"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Directions for Use of B. Braun Glass Containers
Before use, perform the following checks:
- Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Check the security of bail and band.
- Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter; check the bottle for cracks or other damage. In checking for cracks, do not be confused by normal surface marks and seams on the bottom and sides of the bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle.
- To remove the outer closure, lift the tear tab and pull up, over, and down until it is below the stopper (See Figure 1). Use a circular pulling motion on the tab until it breaks away.
- Grasp and remove the metal disk, exercising caution not to touch the sterile
latex disk underneath.
Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
After admixture and during administration, reinspect the solution frequently. If any evidence of solution contamination or instability is found or if the patient exhibits any signs of fever, chills or other reactions not readily explainable, discontinue administration immediately and notify the physician.
When adding medication to the container during administration, swab the triangular medication site, inject medication and mix thoroughly by gentle agitation.
- Refer to Directions for Use for the administration set in use.
Products with Air Tube
- With the sterile latex disk exposed, check for vacuum by confirming the
presence of depressions in the latex disk, which should be held tightly over
stopper (See Figure 2). If the latex disk is puffed or depressions
cannot be seen, the vacuum has dissipated and the bottle should be rejected.
The sterile latex disk provides a surface for aseptic medication addition
prior to administration.
Note: When vacuum is essential for the use of the product (medication addition or transfer, etc.) the latex disk should be left in place until all additions or transfers are completed. Medication addition or transfers should be made immediately after exposing the sterile latex disk. Identify three depressions in the latex disk prior to adding medication (See Figure 2): a triangular medication site, one large round outlet port, and one small air-inletting port.
- Before removing the latex disk, add medication through the triangular (Δ) medication site (See Figure 3). The vacuum in the container will automatically draw the contents of a syringe or spiked vial into the container. Each addition/transfer will reduce the vacuum remaining in the bottle.
- Remove the latex disk prior to inserting administration set. To remove the latex disk, grasp the lip of the disk, lift and pull up and away (See Figure 4). As the disk is lifted, and if no additions have been made, vacuum can be confirmed by an audible hiss.
- Refer to Directions for Use of the set being used. Insert the set spike into the large round outlet port of the stopper and hang container.
Products with Solid Stopper
Designed for use with a vented set.
- Spiking, additions or transfers should be made immediately after exposing the sterile stopper surface. Check for vacuum at first puncture of stopper. Admixture by needle or syringe should be made through the triangular (Δ) medication site; contents should be drawn by vacuum into the bottle. Admixture by spiked vial should be through the outlet port (See Figure 5). If contents of initial addition are not drawn into the bottle, vacuum is not present and the unit should be discarded. Each addition/transfer will reduce the vacuum remaining in the bottle.
- If the first puncture of the stopper is the administration set spike, insert the spike fully into the outlet port of the stopper and promptly invert the bottle. Verify vacuum by observing rising air bubbles. Do not use the bottle if vacuum is not present.
- If admixture or set insertion is not performed immediately following removal of protective metal disk, swab stopper surface
Last reviewed on RxList: 12/18/2008
This monograph has been modified to include the generic and brand name in many instances.
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