Patient leaflet - Gonal-F 900 IU/1.44 ml solution for injection in Pre-filled pen
1. What GONAL-f is and what it is used for
What GONAL-f is
GONAL-f contains a medicine called “follitropin alfa”. Follitropin alfa is a type of “follicle stimulating hormone” (FSH) which belongs to the family of hormones called “gonadotropins”.Gonadotropins are involved in reproduction and fertility.
What GONAL-f is used for
In adult women, GONAL-f is used:
to help release an egg from the ovary
(ovulation) in women that cannot ovulate and that did not respond to treatment with a medicine called “clomiphene citrate”.
together with another medicine called
“lutropin alfa” (“luteinising hormone” or LH) to help release egg from the ovary (ovulation) in women whose body is producing very little gonadotropins (FSH and LH).
to help develop several follicles
(each containing an egg) in women undergoing assisted reproductive technology procedures (procedures that may help you to become pregnant) such as “in vitro fertilisation”, “gamete intra-fallopian transfer” or “zygote intra-fallopian transfer”.
In adult men, GONAL-f is used:
together with another medicine called
“human chorionic gonadotropin” (hCG) to help produce sperm in men that are infertile due to a low level of certain hormones.
2. What you need to know before you use GONAL-f
You and your partner’s fertility should be evaluated before the treatment is started by a doctor experienced in treating fertility disorders.
Do not use GONAL-f
if you are allergic to follicle stimulating
hormone or any of the other ingredients of this medicine listed in section 6.
if you have a tumour in your
hypothalamus or pituitary gland (both are parts of the brain).
if you are a woman:
with large ovaries or sacs of fluids
within the ovaries (ovarian cysts) of unknown origin.
with unexplained vaginal bleeding. - with cancer in your ovaries,
womb or breasts.
with a condition that usually makes
normal pregnancy impossible, such as ovarian failure (early menopause), or malformed reproductive organs.
if you are a man:
with damaged testicles that cannot
be healed.
Do not use GONAL-f if any of the above applies to you. If you are not sure, talk to your doctor before using this medicine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Gonal-f.
Porphyria
Tell your doctor before you start treatment, if you or any member of your family have porphyria (an inability to break down porphyrins that may be passed on from parents to children).
Tell your doctor straight away if:
your skin becomes fragile and easily
blistered, especially skin that has been frequently in the sun, and/or
- you have stomach, arm or leg pain.
In case of the above events your doctor may recommend that you stop treatment.
Ovarian hyper-stimulation syndrome (OHSS)
If you are a woman, this medicine increases your risk of developing OHSS. This is when your follicles develop too much and become large cysts. If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting or if you have difficulty in breathing, talk to your doctor straight away who might ask you to stop using this medicine (see section 4).
In case you are not ovulating, and if the recommended dose and schedule of administration are adhered to, the occurrence of OHSS is less likely. GONAL-f treatment seldom causes severe OHSS unless the medicine that is used for final follicular maturation (containing human chorionic gonadotropin, hCG) is administered. If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you may be told not to have sex or to use a barrier contraceptive method for at least four days.
Multiple pregnancy
When using GONAL-f, you have a higher risk of being pregnant with more than one child at the same time (“multiple pregnancy”, mostly twins), than if you conceived naturally. Multiple pregnancy may lead to medical complications for you and your babies. You can reduce the risk of multiple pregnancy by using the right dose of GONAL-f at the right times. When undergoing assisted reproductive technology, the risk of having
a multiple pregnancy is related to your age, the quality and the number of fertilised eggs or embryos placed inside you.
Miscarriage
When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs, you are more likely to have a miscarriage than the average woman.
Blood clotting problems (thromboembolic events)
If you had in the past or recently blood clots in the leg or in the lung, or a heart attack or stroke, or if those happened in your family, then you might have a higher risk that these problems occur or become worse with GONAL-f treatment.
Men with too much FSH in their blood
If you are a man, having too much FSH in your blood can be a sign of damaged testicles. GONAL-f usually does not work if you have this problem.
If your doctor decides to try GONAL-f treatment, to monitor the treatment, they may ask you to provide semen for analysis 4 to 6 months after starting treatment.
Children and adolescents
GONAL-f is not for use in children and adolescents below 18 years old.
Other medicines and GONAL-f
Tell your doctor if you are taking, have recently taken or might take any other medicines.
If you use GONAL-f with other
medicines which help ovulation (such as hCG or clomiphene citrate), this may increase the response of your follicles.
If you use GONAL-f at the same time
as a “gonadotropin-releasing hormone” (GnRH) agonist or antagonist (these medicines reduce your sex hormone levels and stop you ovulating) you may need a higher dose of GONAL-f to produce follicles.
Pregnancy and breast-feeding
Do not use GONAL-f if you are pregnant or breast-feeding.
Driving and using machines
It is not expected that this medicine will affect your ability to drive and use machines.
GONAL-f contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
3. How to use GONAL-f
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Using this medicine
GONAL-f is intended to be given
by injection just under the skin (subcutaneously). The pre-filled pen can be used for several injections.
The first injection of GONAL-f should
be given under supervision of your doctor.
Your doctor or nurse will show you how
to use the GONAL-f pre-filled pen to inject the medicine.
If you administer GONAL-f to yourself,
please carefully read and follow the “Instructions for use”.
How much to use
Your doctor will decide how much medicine you will take and how often. The doses described below are stated in International Units (IU).
Women
If you are not ovulating and have irregular or no periods.
- GONAL-f is usually given every day.
If you have irregular periods, start
using GONAL-f within the first 7 days of your menstrual cycle. If you do not have periods you can start using the medicine on any convenient day.
The starting dose of GONAL-f is
usually individualised and may be adjusted in a stepwise manner.
The daily dose of GONAL-f should not
exceed 225 IU.
When you get the desired response,
you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5 000 to 10 000 IU of hCG, 24 to 48 hours after your last GONAL-f injection. The best time to have sex is on the day of the hCG injection and the day after.
If your doctor cannot see a desired response, the continuation of that treatment cycle with GONAL-f should be evaluated and managed accordingly to the standard clinical practice.
If your body responds too strongly, your treatment will be stopped and you will not be given any hCG (see section 2, “Ovarian hyper-stimulation syndrome (OHSS)”). For the following cycle, your doctor will give you a lower dose of GONAL-f than before.
If you have been diagnosed with very low levels of FSH and LH hormones
The usual starting dose of GONAL-f
is 75 to 150 IU together with 75 IU of lutropin alfa.
You will use these two medicines each
day for up to five weeks.
Your dose of GONAL-f may be
increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response.
When you get the desired response,
you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5 000 to 10 000 IU of hCG, 24 to 48 hours after your last injections of GONAL-f and lutropin alfa. The best time to have sex is on the day of the hCG injection
and the day after. Alternatively, intrauterine insemination or another medically assisted reproduction procedure may be performed based on your doctor’s judgment.
If your doctor cannot see a response after 5 weeks, that treatment cycle with GONAL-f should be stopped. For the following cycle, your doctor will give you a higher starting dose of GONAL-f than before.
If your body responds too strongly, your treatment with GONAL-f will be stopped and you will not be given any hCG (see section 2, “Ovarian hyper- stimulation syndrome (OHSS)”). For the following cycle, your doctor will give you a lower dose of GONAL-f than before.
If you need to develop several eggs for collection prior to any assisted reproductive technology
The starting dose of GONAL-f is
usually individualised and may be adjusted in a stepwise manner to not higher than 450 IU daily.
Treatment is continued until your eggs
have developed to a desired point. Your doctor will use blood tests and/or an ultrasound machine to check when this is.
When your eggs are ready, you will be
given a single injection of 250 micrograms “recombinant hCG” (r-hCG, an hCG made in a laboratory by
a special recombinant DNA technique), or 5 000 IU to 10 000 IU of hCG, 24 to 48 hours after the last GONAL-f injection. This gets your eggs ready for collection.
Men
The usual dose of GONAL-f is 150 IU
together with hCG.
You will use these two medicines three
times a week for at least 4 months.
If you have not responded to treatment
after 4 months, your doctor may suggest that you continue using these two medicines for at least 18 months.
If you use more GONAL-f than you should
The effects of taking too much GONAL-f are unknown. Nevertheless, one could expect ovarian hyper-stimulation syndrome (OHSS) to occur, which is described in section 4. However, the OHSS will only occur if hCG is also administered (see section 2, “Ovarian hyper-stimulation syndrome (OHSS)”).
If you forget to use GONAL-f
If you forget to use GONAL-f, do not take a double dose to make up for a forgotten dose. Please talk to your doctor as soon as you notice that you forgot a dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects in women
- Lower abdominal pain together with nausea or vomiting may be the symptoms of ovarian hyper-stimulation syndrome (OHSS). This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed (see also in section 2. under “Ovarian hyper- stimulation syndrome (OHSS)”). This side effect is common (may affect up to 1 in 10 people).
- The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest. This side effect is uncommon (may affect up to 1 in 100 people).
- Complications of OHSS such as twisting of ovaries or blood clotting may occur rarely (may affect up to 1 in 1 000 people).
Serious blood clotting complications
(thromboembolic events) sometimes independent of OHSS may be found very rarely (may affect up to 1 in 10 000 people). This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2. under “Blood clotting problems”).
Serious side effects in men and women
- Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing can sometimes be serious. This side effect is very rare (may affect up to 1 in 10 000 people).
If you notice any of the above-listed side effects, you should immediately contact your doctor who might ask you to stop using GONAL-f.
Other side effects in women
Very common (may affect more than 1 in 10 people):
Sacs of fluid within the ovaries
(ovarian cysts)
- Headache
Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
UK61200045P97-A1.1 Common (may affect up to 1 in 10 people):
- Abdominal pain
Feeling sick, vomiting, diarrhoea,
abdominal cramps and bloating
Very rare
(may affect up to 1 in 10 000 people):
Allergic reactions such as rash, red
skin, hives, swelling of your face with difficulty breathing may occur. These reactions can sometimes be serious.
- Your asthma may get worse.
Other side effects in men
Very common
(may affect more than 1 in 10 people):
Local reactions at the injection site,
such as pain, redness, bruising, swelling and/or irritation
Common (may affect up to 1 in 10 people):
Swelling of the veins above and behind
the testicles (varicocele)
Breast development, acne or weight
gain
Very rare
(may affect up to 1 in 10 000 people):
Allergic reactions such as rash, red
skin, hives, swelling of your face with difficulty in breathing may occur. These reactions can sometimes be serious.
- Your asthma may get worse.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store GONAL-f
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cartridge label or carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Before opening and within its shelf life, the product may be stored outside of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to 3 months and must be discarded if it has not been used within these 3 months.
Keep the cap on the pen, in order to protect from light.
Do not use GONAL-f if you notice any visible signs of deterioration, if the liquid contains particles or is not clear.
Once opened, the pen should be stored between 2°C and 25°C for a maximum of
28 days. Do not use any medicine left in your pre-filled pen after 28 days.
At the end of the treatment any unused solution must be discarded.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
If your medicine shows any signs of discolouration or deterioration, you should seek the advice of your pharmacist.
6. Contents of the pack and other information
What GONAL-f contains
- The active substance is follitropin alfa.
Each pre-filled pen with multidose cartridge contains 900 IU
(66 micrograms) of follitropin alfa in 1.44 mL solution.
The other ingredients are poloxamer
188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, as well as concentrated phosphoric acid and sodium hydroxide for pH adjustment and water for injections.
What GONAL-f looks like and contents of the pack
- GONAL-f is presented as a clear, colourless liquid for injection in a pre-filled pen.
- It is supplied in packs with 1 pre-filled pen and 16 disposable needles.
Manufacturer
Merck Serono S.p.A., Via delle Magnolie 15, 70026 Modugno (Bari), Italy
Procured from within the EU and repackaged for the PL Holder:
Abacus Medicine Ltd., Abbey House, 282 Farnborough Road, Farnborough, GU14 7NA, United Kingdom
PL 45763/0505
POM
GONAL-f® is a registered trademark of Merck KGaA
For any information about this medicine, please contact the local representative of the Product Licence Holder: Abacus Medicine Ltd.
tel: +44(0)2036301244,
email: MedInfo@abacusmedicine.co.uk or drugsafetyuk@abacusmedicine.co.uk
This leaflet was last revised on 10.07.2025.
Blind or partially sighted? Is this leaflet hard to see or read? Call 02036301310 or write to info@ abacusmedicine.com to obtain the leaflet in a format suitable for you. Important information about the GONAL-f® pre-filled pen
- Read the Instructions for Use and the Package Leaflet before using your GONAL-f® pre-filled pen.
Always follow all directions in this Instructions for Use and training provided by your healthcare provider
as they may differ from your past experience. This information will allow to prevent incorrect treatment or infection by needle stick or broken glass injury.
- The GONAL-f® pre-filled pen is for subcutaneous injection only.
- Only use the GONAL-f® pre-filled pen if your healthcare provider trains you on how to use it correctly.
Your healthcare provider will tell you how many GONAL-f® pre-filled pens you need to complete
your treatment.
- Give yourself the injection at the same time each day.
The numbers in the Dose Feedback Window represent the number of International Units, or IUs,
and show the dose of follitropin alfa. Your healthcare provider will tell you how many IUs of follitropin alfa to inject each day.
The numbers displayed in the Dose Feedback Window help you to:
a. Dial your prescribed dose (Figure 1).
b. Verify a complete injection (Figure 2).
c. Read the dose remaining to be injected with a second
pen (Figure 3).
- Remove the needle from the pen immediately after each injection.
Do not reuse needles.
Do not share the pen and/or needles with another person.
Do not use the GONAL-f® pre-filled pen if it has been dropped,
or the pen is cracked or damaged as this can cause injury.
How to use your GONAL-f® pre-filled pen treatment diary
A treatment diary is included at the end of the Instructions for Use. Use the treatment diary to record the amount injected.
Injecting an incorrect amount of medicine could affect your treatment.
Record the treatment day number (column 1), date (column 2), time of your injection (column 3),
and volume of your pen (column 4).
- Record your prescribed dose (column 5).
- Check you dial the right dose before injecting (column 6).
- After injection, read the number shown in the Dose Feedback Window.
Confirm you receive a complete injection (column 7) or record the number shown in the
Dose Feedback Window if other than ‘’0’’ (column 8).
When needed, inject yourself using a second pen, dialing your remaining dose written in the
‘’Amount to Be Set for a Second Injection’’ section (column 8).
- Record this remaining dose in the ‘’Amount Set to Inject’’ section (column 6) in the next row.
Using your treatment diary to record your daily injection(s) allows you to verify every day that you received the full prescribed dose.
An example of a treatment diary:
1
Treatment
Day
Number
2
Date
3
Time
4
Pen Volume
900 IU/1.44 mL
5
Prescribed
Dose
6 7 8
Dose Feedback Window Amount
Set to Inject
Amount to Be Set for a Second Injection
#1 10/06 07:00 900 IU 350 350 if "0",
injection
complete
if not "0", need second injection Inject this amount ..........using new pen
#2 11/06 07:00 900 IU 350 350 if "0",
injection
complete
if not "0", need second injection Inject this amount ..........using new pen
#3 12/06 07:00 900 IU 350 350 if "0",
injection
complete
if not "0", need second injection Inject this amount ........ using new pen
#3 12/06 07:00 900 IU N / A 150 if "0",
injection
complete
if not "0", need second injection Inject this amount ..........using new pen
Get familiar with your GONAL-f® pre-filled pen
*For illustration purposes only.The needles supplied may look slightly different.
**The numbers in the Dose Feedback Window and reservoir holder represent the number of International Units (IU) of medicine.
Step 1. Gather your supplies
1.1 Let the pre-filled pen sit at room temperature for at least 30 minutes
before use to allow the medicine to reach room temperature.
Do not use a microwave or other heating element to warm up the pen.
1.2 Prepare a clean area and a flat surface, such as a table or countertop,
in a well-lit area.
1.3 You will also need (not included in the pack):
- Alcohol swabs and a sharps container (Figure 4).
1.4 Wash your hands with soap and water and dry them well (Figure 5).
1.5 Use your hand to remove the GONAL-f® pre-filled pen from the pack.
Do not use any tools, using tools might damage the pen.
1.6 Check the name on the pre-filled pen says GONAL-f®.
1.7 Check the expiration date on the pen label (Figure 6).
Do not use the GONAL-f® pre-filled pen if the expiration date has passed
or if your pre-filled pen does not say GONAL-f®.
Step 2. Get ready for injection
2.1 Pull-off the pen cap (Figure 7).
2.2 Check that medicine is clear, colourless and does not contain particles.
Do not use the pre-filled pen if the medicine is discolored or cloudy, as this can cause an infection.
2.3 Check that the Dose Feedback Window is set to
‘’0’’ (Figure 8).
Choose your injection site:
2.4 Your healthcare provider should show you the injection sites to use around your stomach area (Figure 9). To minimize skin irritation, select a different injection site each day.
2.5 Clean the skin at the injection site by wiping with an alcohol swab. Do not touch or cover the cleaned skin.
Step 3. Attach your needle
Important: Always make sure to use a new needle for each injection. Re-using needles can cause infection.
3.1 Get a new needle. Only use the ‘’single-use’’ needles supplied. 3.2 Check that the outer needle cap is not damaged.
3.3 Hold the outer needle cap firmly.
3.4 Check that the peel-off seal on the outer needle cap is not damaged or loose, and that expiration date has not passed (Figure 10). 3.5 Remove the peel-off seal (Figure 11).
Do not use the needle if it is damaged, expired or if the outer needle cap or the peel-off seal is damaged or loose.
Using expired needles or needles with damaged peel-off seal or outer needle cap can lead to infection.
Throw it away in a sharps container and get a new needle. 3.6 Screw the outer needle cap onto the threaded tip of the GONAL-f® pre-filled pen until you feel a light resistance (Figure 12). Do not attach the needle too tightly; the needle could be difficult to remove after the injection.
3.7 Remove the outer needle cap by pulling it gently (Figure 13). 3.8 Put it aside for later use (Figure 14).
Do not discard the outer needle cap, as it will prevent needle stick injury and infection when detaching the needle from the pre-filled pen. 3.9 Hold the GONAL-f® pre-filled pen with the needle pointing upward
(Figure 15).
3.10 Carefully remove and discard the inner needle shield
(Figure 16).
Do not recap the needle with the inner needle shield, as it can lead to needle stick injury and infection.
3.11 Look closely at the tip of the needle for tiny droplet(s) of liquid (Figure 17).
If Then
Using
a new pen Check for a droplet of liquid at the tip of the needle.
If you see a tiny droplet of liquid, proceed to
Step 4 Dial your dose.
- If you do not see a tiny droplet at or near the needle tip, you must perform the steps in the following section to remove air in the system.
Reusing
a pen It is NOT required to check for a droplet of liquid.
Proceed directly to Step 4 Dial your dose.
If you do not see a tiny droplet(s) of liquid at or near the needle tip the first time you use a new pen:
- 1.
Gently turn the dose setting knob forward until it reads "25" in the Dose Feedback Window
(Figure 18).
- • You can turn the dose knob backward if you turn it past "25".
- 2. Hold the pen with the needle pointing upward.
- 3. Tap the reservoir holder gently (Figure 19).
- 4. Press the dose setting knob as far as it will go. A tiny droplet of liquid will appear at the tip of the needle (Figure 20).
- 5. Check that the Dose Feedback Window reads ‘’0’’ (Figure 21).
- 6. Proceed to Step 4 Dial your dose.
If a tiny droplet of liquid does not appear, contact your healthcare provider. Instructions for use
GONAL-f ® PRE-FILLED PEN 900 IU/1.44 mL Solution for injection in pre-filled pen
(follitropin alfa) UK610503U99-A1.2
Fig. 3
Fig. 18
Fig. 21 Fig. 2 Fig. 1
Fig. 4
Fig. 5
Fig. 6
Fig. 7 Fig. 8
Fig. 9
Fig. 17
Fig. 19 Fig. 20
Your needle*:
Outer needle
cap
Inner needle shield
Removable needle
Peel-off seal tab
Your pre-filled pen: Threaded needle
connector
Plunger piston
Dose Feedback
Window** Dose setting
knob
Pen cap Reservoir holder**
Fig. 10
Fig. 12
Fig. 13
Fig. 14
Fig. 15 Fig. 16
Fig. 11
150 Step 4. Dial your dose
Note: The pen contains 900 IU follitropin alfa. The 900 IU pen maximum single-dose setting is 450 IU. The smallest single-dose setting is 12.5 IU and the dose can be increased in increments of 12.5 IU. 4.1 Turn the dose setting knob until your intended dose shows in the Dose Feedback Window.
- Example: If your intended dose is “150” IU, confirm that the Dose Feedback Window reads “150” (Figure 22). Injecting an incorrect amount of medicine could affect your treatment.
Turn the dose setting knob forward
to dial up (Figure 22).
4.2 Check that the Dose Feedback Window displays your complete prescribed dose before you move on to the next step.
Step 5. Inject your dose
Important: Inject the dose as you were trained to do by your healthcare provider.
5.1 Slowly push the needle into the skin entirely (Figure 24).
5.2 Place your thumb in the middle of the dose setting knob.
Slowly press the dose knob down as far as it will go and hold it to complete the full injection (Figure 25).
Note: The larger the dose, the longer it will take to inject.
5.3 Hold the dose knob down for a minimum of 5 seconds before
you remove the needle from your skin (Figure 26).
- The dose number shown in the Dose Feedback Window will turn back to “0”.
- After a minimum of 5 seconds, pull the needle out of the skin while keeping the dose setting knob pressed down (Figure 27).
- When the needle is out of the skin, release the dose setting knob.
Do not release the dose knob until you remove the needle from the skin.
Step 6. Remove the needle after each injection
6.1 Place the outer needle cap on a flat
surface.
6.2 Hold the GONAL-f® pre-filled pen firmly with
one hand and slip the needle into the outer needle cap (Figure 28).
6.3 Continue by pushing the capped needle
against a firm surface until you hear a
"click" (Figure 29).
6.4 Grip the outer needle cap and unscrew the
needle by turning it in the opposite direction (Figure 30).
6.5 Dispose of the used needle safely in a
sharps container (Figure 31). Handle the needle with care to avoid getting injured by the needle.
Do not reuse or share any used needle.
Step 7. After the injection
7.1 Check you have given a complete injection:
- Check that the Dose Feedback Window shows “0” (Figure 32).
If the Dose Feedback Window shows "0", you have completed your dose. If the Dose Feedback Window shows a number higher than “0”, the GONAL-f® pre-filled pen is empty. You have not received your full prescribed dose and you must perform step 7.2 below.
7.2 Complete a partial injection (only when needed):
- The Dose Feedback Window will indicate the missing amount you need to inject using a new pen. In the example shown, the missing amount is "50" IU (Figure 33).
- To complete the dose with a second pen, repeat Steps 1 through 8.
Step 8. Store the GONAL-f® pre-filled pen
8.1 Put the pen cap back onto the pen to avoid infection (Figure 34). 8.2 Store the pen with the cap on it in a safe place and as indicated
in the Package Leaflet.
8.3 When the pen is empty, ask your healthcare provider how
to dispose of it.
Do not store the pen with the needle still attached, as this may cause infection.
Do not reuse the GONAL-f® pre-filled pen if it has been dropped, or the pen is cracked or damaged as this can cause injury.
Contact your healthcare provider if you have questions.
GONAL-f® pre-filled pen treatment diary
Treatment
Day Number
Date
Time
Pen Volume
900 IU/
1.44 mL
Prescribed
Dose
6 7 8
Dose Feedback Window
Amount
Set to Inject
Amount to Be Set for a Second Injection
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
/ : 900 IU
if "0",
injection
complete
if not "0", need second injection
Inject this amount ..........using new pen
This Instructions for Use has been last revised on 10.07.2025.
Fig. 28
Fig. 29
Fig. 30 Fig. 31
Fig. 32
Fig. 33
Fig. 34
Fig. 23
Fig. 22
You can turn the dose setting knob backwards if you turn it past your intended dose (Figure 23).
Fig. 24Fig. 25
Fig. 26
Fig. 27
