SYNULOX RTU 100ML | INJECTABLE ANTIBIOTIC FOR DOGS AND CATS

SYNULOX Antibacterial, in injectable liquid form, based on amoxicillin and clavulanic acid.

2. COMPOSITION
2.1 Qualitative composition
Active principles
Amoxicillin (trihydrate)……………………………………14 g
Clavulanic acid (potassium clavulanate)………………….3,5 g
Components of the excipient
Phenol…………………………………………………………0,5g
Fractionated coconut oil qsp ………………………100 ml
3. PHARMACEUTICAL FORM
3.1 Pharmaceutical form
Injectable suspension.
3.2 Route of administration
Intramuscular or subcutaneous.
4. PHARMACOLOGICAL PROPERTIES AND PHARMACOKINETIC DATA.
Association of antibacterials whose justification is based on the expansion of the spectrum of the
amoxicillin against beta-lactamase-producing germs.
Amoxicillin is a broad-spectrum bactericidal antibiotic belonging to the group of
beta-lactams. It is a semisynthetic penicillin susceptible to the action of beta-lactamases.
Clavulanic acid is a beta-lactamase inhibitor antibiotic, with little action.
intrinsic antimicrobial.
Mechanism of action:
Amoxicillin prevents the synthesis of the bacterial cell wall by inhibiting the enzymes
transpeptidases and carboxypeptidases, causing an osmotic imbalance that destroys the
bacteria in growth phase.
Clavulanic acid produces a progressive and irreversible inhibition of beta-lactamases
bacteria by forming a stable, molecule-enzyme complex. During the process the acid

clavulanicus is destroyed. In this way, it prevents the beta-lactam ring of amoxicillin from being
broken down by these enzymes and may lose its activity.
Its spectrum of activity is

And also Leptospires spp.
Including penicillinase-producing strains.
It is not indicated for infections caused by Pseudomonas.
In pigs, the serum concentrations of amoxicillin and clavulanic acid after administration
single or repeated intramuscular injection are similar. parameters
pharmacokinetics are:

Amoxicillin and clavulanic acid have similar pharmacokinetic parameters. HE
distribute well and quickly throughout the body, reaching high concentrations in
muscle, liver, kidney, and intestinal tract, due to poor protein binding
plasmatic Amoxicillin diffuses poorly into brain and spinal fluids, except when the
meninges are inflamed. They cross the placental barrier. Its metabolization is poor,
Eliminating both mainly through urine and to a lesser extent through milk and bile.
5. CLINICAL DATA
5.0 Target species
Cattle, dogs, cats, and pigs
5.1 Therapeutic indications specifying the target species
In Bovids, pigs, dogs and cats:
– Infections caused by sensitive germs, located in:
– The digestive tract
– The urogenital tract
- Respiratory tract
– Skin and soft tissues
– As well as bacterial complications sensitive to amoxicillin when required.
5.2 Contraindications
Animals allergic to beta-lactam antibiotics.
Do not administer to rabbits, guinea pigs, hamsters and other small rodents.
5.3 Side Effects (Frequency and Seriousness)
– Sensitization reaction whose severity can vary from a simple urticaria to a
anaphylactic shock.
– In isolated cases, a transient, local tissue reaction is observed at the point of
application.
– Gastrointestinal symptoms mainly in herbivores.
– Suprainfections by non-susceptible germs after prolonged use.
– Occasionally it can occur in some animals, hematic dyscrasias and colitis.
5.4 Special precautions for use
– Adjust the dose in animals with renal disorders.
- Shake it before using.
– Use dry and sterile syringes.
– It should not be administered intravenously.
– Give a light massage at the point of application.
5.5 Use during pregnancy and lactation
Contraindications have not been described.
5.6 Interaction with other medicinal products and other forms of interaction
Do not administer together with bacteriostatic anti-infectives - tetracycline group,
chloramphenicol and sulfonamides
5.7 Amounts to be administered and administration route
SYNULOX can be administered in:
– Dogs and cats: intramuscularly or subcutaneously
– Pigs: intramuscular use only
– Bovine: only intramuscular route, the administration will be alternately on each side of the
animal)
The recommended dose of SYNULOX suspension for injection is 8,75 mg/kg, i.e. 1 ml
for every 20 kg of weight (equivalent to 7 mg of amoxicillin + 1,75 mg of clavulanic acid) repeating
dose every 24 hours.
It is recommended not to prolong the treatment for more than 3-5 days if no improvement is observed at the
first 48 hours, reconsider the diagnosis.
The dose and/or its frequency can be increased according to veterinary criteria.
5.8 Overdose (symptoms, emergency procedures, antidotes)
SYNULOX Suspension for Injection has a wide margin of safety.
In the event of severe allergic reactions, treatment should be discontinued and
Administer corticosteroids and adrenaline. In all other cases, apply a symptomatic treatment.
5.9 Special warnings for each target species
They have not been described.
5.10 Timeout
Cattle: Meat: 54 days.
Milk: 2 days (48 hours)
Porcine: meat: 27 days
5.11 Special safety precautions to be taken by the person handling or
manage the product
Do not leave medicines within the reach of children.
6 PHARMACEUTICAL DATA
6.1 Incompatibilities (important)
They have not been described.
6.2 Period of validity
Commercial product: 18 months.
Reconstituted product: not applicable.
6.3 Special precautions for storage
Store in a cool (T=/< 20ºC) and dry place, protected from light.
6.4 Presentation
Glass vials with capacity for 10, 40 and 100 ml and 6×100 ml with rubber stopper, sealed
with metal capsule.
6.5 Name or business name of the holder of the marketing authorization

28108 Alcobendas (Madrid)
SPAIN
6.6 Special Precautions to Be Observed for Disposal of Unused Medicinal Product
used and/or packaging
Both the containers and the unused medication must be disposed of in designated places.
for this purpose, after properly wrapping them.
FINAL INFORMATION:
– Marketing authorization number: 450 ESP
– Date of authorization/renewal: 15/07/1992
– Last revision of the text: March 16, 2005
– Dispensation conditions: With veterinary prescription.

See technical sheet

Synulox