AMOXICILLIN SODIUM AND CLAVUNATE POTASSIUM FOR INJECTION

IndicationsThis product is indicated for the short-term treatment of the following infections caused by sensitive bacteria:(1) Upper respiratory tract infection (including ear, nose and throat): such

  • Product No.: AMC13027-03
  • Specification: 1.2g/10ml,10vials
  • Trademark: Shinepharm
  • Support OEM/ODM: Yes
  • Mini. Order: 10000Boxs
  • Delivery Time: 30~60 Days
  • Trade Term: FOB,CIF
  • Payment Term: T/T,L/C
  • Standard Available: CP,BP
  • Documents: GMP,COPP,CTD

Indications

This product is indicated for the short-term treatment of the following infections caused by sensitive bacteria:

(1) Upper respiratory tract infection (including ear, nose and throat): such as recurrent tonsillitis,sinusitis, otitis media.

(2) Lower respiratory tract infection: such as acute exacerbations of chronic bronchitis, lobarpneumonia and bronchopneumonia.

(3) Urogenital tract infection: such as cystitis, urethritis, pyelonephritis.

(4) Skin and soft tissue infection: such as furuncle, abscess, cellulitis, traumatic infection.

(5) Bone and joint infection: such as osteomyelitis.

(6) Other infections: such as abdominal infection and so on. This product can also be used to prevent major surgical infection, such as: gastrointestinal, pelvic,head, neck, heart, kidney, joint transplantation and biliary tract surgery.

Dosage and Administration

Usage:Intravenous injection or intravenous drip, and not suitable for intramuscular injection.

For adults and children over 12 years old

Normal dosage: 1.2g every 8 hours; Severely infected person: it can be increased to1.2g every 6 hours.

For children aged 3 months-12 years old

Normal dosage: 30mg*/kg of body weight every8 hours; Severely infected person: it can be increased to30mg*/kg of body weight every 6 hours.

For children aged 0-3 months

Perinatal preterm infants and full-termnewborns, 30mg*/kg of body weight every 12hours; then increased to 30mg*/kg of body weight every 8 hours.

Precautions & Warning:

The product should be used with caution in patients allergic to cephalosporins and having thehistory of asthma, allergic rhinitis, urticaria and other allergic diseases.

(2) The product has cross-anaphylaxis with other penicillins and cephalosporins. If such casesoccur, administration of this product should be discontinued immediately and take appropriatemeasures.

(3) The product has cross-resistance with ampicillin and other penicillins and cephalosporins.

(4) The product should be administered immediately after reconstituted. The remaining medicineliquid should be discarded and not be reused. The prepared solution of the product can not becryopreservation.

Contraindications:

1. This product is contraindicated in patients with positive reaction of penicillins skin test, with ahistory of allergic reactions to this product and other penicillins and patients with infectiousmononucleosis.

2. Previous history of amoxicillin and clavulanate-associated cholestatic jaundice or hepaticdysfunction.

Adverse Reactions:

(1)Lesions of skin and its appendages: Rashes, pruritus, hives, skin flush, erythema multiforme,Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis (erythroderma), acutegeneralized exanthematous pustulosis.

(2) Gastrointestinal impairment: Nausea, vomiting, indigestion, abdominal distension, diarrhea,gastritis, stomatitis, glossitis, black "hairy" tongue, pseudomembranous colitis and hemorrhagiccolitis.

(3) Immune function disorders and infections: Drug induced fever, hypersensitivity vasculitis,angioedema, mucocutaneous candidiasis, superinfection, serum sickness-like reactions (urticariaaccompanied by arthritis, arthralgia, myalgia, and fever), asthma, severe anaphylaxis andanaphylactic shock.

(4) Nervous system impairment: Headache, dizziness, vertigo, insomnia, agitation, anxiety,dysphoria, behavioral changes, confusion and convulsions.

Storage instructions:

Airtight, preserve from light, store in a dry place not exceeding 30℃.