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PROGESTAN 50 mg/ml ampoule containing IM solution for injection For I.M administration only.
Active ingredient
50mg Progesterone
Excipients
Benzyl alcohol and medium chain triglyceride
2. What is PROGESTAN and what is it used for?
In each ampoule, there are 5 and 30 1 ml ampoules in the box, containing 50 mg progesterone as an active substance, administered intramuscularly.
It is used in abnormal uterine bleeding caused by inability to menstruate and hormonal imbalance. It is also used as a support for assisted reproductive techniques in order to ensure that the fertilized egg is attached to the inner wall of the uterus with infertility treatments due to luteal deficiency.
3. How to use PROGESTAN?
Instructions for proper use and dose/frequency of administration
Use in the elderly
In cases of secondary amenorrhea: Inject 5-10 mg/day or 100-150 mg intramuscularly as a single dose for 6-10 consecutive days.
Note: If the patient has menstruation, the treatment should be discontinued. Progesterone should be discontinued if bleeding occurs during progesterone injection.
In functional uterine bleeding: I.M. at a dose of 5-10 mg/day for 6-10 consecutive days. It is administered by the (intramuscular) route.
Note: Bleeding stops within 6 days. When estrogen is started, progesterone intake should be started after the 2nd week of estrogen therapy. Progesterone should be discontinued if bleeding occurs during progesterone injection.
In the absence of the luteal phase: a dose of 12.5 mg or more per day can be started within a few days of ovulation. Treatment usually takes 2 weeks. However, if necessary, it can be continued until the 11th week of pregnancy.
Application route and method
It is administered by injecting the contents of the ampoule into a syringe and injecting it into the muscle at the doses recommended in the instructions for use.
Use in children
The safety and efficacy of PROGESTAN in children have not been studied.
Use in the elderly
The safety and efficacy of PROGESTAN in elderly patients have not been studied.
Special use cases
Since PROGESTAne will cause fluid retention, the complaints of patients with renal dysfunction may increase, and it should be used with caution.
Liver failure:
Use in the elderly
If you have the impression that the effect of PROGESTAN is too strong or weak, talk to your doctor or pharmacist.
If you use more PROGESTA than you should
If you have used more than you should use from PROGESTAN, talk to a doctor or pharmacist.
In case of overdose, the drug should be discontinued and the patient treated symptomatically.
4. What are the possible side effects?
Like all medicines, there may be side effects in people who are sensitive to the substances in the content of PROGESTAN.
If any of the following occur, stop using PROGESTAN and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department:
• Abnormal bleeding from the vagina
• Sudden slowing of breathing; or coughing up blood, indicating possible clot formation in the arms, legs, heart or lungs
• severe headache, vomiting, dizziness, fainting, or changes in vision or speech; Numbness or weakness in the arms or legs, indicating possible clot formation in the brain or eye
• Swelling of the hands, feet, ankles, face, lips, or especially swelling of the mouth or throat that makes it difficult to swallow or breathe.
"All these are serious side effects." If you have any of these, you may need emergency medical attention or hospitalization.
All of these very serious side effects are very rare.
If you notice any of the following, tell your doctor immediately or go to the nearest hospital emergency department:
• Vision problems (such as blurred vision, partial vision, sudden short-term or complete loss of vision)
• Any swelling in the eye
• Migraine type headache
• cholestatic jaundice
This is a serious side effect. Emergency medical attention may be required. Serious side effects are very rare.
Tell your doctor if you notice any of the following:
• Pain and swelling at the injection site
• Dizziness, drowsiness, drowsiness
• Shortening in the duration of menstruation or bleeding in between
• Changes in the breast
• Head and abdominal pain
• Fatigue, skeletal pain
• Irritability
• dry mouth
• Insomnia
• Blurring of consciousness
• Sleeping state
• Pregnancy spot
• Swelling due to fluid retention
• Weight gain, weight loss
• Jaundice (yellow color in the eyes or skin)
• Acne
• Darkening of the face color
• Mental depression
• Fire
• nausea
• Excessive body or facial hair
• Hair loss
These are mild side effects of PROGESTAN.