LUVERIS 75 IU 1 ml.

What Luveris is and what it is used What is Luveris?
Luveris is a medicine containing lutropin alfa, recombinant luteinizing hormone (LH), which is substantially similar to the native human hormone but is produced by means of biotechnology. It belongs to a group of hormones called gonadotropins, which are involved in the normal control of reproduction.

What is Luveris
Treatment with Luveris is recommended for adult women who experience very low levels of certain hormones involved in the natural reproductive cycle. The drug is used in combination with another hormone, called follicle stimulating hormone (FSH) to lead to the development of follicles, which are present in the ovary, wherein the oocytes matured. Then continuing treatment with a single dose of human chorionic gonadotropin (hCG), which leads to the release of an egg from the follicle (ovulation).

2. What you need to know before you use Luveris?
Do not use Luveris
• if you are allergic to gonadotropins (such as luteinising hormone, follicle stimulating hormone or human chorionic gonadotropin), or any of the other ingredients of this medicine (listed in section 6);
• if you have ovarian, uterine or breast;
• If you are diagnosed with a brain tumor;
• if you have ovarian enlargement or ovarian cysts of unknown origin;
• if you have vaginal bleeding of unknown origin.
Do not use Luveris, if any of these applies to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Luveris. Before starting treatment should be assessed your fertility and that of your partner.
It is not recommended to use Luveris, if there are diseases that obstruct normal pregnancy, such as ovaries are not functioning due to a condition known as ovarian failure, or malformations of sexual organs.

Porphyria
Before starting treatment, tell your doctor if you or a member of your family have porphyria (an inability to break down porphyrins that may be passed from parents to children).

Ovarian hyperstimulation syndrome (OHSS)
This medicine stimulates your ovaries. This may increase the risk of developing ovarian hyperstimulation syndrome, or OHSS. In this condition, your follicles grow excessively and become large cysts. If you get pain in the lower abdomen, fast weight gain, you nauseous or vomiting, or if you experience difficulty in breathing, tell your doctor who may advise you to stop using this medicine (see point 4 "Serious side effects ").
If you are not ovulating and follow the recommended dose and schedule of administration, the occurrence of OHSS is less likely. Luveris treatment seldom leads to severe OHSS. This will be much more likely if a drug for final follicular maturation (containing human Chorionic Gonadotropin, hCG) (see detail in section 3, "How much should use"). If you develop OHSS your doctor may not prescribe hCG in this treatment cycle and you may be advised to abstain from sexual intercourse or use a barrier method of contraception for at least four days.
Your doctor will ensure careful monitoring of ovarian response on ultrasound and blood sampling prior to and during the course of treatment.

Multiple pregnancy
When using Luveris, there is a greater risk to conceive more than one child at the same time ("multiple pregnancy", mostly twins) compared with natural conception. Multiple pregnancy can cause medical complications for you and your babies. You can reduce the risk of multiple pregnancy by taking the correct dose Luveris at the right time. When you are undergoing assisted reproductive technology (ART), the risk of multiple pregnancy is related to your age, the quality and the number of fertilized eggs or embryos are implanted you.

Miscarriage
When you are undergoing assisted reproductive technology (ART) or stimulation of the ovaries to produce eggs, there is a greater chance of miscarrying compared to the average woman.

Ectopic pregnancy
In women with spent tubal disease are at risk of ectopic pregnancy (pregnancy where the fetus is fastened outside the uterus), whether the pregnancy is due to spontaneous pregnancy or fertility treatment.

Problems related to blood clots (thromboembolic events)
Before you use Luveris talk to your doctor if you or a family member have ever had blood clots in the legs or lungs, or heart attack or
stroke. You may be at higher risk of blood clots with serious consequences or the status of existing clots may get worse during treatment with Luveris.

Tumors of the genital organs
There have been reports of tumors, benign and malignant ovarian and other reproductive organs in women who have undergone multiple courses of treatment of infertility.

Birth defects
The incidence of birth defects after Assisted Reproductive Technology (ART) may be slightly higher than after natural conception. This may be due to differences in factors related to parents, such as maternal age, genetic factors, as well as the ART procedures and multiple pregnancy.

Children and adolescents
Luveris is not for use in children and adolescents under 18 years of age. Other medicines, Luveris
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Do not use Luveris as a mixture with other drugs in the same injection, except for follitropin alfa, if prescribed by your doctor.

Pregnancy and lactation
Do not use Luveris, if you are pregnant or breast-feeding.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Luveris no or negligible influence on the ability to drive and use machines.
Important information about some of the ingredients of Luveris
Luveris contains less than 1 mmol (23 mg) per dose. Contains virtually no sodium. 3. How to use Luveris
Always use this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor.

Use of the drug
Your doctor will determine the dose and schedule of administration which are most appropriate for you during the course of treatment.
For self-administration by patients at home is more convenient forms. Consult with your doctor to find out if there is a suitable choice for you.

How much should use
Typically Luveris is used every day for a period of three weeks with injections containing FSH.
• The usual starting dose is 75 IU (1 vial) Luveris, together with 75 IU or 150 IU FSH.
• Depending on your response, your doctor may increase your dose of FSH by preferably amounts of 37,5 IU to 75 IU in a 7- to 14-day intervals.
Your doctor may decide to extend your treatment up to 5 weeks.
When the desired response, a single injection of hCG in the range of 24 to 48 hours after the last injection of Luveris and FSH. It is recommended to have sexual intercourse on the day of hCG administration and again the next day. As an alternative to intrauterine insemination (IUI).
If excessive response is obtained, treatment should be stopped and hCG withheld (see. "Possible side effects"). For the next treatment cycle, your doctor will prescribe you a lower dose of FSH from that used in previous cycle.
Luveris is intended for subcutaneous administration, which means that it is administered by injection under the skin. Each vial is for single use only.

If you administer Luveris to yourself, please read the following instructions:
• Wash your hands. It is important that your hands and the items you use be as clean as possible.
• Assemble everything you need. Find a clean area and lay out everything:
- One vial of Luveris,
- One solvent ampoule,
- Two swabs, alcohol,
- One syringe,
- One big needle for reconstitution,
- A fine hypodermic needle,
- Container for disposal of glass and needles.
• Open the ampoule of solvent: On top of the ampoule will see a small colored dot. Just below it is the place for breaking the ampoule, which was made easy to break. Gently tap the top of the bottle to collect all of the solution at the bottom of the ampoule. Then press the ampoule firmly over the neck, and breaking it from the colored. Carefully place the open ampoule upright on the work surface.
• Draw the solution: Put the needle for reconstitution to the syringe.
With the syringe in one hand, pick up the open ampoule, insert the needle and draw up all the solvent. Carefully place the syringe back on the work surface, taking care not to touch the needle.
• Prepare the injection solution: Remove the protective cap from the vial of powder
Luveris, pick up your syringe and slowly inject the solvent into the vial of Luveris. Swirl gently without removing the syringe. Do not shake.
After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles. Turn the vial and gently draw the solution back into the syringe.
You can also mix Luveris and follitropin alfa as an alternative to injecting each medicine separately. Once the powder Luveris, draw the solution back into the syringe and inject it into the container with the follitropin alfa powder. After the powder has dissolved, draw the solution back into the syringe. Check for the presence of particles, as you have done the first time, and do not use if the solution is not clear.
To 1 ml of a solvent can be dissolved in 3 containers of powder.
• Change the needle for reconstitution with a fine-bore needle and remove any air bubbles: If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently tap until all the air collects at the top. Gently push the plunger until all air bubbles disappear.
• Immediately inject the solution: Your doctor or nurse will have already advised you where to inject (eg. Tummy, front of thigh). Wipe the chosen area with a swab with alcohol. Firmly pinch the skin and insert the needle at an angle of 45 ° to 90 ° using the movement, like a dart. Inject under the skin, as you were taught. Do not inject directly into a vein. Inject the solution by pushing gently on the plunger. Take as much time as you need to inject all the solution. Immediately withdraw the needle and clean the skin with an alcohol swab, using a circular motion.
• Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container. Any unused solution should be discarded.

If you use more than the amount of Luveris
Responses in cases of overdose of Luveris are unknown, nevertheless there is a possibility that ovarian hyperstimulation syndrome, which is described in the "Possible side effects". This is possible only in case of application of hCG (see section "Warnings and Precautions").
If you forget to use Luveris
Do not use a double dose to make up the missed dose. Consult with your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

and 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:
Contact your doctor immediately if you notice any of the following side effects. The doctor may ask you to stop using Luveris.

Allergic reaction
Allergic reactions such as rash, redness, hives, facial swelling and difficulty breathing can sometimes be serious. These side effects are very rare.

Ovarian hyperstimulation syndrome
• Pain in the lower abdomen, accompanied by nausea or vomiting. This can be a symptom of ovarian hyperstimulation syndrome (OHSS). Your ovaries can over-respond to treatment and form large bags filled with fluid or cysts (see also section 2 "Ovarian hyperstimulation syndrome"). This side effect is common. If this happens, your doctor will need to examine you as soon as possible.
• Serious complications related to blood clots (thromboembolic events) usually accompanied by severe OHSS are found in very rare cases. This can cause chest pain, breathlessness, stroke or heart attack (see also section 2 "Problems related to blood clots").

Other common side effects
• Headache
• Feelings of nausea, vomiting, diarrhea, abdominal discomfort or abdominal pain
• fluid-filled sacs in the ovaries (ovarian cysts), chest pain and pain in the pelvic area
• Reactions at the injection site, such as pain, itching, bruising, swelling or irritation.
There were no reported cases of torsion (twisting) of the ovary and bleeding into the abdominal cavity during treatment with Luveris, however, there have been rare cases following administration of human menopausal gonadotropin (urinary hMG), which also contains LH.
May develop ectopic pregnancy (implantation of fruit outside the uterus), especially in women with previous tubal disease.
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet.
5. How to store Luveris?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the vials after "EXP". The expiry date refers to the last day of that month.
Do not store above 25 ° C. Store in the original package in order to protect from light.
Do not use this medicine if you notice any visible sign of deterioration of the product, such as discolouration of the powder or the integrity of the package.
The medicine should be administered immediately after reconstitution of the powder.
The solution should not be administered if it contains particles or is not clear.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Luveris?
• The active substance is lutropin alfa. One vial of powder for solution for injection contains 75 IU (International Units).
• Lutropin alpha is recombinant human luteinizing hormone (r-hLH), produced by recombinant DNA technology.
• The other ingredients of the powder are polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid, sodium hydroxide, L-methionine, and nitrogen.
• The solvent is water for injections.