3.75 mg, 11.25 mg, and 30 mg, powder, and solvent for solution for injection in pre-filled syringe leuprorelin, acetate
What Procren Depot Is And What It Is Used For
Procren Depot is a medicine that is given as an injection under the skin. The drug contains leuprorelin acetate, which is a synthetic hormone that reduces testosterone and estrogen levels in the body.
In men
Procren Depot 3.75 mg, 11.25 mg, and 30 mg are used alone or in combination with radiation to treat severe or widespread prostate cancer, as surgery is not required. It is also used as an adjunctive treatment, for example when there is a risk of spreading to the lymph nodes.
In women
Procren Depot 3.75 mg is also used to treat severe endometriosis in women.
In children
Procren Depot 3.75 mg and 11.25 mg can also be used to treat premature puberty in girls under 9 years of age and boys under 10 years of age. This means that sexual maturation occurs too early, with physical and hormonal changes as in normal puberty.
What You Need To Know Before Using Procren Depot
Do Not Use Procren Depot
- If you are allergic to leuprorelin acetate, or any of the other ingredients of Procren depot IVF (listed in section 6), or to other substances similar to leuprorelin ( synthetic GnRH or GnRH derivative )
- If you are pregnant or breastfeeding
- Undiagnosed vaginal bleeding
Warnings And Cautions
Talk to your doctor before taking Procren Depot Injection.
- If you have impaired kidney function
- If you suffer from narrowing of the urinary tract
- If you suffer from spinal cord compression
- If your endometriosis has previously been treated with leuprorelin (women)
- If you have cardiovascular disease, including arrhythmias, or if you are taking medication for this. The risk of heart rhythm disorders may be increased when using Procren Depot Injection.
- If you have high blood sugar, treatment with Procren may lead to the development of diabetes.
- If you have osteoporosis (osteoporosis)
There is an increased risk of developing depression associated with the treatment of Procren. Talk to your doctor if you feel depressed or depressed during treatment with Procren.
In Children
Should abscesses occur at the injection site, your baby’s hormone levels will be monitored as the uptake of leuprorelin from the injection site may be reduced.
If the child has a brain tumor, your doctor will decide if the treatment with Procren Depot is appropriate.
In some cases, displacement of the femoral growth area may occur after treatment is completed.
The skeleton may be weakened during treatment with Procren Depot Injection. After the treatment has ended, the growth of bones continues and in the late teens, the skeleton does not seem to have been affected by the treatment.
Pseudotumor cerebri (PTC) / idiopathic intracranial hypertension (a condition characterized by increased blood pressure in the head/brain) has been reported in children receiving Procren Depot. Keep track of if your child gets signs or symptoms of PTC. These include headaches, vision problems such as
- Blurred vision
- Double vision
- Loss of vision
- Pain behind the eye or pain with eye movements
- Ringing in the ears
- Dizziness
- Nausea
Contact your child’s doctor immediately to find out if your child has papillary edema (pressure in or around the brain that causes swelling of the optic nerve inside the eye). If your child has papillary edema, it means that your child has PTC and needs immediate treatment.
In girls:
After the first injection, vaginal bleeding, spotting, and discharge may occur. Contact your doctor if vaginal bleeding persists after the first month of the treatment.
Other medicines and Procren Depot
Proceed Depot may affect some other medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disorders when used with other medicines such as
- Methadone (used to treat pain and drug addiction)
- Moxifloxacin (an antibiotic )
- Antipsychotics (used for severe mental illness)
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Fertile women are advised to use non-hormonal contraceptives, such as condoms or pessaries, during treatment with Procren Depot as birth control pills may not work.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking Procren depot IVF.
Leuprorelin should not be given to pregnant or breastfeeding women.
Driving And Using Machines
Leuprorelin can cause
- Fatigue
- Tiredness
- Dizziness
can therefore affect your ability to drive or use tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Important Information About Some Of The Ingredients Of Procren Depot Ivf
Procren depot IVF contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. is almost sodium-free.
How To Use Procren Depot
Proceed Depot should only be given by your doctor or nurse who is also prescribing the medicine.
Proceed Depot is given as an injection under the skin by healthcare professionals.
Prostate cancer: The recommended dose for men with prostate cancer is 3.75 mg every four weeks, 11.25 mg every 12 weeks, or 30 mg every six months. Treatment should not be discontinued for remission or improvement.
Endometriosis: The recommended dose is 3.75 mg once a month. Treatment begins on the first to the fifth day of menstruation. The treatment of endometriosis should not exceed 6 months. Proceed supplemented with hormonal replacement therapy ( HST) is recommended at the start of treatment and repeated treatment of endometriosis for up to 12 months.
Premature puberty: Treatment of children with Procren Depot should be supervised by a pediatrician with specialist knowledge in the field. The dosage schedule needs to be adjusted individually. The recommended starting dose depends on body weight.
Children with a body weight of 20 kg or more:
1 ml Procren Depot 3.75 mg is given as a single injection once a month or 1 ml Procren Depot 11.25 mg is given as a single injection every three months.
The doctor will monitor the baby’s weight gain.
Depending on the symptoms, a doctor may increase the dose if your child does not respond adequately to treatment (eg gets vaginal bleeding). Your doctor will determine the right dose for your child using blood tests.
The treatment time is determined by the doctor together with the guardian and, if appropriate, the treated child. The development of the baby’s skeleton will be evaluated at regular intervals. The treatment time depends on the symptoms at the beginning or during the treatment and the development of your child’s skeleton.
In girls, pregnancy should be ruled out before starting treatment. Pregnancy during treatment should be avoided (see other medicines and Procren Depot ) but may occur. In such cases, a doctor should be consulted.
The treatment is a long-term treatment and the injections should be given at regular intervals. Proceed Depot should be administered once a month for Procren Depot 3.75 mg and every three months for Procren Depot 11.25 mg.
A Delay of the injection date by a few days (± 2 days) does not affect the treatment result.
If You Take More Procren Depot Than You Should
Because you are getting an injection in a hospital or a health center by trained staff, it is very unlikely that you will get overdose. Contact a doctor if you suspect that you have been given an overdose of Procren depot.
Possible Procren Depot Side Effects
Like all medicines, Procren depot IVF can cause side effects, although not everybody gets them.
At the beginning of treatment, the disease symptoms of prostate cancer can temporarily worsen, which can lead to
- Bone pain
- Symptoms from the urinary tract
- Weakness in the legs
- Ant crawling
Contact a doctor immediately or go to the nearest hospital if you experience any of the following symptoms – these may be signs of serious side effects and you may need urgent medical attention:
- Swelling of the face, tongue, or throat which may make it difficult to swallow or breathe, and hives.
This may be a sign of a severe allergic reaction. This has been reported in rare cases in adults (occurs in less than 1 in 1,000 users) and in very rare cases in children (occurs in less than 1 in 10,000 users).
- Swelling and slight blue discoloration of an arm or leg.
- Chest pain, sudden unexplained shortness of breath, or bloody coughing.
- Chest pain, rapid or irregular heartbeat, and discomfort in the upper body that radiates to the back, jaw, neck, arm, and abdomen.
- Sudden weakness or numbness in the face, arms, or legs, especially on one side of the body, sudden confusion, difficulty speaking or understanding, sudden difficulty walking, dizziness, loss of balance or coordination; sudden, severe, or prolonged headache for no known reason.
This can be a sign of a blood clot such as a blood clot in the lung, a heart attack, or a stroke. This has been reported for Procren Depot (occurs in an unknown number of users).
The following side effects have also been reported in adults:
Common Procren depot side effects (affects more than 1 user in 100):
- Mood swings, depression.
- Hemorrhoids (sudden feeling of heat), decreased breast size (women), decreased sex drive, sweating, tenderness, and swelling in the breasts (men).
- Nausea/vomiting.
- Rash
- Leg pain at the beginning of treatment.
- Impotence (men), decreased testicle size, vaginal dryness.
- Fatigue, dizziness, headache, and local reactions at the injection site.
Uncommon Procren depot side effects (affects less than 1 user in 100):
- Anemia decreased platelet count, decreased red and white blood cell count, and prolonged bleeding time (women).
- Breast augmentation (men), pelvic floor discomfort.
- Altered liver values, elevated blood levels for fat, sugar (men), potassium, and uric acid.
- Elevation of liver enzymes (an increase of the substance that shows how your liver works).
- An ant crawls (a feeling of being stung by needles).
- Visual disturbances (women).
- Tinnitus (ringing in the ears), hearing loss.
- ECG changes, palpitations (a feeling that the heart is beating fast or hard). High blood pressure.
- Decreased appetite, diarrhea, abdominal pain, constipation, and stomatitis.
- Itching, inflammation of the skin (swelling, redness of the skin), acne, hair loss, and nail changes.
- Joint pain, pain in shoulders, lower back, and skeleton, difficulty walking, and muscle pain (women).
- Increased value for phosphorus and calcium (women).
- Problems emptying the bladder, need to urinate frequently, pain when urinating, blood in the urine, and elevated urea levels.
- Abundant menstruation, irregular menstruation.
- Vulvovaginitis (vaginal infection) (women).
- Increased vaginal discharge or overstimulation of the ovaries. Intercourse pain (women).
- Swelling due to fluid retention ( edema ).
- Weight gain.
- Feeling of pressure over the chest.
- Stiffness
- Increased hair growth
- Carpal tunnel syndrome (women) with symptoms such as
- Burning pain
- Numbness
- Tingling in the palm and fingers
- Fever, sleep disturbance (women), irritability (women), fatigue (women).
Rare Procren depot side effects (affects less than 1 user in 1,000):
- Degradation of muscle tumors in the uterus.
- Seizures.
- Low blood pressure.
- Interstitial pneumonia ( inflammation of the lungs due to infection that causes scar tissue in the lungs).
- Boil at the injection site.
Very rare Procren depot side effects (affects less than 1 user in 10,000):
- Tissue loss in the pituitary gland in patients with pituitary gland tumors ( pituitary adenoma).
Has been reported (occurs in an unknown number of users):
- Blood clot.
- Changes ( QT prolongation) in ECG ( electrocardiogram )
- Interstitial lung disease (scar tissue in the lungs that causes shortness of breath / makes it difficult to breathe)
- Liver damage
- Osteoporosis (osteoporosis)
The following side effects have also been reported in children:
At the beginning of the treatment, there is a transient increase in sex hormones in the blood. This is followed by a decrease in levels normally seen before puberty. Due to this, side effects can occur especially at the beginning of treatment.
Common (affects more than 1 user in 100):
- Mood swings
- Headache
- Stomach cramps/stomach pain
- Nausea/vomiting
- Acne
- Splash bleeding
- Vaginal bleeding
- Relocation
- Reaction at the injection site
Very rare (affects less than 1 user in 10,000):
- General allergic reaction (fever, rash, itching )
- Tissue loss in the pituitary gland in patients with pituitary gland tumors (pituitary adenoma).
Has been reported (occurs in an unknown number of users):
- A condition characterized by increased blood pressure in your head/brain.
Note: if vaginal bleeding (spotting) occurs during continuous treatment (after any bleeding during the first month of treatment) it may be a sign that the treatment is not sufficient. Tell your child’s doctor if vaginal bleeding occurs.
How To Store Procren Depot
- Keep Procren depot IVF out of the sight and reach of children.
- Do not store above 25 ° C in the original package. Sensitive to light.
- After reconstitution, the suspension should be administered immediately.
- Do not use Procren depot IVF after the expiry date which is stated on the carton after EXP.
- The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
The active substance is leuprorelin acetate. One syringe contains either 3.75 mg, 11.25 mg, or 30 mg of leuprorelin acetate.
Other ingredients in the syringe:
- 3.75 mg
- Powder for solution for injection: DL-lactide-glycolide copolymer, mannitol, and gelatin.
- Liquid: Mannitol, caramel sodium, polysorbate 80, acetic acid (for pH adjustment), and water for injections.
- 11.25 mg
- Powder for solution for injection: Poly (DL-lactide) and mannitol.
- Liquid: Mannitol, caramel sodium, polysorbate 80, acetic acid (for pH adjustment), and water for injections.
- 30 mg
- Powder for solution for injection: Poly (DL-lactide) and mannitol.
- Liquid: Mannitol, caramel sodium, polysorbate 80, acetic acid (for pH adjustment), water for injections.
What The Medicine Looks Like And The Contents Of The Pack
The pre-filled syringe is a 2-chamber syringe with an associated injection needle, with white powder in the anterior chamber and clear, colorless liquid in the posterior chamber. The package also contains an alcohol swab.
Procren depot is delivered in packs of cardboard and plastic containing a pre-filled syringe with an associated injection needle.
- 3.75 mg is available in sizes 1 or 3 syringes.
- 11.25 mg is available in a size 1 syringe.
- 30 mg is available in a size 1 syringe.
Marketing Authorisation Holder
Manufacturer
AbbVie Logistics BV
Zuiderzeelaan 53
8017 JV Zwolle
Netherlands
AbbVie Germany
GmbH & Co. KG
Knollstrasse, 67061
Ludwigshafen
Germany