0.1 mg / ml injection solution
triptorelin
1. What Gonapeptyl is and what it is used for
This medicine is supplied as a syringe in a single-use syringe. It is given as an injection under the skin in the lower abdomen.
This medicine contains triptorelin, a chemically produced equivalent of the natural hormone et GnRH (gonadotropin-releasing hormone ). GnRH regulates the secretion of sex hormones in the body (so-called gonadotropins ): luteinizing hormone ( LH ) and follicle-stimulating hormone ( FSH ). Gonapeptyl blocks the effect of GnRH. This reduces the levels of LH and FSH (so-called down-regulation). This prevents premature ovulation.
This medicine is used to treat women in assisted reproduction (ART). In assisted reproduction, ovulation sometimes occurs prematurely, and then the chance of pregnancy decreases. GONAPEPTYL is used for downregulation and prevention of premature LH – release, which could cause such premature ovulation.
Triptorelin contained in Gonapeptyl may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you use Gonapeptyl
Do not use Gonapeptyl
- if you are allergic to triptorelin acetate or any of the other ingredients of this medicine (see section 6 “Other information”)
- if you are allergic to GnRH or any other GnRH – analogue (medicines similar GONAPEPTYL)
- if you are pregnant or breastfeeding. See section “pregnancy and breastfeeding”
Warnings and cautions
Talk to your doctor or nurse before using Gonapeptyl.
- Depression (possibly severe) has been reported in patients taking Gonapeptyl. Tell your doctor if you are taking this medicine and become depressed.
- Mood swings have been reported with the use of this medicine. Your doctor will closely monitor you if you develop depression.
- Because treatment with this drug in some cases can lead to cerebral hemorrhage (pituitary apoplexy). Contact your doctor immediately if you experience sudden headache, vomiting or visual disturbances.
- Because treatment with this drug can lead to a reduction in bone density with the risk of bone damage.
- If you have an increased risk of bone density ( osteoporosis ), tell your doctor before taking this medicine. Risk factors can be:
- If someone in the immediate family has a reduction in bone density.
- If you drink large amounts of alcohol, have an unhealthy diet and / or are a heavy smoker.
- If you are being treated with other medicines that may affect your bone density.
Tell your doctor if any of the following warnings apply to you or have previously been agreed with you.
- if you have mild to severe liver disease
- if you have an active allergic condition or if you have previously had an easy allergic reaction
- if you are administering this medicine yourself. You should be aware of any allergic reactions ( itching , rash, fever). (See section 4 “Possible side effects”).
If you get such reactions after Gonapeptyl injection , talk to a doctor immediately. - If you get:
- abdominal pain
- swelling in the abdomen
- nausea
- vomiting
- diarrhea
- weight gain
- difficulty breathing
- reduced urination
Tell your doctor immediately, even if the symptoms develop a few days after the last injection . This can be a sign of high activity in the ovaries which can be serious (section 4 “Possible side effects”). If these symptoms get worse, treatment should be stopped and you should receive treatment in hospital.
During treatment with this medicine, your doctor will normally prescribe ultrasound and sometimes blood tests to monitor the results of your treatment.
During treatment for infertility with hormonal drugs such as this, the risk may increase:
- ectopic pregnancy (ectopic pregnancy) if you have previously had a disease in the fallopian tube
- miscarriage
- multiple pregnancies (twins, triplets, etc. )
- congenital malformations (physical malformations at birth)
Other medicines and Gonapeptyl
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding and fertility
Do not use this medicine if you are pregnant or breastfeeding.
If there is a possibility that you are pregnant, this should first be investigated and ruled out by your doctor before starting treatment with this medicine.
Do not continue treatment with Gonapeptyl if you find that you are pregnant during treatment. A non-hormonal contraceptive (such as a condom or pessary ) should be used during treatment with Gonapeptyl.
Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines.
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/or side effects. Descriptions of these effects and 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.
Gonapeptyl contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free.
3. How to use Gonapeptyl
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
The recommended dose is an injection under the skin in the lower abdomen once a day. Treatment can be started on days 2-3 or days 21-23 of the menstrual cycle (or 5-7 days before the expected menstruation). After 2-4 weeks, you will receive other hormones to stimulate follicle growth (egg sac growth). In general, Gonapeptyl treatment is continued until the follicles have reached the appropriate size. This normally takes 4-7 weeks.
When there are enough egg sacs, you will receive a single injection of a drug called human chorionic gonadotropin ( hCG ) to induce ovulation.
The doctor will closely monitor events in at least 2 weeks after hCG – injection one.
INSTRUCTIONS FOR USE
If the clinic has asked you to inject the medicine yourself, follow the instructions given to them.
The first injection of one of these medicines should be given under the supervision of a doctor.
- Remove the protective foil and remove the syringe from the package. Hold the syringe upright with the gray protective sleeve facing up. Remove the gray protective sleeve. Carefully push the plunger in until the first drops are visible in the needle.
- Take a grip on the skin between the thumb and forefinger. Push the plunger down and slowly inject the contents of the syringe.
If you use more Gonapeptyl than you should
Tell your doctor or nurse about this.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Gonapeptyl
Tell your doctor or nurse about this.
If you stop using Gonapeptyl
Do not stop using Gonapeptyl yourself, but carefully follow your doctor’s instructions. If you stop treatment too soon, your chances of getting pregnant will decrease. If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effect is (occurring in more than 1 in 10):
| HeadacheVaginal bleeding / intermittent bleedingInflammation at the injection site | Abdominal pain nausea |
Common adverse s (affecting less than 1 in 10):
| ColdSore throatHot flashesFlatulence in the abdomenMiscarriageOvarian hyperstimulation (high activity), see section 2 “Take special care with Gonapeptyl”.Pain during menstruation fatigue | Flu-like symptomsDizzinessVomitingBack painPelvic painOvarian cysts (at the beginning of treatment)Pain or reactions at the injection site |
Less common side effects are (affecting less than 1 in 100):
- Mood swings, depression
No known frequency: Can not be determined from the available data
| Feeling of discomfort in the abdomenHeavy sweatingAllergic reactions (see section 2 “Take special care with Gonapeptyl”)Sleep disordersWeight gainDimsynItchingRashAngioedema (swelling under the skin)WeaknessMuscle cramps | Enlarged ovariesIntermittent bleedingRedness at the injection siteDecreased sex driveRespiratory distressImpaired visionHeavy, prolonged or irregular periodsVaginal drynessPain during intercourseChest painJoint pain |
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Gonapeptyl
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Store in the original package. Sensitive to light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
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. Contents of the packaging and other information
Content declaration
- The active substance is triptorelin acetate. Each pre-filled syringe with 1 ml solution for injection contains 0.1 mg (100 micrograms) of triptorelin acetate corresponding to 95.6 micrograms of triptorelin.
- The other ingredients are sodium chloride, concentrated acetic acid and water for injections.
What the medicine looks like and contents of the pack
This medicine is a clear colorless solution in a 1 ml solid syringe glass syringe. The syringe and needle are sealed with a rubber plug and a needle guard. Gonapeptyl is supplied in a carton of 7 pre-filled syringes.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Ferring Läkemedel AB
Box 4041
203 11 Malmö
Manufacturer:
Ferring GmbH
PO Box 2145
24109 Kiel
Germany