DOSAGE AND ADMINISTRATION
Dose ranging studies using efficacy endpoints have not been
performed.
Chronic Augmentation Therapy
FOR INTRAVENOUS USE ONLY. The recommended dosage of
ARALAST NP is 60 mg/kg body weight administered once weekly by
intravenous infusion. Each vial of ARALAST NP has the functional
activity, as determined by inhibition of porcine pancreatic
elastase, stated on the label. Administration of ARALAST NP
within three hours after reconstitution is recommended to avoid
the potential ill effect of any inadvertent microbial
contamination occurring during reconstitution. Discard any
unused contents.
Infusion Rate
ARALAST NP should be administered at a rate not exceeding
0.08 mL/kg body weight/minute. If adverse events occur, the rate
should be reduced or the infusion interrupted until the symptoms
subside. The infusion may then be resumed at a rate tolerated by
the subject.
RECONSTITUTION
Use Aseptic Technique
1. ARALAST NP and diluent should be at room temperature
before reconstitution.
2. Remove caps from the diluent and product
vials.
3. Swab the exposed stopper surfaces with
alcohol.
4. Remove cover from one end of the double–ended transfer
needle. Insert the exposed end of the needle through the center
of the stopper in the DILUENT vial.
5. Remove plastic cap from the other end of the
double–ended transfer needle now seated in the stopper of the
diluent vial. To reduce any foaming, invert the vial of diluent
and insert the exposed end of the needle through the center of
the stopper in the PRODUCT vial at an angle, making certain that
the diluent vial is always above the product vial. The angle of
insertion directs the flow of diluent against the side of the
product vial. Refer to Figure below. The vacuum in the vial is
sufficient to allow transfer of all of the diluent.
6. Disconnect the two vials by removing the transfer
needle from the diluent vial stopper. Remove the double–ended
transfer needle from the product vial and discard the needle
into the appropriate safety container.
7. Let the vial stand until most of the contents is in
solution, then GENTLY swirl until the powder is completely
dissolved. Reconstitution requires no more than five minutes for
a 0.5 gram vial and no more than 10 minutes for a 1.0 gram
vial.
8. DO NOT SHAKE THE CONTENTS OF THE VIAL. DO NOT INVERT
THE VIAL UNTIL READY TO WITHDRAW CONTENTS.
9. Use within three hours of reconstitution.
10. Inspect parenteral drug products visually for
particulate matter and discoloration prior to administration.
The reconstituted product should be a colorless or slightly
yellow to yellowish-green solution. When reconstitution
procedure is strictly followed, a few small visible particles
may occasionally remain. These will be removed by the
microaggregate filter.
11. Reconstituted product from several vials may be
pooled into an empty, sterile IV solution container by using
aseptic technique. A sterile 20 micron filter is provided for
this purpose.
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