NAM PHUC THINH TRADING CO., LTD

TIERCAL

Composition: Each ml of suspension contains: Ceftiofur 50 mg; excipient q.s 1 ml.

Pharmaceutical form: Injectable Suspension

Properties: TIERCAL is a sterile suspension, contains hydrochloride ceftiofur which is a broad-spectrum of cephalosporin and is active against Gram-positive and Gram-negative bacteria, including strains producing β-lactamases. Like all ceftiofur cephalosporins, is bactericidal. Its mechanism of action is by inhibition of the cell wall. Ceftiofur is used in the respiratory infections treatment in cattle and pigs. It is active against: Pasteurella multocida, Actinobacillus pleuropneumoniae, Streptococcus suis, Bordetella bronchiseptica is inherently resistant to ceftiofur.

Target species: Cattle and swine

Indications for use: TIERCAL is indicated in the treatment and control of infectious processes caused by germs sensitive to Ceftiofur Hydrochloride.

Swine: Treatment of bacterial respiratory disease associated with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis.

Cattle: Treatment of bacterial respiratory disease associated with Pasteurella haemolytica (Mannheimia spp.), Pasteurella multocida and Haemophilus somnus. Treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica).Treatment of the bacterial component of acute post-partum (puerperal) metritis within 10 days after calving associated with Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum, sensitive to ceftiofur.

Dosage in each target species:

Shake well before use.

Swine: 1ml Tiercal/16 kg of body weight/day (equivalent to 3 mg Ceftiofur/kg of body weight/day), for 3 days. INTRAMUSCULAR ROUTE.

Cattle:

Respiratory disease: 1ml Tiercal/50 kg of body weight/day (equivalent to 1 mg ceftiofur/kg of body weight/day), for 3 – 5 days.

Acute interdigital necrobacillosis: 1ml Tiercal/50 kg of body weight/day (equivalent to 1 mg ceftiofur/kg of body weight/day), for 3 days.

Acute post-partum metritis within 10 days after calving: 1ml Tiercal/50 kg of body weight/day (equivalent to 1 mg ceftiofur/kg of body weight/day), for 5 consecutive days.

SUBCUTANEOUS ROUTE

Subsequent injections must be given at different sites.

In case of acute post-partum metritis, additional supportive therapy might be required in some cases.

Contraindications: Do not use in animals with antecedents of hypersensitivity to Ceftiofur or others β-lactam antibiotics. Do not inject intravenously.

Side effects: In pigs, mild reactions at the injection site, such as discoloration of the fascia or fat, have been observed in some animals for up to 20 days after injection. In cattle, mild inflammatory reactions at the injection site, such as tissue oedema and discoloration of the subcutaneous tissue and/or fascial surface of the muscle may be observed. Clinical resolution is reached in most animals by 10 days after injection although slight tissue discoloration may persist for 28 days or more.

Intoxication and overdose in the targeted species: Ceftiofur poses a wide safety margin. The therapeutic index in cattle is 50 times the recommended dose, so overdose poisoning is umlikely. In pigs a dose of 25 mg/kg of body weight has been well tolerated without any side effects observed. In horses the dose to 11 mg/kg per day d=for 30 days were well tolerated. The low toxicity of ceftiofur has been demonstrated in pigs using ceftiofur sodium at doses in excess of 7 times the recommended daily dose of ceftiofur intramuscularly administered for 15 consecutive days. In cattle, no signs of systemic toxicity have been observed following substantial parenteral overdoses.

Interactions: Avoid co-administration with aminoglycosides.

Withdrawal period: Bovine: Meat: 8 days, pigs: meat: 5 days; milk: none

Storage conditions: Store in cool, dry place and protected from light, at a temperature no higher than 250C. After the first puncture the shelf life product once opened is of 28 days.

Presentations: Vials of 50, 100 and 250 ml.

Shelf-life: 2 years from the manufacturing date.

FOR VETERINARY USE ONLY

Keep out of the reach of children

Invesa

Industrial Veterinaria, S.A.

a LIVISTO company

Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona, Spain