Implanon nxt 68 mg implante
Introduction
Label: information for theuser
ImplanonNXT68mg implant
etonogestrel
Read this label carefully before starting to use this medication,because it contains important information for you.
- Keep this label, as you may need to read it again.
- If you have any questions, consult yourdoctor,pharmacistor nurse.
- If you experience any adverse effects,consult your doctor, pharmacist or nurse, evenifthey do not appear in this label. See section 4.
Your doctor will provide you with thePatient Information Leafletthat contains important information you should know. Keep the leaflet in a safe place and show it to your healthcare professionalat any visit related to the use of the implant.
Information for the healthcare professional
1. What is Implanon NXT and what is it used for
Implanon NXTNXTis a preloaded contraceptive implant in a disposable applicator. Its efficacy and safety have been established in women between 18 and 40 years of age. The implant is a small, soft, and flexible plastic rod, measuring 4cm in length and 2mm in diameter, containing 68milligrams of the active ingredient etonogestrel. The applicator allows the healthcare professional to insert the implant just under the skin of the upper arm. Etonogestrel is a synthetic female hormone that resembles progesterone. A small amount of etonogestrel is released continuously into the bloodstream. The implant is made of vinyl acetate-ethylene copolymer, a plastic that does not dissolve in the body. It also contains a small amount of barium sulfate that makes it visible in radiographs.
Implanon NXTis used to prevent pregnancy
How Implanon NXT works
The implant is inserted just under the skin. The active ingredient, etonogestrel acts in two ways:
- Prevents the release of an egg from the ovaries.
- Produces changes in the cervix that make it difficult for sperm to enter the uterus.
As a result, Implanon NXT protects you from pregnancy for a period of three years, but if you have overweight, your doctor may recommend replacing the implant before the three years. Implanon NXT is one of the different existing contraceptive methods. Another common method of birth control is the combined oral contraceptive pill. Unlike combined pills, Implanon NXT can be used by women who cannot or do not want to use estrogens. When using Implanon NXT, you do not need to remember to take a daily pill.
This is one of the reasons why Implanon NXT is very reliable (more than 99% efficacy). If in rare cases the implant is not inserted correctly or has not been inserted at all,you may not be protected against pregnancy. While using Implanon NXT, your menstrual bleeding may change and disappear, become irregular, appear few or many times, be prolonged, or in rare cases, be intense. Your bleeding pattern during the first three months usually indicates your future bleeding pattern. Menstrual pain may improve.
You can stop using Implanon NXT at any time (see also“If you want to stop using Implanon NXT”).
2. What you need to know before starting to use Implanon NXT
Hormonal Contraceptives, Including Implanon NXT, Do Not Protect Against HIV (AIDS) or Any Other Sexually Transmitted Disease.
Do Not Use Implanon NXT.
Do Not Use Implanon NXT If You Have Any of the Following Conditions. If You Have Any of These, Inform Your Doctor Before Implanon NXT Is Inserted. Your Doctor May Advise You to Use a Non-Hormonal Contraceptive Method.
- If You Are Allergic to Etonogestrel or Any of the Other Components of This Medication (Included in Section 6).
- If You Have Thrombosis. Thrombosis Is the Formation of a Blood Clot in a Blood Vessel (For Example, in the Legs (Deep Vein Thrombosis) or in the Lungs (Pulmonary Embolism)).
- If You Have or Have Had Jaundice (Yellowing of the Skin), a Severe Liver Disease (When the Liver Does Not Function Correctly), or a Liver Tumor.
- If You Have Had Breast Cancer or Genital Organ Cancer or Suspect You May Have It.
- If You Have Any Unexplained Vaginal Bleeding.
If Any of These Circumstances Appear for the First Time While Using Implanon NXT, You Must Consult Your Doctor Immediately.
Warnings and Precautions
Consult Your Doctor, Pharmacist, or Nurse Before Starting to Use Implanon NXT.
If You Are to Have Implanon NXT Inserted and Have Any of the Following Diseases, You May Require Special Medical Supervision. Your Doctor Will Explain What You Must Do. If You Have Any of These Diseases, Inform Your Doctor Before Implanon NXT Is Inserted. Also Inform Your Doctor If You Are Diagnosed with Any of These Diseases During Treatment with Implanon NXT, or If You Already Had Them and They Worsen While Using Implanon NXT.
- If You Have Had Breast Cancer;
- If You Have or Have Had a Liver Disease;
- If You Have Had a Blood Clot;
- If You Have Diabetes;
- If You Are Overweight;
- If You Have Epilepsy;
- If You Have Tuberculosis;
- If You Have High Blood Pressure (Elevated Blood Pressure);
- If You Have or Have Had Melasma (Brown or Yellowish Spots on the Skin, Especially on the Face); in This Case, Avoid Intense Sun Exposure or Ultraviolet Radiation.
Severe Circumstances
Cancer
The Following Information Was Obtained from Studies with Women Taking Daily Combined Oral Contraceptives with Two Different Female Hormones (“The Pill”). It Is Not Known If These Data Affect Women Using a Different Hormonal Contraceptive, Such as a Progestin-Only Implant Like Implanon NXT.
A Slightly Higher Frequency of Breast Cancer Cases Has Been Observed in Women Using Combined Oral Contraceptives, Although It Is Unknown If This Is Due to Treatment. For Example, It Could Be That More Tumors Are Found in Women Using Combined Oral Contraceptives Because They Attend Medical Check-Ups More Frequently. This Increased Frequency Gradually Decreases After Stopping Combined Oral Contraceptives.It Is Important to Regularly Examine Your Breasts and Inform Your Doctor If You Notice Any Lumps in Your Chest.Also Inform Your Doctor If Any Close Relatives Have or Have Had Breast Cancer.
Rarely, Cases of Benign Liver Tumors and Even Less Frequently, Malignant Liver Tumors Have Been Notified in Women Using the Pill.Contact Your Doctor Immediately If You Have Severe Abdominal Pain.
Thrombosis
A Blood Clot in a Vein (Called Thrombosis Venosa) Can Block the Vein. It Can Occur in the Veins of the Legs, Lungs (Pulmonary Embolism), or Other Organs. A Blood Clot in an Artery (Called Thrombosis Arterial) Can Block the Artery. For Example, a Blood Clot in an Artery Can Cause a Heart Attack, or in the Brain Can Cause a Stroke.
The Use of Any Combined Hormonal Contraceptive Increases the Risk in Women of Developing These Blood Clots, Compared to Women Not Using Combined Hormonal Contraceptives.
The Risk Is Not as High as the Risk of Developing a Blood Clot During Pregnancy.
It Is Believed That the Risk in Women Using Progestin-Only Contraceptives, Such as Implanon NXT, Is Lower Than in Women Using Combined Oral Contraceptives with Estrogens. Cases of Blood Clot Formation Such as Pulmonary Embolism, Deep Vein Thrombosis, Heart Attack, and Stroke Have Been Notified in Women Using Etonogestrel Implants. However, Available Data Do Not Indicate an Increased Risk of Suffering These Events in Women Using the Implant.
Consult Your Doctor Immediately If You Observe Possible Signs of Thrombosis (See Also “When to Consult Your Doctor”).
Other Situations
Changes in Menstrual Bleeding Pattern
Like Other Progestin-Only Contraceptives, Your Menstrual Bleeding Pattern May Change During Implanon NXT Use. You May Experience Changes in Frequency (Absence, Decrease, More Frequent or Continuous Bleeding), Intensity (Decrease or Increase), or Duration. 1 in 5 Women Do Not Bleed, While 1 in 5 Women Experience Frequent and/or Prolonged Bleeding. Occasionally, Cases of Intense Bleeding Have Been Reported. In Clinical Trials, Changes in Bleeding Were the Most Frequent Reason for Treatment Discontinuation (Approximately 11%). Your Menstrual Bleeding Pattern During the First Three Months Generally Indicates Your Future Menstrual Bleeding Pattern.
A Change in Menstrual Bleeding Pattern Does Not Mean Implanon NXT Is Not Suitable for You or That It Does Not Protect You Against Pregnancy. In General, No Action Is Required. Consult Your Doctor If Menstrual Bleeding Is Intense or Prolonged.
Problems Related to Implant Insertion and Removal
The Implant May Shift from Its Initial Insertion Site Due to Various Reasons, Such as Incorrect Insertion or External Causes (e.g., Manipulation of the Implant or Contact Sports). In Rare Cases, the Implant Has Been Found in the Blood Vessels of the Arm or in the Pulmonary Artery (a Blood Vessel in the Lung). If the Implant Has Shifted from Its Initial Insertion Site, Its Location May Be More Difficult to Determine, and Removal May Require a Larger Incision or a Surgical Procedure in the Hospital. If the Implant Cannot Be Found in the Arm, Your Healthcare Professional May Perform an X-Ray or Use Other Imaging Techniques to Locate It in the Chest. If the Implant Is Found in the Chest, Surgery May Be Necessary. If the Implant Cannot Be Located, and There Is No Evidence That It Has Been Expelled, Contraception and the Risk of Adverse Effects Related to Progestin May Last Longer Than Desired.
Consult Your Doctor as Soon as Possible If You Cannot Locate the Implant.
Mental Health Disorders
Some Women Using Hormonal Contraceptives Like Implanon NXT Have Notified Depression or Depressed Mood. Depression Can Be Severe and Sometimes May Induce Suicidal Thoughts. If You Experience Mood Alterations and Depressive Symptoms, Contact Your Doctor for Additional Medical Advice as Soon as Possible.
Ovarian Cysts
With the Use of All Low-Dose Hormonal Contraceptives, Small Blisters Filled with Fluid May Develop in the Ovaries, Called Ovarian Cysts, and Normally Disappear on Their Own. Occasionally, They May Cause Mild Abdominal Pain and Rarely May Cause More Serious Problems.
Implant Breakage or Folding
The Implant's Function Should Not Be Affected If the Implant Breaks or Folds While It Is Inserted in Your Arm. The Implant May Break or Fold Due to External Forces. A Broken Implant May Shift from Its Initial Insertion Site. If You Have Any Doubts, Consult Your Healthcare Professional.
Using Implanon NXT with Other Medications
Always Inform Your Doctor About the Medications or Herbal Remedies You Are Using. Also Inform Any Doctor or Pharmacist Who Prescribes Another Medication (or Pharmacist) That You Are Using Implanon NXT. They Will Inform You If You Need to Take Additional Contraceptive Measures (e.g., Using Condoms) and If Necessary, for How Long, or If You Need to Modify the Use of the Other Medication.
Some Medications
- May Affect Implanon NXT Blood Levels
- May Make It Less Effective in Preventing Pregnancy
- May Cause Unexpected Bleeding
These Include Medications Used to Treat:
- Epilepsy (e.g., Primidone, Phenobarbital, Barbiturates, Carbamazepine, Oxcarbazepine, Topiramate, Felbamate),
- Tuberculosis (e.g., Rifampicin),
- HIV-SIDA Infections (Ritonavir, Nelfinavir, Nevirapine, Efavirenz),
- Hepatitis C Infections (e.g., Boceprevir, Telaprevir);
- Medications for Other Infections (Griseofulvin),
- High Blood Pressure in Pulmonary Blood Vessels (Bosentan),
- Depressed Mood (e.g., Hypericum or St. John's Wort (Hypericum perforatum)).
Implanon NXT May Affect the Effect of Other Medications, for Example:
- Medications Containing Cyclosporine
- The Antiepileptic Lamotrigine (This May Increase the Frequency of Seizures).
Consult Your Doctor or Pharmacist Before Taking Any Medication.
Implanon NXT with Food and Drinks
There Is No Indication That Food and Drinks Affect Implanon NXT Use.
Pregnancy and Breastfeeding
Do Not Use Implanon NXT If You Are Pregnant or Suspect You May Be. If You Have Any Doubts About Being Pregnant, You Must Have a Pregnancy Test Before Implanon NXT Is Inserted.
Implanon NXT May Be Used During Lactation. Although a Small Amount of the Active Ingredient in Implanon NXT Passes into Breast Milk, It Does Not Affect Milk Production or Quality, or the Growth and Development of Infants.
Consult Your Doctor Before Using This Medication If You Are Breastfeeding.
Children and Adolescents
The Safety and Efficacy of Implanon NXT Have Not Been Established in Adolescents Under 18 Years Old.
Driving and Operating Machines
There Is No Indication That Implanon NXT Use Affects Driving and Operating Machines.
When to Consult Your Doctor
Regular Check-Ups Before Implanon NXT Is Inserted, Your Healthcare Professional Will Ask You Some Questions About Your Medical History (Clinical History) and That of Your Close Relatives. They Will Also Measure Your Blood Pressure, and Depending on Your Situation, They May Request Other Tests. During Implanon NXT Use, Your Doctor May Request a Follow-Up Visit (Routine) Some Time After Implant Insertion. In General, the Frequency and Characteristics of Post-Insertion Follow-Up Visits Will Depend on Your Situation. Your Healthcare Professional Should Palpate the Implant at Each Follow-Up Visit. Contact Your Doctor as Soon as Possible in the Following Cases:
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3. How to use Implanon NXT
Inform your healthcare professional if you are pregnant or think you may be pregnant before Implanon is insertedNXT(for example, if you have had unprotected sex in the current menstrual cycle).
How it is used
Implanon NXT must be inserted and removed only by a healthcare professional who is familiar with the procedures explained in point 7 of this prospectus.
The healthcare professional will decide with you the most suitable time for insertion. This depends on your personal situation (for example, the contraceptive method you are currently using). Unless you change from another hormonal contraceptive method, insertion will be performed on days 1-5 of your spontaneous menstrual bleeding, to rule out pregnancy. If the implant is placed after the fifth day of menstruation, you must use an additional contraceptive method (such as a condom) for the first 7 days after insertion.
Before inserting or removing Implanon NXT, you will be administered local anesthesia. Implanon NXT is inserted just under the skin, on the inner surface of the upper part of the non-dominant arm (the arm not used for writing). In point 6 of the prospectus, the procedures for inserting and removing Implanon NXT are shown.
The implant must be palpable after insertion
Once the insertion is complete, your healthcare professional will ask you to check by palpation that the implant is indeed inserted in your arm (feel the implant under the skin).A correctly inserted implant must be clearly palpable by the healthcare professional and by you, and you must be able to feel its ends between your index and thumb fingers. It should be noted that palpation does not provide a total verification of the presence of the implant.If you cannot palpate the implant immediately after insertion, or at any time, it may be that the implant has not been inserted, may have been inserted deeply, or may have moved from the place where it was inserted.
Therefore, it is essential to occasionally gently palpate the implantto ensure that you know where it is. If you cannot feel the implant at any time, contact your doctor as soon as possible.
If you have the slightest doubt, you must use a barrier contraceptive method (such as a condom) until your healthcare professional and you are completely sure that the implant is inserted. It will be necessary for your healthcare professional to perform a radiograph, ultrasound, or MRI, or to ask you to have blood tests, in order to ensure that the implant is inserted. If the implant cannot be found in the arm after an exhaustive search, your healthcare professional may perform a radiograph or use other imaging methods to locate it in the chest. Once the healthcare professional has located the implant that could not be palpated, it must be removed.
Implanon NXT must be removed or replaced before three years after insertion.
Patient Information Card
To help you remember when and where Implanon NXT was inserted, as well as the removal deadline, your healthcare professional will give you a Patient Information Card with this information.The Patient Information Card includes instructions to occasionally gently palpate the implantto ensure that you know where it is.If you cannot feel the implant at any time, contact your doctor as soon as possible.Save the card in a safe place.Show the Patient Information Card to your healthcare professionalat any visit related to the use of the implant.
If you want a new Implanon NXT to be inserted at the end of the use of the one you have, the new implant must be inserted immediately after the previous one has been removed. The new implant can be inserted in the same arm, often in the same place as the previous implant,as long as the site is in the correct location. Consult with your healthcare professional.
If you want to stop using Implanon NXT
You can ask your healthcare professional to removethe implantat any time you want.
If the implant cannot be located through palpation, your healthcare professional may perform a radiograph, ultrasound, or use magnetic resonance systems to locate the implant. Depending on the exact position of the implant, removal may be more complicated, requiring surgery.
If you do not want to become pregnant after the removal of Implanon NXT, consult with healthcare professionals about other reliable methods of birth control.
If you stop using Implanon NXT because you want to become pregnant, it is generally recommended to wait for a menstrual period before trying to conceive a child. This will help you calculate the time of delivery.
4. Possible Adverse Effects
Like all medications,this medicationcan cause side effects, although not everyone will experience them.
During use of ImplanonNXTmenstrual bleeding may be irregular. This bleeding may consist of a light spotting that does not require the use of sanitary products. It may also consist of a more intense bleeding similar to a light period and may require the use of sanitary products. It may also occur that no bleeding at all. Irregular bleeding is not a sign that the contraceptive protection of ImplanonNXThas decreased. Normally, no action will be necessary. However, consult your doctor if the bleeding is heavy and prolonged.
Severe side effects are explained in section 2 “Cancer”and “Thrombosis”. Read this section for detailed information and consult your doctor immediately if necessary.
The following side effects have been reported:
Very Common (may affect more than 1 in 10 people) | Common (may affect up to 1 in 10 people) | Uncommon (may affect up to 1 in 100 people) |
Acne; headache; weight gain; breast pain and tenderness; irregular bleeding; vaginal infection. | hair loss; dizziness; depressed mood; emotional instability; nervousness; decreased libido; increased appetite; stomach pain; nausea; flatulence; menstrual pain; weight loss; flu-like syndrome; pain; fatigue; migraines; dizziness; implantation site pain; implantation site reaction; ovarian cyst. | itching; genital itching; eruption; excessive hair growth; migraine; anxiety; difficulty falling asleep; drowsiness; diarrhea; vomiting; constipation; urinary tract infection; vaginal discomfort (e.g. discharge); breast enlargement; breast secretion; back pain; fever; fluid retention; difficulty or pain urinating; allergic reaction; inflammation and pain of the throat; rhinitis; joint pain; muscle pain; bone pain. |
In addition to these side effects, occasional increases in blood pressure have been observed. Benign intracranial hypertension (increased pressure in the head) with symptoms such as persistent headache, nausea, vomiting, and changes in vision, including blurred vision, has been reported.
Also, seborrhea (greasy skin) has been observed as a side effect. Seek immediate medical attention if you experience severe allergic reaction symptoms, such as (i) swelling of the face, tongue, or throat; (ii) difficulty swallowing; or (iii) urticaria and difficulty breathing.
During the placement or removal of ImplanonNXT, cardinals (severe in some cases), pain, swelling, or itching may occur, and in rare cases, infection. A scar or abscess may form at the implant site.Due to theimplantationof the implant,you may experience loss of consciousness. Swelling or numbness (or lack of sensation) may occur. It is possible that the implant may be expelled or displaced if it was not inserted properly. In rare cases, implantation in a blood vessel, including a pulmonary vessel, has been reported, which may be associated with difficulty breathing and/or coughing with or without bleeding.Surgery may be necessary to remove the implant.
Reports of blood clots in a vein (venous thrombosis) or artery (arterial thrombosis) have been made in women using etonogestrel implants. A blood clot in a vein may block the vein and may occur in the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs. A blood clot in an artery may block the artery and may cause a heart attack, or in the brain may cause a stroke.
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.
Reporting of side effects:
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Conservation of Implanon NXT
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging (blister and carton).
Store in the original blister.
Do not dispose of medications through drains or trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.
No special storage conditions are required.
6. Contents of the packaging and additional information
Each applicator contains an implant with
- The active principle is: etonogestrel (68 mg).
- The other components are: vinyl acetate and ethylene copolymer, barium sulfate, and magnesium stearate.
Appearance of the product and contents of the pack
Implanon NXT is a long-acting contraceptive, for subcutaneous insertion. It consists of a radiopaque implant that only contains progestogen and is preloaded in a new applicator, ready to use, easy to use, and disposable.
The implant is white, 4 cm long, and 2 mm in diameter, and contains etonogestrel and barium sulfate. The applicator has been designed to facilitate the insertion of the implant just under the skin, in the upper-inner area of the non-dominant arm (the arm not used for writing). The implant must be inserted and removed by a qualified healthcare professional familiar with both procedures. To remove the implant easily, it must be inserted just under the skin. A local anesthetic should be applied before inserting or removing the implant. The risk of complications is small if the instructions provided here are followed.
Package sizes: Box with 1 blister, box with 5 blisters.
Only some package sizes may be commercially available.
Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Phone: 915911279
Responsible for manufacturing:
N.V. Organon
Kloosterstraat 6,
5349 AB Oss,
Netherlands
This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland)with the following names:
Germany, Austria, Belgium, Slovakia, Spain, Ireland, Luxembourg, Malta, Netherlands, Poland, Portugal: Implanon NXT
Denmark, Estonia, Finland, France, Iceland, Italy, Norway, United Kingdom (Northern Ireland), Romania, Sweden: Nexplanon
Last review date of thisleaflet:May 2024.
The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)
The purpose of these pictograms is only to illustrate the procedures for inserting and removing the implantfor the womanwho will use the implant.
Nota: The exact procedures for inserting and removing Implanon NXTNXTby a qualified healthcare professional are described in the Technical Dossier and in section 7, on the other side of this leaflet.
- How to insertImplanon NXT
- The insertion of Implanon NXT should only be performed by a qualified healthcare professional who is familiar with the technique.
- To facilitate the insertion of the implant, lie on your back, with your arm flexed at the elbowand your hand under your head (or as close as possible).
- The implant will be inserted in the inner aspect of the non-dominant arm (the arm not used for writing).
- The insertion site will be marked on the skin, and the insertion site and surrounding skin will be disinfected and anesthetized.
- The skin will be stretched, and the needledirectlyinserted under the skin. Once the tip is inside the skin, the needle will be inserted completely in a parallel motion.
P, proximal (towards the shoulder);
D, distal (towards the elbow)
- The release mechanism will be unlocked by sliding the purple slider to retract the needle. The implant will remain in the upper arm when the needle is removed.
- The presence of the implant should be verified by palpating the area where it was implanted immediately after insertion (feeling it). In a correctly inserted implant, both the healthcare professional and you should be able to feel its ends between your index and middle fingers. It should be noted that palpation does not guarantee 100% presence of the implant.
- If the implant cannot be felt or its presence is doubtful, other methods should be used to confirm its presence.
- Once the healthcare professionalhas located the implant that could not be felt, it should be removed.
- Until the implant has been verified, you may not be protected against a possible pregnancy and therefore you should use a barrier contraceptive method (e.g., condom).
- A small adhesive bandage will be placed over the insertion site, andto minimize bruising (hematoma), a compressive bandage will be applied.You can remove the compressive bandage in 24hours and the small adhesive bandage over the insertion site in 3-5days.
- After the implant insertion, the healthcare professional will give you a Patient Information Cardin which the insertion site, the date of insertion, and the deadline for removal or replacement of the implant will be indicated. Keep this card in a safe place, as the information it contains may be useful for future removal.
- How to remove Implanon NXTNXT
- The removal of the implant should only be performed by a qualified healthcare professional who is familiar with the technique.
- The implant can be removed when you request it orat most three years after it was inserted.
- The location of the insertion site of the implant will be indicated on the Patient Information Card.
- The healthcare professional will locate the implant. If the implant cannot be located, the healthcare professional may need to perform an X-ray,a CT scan,an ultrasound, or an MRI.
- To facilitate the removal of the implant, lie on your back,with your arm flexed at the elbowand your hand under your head (or as close as possible).
- The upper part of your arm will be disinfected and anesthetized.
- A small incision will be made along the arm, just below the end of the implant.
- The implant will be gently pushed towards the incision and removed with forceps.
- In some cases, the implant may be surrounded by a layer of harder tissue. In this case, a small cut will be made in the tissue before removing the implant.
- If you want the healthcare professional to replace Implanon NXT with another implant, the new implant can be inserted in the same incision while the site is in the correct location.
- The incision will be closed with sterile adhesive sutures.
- A compressive bandage will be applied to minimize bruising (hematoma). You can remove the compressive bandage in 24hours and the sterile adhesive sutures over the insertion site in 3-5days.
The following information is intended only for thehealthcare professional.
7.Information for the healthcare professional
7.1When to insert Implanon NXT
IMPORTANT: Pregnancy should be ruled out before inserting the implant.
The timing of insertion depends on the woman's recent history of contraceptive use, as follows:
If the woman has not been using hormonal contraceptives in the last month
The implant should be inserted between Day1 (first day of menstruation) and Day5 of the menstrual cycle, even if the woman is still bleeding.
If the insertion is performed according to the instructions provided, no additional contraceptive method is necessary. If there is any deviation from the correct timing for implant insertion, the woman should use a barrier contraceptive method for 7days after implant insertion. If sexual intercourse has already occurred, pregnancy should be ruled out before insertion.
Change from another hormonal contraceptive to Implanon NXTNXT
Change after a combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or transdermal patch)
The implant should be inserted preferably the day after the last active tablet (the last tablet with active ingredients) of the previous combined oral contraceptive or the day of removal of the vaginal ring or transdermal patch. At the latest, the implant should be inserted the day after the break of any of the aforementioned treatments or the day of administration of inactive tablets (placebo) of the previous combined oral contraceptive. Not all contraceptive methods (transdermal patch, vaginal ring) are commercially available in all countries.
If the insertion is performed according to the instructions provided, no additional contraceptive method is necessary. If there is any deviation from the correct timing for implant insertion, the woman should use a barrier contraceptive method for 7days after implant insertion. If sexual intercourse has already occurred, pregnancy should be ruled out before insertion.
Change after a progestogen-only contraceptive (e.g., progestogen-only pill, injectable, another implant, or intrauterine system of progestogen release [IUS])
Given the various types of progestogen-only contraceptives, the insertion of the implant should be performed as follows:
- Injectables: Insert the implant the day the next injection is due.
- Progestogen-only pill: A woman using the progestogen-only pill can switch to Implanon NXTNXTon any day of the month. The implant should be inserted within 24hours after taking the last tablet.
- Implant/Intrauterine system of progestogen release (IUS): Insert the implant the same day the previous implant or IUS is removed.
If the insertion is performed according to the instructions provided, no additional contraceptive method is necessary. If there is any deviation from the correct timing for implant insertion, the woman should use a barrier contraceptive method for 7days after implant insertion. If sexual intercourse has already occurred, pregnancy should be ruled out before insertion.
After an induced or spontaneous abortion
The implant can be inserted immediately after an induced or spontaneous abortion.
- First trimester: If insertedwithin 5days after, no additional contraceptive method is necessary.
- Second trimester: If insertedwithin 21days after, no additional contraceptive method is necessary.
If inserted after the correct timing for implant insertion, the woman should use a barrier contraceptive method for 7days after implant insertion. If sexual intercourse has already occurred, pregnancy should be ruled out before insertion.
After delivery
The implant can be inserted immediately after delivery, both in breastfeeding women and in those who are notbreastfeeding, after an individual assessment of the benefit/risk.
- If insertedwithin 21days after, no additional contraceptive method is necessary.
- If insertedafter 21days after delivery, the woman should use a barrier contraceptive method for 7days after implant insertion. If sexual intercourse has already occurred, pregnancy should be ruled out before insertion.
7.2How to insert Implanon NXTNXT
The basis for a successful use and subsequent removal of Implanon NXTNXT, consists of the correct and careful insertion of the implant subcutaneously in the non-dominant arm, according to the instructions provided below. Both the healthcare professional and the woman should be able to feel and note the implant under the skin of the woman after its placement.
The implant must be inserted subcutaneously just under the skin in the inner aspect of the upper arm of the non-dominant arm.
- An implant inserted at a greater depth than the subcutaneous layer (deep insertion) may not be palpable and may make it difficult to locate and/or remove (see section4.2 How to remove Implanon NXTNXTand section4.4 of the Technical Dossier).
- If the implant is inserted deeply, it may cause neurological or vascular damage. Cases of deep or incorrect insertions have been associated with paresthesia (neurological damage) and implant displacement (due to intramuscular or fascial insertion), and in rare cases, intravascular insertion.
The insertion of Implanon NXTNXTshould be performed in aseptic conditions and only by a qualified healthcare professional who is familiar with the technique. The implant should only be inserted with the preloaded applicator.
Insertion procedure
To help ensure that the implant is inserted just under the skin, the healthcare professional should position themselves so that they can see the advancement of the needle from the side and not from above the arm. From the side view, the insertion site and the movement of the needle just under the skin can be clearly seen.
For illustrative purposes, the following figures represent the inner aspect of the left arm.
| Figure1 | |
Identify the insertion site, which is located in the inner aspect of the upper arm of the non-dominant arm. The insertion site is located over the triceps muscle, about 8-10 cm from the medial epicondyle of the humerus and 3-5 cm posterior (below) to the canal (groove) between the biceps and triceps muscles (Figures2a, 2b, and 2c). This location has been selected to avoid the large blood vessels and nerves located within and around the canal. If it is not possible to insert the implant in this location (e.g., in women with thin arms), it should be inserted posterior to the canal and as far away from it as possible. | ||
Figure2a Figure2b P - proximal (towards the shoulder); D - distal (towards the elbow) Figure 2c Transverse section of the upper left arm, viewed from the elbow Medial (inner aspect of the arm) Lateral (outer aspect of the arm) | ||
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| Figure3 | |
To help ensure that the implant is inserted just under the skin, you should position yourself so that you can see the advancement of the needle from the side and not from above the arm. From the side view, you can see the insertion site and the movement of the needle just under the skin (see Figure 6). | Figure4 Figure5a | |
| Figure5b | |
If the tip of the needle emerges from the skin before completing the insertion of the needle, withdraw the needle and readjust it to a subcutaneous position to complete the insertion procedure. | Figure 6 | |
Do not move()the applicator while moving the purple release mechanism(Figure 8b). In this way, the implant is now in its final subcutaneous position, and the needle is blocked within the applicator body. You can now remove the applicator (Figure 8c). | Figure7 Figure 8a | |
Figure 8b | Figure 8c | |
If the applicator does not remain in the same position during this procedure or if the purple release mechanism does not move backward completely until it stops, the implant will not be correctly inserted and may protrude from the insertion site. If the implant protrudes from the insertion site, remove the implant and with a new applicator, perform a new procedure in the same insertion site.If the implant protrudes, do not push it back into the incision. | ||
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| Figure9 |
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If the implant is not palpable after insertion
If you cannot feel the implant orwhen its presence is doubtful,the implant may not have been inserted or may have been inserted deeply:
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7.3How to remove Implanon NXT
The removal of the implant should only be performed in aseptic conditions by a qualified healthcare professional who is familiar with the removal technique.If you are not familiar with the removal technique, please contact the Marketing Authorization Holder, Organon Salud, S.L.
Before starting the removal procedure, the healthcare professional should evaluate the implant's location.Verify the exact location of the implant in the arm by palpation.
If the implant is not palpable, consult the Patient Information Card or the woman's medical record to verify which arm the implant was inserted into. If the implant cannot be palpated, it may have been inserted too deeply or may have migrated. Note that the implant may be close to blood vessels and nerves. The removal of non-palpable implants should only be performed by a healthcare professional with experience in removing deeply inserted implants and familiar with the anatomy of the arm. For further information, please contact the Marketing Authorization Holder, Organon Salud, S.L.
See the section “Localization and removal of a non-palpable implant” below if the implant is not palpable.
Removal procedure for a palpable implant
For illustrative purposes, the following figures represent the inner aspect of the left arm.
| Figure 10 |
| Figure11 P, proximal (towards the shoulder); D, distal (towards the elbow) |
| Figure12 |
| Figure13 |
If necessary, remove the tissue adhering to the tip of the implant by dissection. If the tip of the implant is not exposed after dissection, make an incision in the tissue sheath and then remove the implant with forceps (Figures 15 and 16). | Figure14 |
Figure15 | Figure16 |
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- If you cannot grasp the implant, stop the procedure and direct the woman to a healthcare professional with experience in complex implant removal or contact the Marketing Authorization Holder, Organon Salud, S.L.
Figure17 | Figure18 | Figure19 |
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