Testestrone propinate
Testosterone Propionate 100 mg/1 ml

Solution for Injection1. WHAT TESTOSTERONEINJECTION IS AND WHAT IT ISUSED FORThe name of your medicine isTestosterone Propionate 100 mg/1 mlSolution for Injection and is referred to asTestosterone Injection’ in this leaflet.The active ingredient of TestosteroneInjection is testosterone propionate (aform of the hormone testosterone whichis produced naturally by the body in bothmen and women). Each ampoule ofTestosterone Injection contains 100 mg oftestosterone propionate in 1 ml of liquid.Testosterone Injection is used in adultmen for testosterone replacement to treatvarious health problems caused by a lackof testosterone (male hypogonadism).This should be confirmed by two separateblood testosterone measurements andalso include clinical symptoms such as:impotenceinfertilitylow sex drivetirednessdepressive moodsbone loss caused by low hormone levelsIt may also be prescribed in men to treatthe following conditions :Delayed pubertyTesticles which have not dropped(undescended testicles)2. WHAT YOU NEED TO KNOWBEFORE YOU USETESTOSTERONE INJECTIONDo not use Testosterone Injection ifyou are male and have or have had atumour of your prostate or breast, or aresuspected to have one of these tumoursyou suffer, or have suffered, from cancerof the liver you suffer from a disease ofthe kidney called nephrosisyou have been told by your doctor thatyou have high levels of calcium in yourblood or in your urine you are allergic totestosterone propionate or any of the otheringredients of this medicineyou are pregnant, think you may bepregnant or are likely to becomepregnant you are breast feedingTell your doctor if any of the aboveconditions apply to you, before you aregiven Testosterone Injection.

Warnings and precautionsTreatment with male hormones liketestosterone may increase the size of theprostate gland, especially in elderly men.Your doctor will examine your prostategland before giving you TestosteroneInjection, and at regular intervals duringtreatment, by digital rectal examination(DRE) and blood tests for prostate-specific antigen (PSA).Your doctor will also do regular checks onthe oxygen-carrying substance in yourblood (haemoglobin). In very rare casesthe number of red blood cells canincrease too much leading tocomplications.Medical checks may also be necessary insome other conditions. Talk to your doctoror pharmacist before using TestosteroneInjection if you have, or have ever had, orare suspected to have:cancer affecting the bones kidney or lungcancer blood clotting problems -thrombophilia (an abnormality of bloodcoagulation that increases the risk ofthrombosis – blood clots in bloodvessels) high blood pressure, or are beingtreated for high blood pressure, astestosterone may cause a rise in bloodpressureheart failure or other heart diseasereduced liver functionreduced kidney function epilepsydiabetes mellitusmigraine, headachessleep apnoea (temporarily stoppingbreathing during your sleep), sincetestosterone injection may cause it toget worse.If you are suffering from severe heart,liver or kidney disease, treatment withTestosterone Injection may cause severecomplications in the form of waterretention in your body sometimesaccompanied by (congestive) heart failure.If you are being treated with TestosteroneInjection for a long time your doctor willarrange for you to have regular full bloodtests. These will include a check on yourtestosterone levels, blood cells, liverfunction and lipids.3. HOW TO STORE TESTOSTERONEINJECTIONKeep this medicine out of the sight andreach of children.Store your medicine in the originalpackage. Do not store above 25°C.Do not use this medicine after the expirydate which is stated on the label andcarton after the letters “EXP” (expiry date).This is the date when the medicine is nolonger fit for use. The expiry date refers tothe last day of that month.Do not throw away any medicines viawaste water or household waste.Ask your pharmacist how to throw awaymedicines you no longer require. Thesemeasures will help to protect theenvironment.4. CONTENTS OF THE PACK ANDOTHER INFORMATIONWhat Testosterone Injection containsThe active substance is testosteronepropionate, which is an ester of thenatural hormone testosterone. Eachampoule contains 100 mg testosteronepropionate (corresponding to 83.72 mgtestosterone) in 1 ml of liquid.The other ingredient is ethyloleate.What Testosterone Injection looks likeTestosterone Injection is a sterile, paleyellow oily liquid. It is supplied in clearglass ampoules in packs containing 10 ampoules.

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