For Animal Use Only
MULTIBIO
Injectable Suspension
Veterinary Antibacterial- Anti-inflammatory
COMPONENTS
MULTIBIO Suspension for Injection is a cream-coloured sterile suspension containing 100 mg ampicillin (anhydrous), 250,000 IU colistin sulfate, 0.25 mg dextramethasone acephate in 1 ml.
PHARMACOLOGICAL PROPERTIES
Ampicillin: It is bactericidal, especially against gram-positive microorganisms and partially gram-negative pathogens. It shows this activity during the active multiplication phase of the pathogen and by inhibiting the mucopeptide synthesis of the cell wall.
The sensitivity of bacteria to ampicillin is as follows:
- Susceptible bacteria: Most gram-positive bacteria, including beta-hemolytic Streptococcus sp (Streo. Agalactiae, S.canis, S. Zoepidemicus, S.dsygalactiae, S.suis, S.uberis, Bacillus anthracis, Actinomyces sp., most Corynebacter sp. ., Erysipelothrix rhusiopathiae, most Listeria monocytogenes), some anaerobes (Clostridium sp., most Fusobacterium sp., some Bacteroides sp.), some gram-negative aerobes (Haemophilus somnus), Borrelia sp., Leptospira sp., Actinobacillus sp., Haemophilus sp., Moraxella sp., Pasteurella sp.
- Bacterias with moderate sensitivity: Although it varies due to acquired immunity, the following bacteria are moderately sensitive; Resistance development is common in Actinobacillus sp., Borrelia sp., Haemophilus sp., Leptospira sp., Campylobacter sp., Enterococci, Rhodococcus equi, and Enterobacteriaceae.
- Resistant bacterias: Bacteroides fragilis, Bordetalla bronchiseptica, Citrobacter sp., Entrobacter sp., Klebsiella sp., other Proteus sp., Pseudomonas aeroginosa, Serratia sp., Yersinia enterocolitica.
Following IM injection at a dose of 6 mg/kg in cattle, peak serum levels (8.50 μg/ml) are reached an hour later. It easily diffuses into all body fluids and tissues except brain and spinal fluid. After 6 hours, the plasma level decreases to 0.30 μg/ml. After 24 hours, ampicillin is not detectable in plasma (elimination t½=1.35 hours). It is excreted largely unchanged in the urine. It has the lowest protein binding rate among penicillins (20%).
Colistin: It is an antibiotic of the polymyxin (polypeptide) group. It has a bactericidal effect especially against gram-negative microorganisms. As a cationic surfactant, they interact with phospholipids and lipopolysaccharides in the bacterial cell membrane, disrupting the osmotic integrity of the membrane and causing cell components to leak out.
In this combination, colistin potentiates the effect of ampicillin against Gram-negative microorganisms (e.g. E.coli). So the reason for the combination is to provide a wider spectrum of activity.
Microorganisms sensitive to colistin; Aerobacter aerogenes, Corynebacterium diphteriae, E.coli, Haemophilus influenza, Klebsiella pneumoniae, Pseudomonas aeroginosae, Salmonella sp and Shigella sp.
After IM administration, colistin sulfate is easily absorbed and reaches its peak level in serum within 1-2 hours. The elimination half-life does not exceed 5-6 hours. It is mainly excreted by the kidneys. Excretion of colistin through milk is low and only two milkings continue. After 36 hours, the antibiotic level is below 1 IU/ml.
Dexamethasone: It is a powerful anti-inflammatory of the glucocorticoid type. It limits vasodilation and increases capillary toxicity. Dexamethasone is rapidly absorbed from the site of application and is well distributed into tissues, interstitial fluids, and cerebrospinal fluid. Metabolization occurs mainly in the liver. It is eliminated mostly in urine and to a lesser extent excreted in bile and feces.
INDICATIONS
MULTIBIO is used for the treatment of bacterial infections of the respiratory tract in cattle and acute mastitis in dairy cows.
THE WAY OF USE AND DOSAGE
Unless it is advised otherwise by the Veterinarian:
Every 10 kg b.w. once a day for 3-5 days. For 1 ml (0.1 g ampicillin, 250,000 IU colistin and 0.25 mg dexamethasone) MULTIBIO Injectable Suspension is administered intramuscularly (into the muscle).
The practical dose table is below:
| Live weight (kg) | Amount of Multibio to be applied (ml/day) | Application route | Application period |
| 10 kg | 1 ml | Intramuscular (IM) | 3 – 5 days |
| 100 kg | 10 ml | Intramuscular (IM) | 3 – 5 days |
| 500 kg | 50 ml | Intramuscular (IM) | 3 – 5 days |
Shake the preparation well before use.
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGETED SPECIES
It should be used with caution in animals sensitive to ampicillin or colistin.
UNDESIRED/SIDE EFFECTS
Following administration, the animal should be monitored for the immune depressant effects of corticosteroids. Polymyxins have strong undesirable effects on the kidneys and nerves. Its effects on the kidneys are enhanced by aminoglycosides and some cephalosporins (such as cephaloridine). Parenteral administration of polymyxins may cause balance disorders in the patient, decreased or lost sensation in the skin of the head, arms and legs, and muscle weakness. Colistin has a tendency to accumulate in renal failure and tissue following administration of high doses. In individuals sensitive to penicillin, hypersensitivity reactions such as urticaria, fever, angioneurotic edema and, although rare, acute, peracute anaphylaxis and collapse may occur. Treatment should be stopped when symptoms of intolerance occur; If needed, symptomatic and adjunctive treatments (epinephrine and/or oxygen, glucocorticoids) should be administered.
DRUG INTERACTIONS
Since concomitant use of polypeptide antibiotics and cephalosporins may increase the risk of renal toxicity, cephalosporins should not be used with this preparation. Likewise, polypeptide antibiotics and nondepolarizing neuromuscular blocking drugs may cause an increase in neuromuscular effects. Probenecid slows down the tubular secretion of ampicillin: prolongs its elimination half-life. Amoxicillin should not be used together with antibiotics with bacteriostatic effects such as tetracyclines and sulfonamides. Since diuretics accelerate the excretion of amoxicillin, they may reduce the concentration of the antibiotic. Uric acid synthesis inhibitors such as allopurinol accelerates the risk of skin reactions.
OVERDOSE
Doses five times the recommended level did not induce tolerance in cattle.
CONTRAINDICATIONS
It is not used in those who are allergic to penicillin and cephalosporins. It is not used on animals such as horses, rabbits, guinea pigs, hamsters and web-footed animals.
Use During Pregnancy: Not used in pregnant animals.
WARNINGS FOR DRUG RESIDUES IN FOOD
Drug Residue Withdrawal Period (D.R.W.P): Cattle should not be sent to slaughter during the treatment and 21 days after the last drug application. Cow’s milk obtained during the treatment and 5 days (10 milkings) after the last drug application should not be offered for human consumption.
GENERAL WARNINGS
Consult your veterinarian before use and if any unexpected effects occur. Keep it out of reach of children and in its packaging. Keep away from food or food like matters. Do not purchase or use products with damaged packaging.
PRECAUTIONS TO BE TAKEN BY THE APPLICANT AND WARNINGS FOR PHYSICIANS
Individuals known to be allergic to penicillins should avoid contact with the drug. Avoid inhaling drug dust. Wash your hands after administration. If medication splashes on skin and eyes, wash immediately with plenty of water. If symptoms of a severe allergic reaction such as swelling of the face, eyes and lips or difficulty breathing occur following infection, consult a physician immediately.
STORAGE CONDITIONS AND SHELF LIFE
The shelf life is 24 months when stored in its packaging and at room temperature (15 – 25°C).
TRADE DRESS
It is presented in cardboard boxes containing 50, 100 and 250 ml colorless glass vials.
PLACE AND CONDITIONS OF SALE
Sold in veterinary clinics and pharmacies with a veterinarian’s prescription.
