GONAL-f pre-filled Pen

Instructions for use
®
GONAL-f pre-filled Pen
Merck Serono is a
division of Merck
Below is a diagram that shows what the pre-filled
pen looks like along with the labels of the components:
Pen cap
Threaded needle connnector
Pre-filled reservoir holder
Dose display
Outer needle cap
Inner needle shield
Removable needle
Dose setting knob and
injection button
Peel off seal tab
Storage
Always store GONAL-f® pre-filled pen with the pen cap on.
Store in a refrigerator 2o C-8o C. Do not freeze.
Within its shelf life, GONAL-f® may be stored at or below 25o C for up
to 3 months without being refrigerated again and must be discarded if
it has not been used after 3 months.
1
1
Getting your pre-filled pen ready for injection
Read the instructions prior to injection. Please read also the package leaflet
carefully.
• Remove peel off seal tab from outer needle
cap.
• Attach the needle by pressing the threaded
needle connector of the pen into the outer
needle cap. Screw it until it is firmly locked in
place.
• Remove the outer needle cap.
2
2
Setting the dose
1. Gently turn the dose setting knob until your prescribed dose appears in
the dose window on the side of the pen.
2. Always check that the number showing in the dose display
corresponds to the correct dose that your doctor has prescibed
for you. (See exampel 75 IU).
If the dose you dialled is too high or too low, turn the dose setting
knob again in any direction, until the number showing in the dose
window is the dose that you were prescribed.
3
3
Injecting the dose
1. Choose the place to give the injection- where your doctor or nurse
has told you. Clean the recommended injection site with an alcohol swab.
2. Remove carefully the inner needle shield.
3. Firstly, slowly push the needle into the skin and secondly press the
dose setting knob as far in as it will go, as shown in the picture above.
You must keep the needle under the skin with the dose knob pressed
down for at least 10 seconds.
4. After 10 seconds, keep the dose setting knob pressed down and
take the needle out of the skin.
5. The dose number shown in the dose display will turn back to 0.
This confirms that the complete dose has been fully delivered.
If there is not enough dose left, the number shown in the dose display
indicates the missing amount of GONAL-f solution needed to complete
your dose. This is the dose you need to inject using a new pre-filled pen.
4
After your injection
Always remove the needle from the pre-filled pen
before putting the pen cap back on!
• Replace the outer needle cap
• Unscrew it to remove the used needle. Dispose
the used needle safely
• Put the cap back on the pen
5
GONAL-f® pre-filled pen available in
300 IU, 450 IU and 900 IU
I have been prescribed the following pen:
GONAL-f® 900 IU/1,5 ml
including 20 needles for subcutaneous use
varunummer: 016892 GONAL-f 900 IU
GONAL-f® 450 IU/0,75 ml
including 12 needles for subcutaneous use
varunummer: 016938 GONAL-f 450 IU
GONAL-f® 300 IU/0,5 ml
including 8 needles for subcutaneous use
varunummer: 016927 GONAL-f 300 IU
6
Merck AB • Box 3033 • 169 03 Solna • Tel 08-562 44 500 • Fax 08-562 44 510
SE.RH.0065.1210
Read the leaflet carefully before you start using this medicine.
GONAL-f® follitropin alfa, Rx, solution for injection in a pre-filled pen 300 IE/0,5 ml,
450 IE/0,75 ml and 900 IE/1,5 ml. Indication: Anovulation (including polycystic ovarian syndrom, PCOD) in women who have been unresponsive to treatment with
clomiphene citrate.Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in-vitro
fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian
transfer (ZIFT). GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with
severe LH and FSH deficiency. In clinical trials these patients were defined by an
endogenous serum LH level <1.2 IU/l. GONAL-f is indicated for the stimulation
of spermatogenesis in men who have congenital or acquired hypogonadotrophic
hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy.
Price, please see www.fass.se. Included in the drug benefit. Date when the product
information was compiled May 2011.