Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
GLUCOSE AS MONOHYDRATE; SODIUM CHLORIDE
TEVA MEDICAL MARKETING LTD.
B05BB01
SOLUTION FOR INJECTION
SODIUM CHLORIDE 4.5 MG/ML; GLUCOSE AS MONOHYDRATE 50 MG/ML
I.V
Required
TEVA MEDICAL LTD, ISRAEL
ELECTROLYTES
ELECTROLYTES
Provides electrolytes and calories and is a source of water for hydration.
2013-10-31
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור :ךיראת 411.410.41 תילגנאב רישכת םש : Dextrose 5% and Sodium Chloride 0.45% Injection ושיר רפסמ ם : 038 88 22826 00 םושירה לעב םש : Teva Medical LTD ה טורפל דעוימ הז ספוט דבלב תורמחה ! תושקובמה תורמחהה ןולעב קרפ טסקט יחכונ שדח טסקט CONTRAINDICATIONS Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products PRECAUTIONS Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers. DRUG INTERACTIONS Studies have not been conducted to evaluate additional drug/drug or drug/food interactions with Dextrose and Sodium Chloride Injection. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Studies with Dextrose and Sodium Chloride Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. PREGNANCY: TERATOGENIC EFFECTS Pregnancy Category C. Animal reproduction studies have not been conducted with Dextrose and Sodium Chloride Injection, USP. It is also not known whether Dextrose and Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose and Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed. LABOR AND DELIVERY Studies have not been conducted to evaluate the effects of Dextrose and Sodium Ch Lesen Sie das vollständige Dokument
ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ 26.1.2017 -ב ודי לע רשואו קדבנ DEXTROSE 5% IN 0.45% SODIUM CHLORIDE INJECTION SOLUTION FOR INFUSION IN NON PVC BAGS DESCRIPTION Dextrose 5% in 0.45% Sodium Chloride Injection is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. TABLE 1 Size (mL) Composition (g/L) *Osmolarity (mOsmol/L) (calc.) pH nominal (range) Ionic Concentration (mEq/L) Caloric Content (kcal/L) Dextrose Monohydrate Sodium Chloride, (NaCl) Sodium Chloride 5% Dextrose and 0.45% Sodium Chloride Injection 500 1000 50 4.5 406 4.0 77 77 170 * NORMAL PHYSIOLOGIC OSMOLARITY RANGE IS APPROXIMATELY 280 TO 310 MOSMOL/L. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication (see DIRECTIONS FOR USE). The primary function of the overwrap is to protect the container from the physical environment. DESCRIPTION OF THE PRIMARY BAGS: Type and size: Non PVC plastic bag + overpouch; size: 500 ml and 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 Dextrose 5% in 0.45% Sodium Chloride Injection has value as a source of water, electrolytes, and calories. It is capable of inducing diuresis depending on the clinical condition of the patient. INDICATIONS AND USAGE Dextrose 5% in 0.45% Sodium Chloride Injection is indicated to provide electrolytes and calories and as a sourc Lesen Sie das vollständige Dokument