Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
CALCIUM CHLORIDE; LACTIC ACID AS SODIUM; POTASSIUM CHLORIDE; SODIUM CHLORIDE
TEVA MEDICAL MARKETING LTD.
B05BB02
SOLUTION FOR INJECTION
SODIUM CHLORIDE 6 G/L; POTASSIUM CHLORIDE 0.3 G/L; CALCIUM CHLORIDE 0.2 G/L; LACTIC ACID AS SODIUM 3.1 G/L
I.V
Required
TEVA MEDICAL LTD, ISRAEL
ELECTROLYTES WITH CARBOHYDRATES
ELECTROLYTES WITH CARBOHYDRATES
As a supply of water, for administration of electrolytes or calories, or as an alkalinizing agent.
2011-10-31
" ע עבקנ הז ןולע טמרופ " רשואו קדבנ ונכותו תואירבה דרשמ י ." רשואמ ןולע : 7/5/2013 “This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved.” Date of approval: 7/5/2013 LACTATED RINGER'S INJECTION (HARTMANN’S SOLUTION) SOLUTION FOR INJECTION . IN NON PVC BAGS DESCRIPTION Lactated Ringer's Injection (Hartmann’s Solution) Solution for Injection is sterile, nonpyrogenic solutions for fluid and electrolytes replenishment and/or caloric supply in single dose bags for intravenous administration. It contains no antimicrobial agents. The composition, osmolarity, and pH values are shown in Table 1. TABLE 1 COMPOSITION, OSMOLARITY, AND APPROXIMATE PH VALUES Lactated Ringer's Injection (Hartmann’s Solution) Solution for Injection 6.0 3.1 0.3 0.2 273 6.5 * Normal physiologic isotonicity range is approximately 280-310 mOsm/L. Administration of substantially hypotonic solutions may cause hemolysis, and administration of substantially hypertonic solutions may cause vein damage. **Approx. pH values are USP for applicable solutions, corporate specification for non-USP solutions. Approximate ionic concentrations (mEq/L) and calories per liter are shown in Table 2. TABLE 2 APPROXIMATE IONIC CONCENTRATIONS (MEQ/L) AND CALORIES PER LITER IONIC CONCENTRATION (MEQ/L) Lactated Ringer's Injection (Hartmann’s Solution) Solution for Injection 130 4 2.7 109 28 9 LACTATED RINGER’S INJECTION (Hartmann’s Solution) SOLUTION FOR INJECTION IN NON PVC BAGS 8 5. 2013, RH LACTATED RINGER’S INJECTION (Hartmann’s Solution) SOLUTION FOR INJECTION IN NON PVC BAGS 8 5. 2013, RH 2 DESCRIPTION OF THE PRIMARY BAGS: Type and size: Non PVC plastic bag +overpouch; size: 1000 ml. Material composition: - Non PVC plastic film, based on polyethylene, polyamide, and polypropylene. - Overpouch based on co-extruded blend: polypropylene/polyamide/polypropylene film. CLINICAL PHARMACOLOGY As a source of water, electrolytes, and/or calo Baca dokumen lengkap