Active ingredients: Leuprorelin (Leuprorelin Acetate)
ENANTONE 3.75 mg / ml powder and solvent for prolonged-release suspension for injection for intramuscular or subcutaneous use
Enantone package leaflets are available for packs:- ENANTONE 3.75 mg / ml powder and solvent for prolonged-release suspension for injection for intramuscular or subcutaneous use
- ENANTONE 11.25 mg / ml powder and solvent for prolonged-release suspension for injection for intramuscular or subcutaneous use
- ENANTONE DIE 1 mg / 0.2 ml solution for injection for subcutaneous use
Why is Enantone used? What is it for?
ENANTONE is a medicinal product based on leuprorelin acetate, belonging to the group of gonadotropin releasing hormone analogues.
ENANTONE is indicated in the treatment of:
In the "man:
Prostate cancer and its secondary effects.
In women:
Genital and extragenital endometriosis (stages I-IV)
Breast cancer in pre- and perimenopausal women where hormonal treatment is indicated.
Uterine fibroids
Pre-surgical therapy - lasting three months - of myomectomy and hysterectomy in the metrorrhagic patient; pre-surgical treatment - lasting one month - of endometrial ablation and resection of the intrauterine septa by hysteroscopy.
In childhood:
Precocious puberty (before the age of 8 in the girl and before the age of 10 in the boy)
Talk to your doctor if you don't feel better or if you feel worse.
Contraindications When Enantone should not be used
Do not take ENANTONE
- if you are allergic to leuprorelin or any of the other ingredients of this medicine (listed in section 6) or synthetic LH-RH or derivatives of LH-RH.
- Pregnancy.
- Feeding time.
- Contraindicated in the presence of undiagnosed vaginal bleeding.
Precautions for use What you need to know before taking Enantone
Talk to your doctor or pharmacist before taking ENANTONE.
Talk to your doctor if you have any of the following: any heart or blood vessel disorders, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these disorders. The risk of heart rhythm problems may increase with the use of Enantone. In an initial period, after the first administration of the drug, there may be a temporary worsening of the clinical picture. However, these symptoms disappear with continued treatment.
Epidemiological data have shown that changes in metabolic conditions (e.g. decreased glucose tolerance or aggravation of pre-existing diabetes) as well as an increased risk of cardiovascular disease may occur during androgen deprivation therapy. However, prospective data did not confirm the link between treatment with GnRH analogues and increased cardiovascular mortality. Patients at high risk of metabolic or cardiovascular disease should be adequately monitored.
a) In men, isolated cases of worsening of clinical symptoms, such as bone pain, urinary tract obstruction and haematuria, weakness of the lower limbs and paraesthesia, have been reported in the initial phase of treatment with LH-RH analogues. transient type (see undesirable effects), due to a temporary increase in serum testosterone level This justifies a particularly careful medical monitoring during the first weeks of treatment for patients with urinary tract obstruction and for patients with vertebral metastases.
For the same reason, subjects presenting warning signs of spinal cord compression should be carefully monitored at the start of treatment.
In the initial period of treatment, a transient increase in acid phosphatase may be noted.
It may be useful to periodically check for testosteronemia which must not exceed 1 ng / ml, PSA and acid phosphatase, which may transiently increase in the first weeks of treatment.
The therapeutic response can be assessed at the bone level through scintigraphic and / or tomographic examination; at the prostatic level, the response will be assessed by ultrasound and / or tomography (in addition to clinical examination and rectal exploration). In case of prolonged treatment, it may be useful to periodically check the bone densitometry values as the LH-RH analogues produce a state of hypoandrogenism, which can also occur in patients undergoing bilateral orchiectomy, which induces a reduction in bone mineral content.
In patients with additional risk factors, it can lead to osteoporosis and an increased risk of bone fractures.
b) In the woman, in case of prolonged treatment, it may be useful to periodically check the bone densitometry values as the analogues of the gonadotropin releasing hormone produce a state of hypoestrogenism which can also occur in patients undergoing bilateral ovariectomy, which induces a reduction of bone mineral content. In patients with additional risk factors, it can lead to osteoporosis and an increased risk of bone fractures. Therefore, the duration of treatment should still be limited to 6 months. When repeat treatment is necessary, they should bone mass checks should be performed as much as possible.
Before treatment, women of childbearing potential must undergo careful checks to rule out an ongoing pregnancy. Non-hormonal contraceptive methods should be used during treatment. Such methods must be maintained until the menstrual cycle resumes.
In women suffering from endometriosis and uterine fibroids, any onset of severe bleeding during treatment is to be considered abnormal and involves checking the plasma estradiol level which, if less than 50 pg / ml, requires investigations for the identification of any associated organic lesions.
If severe vaginal bleeding occurs during treatment, the patient should be monitored closely and, if necessary, appropriate action should be taken.
Children and adolescents
c) In childhood, in relation to weight growth, it is advisable to regularly check that the levels of estradiol / testosterone remain prepubertal especially if the weight approaches 20 kg.
Cases of depression, including severe depression, have been reported in patients taking Enantone. Tell your doctor if you are taking Enantone and have a depressed mood.
In the girl with precocious puberty, the appearance of small genital hemorrhages after the first injection requires the addition of adequate treatment only if this symptom "continues" beyond the first month of treatment.
In patients with progressive brain tumors, caution should be exercised if the risk from a clinical point of view substantially outweighs the benefits.
Interactions Which drugs or foods can modify the effect of Enantone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Enanthone may interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or may increase the risk of heart rhythm problems when used with certain other medicines (e.g. methadone (used to relieve pain and drug addiction detox programs), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illness).
Warnings It is important to know that:
Pregnancy and breastfeeding
The medicine should not be used during pregnancy and breastfeeding (see section 2. Do not use ENANTONE).
Before treatment, women of childbearing potential must undergo careful checks to rule out an ongoing pregnancy. Non-hormonal contraceptive methods should be used during treatment. Such methods must be maintained until the menstrual cycle resumes.
Driving and using machines
ENANTONE can affect the ability to drive or use machines.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dosage and method of use How to use Enantone: Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is 3.75 mg (full contents of the pre-filled syringe) of the active ingredient to be administered once a month in men and women.
The duration of treatment for endometriosis is 6 months.
The duration of treatment for uterine fibroids is 6 months.
- Screw the plunger onto the end cap until the end cap starts to turn.
- Check that the needle is secure by screwing the needle cap clockwise. Do not over tighten.
- Keeping the syringe straight up, SLOWLY lower the plunger by pushing the plunger until the intermediate plug reaches the blue line in the center of the syringe. NOTE: Pushing the plunger quickly or beyond the blue line may cause a loss of suspension from the needle.
- Gently tap the syringe into the palm of your hand while keeping the syringe straight to completely mix the particles to form a uniform suspension. The suspension will appear cloudy. NOTE: Avoid hard banging to prevent bubble formation.
- If particles adhere to the cap, tap the syringe with your finger.
- Remove the needle cap and push the plunger to push the air out of the syringe.
- At the time of injection, check the direction of the safety device (the round mark must point upwards, as shown in fig. 1).
- Inject the contents of the syringe subcutaneously or intramuscularly as for a normal injection.
- AFTER THE INJECTION, move the needle away from the patient and immediately activate the safety device to cover the needle, pushing the flap forward with a finger, as shown in figure 2, until you hear the click that indicates that the device is fully extended and the needle covered (fig. 3 and 4).
Use in children and adolescents
In the child with precocious puberty the necessary dosage is equal to: 1.88 mg (half the content of the pre-filled syringe) in children weighing less than 20 kg, 3.75 mg (full content of the pre-filled syringe) in children of the same weight. or more than 20 Kg.
Overdose What to do if you have taken too much Enanthone
If you take more ENANTONE than you should
In the event of an overdose, the patient should be closely monitored and symptomatic and supportive treatment instituted.
If you forget to take ENANTONE
Do not take a double dose to make up for a forgotten dose.
If you stop taking ENANTONE
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Enantone
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are listed by frequency below:
Very common (may affect more than 1 in 10 people)
Sleep disturbances (sleepiness or insomnia), vaginitis
Common (may affect more than 1 in 100 people)
Mood disorders (long-term use), depression (long-term use)
Dyspnea, constipation, vaginal dryness
Uncommon (may affect more than 1 in 1000 people)
Fever, hypersensitivity reactions including rash, itching and rarely wheezing, flushing, mood disorders (short term use), depression (short term use), headache (occasionally severe).
Rare (may affect more than 1 in 10,000 people)
Impotence, decreased libido, dizziness, paraesthesia, sweating, palpitations, nausea, vomiting, diarrhea, anorexia, hair loss, arthralgia, myalgia, reduced bone mass which can occur with the use of GnRH agonists, changes in breast size in women , peripheral edema, weight changes, injection site reactions, liver function test elevations (usually transient)
Very rare (may affect less than 1 in 10,000 people)
Anaphylactic reactions, pituitary apoplexy has been reported following initial administration in patients with pituitary adenoma, visual disturbances, orchiartrophy, gynaecomastia in men.
Not known (frequency cannot be estimated from the available data).
Changes in the ECG tracing (QT prolongation). Men: In the event of tumor recurrence following therapy with Enantone, an "exacerbation of any signs and symptoms related to the disease, eg bone pain, obstruction of the urinary tract, weakness may occur. extremities and paraesthesia These symptoms lead to continuation of therapy.
Women: The most recurrent side effects are associated with hypoestrogenism. Estrogen levels return to normal upon discontinuation of treatment.
The state of hypoestrogenism leads to a slight decrease in bone density during treatment, which is sometimes not reversible (see section Warnings and precautions).
Vaginal bleeding may occur during therapy due to acute degeneration of submucosal fibroids (see section Warnings and precautions).
Additional side effects in children and adolescents
As with other medicinal products of this class, pituitary apoplexy has been reported following initial administration in patients with pituitary adenoma.
Small genital bleeding may occur in girls with precocious puberty after the first injection (see Warnings and precautions).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety of this medicine.
Expiry and Retention
This medicinal product does not require any special storage temperatures.
Do not refrigerate or freeze.
Store in the original package to protect the medicine from light.
Once reconstituted, the suspension should be administered immediately.
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 expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What ENANTONE contains
- The active ingredient is leuprorelin.
- The other ingredients are copolymer of DL-lactic acid and glycolic acid, mannitol, gelatin Solvent: mannitol, carmellose sodium, polysorbate 80, water for injections
Description of the appearance of ENANTONE and contents of the pack
White powder and clear, colorless solvent for prolonged-release suspension for injection for intramuscular or subcutaneous use.
Carton of 1 pre-filled double chamber syringe, containing the lyophilized powder (3.75 mg leuprorelin acetate) in the anterior chamber and the solvent (1 ml) in the posterior chamber, 1 needle with safety device, 1 plunger.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ENANTONE 3.75 MG / ML POWDER AND SOLVENT FOR INJECTABLE SUSPENSION WITH PROLONGED RELEASE FOR INTRAMUSCULAR OR SUBCUTANEOUS USE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe contains:
Active ingredient: Leuprorelin acetate 3.75 mg
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Prolonged-release powder and solvent for suspension for injection for intramuscular or subcutaneous use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
In the "man:
Prostate cancer and its secondary effects.
In the woman:
Endometriosis with genital and extragenital localization (stages I-IV).
Breast cancer in pre- and perimenopausal women where hormonal treatment is indicated.
Uterine fibroids.
Pre-surgical therapy - lasting three months - of myomectomy and hysterectomy in the metrorrhagic patient; pre-surgical treatment - lasting one month - of endometrial ablation and resection of the intrauterine septa by hysteroscopy.
In children:
Precocious puberty (before the age of 8 in the girl and before the age of 10 in the boy).
04.2 Posology and method of administration
Dosage
In both men and women, the required dosage is 3.75 mg (full content of the pre-filled syringe) of the active ingredient to be administered once a month.
In the child with precocious puberty the necessary dosage is equal to:
1.88 mg (half the content of the pre-filled syringe) in children weighing less than 20 kg.
3.75 mg (full content of the pre-filled syringe) in a child weighing 20 kg or more.
The duration of treatment for endometriosis is 6 months.
The duration of treatment for uterine fibroids is 6 months.
How to use
• Screw the plunger onto the end cap, until the end cap starts to turn.
• Check that the needle is secure by screwing the needle cap clockwise. Do not over tighten.
• Keeping the syringe straight up, SLOWLY lower the plunger by pushing the plunger until the intermediate cap reaches the blue line in the center of the syringe.
NOTE: Pushing the plunger quickly or beyond the blue line may cause the suspension to leak from the needle.
• Gently tap the syringe into the palm of your hand while keeping the syringe straight to completely mix the particles to form a uniform suspension. The suspension will appear cloudy.
NOTE: Avoid hard banging to prevent bubble formation.
• If particles adhere to the cap, tap the syringe with your finger.
• Remove the needle cap and push the plunger to push the air out of the syringe.
• At the time of injection, check the direction of the safety device (the round mark must point upwards).
• Inject the contents of the syringe subcutaneously or intramuscularly as for a normal injection.
• AFTER THE INJECTION, move the needle away from the patient and immediately activate the safety device to cover the needle, pushing the flap forward with a finger, until you hear the click indicating that the device is fully extended and " covered needle.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients,
Pregnancy. Feeding time.
Contraindicated in the presence of undiagnosed vaginal bleeding.
04.4 Special warnings and appropriate precautions for use
In the "manIn the initial phase of treatment with LH-RH analogues, isolated cases of worsening of clinical symptoms, such as bone pain, urinary tract obstruction and haematuria, weakness of the lower limbs and paraesthesia, of transient type, have been reported (see section 4.8) due to a temporary increase in serum testosterone level. This justifies a particularly careful medical monitoring during the first weeks of treatment for patients with obstruction of the urinary tract and for patients with vertebral metastases.
For the same reason, subjects presenting warning signs of spinal cord compression should be carefully monitored at the start of treatment.
In the initial period of treatment, a transient increase in acid phosphatase may be noted.
The initiation of treatment is sometimes accompanied by accentuation of clinical signs and symptoms (particularly bone pain).
A few cases of accentuation of pre-existing haematuria or urinary obstruction, feeling of weakness or paresthesia in the lower limbs have been reported with the analogues of the LH-RH.
These manifestations are usually transient, and disappear within one to two weeks of starting treatment. Furthermore, the possibility of a temporary exacerbation of symptoms during the first weeks of treatment should be considered in patients with neurological signs of spinal cord compression or those who have urinary obstruction.
It may be useful to periodically check for testosteronemia which must not exceed 1 ng / ml, PSA and acid phosphatase, which may transiently increase in the first weeks of treatment.
The therapeutic response can be assessed at the bone level through scintigraphic and / or tomographic examination; at the prostatic level, the response will be assessed by ultrasound and / or tomography (in addition to clinical examination and rectal exploration).
In the woman suffering from endometriosis and uterine fibroids the possible onset of severe bleeding during treatment is to be considered abnormal and involves checking the plasma estradiol rate which, if less than 50 pg / ml, requires investigations to identify any lesions associated organic.
If severe vaginal bleeding occurs during treatment, the patient should be monitored closely and, if necessary, appropriate action should be taken.
Before treatment, women of childbearing potential must undergo careful checks to rule out an ongoing pregnancy. Non-hormonal contraceptive methods should be used during treatment. Such methods must be maintained until the menstrual cycle resumes.
In case of prolonged treatment, it may be useful to periodically check the bone densitometry values as the LHRH analogues produce a state of hypoestrogenism which induces a reduction in bone mineral content. The duration of treatment should however be limited to 6 months.
In an initial period, after the first administration of the drug, a temporary worsening of the clinical picture may occur. However, this symptomatology disappears with continued treatment.
In the little girl affected by precocious puberty, gonadal stimulation may be responsible for small genital hemorrhages after the first injection which require the addition of adequate treatment only if these occur after the first month of treatment.
In childhood: the inhibition of the pituitary gonadotropic activity occurs in both sexes with the suppression of the secretion of estradiol or testosterone, with the lowering of the LH peak and with an improvement in the statural age / bone age ratio.
Due to the growth of the child it is advisable to regularly check that the estradiol / testosterone levels remain low especially if the weight approaches 20 kg.
There is an increased risk of incident depression (which can be severe) in patients being treated with GNRH agonists, such as leuprorelin. Patients should be informed accordingly and treated appropriately if symptoms occur.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions with other drugs have been reported.
04.6 Pregnancy and lactation
The medicine should not be used during pregnancy and breastfeeding.
Before treatment, women of childbearing potential must undergo careful checks to rule out an ongoing pregnancy. Non-hormonal contraceptive methods should be used during treatment. Such methods must be maintained until the menstrual cycle resumes.
04.7 Effects on ability to drive and use machines
No interference was reported.
04.8 Undesirable effects
The most common effect during leuprolide therapy is hot flashes secondary to endocrine changes caused by the product (suppression of testosteronic secretion in men and menopausal-like hypoestrogenism in women). Other endocrine effects in men are decreased libido. , loss of bone mass, impotence, gynecomastia and decrease in testicular volume, testicular atrophy and in women decreased libido, menstrual disturbances, vaginitis with blood loss, vaginal dryness, breast volume reduction, arthralgia, myalgia.
Other effects of the drug in man are represented by the initial worsening of obstructive urinary symptoms (dysuria, hematuria, lumbar pain), musculoskeletal symptoms (bone pain) or neurological signs of compression (sense of weakness or paraesthesia in the lower limbs). These manifestations are usually transient and usually disappear within one to two weeks of starting therapy.
The following side effects have also been reported during treatment with the drug: headache, nausea, vomiting, alvus disorders (constipation or diarrhea), anorexia, fever, increased sweating, skin rash, itching, anaphylactic reactions, site reactions injection, hair loss, dizziness, sleep disturbances (drowsiness or insomnia), generalized pain, paraesthesia, visual disturbances, psychiatric disorders: irritability, emotional lability, mood changes and depression (frequency: common (long-term use ); uncommon (short-term use); palpitations, edema, dyspnoea, weight changes, changes, usually transient, in liver function parameters.
In girls with precocious puberty, small genital bleeding is possible after the first injection (see section 4.4). Irritation at the injection site is possible.
As with other drugs of this class, very rare cases of pituitary apoplexy have been reported following initial administration in patients with pituitary adenoma.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Gonadotropin releasing hormone analogues - ATC code: L02AE02
Leuprorelin acetate active ingredient of Enanthone 3.75 mg is an analogue of the natural hormone LH-RH. Leuprorelin is much more active than natural LH-RH and can be defined as a superagonist of the hypothalamic physiological decapeptide. Leuprorelin is not chemically related to steroids.
Enantone 3.75 mg is formulated in such a way as to allow, after administration, a continuous and uniform release of the active principle from the injection site over a period of one month.
After administration of Enanthone 3.75 mg there is initially a transient increase in sex steroids due to stimulation of the pituitary secretion of gonadotropins (agonist effect). Within 3 weeks of single administration there is a secretory inhibition of the pituitary gland (antagonistic effect) and suppression of gonadal function.
In the "man this produces a reduction of testosteronemia to the characteristic values of castration which is maintained for at least 6 weeks.
With repeated administration every month, suppression of testosteronemia is maintained throughout the duration of treatment.
In the woman induces a state of hypoestrogenism comparable to that observed in menopause.
With repeated administration every month, this state of hypoestrogenism is maintained for the duration of the treatment, causing a drop in estradiol and progesterone, creating a condition of "reversible castration".
These effects can be usefully employed in hormone-dependent diseases. As regards breast cancer, in addition to the presence of specific receptors for GnRH, a direct action of LHRH analogues on tumor tissue has been demonstrated regardless of estrogen depletion.
In childhood the inhibition of the early gonadotropic pituitary activity manifests itself, in both sexes, with the lowering of the LH and FSH peaks, with the suppression of sex hormones (estradiol or testosterone). This results in an improvement in the chronological age / bone age ratio. Initial transient gonadal hyperstimulation may be responsible for minor genital bleeding in the child during the first month of treatment.
05.2 Pharmacokinetic properties
Immediately following the administration of ENANTONE 3.75 mg, a blood peak of leuprolide occurs, followed by a plateau level proportional to the administered dose. The product is released for about a month (4-6 weeks) in a uniform and constant way (2.8% / day of the administered dose) from the injection site without particular difference between the administration routes (im, sc) and the 2 species of animals used (dog and rat). In tests of repeated administration no accumulation phenomena were observed.
After injection of Enanthone 3.75 mg there is a dose-dependent increase in serum concentrations of leuprolide. Within 3 hours of administration, serum peaks are reached (initial phase of rapid absorption) which is followed by the subsequent phase of decrease or phase of slow release of the active principle which continues steadily for at least 35 days from administration. Serum levels of leuprolide are still detectable after 42 days.
In men, the single administration of Enanthone 3.75 mg produced (after a transient increase within the first week) a rapid decrease within 2-4 weeks of the serum levels of testosterone and its active metabolite, dihydrotestosterone, up to castration values in all patients evaluated. This phenomenon lasted until the last observation period of the study (5th-7th week).
In women, regular administration of Enanthone 3.75 mg results in suppression of gonadal function which induces a "hypogonadotropic amenorrhea.
In children, the administration of slow-release 3.75 mg leuprorelin has shown that the concentrations of the active ingredient are similar to those of adults and that they cause a decrease in estradiol / testosterone hormone rates comparable to prepubertal levels.
05.3 Preclinical safety data
The maximum single non-lethal dose in mice and rats by parenteral route was found to be greater than 100 mg / kg with the active ingredient alone. The LD50 of Enanthone 3.75 mg is greater than 2000 mg / kg by the im route. In the chronic toxicity studies conducted on monkeys, rats and mice, no unexpected toxic effects emerged but only pharmacodynamic effects attributable to the product. In the rat treated for 2 years it is a (not statistically significant) trend of benign pituitary adenoma emerged. These modifications, which have no correlation in humans, are attributable to the animal species used and the pharmacodynamics of the product.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Dust : copolymer of DL-lactic acid and glycolic acid, mannitol, gelatin
Solvent: mannitol, carmellose sodium, polysorbate 80, water for injections
06.2 Incompatibility
Not applicable.
06.3 Period of validity
3 years.
Once reconstituted, the suspension should be administered immediately
06.4 Special precautions for storage
This medicinal product does not require any special storage temperatures
Do not refrigerate or freeze.
Store in the original package to protect the medicine from light.
For storage conditions after reconstitution see section 6.3
06.5 Nature of the immediate packaging and contents of the package
Double chamber pre-filled syringe containing lyophilized powder (3.75 mg leuprorelin acetate) in the anterior chamber and sterile solvent (1 ml) in the posterior chamber
1 x 23 gauge needle with safety device; 1 plunger
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Takeda Italia S.p.A. - Via Elio Vittorini 129 - Rome
under license from Takeda Pharmaceutical Company Ltd - Osaka (Japan)
08.0 MARKETING AUTHORIZATION NUMBER
ENANTONE 3.75 mg / ml powder and solvent for prolonged-release suspension for injection for intramuscular or subcutaneous use - 1 double chamber pre-filled syringe A.I.C. 027066125
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
July 2013
10.0 DATE OF REVISION OF THE TEXT
05/2014
