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SODIUM LACTATE INJECTION USP

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PRODUCT SUMMARY
1. Trade name of the medicinal product
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2. Qualitative and quantitative composition
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3. Pharmaceutical form
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4. CLINICAL PARTICULARS
4.1 Therapeutic indicators
FOR ADMINISTRATION BY INTRAVENOUS INFUSION.
4.2 Posology and method of administration
THE DOSAGE OF SODIUM LACTATE INTRAVENOUS INFUSION IS DEPENDANT UPON THE
AGE, WEIGHT AND CLINICAL CONDITIONS OF THE PATIENT.
4.3/4.9 Clinical particulars section
A) CONTRAINDICATIONS: PATIENTS WITH SEVERE LIVER DAMAGE WITH AN
IMPAIRMENT OF LACTATE UTILISATION. PATIENTS WHO HAVE AN IMPAIRED
ABILITY TO HANDLE SODIUM SUCH AS ORGANIC DISEASE, ESPECIALLY WITH A
HISTORY OF CONGESTIVE HEART FAILURE, PATIENTS WITH RENAL INSUFFICIENCY,
CIRRHOSIS OF THE LIVER, CARDIOPULMONARY DISEASE OR PATIENTS RECEIVING
SALT-RETAINING STEROIDS.
B) INTERACTIONS WITH OTHER MEDICAMENTS: NONE STATED
C) EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: NONE STATED
D) OTHER UNDESIRABLE EFFECTS: PROLONGED INTRAVENOUS INFUSION MAY CAUSE
THROMBOPHLEBITIS EXTENDING FROM THE SITE OF INFUSION.
E) USE I N PREGNANCY AND LACTATION: NONE STATED
F) OTHER SPECIAL WARNINGS AND PRECAUTIONS:
I)
ADMINISTER WITH CAUTION IN ALL PATIENTS TO AVOID METABOLIC
ALKALOSIS RESULTING FROM EXCESS ADMINISTRATION.
II) ADMINISTER WITH CAUTION TO PATIENTS WITH DECOMPENSATED
CARDIOVASCULAR, CIRRHOTIC AND NEPHROTIC DISEASE AND TO PATIENTS
RECEIVING CORTICOSTEROIDS OR CORTICOTROPHIN.
III) THE SOLUTION SHOULD NOT BE USED UNLESS IT IS CLEAR AND THE
CONTAINER UNDAMAGED.
G) OVERDOSE: DISCONTINUE INFUSION IF ADVERSE REACTION OCCURS.
H) INCOMPATIBILITIES: COMPATIBILITIES SHOULD BE CHECKED WHEN ADDITIVES
ARE USED.

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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PHARMACEUTICAL PROPERTIES
6.1 List of excipients
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6.2 Incompatibilites
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Instructions for use/handling
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ADMINISTRATION DETAILS
7. Marketing authorization holder
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8. Marketing Authorization number
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9. Date of first authorization/renewal of authorization
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10. Date of (partial) revision of the text
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