Infusion bags

IV administration Administer over a period of 30 to 120 minutes. Do not use IV infusion bag in series connections. Do not introduce additives into this solution. Do not administer concomitantly with another drug administer each drug separately. Compatible IV solutions 5% dextrose injection, 0.9% sodium chloride injection lactated Ringer s injection. 

Amphotericin B iipid compiex (Abeicet) - The recommended dose is 5 mg/kg/day prepared as a 1 mg/mL infusion and delivered at a rate of 2.5 mg/kg/hr. For pediatric patients and patients with cardiovascular disease, the drug may be diluted to a final concentration of 2 mg/mL. If the infusion exceeds 2 hours, mix the contents by shaking the infusion bag every 2 hours. Do not use an in-line filter. 

Fever, chills, and tachypnea commonly occur shortly after the initial intravenous doses of amphotericin B this is not generally an allergic hypersensitivity to the drug, which is extremely rare. Continued administration of amphotericin B is accomplished by premedication with acetaminophen, aspirin, and/or diphenhydramine or the addition of hydrocortisone to the infusion bag. 

Studies conducted by different authors on the release of chemical substances from medical devices, mainly those used for infusing solutions, show that these are potential sources of contamination for pharmaceutical formulations. One of the most studied is diethylhexyl phthalate, the same plasticizer found in PVC infusion bags to give flexibility. The same concerns about the use of PVC bags for the storage of lipids or lipophilic formulations are valid for tubing. 

The sorption of two weak acids (warfarin and thiopentone) and two weak bases (chlorpromazine and diltiazem) into PVC infusion bags was described by a constant partition model. PVC-water partition coefficients were obtained using three different methods equilibrium values for sorption into PVC bags, the sorption versus pH relationship, and partition into PVC strips. The data were compared with similar values derived from a liquid-liquid partition system and different organic solvents (octanol, dichloromethane, carbon tetrachloride, and hexane). Octanol is the preferred solvent, and it is suggested that octanol-water partition data can be used to predict sorption behavior [182]. 

Ilium, L., Bundgaard, H., and Davis, S. S. (1983), A constant partition model for examining the sorption of drugs by plastic infusion bags, Int. J. Pharm., 17,183-192. 

Jenke, D. R. (1993), Modehng of solute sorption by polyvinyl chloride plastic infusion bags,/. Pharm. Sci., 82(11), 1134-1139. 

Further, they can be used for medical purposes, such as press-through packages, disposable syringes, liquid medicine vials, and infusion bags. They are suitable for electric or electronic materials, such as wire coating. In addition, packaging films, such as wrapping films, stretch films, shrink films, and blister packs can be produced. 

Roberts, M.S., Kowaluk, E.A., Polack, A.E. (1991) Prediction of solute sorption by polyvinylchloride plastic infusion bags. J. Pharm. Sci. 80, 449 155. 

S.J. Weir, et al., Sorption of amiodarone to polyvinyl chloride infusion bags and administration sets. Am. J. Hosp. Pharmacol. 42 2679-2683, 1985. 

Absorption of clomethiazole edisylate and thiopental sodium into PVC infusion bags was observed [28],... 

The pH dependence of adsorption/absorption of acidic drug substances such as warfarin and thiopental and basic drug substances such as chlorpromazine and dil-tiazem indicates that only the un-ionized form of the drug substance is adsorbed onto or absorbed into PVC infusion bags [29],... 

The maximum surface temperature that may occur under total incident radiation can be measured by use of a black standard thermometer. Alternatively, a white standard thermometer can be used to predict the surface temperature of a reflecting surface, e.g., white tablets. In our laboratory, we have found the use of a temperature level strip (Thermax, Thermographic Measurements Ltd., South Wirral, U.K.) quite convenient to predict the temperature of the exposed sample. The strip can be placed on the exposed surface (e.g., surface of an infusion bag) or inside a container (e.g., inside a petri dish). A color change indicates that the rating quoted on the indicator has been reached. The maximum temperature reached during the exposure is thereby registered with good accuracy ( 1%). 

Colourless glass does not appreciably transmit radiation wavelengths below about 310 run, and amber glass does not appreciably transmit wavelengths below 400 nm. Clear glass is moreover, used to facilitate visual inspection of the infusion solutions during administration. For this same reason, in clinical practice, clear infusion bags are often preferred to opalescent polyethylene (PE) or polypropylene bottles. 

In another experiment, infusion bags containing 1.6mg/mL of pefloxacin or 0.8 mg/mL of ofloxacin or ciprofloxacin solutions were stored for eight hours without photoprotection. No significant losses of the parent drug were detected (25). No loss of diluted ciprofloxacin, 1.5mg/mL, was found by HPLC assay after 48 hours exposure at 25°C. This study used samples prepared in 5% glucose injection, or 0.9% sodium chloride injection, and all samples were exposed to fluorescent radiation (3). 

Dynamic experiments also demonstrated photostability of molsidomine infusion under condition of artificial source illumination. A flow rate of 12.5mL/hr was used, resulting in a residence time of one hour in the infusion tubing. Simulated infusions exposed to window-glass-filtered daylight or simulated sunlight (Ultra-Vitalux lamps) showed that protection of the infusion bag alone, results in a degradation rate similar to that found for unprotected infusion bags (Fig. 8). 

Figure 7 Mean molsidomine concentrations of unprotected infusion bags of product stored on a windowsill at three different irradiation levels (each n = 3) ( ) protected from daylight ( ) 3.9 lux (a) 5.5 lux ( ) 12.5 lux. Source. From Ref. 64.

Figure 8 Mean molsidomine concentrations (% initial) as a function of time for dynamic experiments, performed in simulated sunlight with an unprotected infusion bag and unprotected infusion tubing ( ), with an infusion bag, covered with aluminium foil and an unprotected infusion tubing (A), with an infusion bag, covered with a ultraviolet (UV)-cover and an infusion tubing with UV-filter ( ) n= 1). Source From Ref. 64.

Faouzi M A, Dine T, Luyckx M, et al. Stability and compatibility of pefloxacin, ofloxacin, and ciprofloxacin with PVC infusion bags. Int J Pharm 1993 89 125-131. 

Dine T, Khalfi F, Gressier B, et al. Stability study of fotemustine in PVC infusion bags and sets under various conditions using a stability-indicating high-performance liquid chromatographic assay. J Pharm Biomed Anal 1998 18 373-381. 

Bacterial growth in infusion bags has not been detected, and complications such as infections during the postoperative period have not been observed (18). 

Some relation has been found between the rate of sorption by poly (vinyl chloride) (PVC) bags of a series of dmgs and their hexane/ water partition coefficients.Table 5.20 shows the data for sorption of 100 cm PVC infusion bags (equivalent to 11 g of PVC). In the table,... 

Some idea of the rate and extent of disappearance of warfarin sodium from PVC infusion bags can be gained from Fig. 10.19. The marked effect of pH is seen. Losses can... 

Figure 10.19 Disappearance of warfarin sodium from aqueous buffered solutions stored in 100 cm PVC infusion bags at room temperature.

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