Chemical Waste

Western medicine Ampicilin Sodium and Cloxacillin Sodium Powder for injection 500mg(250mg+250mg) bactericidal activity

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One vial of 10 ml contains:

Active Ingredients: Ampicilin Sodium and cloxacillin Sodium

Equivalent to Ampicillin 250 mg and Cloxacillin 250 mg

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Read all of this leaflet carefully before you start taking this medicine.
# Keep the leaflet, Perhaps you may read if again.
# If you have any questions ,please contact your doctor or pharmacist.
# This medicine has been prescribed for you. Pass it not to others. It may harm them, even if these symptoms are the same as yours.
# If any of the above listed aide effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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Ampicilin Sodium and cloxacillin Sodium 500 mg exhibits in vivo and in vitro bactericidal activity against Gram-positive and Gram-negative organisms. The use f this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity resting should. therefore, be carried out infections caused by susceptible organisms where a mixed infection is present and includes penicillin-resistant staphylococcal.

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Contra-indications:

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Known allergy to penicillin or cephalosporins . Cases of cross sensitivity have been reported.

Babies born of hypersensitive mothers in the neonatal period .

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Warnings:

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When administered to a patient with penicillin allergy anaphylactic shock may occur. Adrenaline, corticosteroids and antihistamines should be used to treat anaphylaxis .Use with caution in patients with a known history of allergy.

Because of the variability in intestinal absorption of cloxacillin containing products, oral administration is not a suitable substitute for the parenteral route in treatment of severe infections.

Intrathecal administration of penicillins is not recommended, because it is a potent convulsant when given by this route.

Care should be taken when high doses are given to patients with renal impairment (because of the risk of neurotoxicity) or congestive heart failure. Renal and haematological systems should be monitored during prolonged and high dose therapy.

Care should be taken when treating patients with syphilis, as the Jarisch-Herxheimer reaction may occur shortly after starting treatment.This reaction, manifesting as fever, chills, headache and reactions at the site of the lesion, can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as with optic atrophy.

Haemolytic anemia and leucopenia, prolongation of bleeding time and detective platelet function have been observed usually following high intravenous doses. Convulsions and other signs of toxicity to the CNS may occur particularly with intravenous administration or in patients with renal failure.

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How is?it applied?

Dosage and directions for use:

The average adult dose of San-Ampiclox 500 mg is 2-4 g per day. In severe infection, dosage may be safely increased.Parenteral

Adult and children over 10 : 500 mg-1g intravenously or intramuscularly every 4-6 hours or as dictated be the severity of infection.

Children 2-10 years :Half of adult dose.

Children up to 2 years : Quarter the adult dose.

Neonates : 75 mg (i.e. 1 neonatal vial) every 8 hours.

These dosages should correspond to daily dosage 50-150 mg/kg.

Direction for use:

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Intramuscular injection:

500 mg vial – add 1.5 mal Water for injection B.P. and shake vigorously.

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Intravenous injection:

Normally given by slow intravenous injection.

500 mg– dissolve in 10 ml of Water for injections B.P. by first dissolving the content of the vial in approximately 3 ml of the Water for injections

vial B.P. and then withdrawing the dissolved content into a 10 ml syringe containing the remaining Water for Injection B.P.

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intravenous infusion:

Vial content should be dissolved in a suitable volume of fluid and given as a rapid intravenous infusion over 30 minutes or suitable diluted into the drip tubing. Solution must be used within 30 minutes of preparation.

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Storage conditions:

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Keep medicines away from reach children.

You may not use this medicine after the are not longer on label after EXP expiration date. The expiry date refers to last day of the month.

Do not above 25c

Shelf life 3 years

The reconstituted solution has be used immediately.

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Name of Drug | Ampicilin Sodium and cloxacillin Sodium 500mg |
REG.NO. | 014648 | Batch No. | W160530 |
Mfg. Date | 05/2016 | Exp. Date | 04/2020 |
Sampling Date | 02/06/2016 | Report Date | 18/06/2016 |
Specification | 500mg | Quantity | 40,000box |
Standards: | USP27 |
ITEMS STANDARDS RESULTS Characteristics : white powder Identification: Should Positive reaction The main peak retention time of the sample solution should match the reference solution Uniformity of weight Meet the specification Loading capacity Should no less than 1ml Visible foreign matter: Meet the requirements Particular matter: Meet the specification Related substances: Meet the specification Complies ? Assay: 90.0%-110.0% 97.9% |
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