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For Medical Professional Use Only
Clip’n’Ject® Preparation
Wash your hands with soap and hot water and put on gloves immediately prior to preparing
the injection. Place the package containing the Clip'n'Ject system and the TrelstarŪ
vial on a clean, flat surface that is covered with a sterile pad or cloth. Peel
the TyvekŪ cover away from the blister package, and place the vial, connector, alcohol
swab, and plunger rod on the prepared surface.
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1. Be sure to begin by removing the Flip-Off® button from the top
of the vial, revealing the rubber stopper. |
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2. Disinfect the rubber portion of the vial cap with the alcohol
swab. Discard the alcohol swab and let the alcohol dry. |
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3. Proceed to Clip'n'Ject Activation. |
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Clip’n’Ject Activation
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1. Holding the vial upright and flat on the table surface with
one hand, place the plastic connector directly over the top of the Trelstar vial
with the other hand. Press the connector down firmly on the vial top. This will
ensure proper positioning of the vial. |
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4. a. With the vial still on the flat surface,
place your thumb on the plunger rod and depress the plunger rod to inject the sterile
water diluent into the vial. b. With your thumb on the plunger
rod, place two fingers under the plastic tab on the connector to keep the assembly
together. Gently rotate the system so that the diluent rinses the vial sides to
ensure complete mixing of Trelstar and the sterile water diluent. The solution
will now have a milky appearance. In order to avoid separation of the solution,
proceed to the next steps without delay. |
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2. Still holding the vial with one hand, press the syringe barrel
downward as far as it will go in the connector. This results in insertion of the
needle into the rubber stopper in the vial top to the predetermined depth. |
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5. Hold the Clip'n'Ject system in a vertical position with the
connector at 12 o'clock and the syringe plunger rod at 6 o'clock. Double check to
make sure that the syringe is still as far forward as possible in the connector
with the needle situated in the vial. Grasp the Clip'n'Ject system firmly by the
syringe barrel and pull back the plunger rod to draw the reconstituted Trelstar
into the syringe. |
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3. Check to make sure that the needle is inserted into the vial.
Now, screw the plunger rod into the end of the plastic grip on the syringe barrel. |
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6. Immediately before injecting Trelstar, remove the filled syringe
from the connector by holding the syringe by the barrel and pressing your thumbs
against the plastic tabs of the connector and pulling the syringe section from the
connector. Trelstar is now ready for administration. Suspension should be discarded
if not used immediately after reconstitution. |
Clip’n’Ject Disposal
After administering Trelstar, dispose of the Clip'n'Ject system as follows:
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a. |
Place Clip'n'Ject with attached vial in standing upright position
on a flat surface.
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b. |
Using one hand, replace the syringe into the Clip'n'Ject connector.
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c. |
Dispose of syringe and attached Clip'n'Ject connector with vial
into a suitable sharps container.
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Indications and Usage
TRELSTAR® Depot and TRELSTAR®
LA are indicated in the palliative treatment of advanced prostate cancer. TRELSTAR
Depot or TRELSTAR LA offer an alternative treatment for prostate cancer when orchiectomy
or estrogen administration are either not indicated or unacceptable to the patient. |
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Safety Information
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The most commonly reported adverse events associated with the use of TRELSTAR®
Depot/TRELSTAR® LA included hot flushes (58.6%/73.0%), skeletal pain
(12.1%/13.2%), impotence (7.1%/2.3%), headache (5.0%/6.9%), leg pain (2.1%/5.2%),
and edema in legs (0.0%/6.3%) . TRELSTAR is contraindicated in women who are or
may become pregnant as well as patients who are hypersensitive to triptorelin, other
LHRH agonists, or LHRH . Infrequent postmarketing reports of anaphylactic shock
and angioedema have been received since 1986 (global experience) . As with all LHRH
agonists, triptorelin causes an initial transient increase in testosterone levels.
Patients may experience the onset or exacerbation of symptoms during this period,
including bone pain, neuropathy, hematuria, spinal cord compression, or urethral
or bladder outlet obstruction. Patients with metastatic vertebral lesions and/or
urinary tract obstruction should be closely observed. |
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