SPIRANIX® Injection

ASPIRANIX® Injection

For Veterinary Use Only

Composition

Each ml contains:

• Spiramycin (as spiramycin base) ............... 100 mg

• Excipients ...................................................... q.s. to 1 ml

(Strength may be adjusted according to your final formulation; commonly 100 mg/ml)

Pharmacological Class

Macrolide antibiotic

Indications

ASPIRANIX® Injection is indicated for the treatment of bacterial infections caused by spiramycin-sensitive organisms in animals, including:

• Respiratory tract infections
  (Mycoplasma spp., Streptococcus spp., Pasteurella spp.)

• Gastrointestinal infections

• Mastitis caused by susceptible Gram-positive bacteria

• Metritis and uterine infections

• Skin and soft tissue infections

• Mycoplasmal infections

Spiramycin is characterized by good tissue penetration, particularly in respiratory tissues, and prolonged antibacterial activity.

Dosage and Administration

Route: Intramuscular (IM) injection

Recommended dosage:

• Cattle, Camels, Horses:
  10–20 mg spiramycin/kg body weight
  (Equivalent to 1–2 ml per 10 kg BW)
  Once daily for 3–5 days

• Sheep & Goats:
  10–20 mg/kg body weight
  Once daily for 3–5 days

• Dogs & Cats:
  15–25 mg/kg body weight
  Once daily for 3–5 days

Dosage and duration may be adjusted according to severity of infection and veterinary judgment.

Target Species

Cattle, camels, horses, sheep, goats, dogs, and cats

Contraindications

• Hypersensitivity to spiramycin or other macrolide antibiotics

• Do not use in animals with known macrolide hypersensitivity

Precautions

• For veterinary use only

• Use under veterinary supervision

• Do not administer intravenously

• Use sterile injection technique

• Do not mix with other injectable products in the same syringe

• Keep out of reach of children

Withdrawal Period

(Subject to national regulatory approval)

• Meat: Typically 7–21 days

• Milk: Typically 3–5 days
  (Confirm exact withdrawal periods according to local regulations)

Storage

• Store below 25°C

• Protect from light

• Do not freeze

• Keep container tightly closed

Presentation

• Multidose vials (e.g. 50 ml, 100 ml)