A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Cetrotide Patient, Information, Instructions - Cetrorelix
Cetrotide Patient, Information, Instructions - Cetrorelix
PATIENT INFORMATION
Summary
Cetrotide® blocks the effects of a natural hormone,
called gonadotropin-releasing hormone (GnRH). GnRH controls the secretion of
another hormone, called luteinizing hormone (LH), which induces ovulation during
the menstrual cycle. During hormone treatment for ovarian stimulation, premature
ovulation may lead to eggs that are not suitable for fertilization. Cetrotide®
blocks such undesirable premature ovulation.
Uses
Cetrotide® is used to prevent premature ovulation
during controlled ovarian stimulation.
General Cautions
Do not use Cetrotide® if you
• have kidney disease
• are allergic to cetrorelix acetate, mannitol or exogenous
peptide hormones (medicines similar to Cetrotide®) or
• are pregnant, or think that you might be pregnant, or if
you are breast-feeding. Consult your doctor before taking Cetrotide®
if you have had severe allergic reactions.
Proper Use
Ovarian stimulation therapy is started on cycle Day 2 or 3.
Cetrotide® is injected under the skin either once daily (0.25
mg dose) or once (3 mg dose), as directed by your physician. When an ultrasound
examination shows that you are ready, another drug (hCG) is injected to induce
ovulation.
How should you use Cetrotide®?
You may self-inject Cetrotide® after special
instruction from your doctor.
To fully benefit from Cetrotide®, please read
carefully and follow the instructions given below, unless your doctor advises
you otherwise.
Cetrotide® is for injection under the skin of
the lower abdominal area, preferably around, but staying at least one inch away
from the belly button. If you are on a multiple dose (0.25 mg) regimen, choose
a different injection site each day to minimize local irritation. Dissolve Cetrotide®
powder only with the water contained in the pre-filled syringe. Do not use a
Cetrotide® solution if it contains particles or if it is not
clear.
Before you inject Cetrotide® yourself, please
read the following instructions carefully:
Directions for using Cetrotide® 0.25 mg or 3
mg with the enclosed needles and pre-filled syringe:
1. Wash your hands thoroughly with soap and water.
2. On a clean flat surface, lay out everything you need
(one vial of powder, one pre-filled syringe, one injection needle with a yellow
mark, one injection needle with a grey mark, and two alcohol wipes).
3. Flip off the plastic cover of the vial. Wipe the aluminum
ring and the rubber stopper with an alcohol wipe.
4. Take the injection needle with the yellow mark and remove
the wrapping. Take the pre-filled syringe and remove the cover. Twist the needle
on the syringe and remove the cover of the needle.
5. Push the needle through the center of the rubber stopper
of the vial. Inject the water into the vial by slowly pushing down on the plunger
of the syringe.
6. Leave the syringe in the vial. Gently shake the vial
until the solution is clear and without residue. Avoid forming bubbles during
dissolution.
7. Draw the total contents of the vial into the syringe.
If liquid is left in the vial, invert the vial, pull back the needle until the
opening of the needle is just inside the stopper. If you look from the side
through the gap in the stopper, you can control the movement of the needle and
the liquid. It is important to withdraw the entire contents of the vial.
8. Detach the syringe from the needle and lay down the syringe.
Take the injection needle with the grey mark and remove its wrapping. Twist
the needle on the syringe and remove the cover of the needle.
9. Invert the syringe and push the plunger until all air
bubbles have been pushed out. Do not touch the needle or allow the needle to
touch any surface.
10. Choose an injection site in the lower abdominal area, preferably
around, but at least one inch away from the belly button. If you are on a multiple
dose (0.25 mg) regimen, choose a different injection site each day to minimize
local irritation.
Take the second alcohol wipe and clean the skin at the injection
site and allow alcohol to dry. Inject the prescribed dose as directed by your
doctor, nurse or pharmacist.
11. Use the syringe and needles only once. Dispose of the syringe
and needles immediately after use (put the covers on the needles to avoid injury).
A medical waste container should be used for disposal.
Directions for using Cetrotide® 0.25 mg with
the Serono Fertility Auto-injectorTM:
1. Follow Steps 1-5 above for enclosed needles and syringe.
2. Remove the empty syringe from the vial and discard. Gently
swirl the vial until the solution is clear and without residues. Avoid forming
bubbles during dissolution.
3. Insert the 1 mL fixed needle syringe (provided for use
with the Serono Fertility Auto-injectorTM) through the center of
the rubber stopper of the vial. Keeping the needle in the vial, lift the vial
and turn it upside down with the needle pointing toward the ceiling. With the
needle tip in the liquid, draw the total contents of the vial into the syringe.
If liquid is left in the vial, invert the vial and pull back the needle until
the opening of the needle is just inside the stopper. If you look through the
side through the gap in the stopper, you can control the movement of the needle
and the liquid. It is important to withdraw the entire contents of the vial.
Remove the needle from the vial.
4. Proceed to Instructions for Use provided with the Serono
Fertility Auto-injectorTM for use with a 1 mL fixed needle syringe.
SPECIAL ADVICE
What do you do if you have used too much Cetrotide®?
Contact your doctor in case of overdosage immediately to check
whether an adjustment of the further ovarian stimulation procedure is required.
Possible Side Effects
Mild and short lasting reactions may occur at the injection
site like reddening, itching, and swelling. Nausea and headache have also been
reported.
Call your doctor if you have any side effect not mentioned
in this leaflet or if you are unsure about the effect of this medicine.
Storage
How is Cetrotide® to be stored?
Store Cetrotide® in a cool dry place protected
from excess moisture and heat. Store Cetrotide® 3 mg at 25°C
(77°F). Excursions are permitted to 15-30ºC (59-86ºF). Store Cetrotide®
0.25 mg in the refrigerator at 2-8°C (36-46°F). Keep the packaged tray in the
outer carton in order to protect it from light.
How long may Cetrotide® be stored?
Do not use the Cetrotide® powder or the pre-filled
syringe after the expiration date, which is printed on the labels and on the
carton, and dispose of the vial and the syringe properly.
How long can you keep Cetrotide® after preparation
of the solution?
The solution should be used immediately after preparation.
Store the medicine out of the reach of children.
If you suspect that you may have taken more than the prescribed
dose of this medicine, contact your doctor immediately. This medicine was prescribed
for your particular condition. Do not use it for another condition or give the
drug to others.
This leaflet provides a summary of the information about Cetrotide®.
Medicines are sometimes prescribed for uses other than those listed in the Leaflet.
If you have any questions or concerns, or want more information about Cetrotide®,
contact your doctor or pharmacist.
March 2004
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