NAM PHUC THINH TRADING CO., LTD

RHEMOX PREMIX

Composition: Each kg of product contains: Amoxicillin base as trihydrate 100 g; excipient q.s 1 kg.

Pharmaceutical form: Premix for medicated feeding stuff. Light brown granules

Properties: Amoxicillin is a broad spectrum β-lactam antibiotic belonging to the aminopenicillins group. It acts against Gram positive and Gram negative germs including: Streptococcus, Corynebacterium spp., Erysipelothrix rhusiopathiae, Listeria, Staphylococcus spp., Clostridium spp. In addition, it also acts against: E.coli, Pasteurella, Proteus and Salmonella…The antibacterial mechanism of action of amoxicillin consists of the inhibition of the biochemical processes of bacterial cell wall synthesis by selectively and irreversible blocking diferent enzymes involved in such processes, largely transpeptidase, endopeptidase and carboxypeptidase. The inadequate synthesis of the bacterial wall in susceptible apecies produces an osmotic imbalance which particularly affects growing bacteria (when bacterial wall synthesis processes are especially important), finally leading to lysis of the bacterial cell.

Advantages:

Rhemox Premix is produced by BMP (Bi Modal Protection) molecular protection with the following effects:

-Long-preserved by the membrane covering the antibiotic, this membrane is produced vegetal carrier with 3 layers of protection.

-Stabilize antibiotic activity; protect the antibiotic from degradation by high temperature, light, oxidant, moisture…

• - The product is covered by a special carrier produced by from Europe technology, thus the product are resistant to the highest heat as 1050C - 1100C. at this range of temperature, the degradation is from 0.5 to 1.5%. This also means that antibiotic activity is almost unchanged. If it is used at temperatures higher than 1200C, then the degradation will be higher.

Target species: Pigs (after weaning)

Indications:

Treatment and prevention of infectious processes caused by Streptococcus suis susceptible to amoxicillin in pigs after weaning. The presence of disease in the herd should be established before treatment.

Amount to be administered and administration route:

In feed use.

15 mg of amoxicillin/kg of b.w./day during 15 days. This dose is equivalent to 0.15 g Rhemox Premix/kg b.w./day.

To calculate the dosage of Rhemox Premix to be incorporated into feed: g of Rhemox Premix per kg of feed:
0.15 g Rhemox Premix           x          kg (body weight)/Daily feed intake (kg feed)
Considering that a pig consumes approximately 5% of its body weight per day, this dose corresponds to 300 mg of amoxicillin per kg of feed which gives a rate of incorporation of 3.0 kg/Ton (flour or granules). The feed consumption will depend on the clinical condition of the animal. In order to obtain a correct dosage, the concentration of the antimicrobial agent should be adjusted taking into account the daily feed intake at the onset of treatment.

Contraindications: Do not administer to animals with a previous history of hypersensitivity to penicillins or other antimicrobials of the β-lactamase producing bacteria.

Adverse reactions: Hypersensitivity reactions; severity can range from a simple rash to anaphylactic shock. Gastrointestinal symptoms (vomiting, diarrhea). Suprainfections caused by non-sensitive germs after prolonged use.

Overdose: No adverse reactions were showed at 3 times higher than the recommended dose (45 mg/kg) for 15 days and at dose levels but twice time the period treatment (30 days). If allergic or anaphylactic reactions were appearing, the medication will be suspended and the veterinarian will be warned. The immediately administration of epinephrine, antihistamines and/or corticoids is considered to be a suitable therapy of emergency.

Interaction with other medicinal products and other forms of interaction: Do not administer together with bacteriostatic anti-infectious agents (tetracyclines, sulphamides, spectinomycin, trimethoprim, chloramphenicol, macrolides and lincosamides). Do not use simultaneously with neomycin as it blocks the absorption of oral penicillins. Do not use with antibiotics which inhibit bacterial protein synthesis as they can antagonize the bactericide effect of penicillins, except for aminoglycoside antibiotics which are recommended for use with penicillins.

Withdrawal period: Meat and offal: 4 days

Storage conditions: Do not store above 250C. Store in a dry place. After first opening, keep the container tightly closed.

Presentations: Bags of 1 and 24 kg.

Shelf-life: 3 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