25 mg solution for Prolutex injection
Progesterone
What Prolutex Is And What It Is Used For
Prolutex contains the active substance progesterone. Progesterone is a naturally occurring female sex hormone. The drug acts on the uterine lining and helps you get pregnant and stay pregnant.
Prolutex is for women who need extra progesterone while undergoing treatment in an assisted reproduction program (ART) and who cannot use or tolerate vaginal preparations.
Progesterone contained in Prolutex may also be approved for the treatment of other conditions not mentioned in this product information.
Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions
What You Need To Know Before Uses Prolutex
Do Not Use Prolutex
- If you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6)
- If you suffer from vaginal bleeding (other than normal menstruation) that has not been investigated by your doctor
- If you have had a miscarriage and your doctor suspects that there is still tissue left in the uterus
- If you have had an ectopic pregnancy (ectopic pregnancy)
- If you currently have or have had severe liver problems
- If you have known or suspected breast or genital cancer
- If you have or have had blood clots in your legs, lungs, eyes, or anywhere else in your body
- If you have porphyria (a group of hereditary or acquired disorders of certain enzymes )
- If you have had jaundice during pregnancy (yellow eyes and skin due to liver problems), severe itching and/or blisters on the skin
- If you are under 18 years of age.
Warnings And Cautions
Take special care with Prolutex
If you experience any of the following during treatment, tell your doctor immediately as treatment may need to be stopped. Also, tell your doctor immediately if you experience these a few days after the last dose:
- Myocardial infarction (chest pain or back pain and/or aching and throbbing in one or both arms, sudden shortness of breath, sweating, dizziness, dizziness, nausea, palpitations)
- Stroke (severe headache or vomiting, dizziness, fainting or changes in vision or speech, weakness or numbness in one arm or leg.)
- Blood clots in the eyes or anywhere in the body (pain in the eyes of pain and swelling in the ankles, feet, and hands)
- Exacerbated depression
- Severe headache, vision changes.
Before treatment with Prolutex
Tell your doctor if you have had or have any of the following before using Prolutex:
- Liver problems (mild or moderate)
- Epilepsy
- Migraine
- Asthma
- Heart or kidney problems
- Diabetes
- Depression
If any of the above apply to you, your doctor will monitor you closely during the treatment.
Children And Young People
This medicine should not be used by children or adolescents.
Other Medicines And Prolutex
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines. Some medicines may interact with Prolutex. For example:
- Carbamazepine (used to treat seizures/seizures)
- Rifampicin (an antibiotic )
- Griseofulvin (a fungicide)
- Phenytoin and phenobarbital (used to treat epilepsy )
- St. John’s wort -containing traditional herbal medicines
- Ciclosporin (a medicine for certain types of inflammation and after organ transplants)
- Diabetes drugs
- Ketoconazole (an antifungal drug)
Do not use Prolutex at the same time as any other medicine for injection.
Pregnancy And Breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
- Prolutex can be used during the first three months of pregnancy.
- This medicine should not be used during breastfeeding.
Driving And Using Machines
Do not drive or use any tools or machines if you feel drowsy and/or dizzy while taking Prolutex. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects.
Descriptions of these effects and prolutex 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.
Prolutex Contains Hydroxypropyl Betadex
If you have kidney disease, consult a doctor before using the medicine.
How To Use Prolutex
Always use this medicine exactly as your doctor has told you. Remember that Prolutex should only be used under the supervision of a doctor who has experience in treating fertility problems.
How Much Prolutex Should You Use And For How Long?
The usual dose of prolutex 25 mg injection is once daily, usually up to 12 weeks of confirmed pregnancy (ie 10 weeks of treatment).
How Prolutex Is Given
Prolutex can be given either under the skin ( subcutaneous injection ) or in a muscle ( intramuscular injection ).
You will be able to inject prolutex 25 mg injection subcutaneously after appropriate advice and training from your doctor or healthcare professional.
Subcutaneous injection:
Before injecting Prolutex, you will receive the following training and advice:
- Exercise in giving subcutaneous injections er
- Where to inject your medicine
- How to prepare your solution for injection
- How to inject your medicine.
Read The Instructions Below For Reconstitution And Injection of Prolutex.
Prolutex 25 mg injection how to use
The steps for self-treatment are:
- Prepare your injection
- Check the packaging
- Prepare the vial and syringe
- Filling the syringe
- Replace injection needle
- Remove air bubbles
- Injection by subcutaneous injection
- Disposal of used items.
These steps are explained in Prolutex 25 mg injection and how to use it in full below.
IMPORTANT: Each vial should only be used once. The solutions should be used immediately after opening the vial. It should not be stored in the syringe.
A. Prepare your injection
It is important to keep everything as clean as possible, so start by washing your hands thoroughly and wiping with a clean towel. Choose a clean area to prepare your medicine:
- A vial containing Prolutex solution for injection
The following is not included in your medicine. Your doctor or pharmacist will provide you with this equipment.
- A syringe
- A large needle (usually a 21G green needle; for intramuscular injection )
- A small fine needle (usually a 27G gray needle; for subcutaneous injection )
- Two alcohol wipes
- A container for sharp objects (for safe disposal of needles, ampoules, etc.)
B. Checking packaging
- The syringe and needles for Prolutex all have protective covers.
- Check that all covers are properly seated, and if they are not properly seated or damaged, do not use them
- Make sure that the expiry date is still valid on the Prolutex vial. Do not use the products if the expiration date has passed.
C. Prepare the vial and syringeShow larger
D. Filling the syringe show larger
E. Replace the injection needle
This step is only needed if you are doing a subcutaneous injection. If your doctor performs an intramuscular injection, they will proceed to dose and inject one.
- Put the needle cover on the large 21G green needle and then carefully remove the large needle from the syringe
- Take the smaller 27G gray injection needle out of the package and keep the needle cover on
- Attach the small 27G gray needle to the syringe and then remove the needle cover.
F. Remove air bubbles show larger
G. Injection by subcutaneous injection
- Your doctor or healthcare professional has already shown you where to inject Prolutex (eg stomach or front of thigh)
- Open the alcohol swab and gently clean the area of the skin to be injected, and allow it to dry
- Hold the syringe in one hand. Use the other hand to gently squeeze the skin at the injection site between the thumb and forefinger
Show larger
| Use an arrow-throwing motion to insert the fine 27G gray needle into the skin so that the skin and the needle form a right angle. |
- Insert the small 27G gray needle completely into the skin. Do not inject directly into a vein
- Inject the solution by gently pressing the plunger in a slow, steady motion until the entire solution has been injected under the skin. Inject all solutions according to the prescribed dosage
- Release the skin and pull the needle straight out
- Wipe the skin at the injection site with an alcohol swab in a circular motion.
H. Disposal of used items
- Once you have finished injecting one, place all the needles, empty vials, and syringes in a container for sharp objects.
- Any unused solution must also be discarded.
Injection by intramuscular injection should only be given by a doctor or healthcare professional
For all intramuscular injections, your doctor or other healthcare professional will perform an injection.
Prolutex injection is given in the side of the thigh or the tail muscle. Your doctor or healthcare professional will clean the area of skin to be injected with an alcohol swab and allow it to dry. Using an arrow-throwing motion, they insert the large needle into the muscle.
They will inject the solution by gently pressing the plunger in a slow and steady motion until the entire solution is injected into the muscle. They pull the needle straight out and wipe the skin at the injection site with an alcohol swab.
If You Use More Prolutex Than You Should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Symptoms of overdose include drowsiness.
If You Forget To Prolutex 25 mg Uses
Take a dose as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten dose. Tell your doctor what you did.
If You Stop Using Prolutex
Do not stop using Prolutex without first talking to your doctor or pharmacist. Abrupt discontinuation of Prolutex 25 mg uses may cause increased anxiety, and mood swings and increase the risk of seizures.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Prolutex 25 mg Side-Effects
Like all other medicines, prolutex side effects can effect , although not everybody gets them.
Stop taking this medicine and seek immediate medical attention if you have any of the following symptoms:
- Overstimulation of the ovaries (symptoms include pain in the lower abdomen, feeling of thirst and nausea, sometimes vomiting, decreased concentration of urine, and weight gain),
- Depression,
- Yellowing of your skin and whites of the eyes (jaundice),
- The severe allergic reaction may cause difficulty breathing, swelling of the face and throat, or severe skin rash (anaphylactoid reactions).
Very common (may affect more than 1 user in 10):
- Pain, redness, itching, irritation, or swelling at the injection site
- Spasm of the uterus
- Vaginal bleeding.
Common (may affect up to 1 in 10 people):
- Headache
- Inflated stomach
- Magnet
- Constipation
- To be sick and to feel sick
- Tenderness and/or pain in the chest
- Vaginal discharge
- A stinging or unpleasant irritation or itching in the vagina and the surrounding area
- Hardening in the area around the injection site
- Bruises around the injection site
- Fatigue (excessive fatigue, exhaustion, lethargy).
Uncommon (may affect up to 1 in 100 people):
- Mood swings
- Dizziness
- Insomnia
- Gastrointestinal disorders (including stomach upset and/or soreness, gas, painful spasms, and nausea)
- Skin rash (including red, hot skin, or raised, itchy lumps or hives, or dry, cracked or blistering, or swollen skin)
- Breast swelling and/or enlargement
- Feeling of warmth
- A general feeling of discomfort or being “out of the thread”
- Pain.
Has been reported (occurs in an unknown number of users): can not be calculated from available data
The following disorders, although not reported by patients in clinical trials with Prolutex, have been described with other progestins: inability to sleep (insomnia), premenstrual-like syndrome and menstrual disorders, hives, acne, excessive hair growth, hair loss ( alopecia ), weight gain.
Prolutex Injection Side Effects
- Avoid using estrogens with a progestin-like Prolutex injection to prevent heart sickness or dementia. Using estrogens with progestin might raise the risks of having a heart attack, breast cancer, a stroke, dementia, or a blood clot.
- Use Prolutex injection with or without progestin for the limited time needed at the lowest suitable dose.
How To Store Prolutex
Keep this medicine out of the sight and reach of children.
Store below 25 ° C.
Store in a cold place.
Store in the original package. Sensitive to light.
This medicine must be used immediately after the first opening.
Any remaining solution must be discarded.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you notice particles in the solution or if the solution is not clear.
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 progesterone . Each vial (1.112 ml) contains 25 mg progesterone (theoretical concentration 22.48 mg / ml).
The other ingredients are hydroxypropylbetadex and water for injections
What The Medicine Looks Like And The Contents Of The Pack
Prolutex is a clear colorless solution that is delivered in a colorless glass vial.
Each pack contains 1, 7, or 14 vials. Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Via Martiri di Cefalonia, 2
26900 Lodi – Italy