|801-2, Jindong Mansion, No. 536 Xueshi Road, Yinzhou, Ningbo 315100, P.R.Chinafirstname.lastname@example.org|
|Place of Origin:||China|
|Model Number:||0.6g; 1.2g, 5:1|
|Minimum Order Quantity:||100000 vials|
|Packaging Details:||1vial or 50vials/Box|
|Delivery Time:||45 days|
|Payment Terms:||L/C, T/T|
|Supply Ability:||500, 000 vials per day|
|Strength:||0.6g; 1.2g, 5:1||Packing:||10/50 Vials/box|
|Dosage Form:||Powder For Injection||Active Ingredients:||Amoxicillin Sodium And Clavulanate Potassium 5:1|
Dry Powder For Injection
Dry Powder Injection Amoxicillin Clavulanate Potassium
PRODUCT: Amoxicillin Sodium and Clavulanate Potassium for Injection
Dosage and Strenth: Powder For Injection, 500mg/100mg; 1000mg/200mg
PACKING: 1vial or 50vials/Box
Standard: USP or BP
Dossier: Ready to submit
For 0.6g vial, each vial contains 500mg amoxicillin (as sodium salt) and 100mg clavulanic acid (as potassium salt).
For 1.2g vial, each vial contains 1000mg amoxicillin (as sodium salt) and 200mg clavulanic acid (as potassium salt).
Each ml of reconstituted solution contains 50mg amoxicillin (as sodium salt) and 10mg clavulanic acid (as potassium salt).
INDICATIONS AND USAGE
Amoxicillin Sodium and Clavulanate Potassium for Injection is indicated for the treatment of the following infections in adults and children:
• Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis and sinusitis when accompanied by severe systemic signs and symptoms)
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.
• Bone and joint infections, in particular osteomyelitis
• Intra-abdominal infections
• Femal genital infections
Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the:
• Gastrointestinal tract
• Pelvic cavity
• Head and neck
• Biliary tract surgery
Consideration should be given to the official guidance on the appropriate use of antibacterial agents.
You will never give yourself this medicine. A qualified person, like a doctor or a nurse, will give you this medicine.
The usual doses are:
Adults, and children weighing 40 kg and over
|Standard dose||1000 mg/200 mg every 8 hours.|
|To stop infections during and after surgery||
1000 mg/200 mg before the surgery when you are given your anaesthetic.
The dose can differ depending on the type of operation you are having. Your doctor may repeat the dose if your surgery takes longer than 1 hour.
Children weighing less than 40 kg
• All doses are worked out depending on the child’s bodyweight in kilograms.
|Children aged 3 months and over:||25 mg/5 mg for each kilogram of bodyweight every 8 hours.|
|Children aged less than 3 months or weighing less than 4 kg||25 mg/5 mg for each kilogram of bodyweight every 12 hours.|
Patients with kidney and liver problems
• If you have kidney problems you may be given a different dose. A different strength or a different medicine may be chosen by your doctor.
• If you have liver problems your doctor will keep a close check on you and you may have more regular liver function tests.
Possible side effects
Like all medicines, Amoxicillin Sodium and Clavulanate Potassium for Injection can cause side effects, although not everybody gets them. The side effects below may happen with this medicine.
Conditions you need to look out for Allergic reactions:
• skin rash
• inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body
• fever, joint pain, swollen glands in the neck, armpit or groin
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
→ Contact a doctor immediately if you get any of these symptoms. Stop taking Amoxicillin Sodium and Clavulanate Potassium for Injection.
Inflammation of large intestine
Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus,
stomach pain and/or fever.
→ Contact your doctor as soon as possible for advice if you get these symptoms.
Common side effects (may affect up to 1 in 10 people)
• thrush (candida - a yeast infection of the vagina, mouth or skin folds)
Uncommon side effects (may affect up to 1 in 100 people)
• skin rash, itching
• raised itchy rash (hives)
• feeling sick (nausea), especially when taking high doses
→ if affected take Amoxicillin Sodium and Clavulanate Potassium for Injection before food
Uncommon side effects that may show up in your blood tests:
• increase in some substances (enzymes) produced by the liver.
Rare side effects (may affect up to 1 in 1000 people)
• skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler
area, with a dark ring around the edge – erythema multiforme)
→ if you notice any of these symptoms contact a doctor urgently.
• swelling and redness along a vein which is extremely tender when touched
Rare side effects that may show up in your blood tests:
• low number of cells involved in blood clotting
• low number of white blood cells.
Other side effects
Other side effects have occurred in a very small number of people but their exact frequency is unknown.
• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Serious skin reactions:
- a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis)
- widespread red skin rash with small pus-containing blisters (bullous Exfoliative dermatitis)
- a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis).
- flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
→ Contact a doctor immediately if you get any of these symptoms.
• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your skin and whites of the eyes appear yellow
• inflammation of tubes in the kidney
• blood takes longer to clot
• convulsions (in people taking high doses of Amoxicillin Sodium and Clavulanate Potassium for Injection or who have kidney problems).
Side effects that may show up in your blood or urine tests:
• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in urine.
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