Meriofert Kit 75 UI powder and solvent for solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Meriofert Kit 75 UI powder and solvent for solution for injection
menotropin
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
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- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
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If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
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In this leaflet, Meriofert 75 UI powder and solvent for solution for injection is referred to as Meriofert Kit.
Leaflet contents
- What Meriofert Kit is and what it is used for
- What you need to know before using Meriofert Kit
- How to use Meriofert Kit
- Possible adverse effects
- How to store Meriofert Kit
- Contents of the pack and other information
1. What Meriofert Kit is and what it is used for
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Meriofert Kit is used to stimulate ovulation in women who do not ovulate and who have not responded to other treatment (clomiphene citrate).
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Meriofert Kit is used to induce the development of multiple follicles (and therefore multiple oocytes) in women undergoing fertility treatment.
Meriofert Kit is a highly purified human menopausal gonadotropin, belonging to a group of medicines called gonadotropins.
Each vial contains a lyophilized powder with 75 IU of human follicle-stimulating hormone (FSH) activity and 75 IU of human luteinizing hormone (LH) activity.
Human menopausal gonadotropin (HMG) is extracted from the urine of postmenopausal women. Human chorionic gonadotropin (hCG), extracted from the urine of pregnant women, is added to contribute to the total LH activity.
This medicine must be used under the supervision of a physician.
2. What you need to know before using Meriofert Kit
Before starting treatment, your fertility and that of your partner will be evaluated.
Do not use Meriofert Kit
- If you have enlarged ovaries or ovarian cysts not caused by a hormonal disorder (polycystic ovarian disease).
- If you have unexplained vaginal bleeding.
- If you have cancer of the ovary, uterus, or breast.
- If you have an abnormal swelling (tumor) of the pituitary gland or hypothalamus (in the brain).
- If you are allergic to menotropin or to any of the other ingredients of this medicine (listed in section 6).
You should not use this medicine if you have premature menopause, malformation of the genital organs, or certain uterine tumors that would prevent a normal pregnancy.
Warnings and precautions
Talk to your doctor before starting treatment with Meriofert Kit.
Although allergic reactions to Meriofert Kit have not yet been reported, you should inform your doctor if you have ever had an allergic reaction to similar medicines.
This treatment increases the risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see section 4). If ovarian hyperstimulation occurs, treatment will be stopped and pregnancy must be avoided. Early signs of ovarian hyperstimulation include lower abdominal pain, nausea, vomiting, and weight gain. If these symptoms occur, you should see a doctor as soon as possible. In rare but severe cases, the ovaries may enlarge and fluid may accumulate in the abdomen or chest.
The medication used to trigger final release of mature eggs (containing human chorionic gonadotropin, hCG) may increase the likelihood of developing OHSS. Therefore, hCG should not be used if OHSS is occurring, and sexual intercourse should be avoided for at least 4 days, even when using a barrier contraceptive method.
It should be noted that women with fertility problems have a higher rate of miscarriage than the general population.
The frequency of multiple pregnancies and multiple births in patients undergoing ovulation stimulation treatment is higher than in women who conceive naturally. However, this risk can be minimized by using the recommended dose.
The risk of ectopic pregnancy (pregnancy outside the uterus) is slightly higher in women with damage to the Fallopian tubes.
Multiple pregnancies and parental characteristics in fertility treatments (e.g., maternal age or semen characteristics) may be associated with an increased risk of birth defects.
Treatment with Meriofert Kit, as well as pregnancy itself, may increase the risk of thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, most commonly in the veins of the legs or lungs.
Discuss this with your doctor before starting treatment, especially:
- If you already know you have an increased risk of thrombosis.
- If you or a close family member has ever had a thrombosis.
- If you have severe obesity.
Pediatric population
This medicine is not intended for use in children.
Use of Meriofert Kit with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
Driving and using machines
The influence of Meriofert Kit on the ability to drive and operate machinery is negligible or none.
Meriofert Kit contains sodium
This medicine contains less than 23 mg (1 mmol) of sodium per dose, therefore it is considered essentially “sodium-free.”
3. How to use Meriofert Kit
Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again.
Dosage and duration of treatment
Women who do not ovulate and have irregular periods or absence of menstruation
Generally, the first injection of a 75 IU vial of menotropin is administered during the first week of the cycle following spontaneous or induced menstruation.
Subsequently, inject the dose of this medicine prescribed by your doctor every day, continuing treatment until one or more mature follicles have formed in the ovary. Your doctor will adjust the dose of this medicine depending on the ovarian response, which is determined by clinical examinations.
Once a follicle has reached the necessary stage of development, treatment with this medicine will be stopped and ovulation will be triggered with another hormone (chorionic gonadotropin, hCG).
Ovulation usually occurs within 32 to 48 hours.
During this phase of treatment, fertilization is possible. You will be advised to have sexual intercourse daily starting from the day before hCG administration. If pregnancy is not achieved despite ovulation, the treatment may be repeated.
Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilization or other assisted reproductive techniques
The aim of this method is to achieve simultaneous multiple follicular development. Treatment will begin on the second or third day of the cycle with injections of 150 to 300 IU of this medicine (1 or 2 vials of Meriofert Kit 150 IU). Your doctor may choose to administer higher doses if necessary. The dose of this medicine injected is higher than that used in the method for natural fertilization. Your doctor will individually adjust the continuation of treatment.
Once a sufficient number of follicles have developed, treatment with this medicine will be stopped and ovulation will be triggered by injection of another hormone (chorionic gonadotropin, hCG).
How to administer Meriofert Kit
This medicine is administered as an injection under the skin (subcutaneously) or into the muscle (intramuscularly).
Vials must only be used once, and the injection must be administered immediately after preparation.
After properly advising and instructing you, your doctor may ask you to self-administer the Meriofert Kit injection.
The first time you do this, your doctor should:
- allow you to practice self-administering a subcutaneous injection,
- indicate the sites where you may administer the injection,
- teach you how to prepare the injectable solution,
- explain how to prepare the correct dose for injection.
Before administering your Meriofert Kit injection, carefully read the following instructions.
How to prepare and inject 1 vial of Meriofert Kit
The injection must be prepared just before you are ready to use it, using the pre-filled syringe of solvent (a solution of sodium chloride 9 mg/ml in water for injections) included in each pack of Meriofert Kit.
Prepare a clean surface and wash your hands. It is important that your hands and the items you use are as clean as possible.
Place the following items on the surface:
- two alcohol swabs (not included),
- one vial of Meriofert Kit powder,
- one pre-filled syringe of solvent,
- one needle for preparing the injection,
- one fine needle for subcutaneous injection.
REMEMBER: do not remove the support tab (white piece) from the pre-filled syringe, as it prevents the plunger from being accidentally withdrawn and improves syringe handling during injection.
Reconstitution of the injectable solution
Preparation of the injection
- • Remove the cap from the pre-filled syringe; insert the reconstitution needle (long needle) into the syringe. • Carefully place the syringe on the clean surface. • Avoid touching the needle.
Prepare the solution for injection
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• Remove the colored plastic cap (light green for the 75 IU presentation and dark green for the 150 IU presentation) from the Meriofert Kit vial by gently pushing it upwards.
- Clean the rubber top with an alcohol swab and wait for it to dry.
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• Take the syringe, remove the protective cap from the needle, and insert the needle through the center of the rubber top of the Meriofert Kit vial.
- Firmly push the plunger down to spray the entire solution onto the powder.
- DO NOT SHAKE THE VIAL; gently swirl it in circles until a clear solution is obtained. The medicine usually dissolves immediately.
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• With the needle still inserted, turn the vial upside down.
- Ensure the tip of the needle is below the liquid level.
- Carefully pull back the plunger to draw all of the Meriofert Kit solution into the syringe.
• Check that the reconstituted solution is clear.
When reconstituting more than 1 vial of Meriofert Kit, re-inject the contents of the first vial back into the syringe and slowly inject it into a second vial after repeating steps 2 to 4.
Subcutaneous injection of the medicine
When the syringe contains the prescribed dose, place the protective cap on the needle. Remove the needle from the syringe and replace it with the fine needle for subcutaneous injection with its protective cap.- Firmly insert the fine needle into the syringe barrel, then gently twist to ensure it is fully screwed on and forms a tight seal.
Remove the protective cap from the needle. Hold the syringe with the needle pointing upwards and gently tap the side of the syringe to allow air bubbles to rise to the top;- Push the plunger until a drop of liquid appears at the tip of the needle.
- Do not use if the solution contains particles or appears cloudy.
Injection site
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Your doctor or nurse will have already explained to you where on the body you should administer the medicine. Usual sites are the thigh or the lower abdominal wall below the navel.
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Clean the injection site with an alcohol swab.
Needle insertion
? Pinch and firmly squeeze the skin. With the other hand, insert the needle with a quick, firm motion at an angle of 45° or 90°.
Injection of the solution
- Inject the syringe under the skin as instructed. Do not inject directly into a vein. Push the plunger slowly and continuously so that the solution is properly injected and skin tissues are not damaged.
Take the time needed to inject the prescribed volume of solution. Depending on the dose prescribed by your doctor, you may not use the entire volume of the solution.
Removal of the needle
- Quickly remove the syringe and press the injection site with an antiseptic swab. Gentle massage over the area (while maintaining pressure) helps disperse the Meriofert Kit solution and relieves any discomfort.
Intramuscular injection of the medicine
For intramuscular injections, a healthcare professional will prepare and administer this medicine into the outer thigh or buttock.
Dispose of all used items
After completing the injection, place all needles, vials, and empty syringes into a sharps container. Disposal of unused solution and all materials that have come into contact with it must be carried out in accordance with local regulations.
If you use more Meriofert Kit than you should
The effects of overdose with this medicine are unknown; however, ovarian hyperstimulation syndrome would be expected (see section 4). If you use more medicine than you should, consult your doctor or nurse.
If you forget to use Meriofert Kit
Use it as soon as possible within the time of your next scheduled injection. Do not take a double dose to make up for missed doses.
If you stop using Meriofert Kit
Do not stop treatment on your own initiative.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effect is important and requires immediate intervention if it occurs. You must stop taking this medicine and contact your doctor immediately if the following occurs:
Common: may affect up to 1 in 10 people
- Ovarian hyperstimulation syndrome (symptoms include the formation of ovarian cysts or enlargement of existing cysts, pain in the lower abdomen, feeling thirsty and nausea with occasional vomiting, passage of small amounts of concentrated urine, and weight gain) (see section 2 for additional information).
The following adverse effects have also been reported:
Very common: may affect more than 1 in 10 people
- Headache
- Stomach swelling or flatulence
Common: may affect up to 1 in 10 people
- Abdominal pain or discomfort
- Pelvic pain
- Back pain
- Feeling of heaviness
- Breast discomfort
- Dizziness
- Hot flushes
- Thirst
- Feeling unwell
- Fatigue
- Malaise
- Reactions at the injection site, such as pain and inflammation (more frequent with IM injection than SC).
Rare: may affect up to 1 in 1,000 people
- Ovarian torsion (rotation of the ovary causing severe pain in the lower abdomen)
- Thromboembolism (formation of a blood clot in a blood vessel that detaches and travels through the bloodstream to block another vessel).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Meriofert Kit
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep the vial and the pre-filled syringe of solvent in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the outer packaging, vial, and pre-filled syringe of solvent after EXP. If the expiry date is expressed as month/year, the expiry date refers to the last day of the stated month.
Use immediately after reconstitution.
Do not use this medicine if the solution is not clear. After reconstitution, the solution must be clear and colourless.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point 
at your pharmacy. In case of doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the container and other information
Composition of Meriofert Kit
The active substance is menotropin.
Each vial contains a lyophilized powder with 75 IU of human follicle-stimulating hormone (FSH) activity and 75 IU of human luteinizing hormone (LH) activity.
Human menopausal gonadotropin (HMG) is extracted from the urine of postmenopausal women.
Human chorionic gonadotropin (hCG), extracted from the urine of pregnant women, is added to contribute to the total LH activity.
If multiple vials of powder are used, the amount of menotropin in 1 ml of reconstituted solution will be as follows:
Meriofert Kit 75UI powder and solvent for injectable solution | |
Number of vials used | Total amount of menotropin in 1 ml of solution |
1 | 75 IU |
2 | 150 IU |
3 | 225 IU |
4 | 300 IU |
5 | 375 IU |
6 | 450 IU |
The other components are
Vial of powder: monohydrate lactose
Pre-filled syringe with solvent: 9 mg/ml sodium chloride solution
Appearance of the product and contents of the pack
Powder: white lyophilized cake or powder
Solvent: clear, colourless solution
Meriofert Kit is presented as a powder and solvent for injectable solution.
1 pack contains the following:
- One vial containing a white lyophilized cake or powder
- One pre-filled syringe (1 ml) with a clear, colourless solution
- One needle for reconstitution and intramuscular injection (long needle)
- One needle for subcutaneous injection (short needle)
Supplied in packs of 1, 5 or 10 kits.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
IBSA Farmaceutici Italia Srl
Via Martiri di Cefalonia 2
26900 Lodi, Italy
Manufacturer:
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi – Italy
or (for the United Kingdom)
IBSA Pharma Limited
Units 4-6
Colonial Business Park
Colonial Way
Watford WD24 4PR
United Kingdom
You can request further information about this medicinal product from the local representative of the Marketing Authorisation Holder:
Instituto Bioquímico Ibérico IBSA S.L.
Avenida Diagonal 605,
8th Floor, Office 1,
08028 Barcelona (Spain)
This medicinal product is authorised in the Member States of the European Economic Area under the following names (concentrations and pharmaceutical forms are identical in all countries; only the brand names differ):
Austria: Meriofert PFS
Belgium: Fertinorm Kit
Bulgaria: Meriofert PFS
Cyprus: Meriofert PFS
Czech Republic: Meriofert Set
Denmark: Meriofert Set
Estonia: Meriofert Set
Finland: Meriofert Set
France: Fertistartkit
Greece: Meriofert
Hungary: Meriofert Kit
Italy: Meriofert
Latvia: Meriofert Set
Lithuania: Meriofert Set
Luxembourg: Fertinorm Kit
Norway: Meriofert Set
Poland: Mensinorm Set
Romania: Meriofert PFS
Slovakia: Meriofert Kit
Spain: Meriofert Kit
Netherlands: Meriofert spuit
United Kingdom: Meriofert PFS
Sweden: Meriofert Set
Date of the most recent review of this leaflet: May 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es