1 x 100 ml
04491/5061
Zactran
Boehringer Ingelheim Animal Health
1 x 250 ml
04491/5061
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