Censutrim 200 mg/ml + 40 mg/ml Solution for Injection for Cattle, Pigs, Horses, Dogs and Cats

colostral phase), because it could select antimicrobial-resistant bacteria within the
intestinal microbiota of the calf and increase the faecal shedding of these bacteria.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
• This product may cause an allergic reaction in people sensitised to sulfonamides
and/or chlorocresol. Hypersensitivity to sulfonamides may lead to cross reactions
with other antibiotics. Allergic reactions to these substances may occasionally be
serious. People with known hypersensitivity to sulfonamides or chlorocresol should
avoid contact with the product.
• Administer the product with caution to avoid accidental self injection and skin
contact. In case of accidental self-injection, seek medical advice immediately and
show the package leaflet or the label to the physician.
• This product may cause eye and skin irritation. Avoid the contact with skin and
eyes. In case of contact with skin or eyes, rinse immediately with plenty of water. If
irritation persists, seek medical attention.
• If you develop symptoms following exposure, such as a skin rash, you should
seek medical advice and show the physician this warning. Swelling of the face, lips
or eyes, or difficulty with breathing are more serious symptoms and require urgent
medical attention.
• Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have
shown evidence of foetotoxic effects. Women of childbearing age, pregnant women
or women suspected of being pregnant should use the veterinary medicinal product
with serious caution to avoid accidental self-injection.
• Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Cattle, pigs, horses, dogs and cats:
Rare
(1 to 10 animals / 10,000 animals
treated):
Anaphylactic shock
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Application site swelling and/or
tenderness
Crystalluria, haematuria, renal obstruction.
Alterations in haematopoietic function.
Particularly after the intravenous route (see section 3.5). At the first sign of
intolerance the injection should be interrupted and shock treatment initiated.
These lesions are of a transient nature, resolving within one week after treatment.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product.
Reports should be sent, preferably via a veterinarian, to either the marketing
authorisation or the national competent authority via the national reporting system.
See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established in cattle,
pigs, horses, dogs and cats during pregnancy, lactation or in animals intended for
breeding.
Laboratory studies with the excipient N-methyl pyrrolidone have shown evidence of
foetal malformations in rabbits and rats. Use only according to the benefit-risk
assessment by the responsible veterinarian.
3.8 Interaction with other medicinal products and other forms of interaction
Do not administer with para-aminobenzoic (PABA) acid and its derivatives.
Local anaesthetics from the group of para-aminobenzoic acid esters (procaine,
tetracaine) can locally inhibit the effect of sulfonamides.
Do not administer with oral anticoagulants or urinary acidifiers.
Administration of potentiated sulphonamides, simultaneously with alpha-2-adrenergic
agents and certain anaesthetics, may cause cardiac arrhythmias in horses.
3.9 Administration routes and dosage
Intramuscular, intravenous or subcutaneous route.
Cattle, pigs and horses: 12.5 mg of sulfadiazine + 2.5 mg of trimethoprim / kg
bodyweight, equivalent to 1 ml of veterinary medicinal product / 16 kg bodyweight.
- Cattle and pigs: administer by intramuscular or slow intravenous injection, once
daily until 2 days after symptoms resolve up to a maximum of 5 days. Maximum
recommended volume to be administered at a single intramuscular site: 15 ml of
product.
- Horses: administration is by slow intravenous injection only, once daily until 2 days
after symptoms resolve up to a maximum of 5 days.
Dogs and cats: 25 mg of sulfadiazine + 5 mg of trimethoprim / kg bodyweight,
equivalent to 1 ml of veterinary medicinal product / 8 kg bodyweight. Administration is
by subcutaneous injection only, once daily until 2 days after symptoms resolve up to
a maximum of 5 days.
To ensure a correct dosage, bodyweight should be determined as accurately as
possible.
The cap may be safely punctured up to 40 times using a 20-gauge needle or up to
20 times using a 16-gauge needle. The user should choose the most appropriate vial
size according to the target species to be treated.
3.10 Symptoms of overdose (and where applicable, emergency procedures
and antidotes)
Crystalluria and nerve and hematic disorders may occur.
In case of overdose, suspend the treatment and administer abundant water and folic
acid.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable
3.12 Withdrawal periods
Cattle:
Meat and offal: 12 days
Milk: 48 hours
Pigs:
Meat and offal: 20 days
Horses:
Not to be used for horses intended for human consumption. Treated horses may
never be slaughtered for human consumption. The horse must have been declared
as not intended for human consumption under national horse passport legislation.
4.