Salvacyl (Triptorelin)
Salvacyl 11.25 mg powder and solvent for suspension for injection
Triptorelin
1. WHAT SALVACYL IS AND WHAT IT IS USED FOR
Salvacyl reduces the level of male sex hormone (testosterone) and is used to decrease the sexual drive in men with a sexually-deviant behaviour. The treatment should be combined with psychotherapy.
2. BEFORE YOU USE SALVACYL
Do not use Salvacyl
• If you suffer from serious osteoporosis.
• If you are allergic (hypersensitive) to triptorelin, other medicines that regulate the production and release of sex hormones, or any of the other ingredients of Salvacyl.
Take special care with Salvacyl
• If you are using anticoagulants (medicines that reduce blood clotting), since you may experience bruising at the site of injection.
• At the beginning of treatment there will be an increased amount of testosterone in your body. This might result in an increase in sexual drive. Your doctor may give you some medicine (an anti-androgen) to counteract this effect.
• When the treatment is stopped, testosterone will return to normal levels and your sexual drive may increase again. Therefore, your doctor may give you another medicine in order to control this effect.
Using Salvacyl for a long time period may result in a loss in bone density, which may lead to brittle bones and an increased risk of fractures. In order to reduce the risk of brittle bones, a healthy lifestyle is recommended including no smoking, moderation of alcohol intake and regular weight bearing exercises (e.g. walking, jogging or other sports that put a load on the skeleton and therefore strengthen it). You should make sure that your diet contains enough calcium and vitamin D.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Salvacyl is not to be used by women.
Driving and using machines
No studies have been performed. However, some of Salvacyl’s side effects such as dizziness, tiredness and visual disturbances can reduce your ability to react, drive or operate machinery. If you experience any of these undesirable effects, you should avoid these activities.
3. HOW TO USE SALVACYL
Salvacyl is prepared by and is always given to you by a doctor or nurse.
The usual dose is 11.25 mg (one vial) of Salvacyl, given as a single injection into a muscle every twelve weeks.
If you think the effect of Salvacyl is too strong or too weak, contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Salvacyl can cause side effects, although not everybody gets them.
Many of the side effects are expected due to the change in the level of testosterone.
Very common (more than 1 in 10 persons are affected): • hot flushes.
Common (more than 1 in 100, less than 1 in 10 persons are affected):
| • nausea | |||
| • weakness | |||
| • pain at the injection site | |||
| • fluid accumulation in the body (oedema) | |||
| • back pain | |||
| • pain in the arms and legs | |||
| • dizziness | |||
| • headache | |||
| • impotence | |||
| • decreased libido | |||
Uncommon (more than 1 in 1000, less than 1 in 100 persons are affected):
| • small numerous bleedings in the skin and mucous membranes | |
| • ringing in the ears (tinnitus) | |
| • diabetes | |
| • abnormal sensation in the eyes | |
| • visual disturbances | |
| • abdominal distension (swelling) | |
| • abdominal pain | |
| • constipation | |
| • diarrhoea | |
| • dry mouth | |
| • taste disturbances | |
| • flatulence | |
| • vomiting | |
| • chest pain | |
| • difficulties standing | |
| • fatigue | |
| • influenza-like illness | |
| • reactions at the injection site such as bruises | |
| • burning sensation | |
| • redness and induration (hardening of the tissue) | |
| • pain | |
| • fever | |
| • stiffness | |
| • drowsiness | |
| • severe allergic reaction | |
| • hypersensitivity | |
| • inflammation in the throat | |
| • altered results of some laboratory tests | |
| • increased body temperature | |
| • decreased or increased weight | |
| • anorexia | |
| • gout | |
| • increased appetite | |
| • joint ache | |
| • joint stiffness | |
| • joint swelling | |
| • muscle cramps | |
| • muscle weakness | |
| • muscle pain | |
| • neck pain | |
| • formication (prickling sensation in the skin) | |
| • vertigo | |
| • confusion | |
| • decreased activity | |
| • depression | |
| • euphoric mood | |
| • difficulty getting to sleep | |
| • irritability | |
| • mood swings | |
| • pain and tenderness in the breast | |
| tissue | |
| • failure to ejaculate | |
| • enlarged breast tissue in men | |
| • tenderness in the nipples | |
| • pain in the testicles | |
| • difficulty in breathing | |
| • breathlessness at rest | |
| • acne | |
| • hair loss | |
| • blisters | |
| • itching | |
| • nose bleeds | |
| • high blood pressure | |
| • low blood pressure | |
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE SALVACYL
Keep out of the reach and sight of children.
Do not use Salvacyl after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 25° C.
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.
6. FURTHER INFORMATION
What Salvacyl contains
The active substance is:
Triptorelin 11.25 mg
One vial of powder contains 11.25 mg of triptorelin, as triptorelin pamoate.
Reconstituted suspension (2 ml_) contains 11.25 mg of triptorelin, as triptorelin pamoate.
The other ingredients are:
Powder: poly (d, l-lactide-co-glycolide), mannitol, carmellose sodium and polysorbate 80.
Solvent : water for injections.
What Salvacyl looks like and contents of the pack
Salvacyl is a white to off-white powder. The solvent is a clear solution
The package contains:
1 vial with powder
1 ampoule with 2 ml_ of solvent
1 injection syringe
2 needles
The following information is intended for medical or healthcare professionals only: Instructions for reconstitution
1 PREPARATION OF THE INJECTION (Simple needle)
• The suspension for injection should be prepared immediately before injection.
• Tap any solution within the tip of the ampoule back into the main body of the ampoule.
• Tap any powder which has accumulated at the top of the vial back to the bottom of the vial.
• Remove the plastic cap from the vial.
• Screw the needle without safety system onto the syringe (do not remove the needle protection yet!).
• Break open the ampoule (dot face up).
• Remove the needle protection from the needle and draw up all of the solvent into the syringe.
• Insert the needle through the rubber stopper of the vial and inject the solvent slowly, so that, if possible, it washes down the entire upper part of the vial.
• Pull up the needle above the liquid level while reconstituting the homogenous, milky injection suspension by swinging the vial gently. Caution: Mixing must not be performed by repeatedly drawing up and discharging the syringe!
• Then draw up all of the suspension for injection into the syringe.
• Remove the simple needle. Attach the needle equipped with the safety system on the syringe tip (screw on tight). Only grasp the colored hub to connect needle.
• Push the air from the syringe
2 INJECT (Needle with safety system)
• Inject immediately the suspension for injection intramuscularly.
3 AFTER USE
• Immediately following the injection procedure, lock the safety needle shield using any of the following methods :
Push the safety shield forward in a single-handed manner to cover the needle and lock the shield.
Keep your finger or thumb behind the needle tip at all times.
OR
Press the safety shield, lever side down, onto a flat surface to cover the needle and lock the shield, i.e. bedside table .
• The safety needle is locked once the needle tip is completely covered. Verify locked position through audible, tactile, and/or visual feedback.
• Only grasp the colored hub to disconnect needle from syringe.
• Dispose the needles in designated sharp container.
• For single use only. Any unused suspension must be discarded.
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