FOSTIMON 150 IU. 10 solution for injection

WHAT FOSTIMON 150IU AND WHAT IT IS USED FOR?
• Each vial Fostimon 75 IU contains the active substance Urofollitropin (Follicle - stimulating hormone) 75 IU.
• Fostimon 150 IU is used in women who do not ovulate and do not respond to other treatments (clomiphene citrate).
• It is used to induce the development of several follicles (and therefore several eggs) for women undergoing treatment for fertility.
Fostimon is a powder in a vial and comes with solvent ampoule. They are used to prepare injection you. Urofollitropin is highly purified human follicle stimulating hormone, the group of gonadotropins.
This medicine should be taken under medical supervision. 2. BEFORE YOU USE FOSTIMON 150IU
You and your partner should be tested for fertility before starting treatment.
DO NOT USE FOSTIMON 150IU if you have:
• enlarged ovaries or cysts caused by hormonal disorders (polycystic ovaries).
• Bleeding of unknown origin.
• Cancer of the ovaries, uterus or breast.
• unusual / abnormal swelling (tumor) of the pituitary gland or hypothalamus (brain).
• If you are allergic (hypersensitive) to Urofolitropin or any of the other ingredients of FOSTIMON 150 IU.
This medicine should not be used if you have early menopause, malformations of the sexual organs or certain tumors of the uterus which make a normal pregnancy impossible.
Take special care with FOSTIMON 150IU
Treatment with Fostimon increases the risk of developing a condition known as syndrome of ovarian hyperstimulation (SHSYA) (see possible side effects). This is rare, if not ovulating and treatment is carried out as recommended. It is possible, however, the drug (containing human chorionic gonadotropin-hCG), which is used to cause the release of a mature egg to increase the likelihood of hyperstimulation syndrome. Is therefore not recommended to use hCG in cases where developing this syndrome and you should not have sexual intercourse, even if using mechanical methods of contraception for at least 4 days.
In patients in which the treatment to promote ovulation, the incidence of multiple pregnancies and births is increased compared with natural conception. The risk, however, should be minimized by taking the recommended dose.
It should be noted that in women with fertility problems have a greater percentage of abortions than others.
Although so far no reported allergic reactions to FOSTIMON 150 IU, you should inform your doctor if you have allergies to such drugs.
This medicine is prepared with human urine. The risk to pass infectious agents that can cause infection or disease, it can not be categorically excluded, but it is limited by the steps of removing viruses, especially HIV, Herpesvirus and Papillomavirus, during the manufacturing process. Not reported cases of viral contamination.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those obtained without a prescription.
Pregnancy and lactation
FOSTIMON 150 IU must not be used if you are pregnant or breast-feeding.
Important information about some of the ingredients of FOSTIMON 150 IU
If your doctor has told you that you have an intolerance to some sugars, please report it before you inject.
3. HOW TO TAKE FOSTIMON 150IU?
Dosage and duration of treatment:
Follow the prescribed dose. If you are in doubt, contact your doctor.
Anovulatory women with no or irregular menstruation:
If you are menstruating, treatment should begin within 7 days of the cycle (the first 7 days of the menstrual cycle). Place a single injection daily, either subcutaneously or intramuscularly. The usual initial dose is 75 to 150 IU FOSTIMON every day. This dose can be increased if necessary by 37.5 to 75 IU of FOSTIMON 7, or preferably 14-day intervals, to the required reaction. The maximum daily dose of 75 IU FOSTIMON not normally exceed 225 IU. If your doctor can not see results after 4 weeks of treatment, this treatment cycle is stopped. For the next cycle physician determined more starting dose. If the response is good (satisfactory follicular growth), is placed a single injection of another drug (hCG), which leads to the final maturation of the follicle and release of eggs. This is from 24 to 48 hours after the last injection of FOSTIMON 150 IU. Have sexual intercourse on the day of placement of hCG injection and again the next day.
If the response to treatment was extremely good, it is stopped and is not called hCG (see possible side effects). For the following cycle your doctor will prescribe a lower starting dose.
Women undergoing ovarian stimulation for multiple follicular development prior to in-vitro fertilization or other assisted reproductive technologies:
Situation 1 - If you have menstruation
Treatment should be initiated 2-3 days after the beginning of the cycle (the first 2-3 days of the menstrual cycle). Will be given one injection per day subcutaneously or intramuscularly. The usual starting dose for svrahrovulatsiya is 150 to 225 IU FOSTIMON 150 IU daily. Treatment is continued, the dose varies depending on the reaction while you achieve follicular development. This is usually achieved on average by the 10th day of treatment (between 5 and 20 days) and is measured by blood tests and / or examinations using ultrasound.
Upon reaching follicular development, a single injection is placed, which leads to the final maturation of the follicle. It contains up to 10,000 IU human chorionic gonadotropin (hCG).
This is from 24 to 48 hours after the last injection of FOSTIMON 150 IU. Case 2 - When using a gonadotrophin releasing hormone (GnRH) FOSTIMON 150 IU was administered about 2 weeks after the start of treatment. Both treatments continue to achieve follicular development. FOSTIMON 150 IU was administered once per day subcutaneously or intramuscularly. For example, after two weeks of treatment with an agonist of GnRH, from 150 to 225 IU FOSTIMON apply the first 7 days. The dose is then refined according to the ovarian response.
How to apply FOSTIMON 150IU:
FOSTIMON 150 IU place by injection, either subcutaneously or intramuscularly.
Each vial should be used only once and injection to be made immediately after preparation.
After appropriate advice and training, your doctor may suggest that you have your FOSTIMON 150IU alone. First doctor should:
- Make you practice your putting subcutaneous injection show the appropriate injection sites show how to prepare the injection solution,
- Explain how to prepare the correct dose for injection.
Before you inject 150 FOSTIMON it yourself, read the instructions carefully:
How to prepare and inject 1 vial FOSTIMON 150 IU:
The injection should be prepared immediately before application, using the solvent (0.9% w / v saline sodium chloride) placed in each package FOSTIMON. 1
Prepare a clean surface and wash your hands. It is important that your hands and everything you use be as clean as possible.
On this surface place:
- Two alcohol soaked cotton (not included in the package)
- One vial of powder FOSTIMON 150 IU,
- One solvent ampoule,
- One syringe (not included in the package)
- A needle for the preparation of the injection solution (not included in the package)
- A fine hypodermic needle (not included in the package).
Preparing the injection:
Open the ampoule with the clear solution:
On the neck of the ampoule with solvent has a small color mark where it breaks easily. Gently tap the top of the ampoule so that no liquid there. Firmly press the ampoule neck over and break a marked spot. Carefully place the open ampoule the blast.
Download solvent:
Insert the needle to prepare the injection syringe. With the syringe in one hand, pick up the open ampoule, insert to needle and withdraw the entire amount. Carefully place the syringe on the surface, being careful not to touch the needle. Prepare the injection solution:
1 Remove the aluminum coating of powder vials FOSTIMON 150 IU and clean the rubber stopper with alcohol.
Take the syringe and slowly inject the solvent into the vial through the rubber stopper.
After the powder has dissolved (usually occurs immediately), slowly withdraw the entire amount in the syringe.
Subcutaneous injection of the solution:
solvent
Replace the big needle syringe with a thin needle for injection. Perform a safety test: All bubbles need to be removed as a stand syringe with the needle up, gently tap and carefully move the plunger until the needle tip came one drop.
The amount Fostimon 150 IU, in the syringe should be recommended by the physician.
The doctor or nurse will have already shown you where to inject Fostimon (eg. Tummy, front of thigh). Clean the area with cotton soaked with alcohol. Pinch the skin and jerk push the needle at an angle of 45 ° or 90 °. Inject under the skin as you indicated. Do not inject into a vein. Inject the solution by pushing gently on the plunger. Do not hurry because you need to inject all the prescribed amount. Remove the needle immediately and then clean the area with a cotton swab in a circular motion.
Discard all used:
Once the injection is inserted, insert needles and all your container. Any unused solution should be discarded.
If you use more than the amount of 150 IU FOSTIMON
The effect of overdose FOSTIMON 150 IU has not been known, but could be expected to occur syndrome ovarian hyperstimulation (see possible side effects). If you use more than you need FOSTIMON 150 IU, contact your doctor or pharmacist.
If you forget to use FOSTIMON 150IU:
The next injection should be placed at its regular time. Do not take extra amounts to compensate for missed doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, FOSTIMON 150 IU can cause side effects, although not everybody gets them.
Side effects can be grouped into the following categories: (in MedDRA
Very common occurs in more than 1 in 10 patients.
Common occur in 1 to 10 in every 100 patients.
Uncommon occur in 1 to 10 in every 1,000 patients.
Rare occur in 1 to 10 in every 10,000 patients.
Very rarely occur in less than 1 in 10,000 patients
Reported side effects include:
- Headache, bloating, constipation, hyperstimulation syndrome and pain at the injection.
- Nausea, abdominal pain, fatigue, difficulty breathing
Rare or other reactions at the injection site (redness and itching), very rare:
- Breast enlargement, breast pain, hot flushes, dizziness
- World, drowsiness, mood changes, slowed reactions, cystitis, increased thyroid gland, redness, itching, nosebleeds and increased bleeding time.
When FOSTIMON 150 IU was used in combination with hCG:
Rarely seen abnormal blood clots with similar medicines.
It is possible overstimulation of the ovaries. If this happens, can form large ovarian cysts. The first signs are pains in the lower abdomen, and nausea, vomiting, and weight gain. If these symptoms occur, you should be examined by a doctor as soon as possible. In serious, but rare cases, the ovaries may increase and collect fluid in the abdomen or chest. To prevent such instances of excessive ovarian response, your doctor may stop treatment with FOSTIMON 150 IU and to discontinue therapy with hCG.
Ectopic pregnancy (ectopic pregnancy) is possible, especially in women with previous tubal disease.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE FOSTIMON 150IU?
Keep out of reach of children.
Do not store above 25 ° C Store in the original package. Protect from light.
Do not use FOSTIMON 150 IU after the expiry date stated on the carton. The expiry date refers to the last day of that month.
To be used immediately after preparation.
Do not use FOSTIMON 150 IU if the solution does not appear clear.
Medicines should not be disposed of via wastewater or household otpadatsi.Popitayte your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment
5. ADDITIONAL INFORMATION
What?
- The active substance is Urofolitropin 150 IU.
Excipients: For powder: lactose monohydrate
For the solvent, physiological saline, sodium chloride
Looks Fostimon 150IU and contents of the pack?
Packaged in quantities of 1 or 10, each vial of powder contains 150IU urofolitropin and ampoule of solvent contains 1 ml of sterile sodium chloride 0.9%