Proluton Depot 500 MG/2ML 1 Vial View larger

Proluton Depot Injection (hydroxyprogesterone ) 500 MG/2ML 1 Vial


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PROLUTON® DEPOT ampoule 500 mg/2 ml
It is administered intramuscularly.
• Active ingredient: Contains 250 mg of hydroxyprogesterone caproate in 1 ml of solution.
• Excipients: Benzyl benzoate, castor oil for injection.

1. What is PROLUTON DEPOT and what is it used for?

• PROLUTON DEPOT contains 250 mg of hydroxyprogesterone caproate in 1 ml of solution. • Hydroxyprogesterone caproate, the active ingredient of PROLUTON DEPOT, is natural
hydroxyprogesterone ester. In women, it provides the development of the inner lining of the uterus and the thickening of the fluid secreted from the cervix.
• PROLUTON DEPOT is available as 1 ampoule containing 2 ml of clear and particle-free solution.

• PROLUTON DEPOT is used in cases of recurrent miscarriage (habitual abortion) and threat of miscarriage, infertility due to yellow body (corpus luteum) insufficiency, amenorrhea (primary and secondary amenorrhea).

2. Before you use PROLUTON DEPOT

DO NOT USE PROLUTON DEPOT in the following situations
• If you are allergic to any of the ingredients of PROLUTON DEPOT
• A blood clot in a vein (thrombosis), for example in your legs (deep vein thrombosis),
in your lungs (pulmonary embolism) (see section "USE PROLUTON DEPOT CAREFULLY in the following conditions")
• If you have (or have had in the past) a disease affecting the arteries, such as a heart attack or stroke
• If you have diabetes that affects the veins
• If you have current or previous severe liver disease (symptoms may include jaundice or itchy skin) and your liver is still not working normally
• If you have (or have had) a benign or malignant liver tumor
• If you have cancer (for example, breast or genital organ) that may progress under the influence of sex hormones (or if it has happened in the past)
If any of these conditions occur to you the first time you use the medicine, stop using it immediately and consult your doctor.
USE PROLUTON DEPOT CAREFULLY in the following situations
If risk factors or any of these conditions occur for the first time, or if the events worsen or increase, consult your doctor immediately. If you follow closely
If you need to be treated, your doctor will evaluate the benefits and possible risks of using PROLUTON DEPOT before you start or continue to use it.
will discuss with you before starting.
• If you have a history of atherosclerosis
• If you are at risk for atherosclerosis (family history, advanced age, obesity, prolonged inactivity, major surgery or trauma)
• If you have diabetes
• If you are overweight
• If you have (or have had in the past) thrombosis / embolism
• Clot formation in a close relative (in a sibling or parent's early venous
• If your close relatives have or have had breast cancer
• If there are yellow-brown spots (chloasma) on the face that may occur due to pregnancy
(In this case, do not be exposed to direct sun or ultraviolet light)
• If you have a history of depression Blood clots
In the light of information obtained from epidemiological studies, oral estrogen/progesterone containing
use of birth control pills in women who use these pills compared to those who do not
It was concluded that the risk of developing venous thrombosis increases.
The risk of venous blood clots is increased by the following factors:
• Increasing age,
• Overweight,
• If your close relatives have clot formation (venous thromboembolism in a sibling or parent's early life)
• If you are going to have an operation (surgery), stay immobile for a long time, or have had a serious accident. If you are using PROLUTON DEPOT as a treatment, if you have hospitalization or surgery, you should tell your doctor beforehand.
is important. Your doctor can make you stop the medicine and will tell you when to start again.
The risk of thromboembolism increases for a short time after birth.
Blood clots can also rarely form in the heart blood vessels (causing a heart attack) or in the brain (causing a stroke).
Very rarely, thrombosis can lead to serious permanent disability; it can even be fatal. If you notice possible signs of thrombosis, stop taking PROLUTON DEPOT immediately.
Consult your doctor (see also " Consult your doctor in the following cases") Cancer is rare in people using similar hormone-containing substances in PROLUTON DEPOT.
In rare cases, benign liver tumors and, in even more rare cases, malignant liver tumors have been reported. These tumors can lead to internal bleeding. If you feel severe pain in your abdomen, contact your doctor immediately. Consult your doctor in the following cases:
regular check-ups
• If you are using PROLUTON DEPOT, your doctor will ask you to come for regular check-ups.
will want.