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Bemfola 150 IU / 0.25 ml. 1 injection

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What Bemfola is and what it is used for What is Bemfola
This medicine contains the active substance follitropin alfa, which is almost identical to a natural hormone produced by your body called follicle stimulating hormone (FSH). FSH is a gonadotropin, a type of hormone that plays an important role in fertility and reproduction in humans. In women, FSH is necessary for the growth and development of ovarian follicles that contain the egg cells. In men, FSH is required for the production of sperm.

What Bemfola is used for
In women, Bemfola is used:

to aid the ovarian release of ovarian (ovulation) in women who have no ovulation and have not responded to treatment with a medicine called "clomiphene citrate";
together with another medicine called "lutropin alfa" (Luteinizing Hormone or LH) to help ovulatory release in ovarian women (ovulation) in non-ovulated women because their body produces very few gonadotropins (FSH and LH);
to support the development of multiple follicles (each containing an egg) in women undergoing assisted reproductive technologies (procedures that can help you become pregnant) such as "in vitro fertilization", "gamma intrafalfa transfer" or "intragopoietic transfer of zygote ".
In men, Bemfola is used:

along with another medicine called "human chorionic gonadotrophin" (hCG), to help form sperm in men who are sterile due to low levels of certain hormones.
2. What you need to know before using Bemfola
Before starting treatment, your fertility and that of your partner should be investigated by a physician experienced in the treatment of fertility disorders.

Do not use Bemfola:

if you are allergic (hypersensitive) to follicle-stimulating hormone or any of the other ingredients of this medicine (listed in section 6);
if you have a tumor of the hypothalamus or of the pituitary gland (both are parts of the brain);
If you are a woman:
with ovarian enlargement or ovarian fluid bags (ovarian cysts) of unknown origin;
with unexplained vaginal bleeding;
with ovarian, uterine or breast cancer;
if you have a condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause) or malformations of the reproductive organs;
If you are a man:
with incurable testicular damage.
Do not use Bemfola if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.

Warnings and precautions
Porphyria
Tell your doctor before starting treatment if you or any of your family members have porphyria (inability to break down porphyrins that can be transmitted by parents of children).

Tell your doctor immediately if:

your skin starts to crack and easily sputter, especially the part of it that is often exposed to sunlight;
if you have stomach or pain in your hands or feet.
In the event of the above events, your doctor may recommend stopping your treatment.

Ovarian Hyperstimulation Syndrome (OHSS)
If you are a woman, this medicine increases the risk of developing OHSS. In this syndrome, follicles develop too much and become large cysts. If you experience lower back pain, quickly increase your weight, get upset or vomit, or if you have difficulty breathing, consult your doctor immediately, who may recommend stopping this medicine (see section 4).
If you do not have ovulation and if you adhere to the recommended dose and schedule, the onset of OHSS is less likely. Treatment with Bemfola rarely causes severe OHSS unless the drug used to stimulate the last stage of follicle maturation (containing human chorionic gonadotropin - hCG) is administered. If you develop OHSS, your doctor may not give you hCG in this treatment cycle and may recommend you to avoid sexual contact or to use a barrier method of contraception for at least four days.

Multiple pregnancy
When using Bemfola, there is a greater risk of conceiving more than one child ("multiple pregnancy", most often twins) than if you become pregnant in a natural way. Multiple pregnancies can cause medical complications for you and babies. You can reduce the risk of multiple pregnancies by applying the correct dose of Bemfola at the right time. When you are undergoing assisted reproductive technology, the risk of having multiple pregnancies is related to your age, quality and number of fertilized ova or embryos introduced into you.

Miscarriage
When you are undergoing assisted reproductive technology or stimulation of the ovaries to form oocytes, you are more likely to have a miscarriage than other women.
Men with too high levels of FSH in the blood
If you are a man, excessively high levels of FSH in the blood may be an indicator of testicular damage. Normally, if you have such a problem, Bemfola does not work. If your doctor decides to try Bemfola treatment, you may want to give your sperm for analysis 4 to 6 months after starting treatment to monitor it.

Children and adolescents
Bemfola is not indicated for use in children and adolescents under 18 years of age.

Other medicines and Bemfola
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you use Bemfola with other medicines that promote ovulation (such as hCG or clomiphene citrate), this may increase the stimulation of your follicles.
If you use Bemfola concomitantly with a GnRH agonist or antagonist (these medicines reduce your sex hormone levels and stop ovulation), you may need a higher dose of Bemfola to form follicles.

Pregnancy and breastfeeding
Do not use Bemfola if you are pregnant or breast-feeding.

Driving and using machines
This medicine is not expected to affect your ability to drive or use machines.

Bemfola contains sodium
Bemfola contains sodium less than 1 mmol (23 mg) per dose, so it is considered to be virtually non-sodium.

3. How to use Bemfola
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Using this medicine

Bemfola is for administration by injection directly under the skin (subcutaneously). The pre-filled pen is only used once and then discarded. The reconstituted solution should not be applied if it contains particles or is not clear;
The first injection of Bemfola should be done under the supervision of your doctor;
Your doctor or nurse will show you how to use the Bemfola pre-filled pen to inject the medicine;
If you apply Bemfola yourself, read the instructions carefully and follow them. These instructions can be found at the end of the leaflet.
How much to use
Your doctor will decide how much to use and how often. The doses listed below are given in International Units (IU) and milliliters (ml).

Women
If you do not have ovulation and have irregular or missing menstruation:

Bemfola is usually applied daily.
If you have irregular menstruation, start using Bemfola within the first 7 days of the menstrual cycle. If you do not have menstruation, you may start using the medicine on any day that is convenient for you.
The usual starting dose of Bemfola is 75 to 150 IU (0.12 to 0.25 ml) every day.
Your Bemfola dose may be increased every 7 or every 14 days with 37.5 to 75 IU until the desired response is reached.
The maximum daily dose of Bemfola is usually not more than 225 IU (0.375 ml).
Once the desired response is reached, you will be given a single injection of 250 micrograms of "recombinant hCG" (r-hCG, laboratory-produced hCG by special DNA technology) or 5000 to 10,000 IU hCG, 24 to 48 hours after your last Bemfola injection. The best time for intercourse is on the day of injection with hCG and the next day.
If your doctor does not find the desired response after 4 weeks, this cycle of treatment with Bemfola should be discontinued. For the next treatment cycle, your doctor will prescribe a starting dose of Bemfola higher than the previous dose.
If your body is affected too much, your treatment will be stopped and you will not receive hCG (see section 2, WHO). For the next treatment cycle, your doctor will prescribe a lower dose of Bemfola than the previous one.

If you do not have ovulation, you have no menstruation, and you have very low levels of FSH and LH:

The usual starting dose of Bemfola is 75 to 150 IU (0.12 to 0.25 ml) with 75 IU (0.12 ml) of lutropin alfa.
You will use these two medicines every day for up to five weeks.
Your Bemfola dose may be increased every 7 or every 14 days with 37.5 to 75 IU until the desired response is reached.
Once the desired response is reached, you will be given a single injection of 250 micrograms of "recombinant hCG" (r-hCG, laboratory-produced hCG by special DNA technology) or 5000 to 10,000 IU of hCG, 24 to 48 hours after your last Bemfola injection lutropin alfa. The best time for intercourse is on the day of injection with hCG and the next day. Another possibility is to make intrauterine insemination by introducing sperm into the uterine cavity.
If your doctor does not find the desired response after 5 weeks, this Bemfola treatment cycle should be discontinued. For the next treatment cycle, your doctor will prescribe a starting dose of Bemfola higher than the previous dose.
If your body is affected too much, your Bemfola treatment will be stopped and you will not be given hCG (see point

Occasionally complications of OHSS such as twitching of the ovaries or the formation of blood clots (may affect up to 1 in 1,000 people) may occur;
Very rarely, serious bleeding complications (thromboembolic events), sometimes independent of OHSS (may affect up to 1 in 10,000 people), may occur. This could cause chest pain, shortness of breath, stroke or heart attack (see also section 2 "Warnings and precautions for using Bemfola").
Serious adverse reactions in males and females

Allergic reactions such as rash, skin redness, urticaria, swelling of the person with difficulty breathing can sometimes be serious. These side effects are very rare (likely to affect up to 1 in 10,000 people).
If you notice any of the side effects listed above, you should contact your doctor immediately, who may tell you to stop using Bemfola.

Other side effects in women
Very common (may affect more than 1 in 10 people):

Ovarian fluid bags (ovarian cysts);
Headache;
Local reactions at the injection site such as pain, redness, bruising, swelling and / or irritation.
Common (may affect up to 1 in 10 people):

Stomach ache;
Nausea, vomiting, diarrhea, abdominal cramps and swelling.
Very rare (may affect up to 1 in 10,000 people):

Allergic reactions such as rash, skin redness, urticaria, swelling of the face with difficulty breathing may occur. These reactions can sometimes be serious.
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 (varicoceles);
Development of breasts, acne or weight gain.
Very rare (may affect up to 1 in 10,000 people):

Allergic reactions such as rash, skin redness, urticaria, swelling of the face with difficulty breathing may occur. These reactions can sometimes be serious;
Your asthma may go wrong

How to store Bemfola
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label of the pen 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.
Within the shelf-life, the unopened product can be stored below 25 ° C for up to 3 months without re-refrigeration and should be discarded after 3 months if it has not been used.
Store in the original package in order to protect from light.
Do not use this medicine if you notice any visible signs of disturbing the quality of the product if the fluid contains particles or is not clear.
Once opened, the drug should be injected immediately.
Do not dispose of medicines in the sewer or in the household waste container.
Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Bemfola contains
The active substance is follitropin alfa.

Bemfola 75 IU / 0.125 ml: Each cartridge contains 75 IU (equivalent to 5.5 micrograms) of follitropin alfa in 0.125 ml of solution;
Bemfola 150 IU / 0.25 ml: Each cartridge contains 150 IU (equivalent to 11 micrograms) of follitropin alfa in 0.25 ml solution;
Bemfola 225 IU / 0.375 ml: Each cartridge contains 225 IU (equivalent to 16.5 micrograms) of follitropin alfa in 0.375 ml of solution;
Bemfola 300 IU / 0.50 ml: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.50 ml solution;
Bemfola 450 IU / 0.75 ml: Each cartridge contains 450 IU (equivalent to 33 micrograms) of follitropin alfa in 0.70 ml of solution;
Each ml of solution contains 600 IU (equivalent to 44 micrograms) of follitropin alfa.
The other ingredients are: poloxamer 188, sucrose, methionine, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid and water for injections.

What Bemfola looks like and contents of the pack
Bemfola is in the form of a clear, colorless liquid in a pre-filled pen.
Bemfola is available in packs of 1, 5 or 10 pre-filled pens, 1, 5 or 10 single needles and 1, 5 or 10 alcohol swabs.
Not all pack sizes may be marketed.

 

 

 

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