Active ingredients: Sevelamer (sevelamer carbonate)
Renvela 800 mg film-coated tablets
Renvela package inserts are available for pack sizes:- Renvela 800 mg film-coated tablets
- Renvela 1.6g Powder for Oral Suspension
- Renvela 2.4g Powder for Oral Suspension
Indications Why is Renvela used? What is it for?
Renvela contains the active substance sevelamer carbonate which works by preventing the absorption of phosphate present in food into the digestive system and in this way reduces the levels of phosphate in the blood.
Renvela is used to control hyperphosphataemia (high levels of phosphate in the blood) in:
- adult patients on dialysis (a blood clearance technique). The medicine can be used in patients undergoing hemodialysis (using a blood filtration machine) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal membrane of the body filters the blood);
- Chronic kidney disease patients who are not on dialysis and have a blood phosphate level equal to or greater than 1.78 mmol / L.
Renvela must be used with other treatments, such as calcium and vitamin D supplements, to prevent the development of bone disease.
Increased levels of phosphate in the blood can cause solid deposits to form in the body called calcifications. These deposits can stiffen blood vessels and make it more difficult for blood to distribute throughout the body. In addition, the increase in phosphate in the blood can cause itchy skin, red eyes, bone pain and fractures.
Contraindications When Renvela should not be used
Do not take Renvela
- if you have low levels of phosphate in your blood (your doctor will check you)
- if you suffer from intestinal obstruction
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before you take Renvela
Talk to your doctor before taking Renvela if any of the following apply to you:
- swallowing problems
- motility (movement) problems in the stomach and intestines
- frequent vomiting
- active inflammation of the intestine
- has undergone major stomach or bowel surgery
Children and adolescents
The safety and efficacy in children (below 18 years) have not been studied. Therefore, the use of Renvela is not recommended in children.
Further treatments:
Due to kidney disease or dialysis treatment, you may:
- experience low or high levels of calcium in the blood. As Renvela does not contain calcium, your doctor may prescribe calcium supplements.
- have a low level of vitamin D in the blood. As a result, your doctor may check the vitamin D levels in your blood and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also have low levels of vitamins A, E, K and folic acid in your blood, and therefore your doctor may check these levels and prescribe vitamin supplements as needed.
Special note for patients undergoing peritoneal dialysis:
You may have peritonitis (abdominal fluid infection) associated with peritoneal dialysis. This risk can be reduced by adopting rigorous aseptic techniques when replacing bags. Tell your doctor immediately if you get any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or abdominal stiffness, constipation, fever, chills, nausea or vomiting.
You will be subjected to more careful checks in case of problems related to low levels of vitamins A, D, E, K and folic acid.
Interactions Which drugs or foods may change the effect of Renvela
Tell your doctor if you are taking or have recently taken or might take any other medicines.
- Renvela must not be taken simultaneously with ciprofloxacin (an antibiotic).
- If you are taking medicines for heart rhythm problems or epilepsy, consult your doctor when taking Renvela.
- Renvela may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil and tacrolimus (medicines used to reduce the activity of the immune system). Your doctor will advise you on what to do if you take these medicines.
- The concomitant use of levothyroxine (a medicine used to treat low thyroid hormone levels) and Renvela has uncommonly resulted in thyroid hormone deficiency in some patients. As a result, the doctor may monitor thyroid stimulating hormone levels more closely in the his blood.
- If you are taking medicines such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease or stomach ulcer, consult your doctor when taking Renvela.
Your doctor will check for any interactions between Renvela and other medicines at regular intervals.
In some cases, when Renvela has to be taken at the same time as another medicine, your doctor may advise you to take this medicine 1 hour before or 3 hours after taking Renvela, or consider checking the levels of that medicine in your blood.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is not known whether Renvela affects the fetus.
Tell your doctor if you want to breastfeed your baby. It is not known whether Renvela can pass through breast milk and affect the baby.
Driving and using machines
Renvela is unlikely to affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Renvela: Posology
You must take Renvela exactly as your doctor has told you. Your doctor will base the dose on your blood phosphate level.
The recommended starting dose of Renvela tablets for adults and the elderly (over 65 years of age) is one or two tablets of 800 mg, 3 times a day with main meals.
The tablets should be swallowed whole. Do not crush, chew or break the tablets.
Your doctor will initially check the phosphate levels in your blood every 2-4 weeks and may adjust the dose of Renvela, if necessary, to reach the appropriate level of phosphate.
Patients taking Renvela must adhere to the prescribed diet.
If you forget to take Renvela
If you miss a dose, take your next dose at the usual time with a meal. Do not take a double dose to make up for a forgotten dose.
Overdose What to do if you have taken too much Renvela
In the event of a possible overdose, contact your doctor immediately.
Side Effects What are the side effects of Renvela
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since constipation can be an early symptom of an intestinal blockage, tell your doctor or pharmacist.
The following side effects have been reported in patients taking Renvela:
Very common (may affect more than 1 in 10 users):
Vomiting, constipation, pain in the upper abdomen, nausea.
Common (may affect up to 1 user in 10):
Diarrhea, abdominal pain, indigestion, flatulence.
Very rare (may affect up to 1 user in 10,000):
Hypersensitivity.
Not known (frequency cannot be estimated from the available data):
Cases of itching, rash, slow bowel motility (movement) / intestinal blockage and perforation of the intestinal wall have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 bottle and carton after "EXP".
Keep the container tightly closed to protect the medicine from moisture.
This medicine does not require any special storage conditions.
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.
Deadline "> Other information
What Renvela contains
- The active ingredient is sevelamer carbonate. Each Renvela film-coated tablet contains 800 mg of sevelamer carbonate.
- The other ingredients are microcrystalline cellulose, sodium chloride and zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides. The printing ink contains black iron oxide (E172), isopropyl alcohol, propylene glycol and hypromellose (E464).
What Renvela looks like and contents of the pack
Renvela film-coated tablets are white tablets with RENVELA 800 engraved on one side.
The tablets are packaged in high-density polyethylene bottles, fitted with a polypropylene cap and an induction closure.
Packaging:
- 1 x 30 tablets per bottle
- 1 x 180 tablets per bottle
- 180 tablets (6 bottles of 30 tablets)
Not all pack sizes may be marketed.
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 -
RENVELA 800 MG TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Each tablet contains 800 mg of sevelamer carbonate.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Film-coated tablet (tablet).
The white to off-white tablets are marked "RENVELA 800" on one side.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Renvela is indicated for the control of hyperphosphataemia in adult patients undergoing hemodialysis or peritoneal dialysis.
Renvela is also indicated in the control of hyperphosphataemia in adult patients with chronic kidney disease not undergoing dialysis with serum phosphorus> 1.78 mmol / l.
Renvela should be used in the context of a multi-therapeutic approach which could include calcium supplements, 1,25-dihydroxy-vitamin D3 or one of its analogues to control the development of renal bone disease.
04.2 Posology and method of administration -
Dosage
Initial dose
The recommended starting dose for sevelamer carbonate is 2.4 g or 4.8 g per day, based on clinical needs and serum phosphorus levels. Renvela should be taken three times a day, with meals.
* Plus subsequent titration according to instructions
For patients who have previously taken phosphate binders (sevelamer hydrochloride or calcium-based), Renvela should be administered on a gram-for-gram basis, with monitoring of phosphate levels to ensure optimal daily doses.
Titration and maintenance
Phosphate levels should be monitored and the dose of sevelamer carbonate titrated in increments of 0.8 g three times a day (2.4 g / day) every 2-4 weeks until an acceptable serum phosphorus level is reached, followed by regular monitoring.
Patients taking Renvela must adhere to prescribed diets.
In clinical practice, the treatment will be continuous, based on the need to control phosphate levels, the expected dose will be on average about 6 g per day.
Pediatric population
The safety and efficacy of Renvela have not been established in children below 18 years of age.
Method of administration
Oral use.
The tablets should be swallowed whole and should not be crushed, chewed or crushed prior to administration
04.3 Contraindications -
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Hypophosphatemia
• Bowel obstruction.
04.4 Special warnings and appropriate precautions for use -
The safety and efficacy of Renvela have not been established in adult patients with chronic kidney disease not undergoing dialysis with serum phosphorus.
The safety and efficacy of Renvela have not been established in patients with the following disorders:
• dysphagia
• swallowing disorders
• severe gastrointestinal motility disorders including severe or untreated gastroparesis, retention of stomach contents and abnormal or irregular bowel motility
• active inflammatory bowel disease
• major surgery on the gastrointestinal tract
Therefore, caution should be exercised in the use of Renvela in these patients.
Intestinal obstruction and ileus / subileus
In very rare cases, bowel obstruction and ileus / subileus have been observed in patients during treatment with sevelamer hydrochloride (capsules / tablets), which contains the same active moiety as sevelamer carbonate. Constipation can be a prodrome. Patients suffering from constipation should be monitored closely during Renvela treatment. Renvela treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Fat-soluble vitamins
Patients with CKD (chronic kidney disease, chronic kidney disease) may show a deficiency of fat-soluble vitamins A, D, E and K, depending on the diet and the severity of the disease. It cannot be ruled out that Renvela may bind to fat-soluble vitamins contained in ingested foods. In patients taking sevelamer but no vitamin supplements, serum levels of vitamins A, D, E and K should be assessed at regular intervals. If necessary, vitamin supplements are recommended. Vitamin D supplements (approximately 400 IU native vitamin D per day) are recommended for CKD patients not undergoing dialysis, which may be part of a multivitamin preparation to be taken away from the dose of Renvela. In patients undergoing peritoneal dialysis, additional monitoring of fat-soluble vitamins and folic acid is recommended as vitamin A, D, E and K levels were not measured in a clinical study of these patients.
Folate deficiency
There are currently insufficient data to rule out the possibility of folate deficiency during long-term treatment with Renvela.
Hypocalcemia / hypercalcemia
Patients with CKD can develop hypocalcemia or hypercalcemia. Renvela does not contain calcium. Consequently, serum calcium levels should be monitored at regular intervals and an elemental calcium supplement administered if necessary.
Metabolic acidosis
Patients with chronic kidney disease are predisposed to "metabolic acidosis. As part of good clinical practice, monitoring of serum bicarbonate levels is therefore recommended."
Peritonitis
Dialysis patients are subject to certain risks of infection inherent in the specific modality of dialysis. Peritonitis is a known complication in patients undergoing peritoneal dialysis, and more cases of peritonitis were reported in the sevelamer group than in the control group in a clinical study of sevelamer hydrochloride. Patients receiving peritoneal dialysis should be followed closely to ensure the use of correct aseptic technique and the timely identification and management of any signs and symptoms associated with peritonitis.
Difficulty swallowing and choking
Difficulty swallowing Renvela tablets have been reported rarely. Many of these cases involved patients with comorbid conditions, including swallowing disorders or esophageal abnormalities. Therefore, caution should be exercised when Renvela is administered to patients with swallowing difficulties. Renvela powder for oral suspension should be used for patients with a history of swallowing difficulties.
Hypothyroidism
Closer monitoring of patients with hypothyroidism co-administered with sevelamer carbonate and levothyroxine is recommended (see section 4.5).
Long-term chronic treatment
There was no evidence of accumulation of sevelamer from a one-year clinical study. However, the potential for absorption and accumulation of sevelamer in chronic long-term (> one year) treatment cannot be fully excluded (see section 5.2).
Hyperparathyroidism
Renvela is not indicated to control hyperparathyroidism. In patients with secondary hyperparathyroidism, Renvela should be used in the context of a multi-therapeutic approach, which may include calcium supplements, 1,25-dihydroxy-vitamin D3 or one of its analogues, to reduce intact parathyroid hormone (iPTH) levels.
04.5 Interactions with other medicinal products and other forms of interaction -
Dialysis
No interaction studies have been performed in dialysis patients.
Ciprofloxacin
In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as Renvela, reduced the bioavailability of ciprofloxacin by approximately 50% with simultaneous administration of sevelamer hydrochloride in a single-dose study. Consequently, Renvela it must not be taken at the same time as ciprofloxacin.
Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients
Reduced levels of cyclosporine, mycophenolate mofetil and tacrolimus have been reported in transplant recipients, with concomitant administration with sevelamer hydrochloride, without clinical sequelae (e.g. transplant rejection). Interactions cannot be excluded, therefore careful monitoring of the blood concentrations of cyclosporine, mycophenolate mofetil and tacrolimus should be considered during use of the combination and after its discontinuation.
Levothyroxine
Very rare cases of hypothyroidism have been reported in patients with concomitant administration of sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, and levothyroxine. Therefore, careful monitoring of thyroid stimulating hormone (TSH) levels is recommended in patients receiving sevelamer carbonate and levothyroxine.
Antiarrimic and anticonvulsant medicines
Patients taking antiarrhythmics to control arrhythmias and anticonvulsants to control seizure disorders were excluded from clinical trials. Caution should be exercised when prescribing Renvela to patients also taking these medicinal products.
Digoxin, warfarin, enalapril or metoprolol
In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Bioavailability
Renvela is not absorbed and may affect the bioavailability of other medicinal products. When administering any medicinal product, where any reduction in bioavailability would have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before, or at least three hours after, taking Renvela. Alternatively, the physician should consider checking the blood levels.
04.6 Pregnancy and breastfeeding -
Pregnancy
There are no or limited data from the use of sevelamer in pregnant women. Animal studies have shown reproductive toxicity with the administration of sevelamer at high doses in rats (see section 5.3). It has also been demonstrated. that sevelamer reduces the absorption of several vitamins, including folic acid (see sections 4.4 and 5.3). The potential risk for humans is unknown. Renvela should only be administered to pregnant women if clearly needed and after a " careful analysis of the risk / benefit ratio for both the mother and the fetus.
Feeding time
It is unknown whether sevelamer / metabolites are excreted in human breast milk. The fact that sevelamer is not absorbed makes its excretion into breast milk unlikely. A decision to continue / discontinue breastfeeding or to continue / discontinue Renvela therapy must be made considering the benefit of breastfeeding for the child and the benefit of Renvela therapy for the woman.
Fertility
There are no data on the effect of sevelamer on human fertility. Animal studies have shown that sevelamer did not affect fertility in male and female rats at human equivalent dose exposures twice the maximum clinical trial dose of 13 g / day based on relative body surface area comparison.
04.7 Effects on ability to drive and use machines -
Sevelamer has no or negligible influence on the ability to drive or use machines.
04.8 Undesirable effects -
Summary of the safety profile
The most common adverse reactions (> 5% of patients) all fell into the gastrointestinal disease class by system organ class. Most of these adverse reactions were mild to moderate in intensity.
Table of adverse reactions
The safety of sevelamer (both as carbonate salts and hydrochloride) has been examined in numerous clinical studies involving a total of 969 patients undergoing hemodialysis, with treatments lasting 4 - 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with 12-week treatment (all treated with sevelamer hydrochloride) and 128 non-dialyzed CKD patients on treatment for 8 - 12 weeks (treatment of 79 patients with sevelamer hydrochloride and 49 with sevelamer carbonate).
Adverse reactions are listed by frequency in the table below. The frequency of reporting is classified as very common (> 1/10), common (> 1/100, 1 / 1,000, 1 / 10,000,
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. in "Annex V.
04.9 Overdose -
Sevelamer hydrochloride, which contains the same active fraction as sevelamer carbonate, has been administered to normal healthy volunteers at doses up to 14 grams / day for eight days, without causing undesirable effects. In patients with CKD, the maximum daily dose studied was on average 14.4 grams of sevelamer carbonate in a single daily dose.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: treatment of hyperphosphataemia.
ATC code: V03A E02.
Renvela contains sevelamer, a non-absorbable, phosphate-chelating, cross-linked polymer that is free of metal or calcium. Sevelamer contains multiple amines separated through a carbon from the core structure of the polymer, which becomes protonated in the stomach. These protonated amines negatively bind charged ions, such as dietary phosphate, in the intestine. By binding phosphate in the intestinal tract and attenuating its absorption, sevelamer reduces the serum concentration of phosphorus. Regular monitoring of phosphate levels is invariably necessary during administration of phosphate binders.
In two randomized, crossover clinical trials, sevelamer carbonate, in both tablet and powder formulations, was shown to be therapeutically equivalent to sevelamer hydrochloride when administered three times daily, and therefore effective in controlling phosphatemia in patients. with CKD undergoing hemodialysis.
The first study showed that taking sevelamer carbonate three times / day was equivalent to sevelamer hydrochloride tablets three times / day in 79 hemodialysis patients treated over two 8-week randomized therapy periods (with time-weighted averages average serum phosphate equal to 1.5 ± 0.3 mmol / l for both sevelamer carbonate and sevelamer hydrochloride). The second study demonstrated equivalence between sevelamer carbonate powder, administered three times daily, and sevelamer hydrochloride tablets administered three times daily to 31 hemodialysis patients with hyperphosphataemia (defined as serum phosphate levels> 1.78 mmol / l), in the " span of two 4-week randomized treatment periods (with time-weighted mean serum phosphate averages of 1.6 ± 0.5 mmol / l for sevelamer carbonate powder, and 1.7 ± 0.4 mmol / l for sevelamer hydrochloride tablets).
In clinical studies in hemodialysis patients, sevelamer alone did not show a consistent and clinically significant effect on serum intact parathyroid hormone (iPTH) levels. In a 12-week study of patients undergoing peritoneal dialysis, however, decreases in iPTH similar to those for patients receiving calcium acetate were observed. In patients with secondary hyperparathyroidism, Renvela should be used in the context of a multiple therapeutic approach, which could include calcium as supplements, 1,25-dihydroxy-vitamin D3 or one of its analogues, to reduce intact parathyroid hormone (iPTH ).
The binding of sevelamer to bile acids has been demonstrated in vitro And in vivo, within experimental animal models. Bile acid binding by ion exchange resins is a proven method for lowering blood cholesterol. In clinical studies of sevelamer, both mean total cholesterol and LDL cholesterol dropped by 15- 39%. The reduction in cholesterol was observed after 2 weeks of treatment and is maintained with long-term treatment. Triglycerides, HDL cholesterol and albumin did not change following treatment with sevelamer.
Since sevelamer binds bile acids, it may interfere with the absorption of fat-soluble vitamins such as vitamins A, D, E and K.
Sevelamer does not contain calcium and reduces the incidence of hypercalcaemic episodes, compared to patients taking only calcium-based phosphate binders. The effects of sevelamer on phosphorus and calcium have been shown to be maintained throughout the duration of a follow-up study. -up of one year This information was obtained from studies in which sevelamer hydrochloride was used.
05.2 "Pharmacokinetic properties -
Pharmacokinetic studies on sevelamer carbonate have not been performed. Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, is not absorbed from the gastrointestinal tract, as confirmed by an absorption study in healthy volunteers.
05.3 Preclinical safety data -
Non-clinical data on sevelamer reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity.
Carcinogenicity studies with oral sevelamer hydrochloride were performed in mice (doses up to 9 g / kg / day) and rats (0.3, 1 or 3 g / kg / day). There was an "increased incidence of transient cell papilloma of the urinary bladder in male rats, in the high dose group (human equivalent dose twice the maximum clinical trial dose of 14.4 g). There was no increase in the incidence. tumors in mice (human equivalent dose triple the maximum dose in clinical studies).
In a cytogenetic test in vitro in mammals, with metabolic activation, sevelamer hydrochloride caused a statistically significant increase in the number of structural chromosomal aberrations. Sevelamer hydrochloride was not mutagenic in the Ames bacterial mutation assay.
In rats and dogs, sevelamer reduced the absorption of fat-soluble vitamins D, E and K (clotting factors) and folic acid.
Deficits in skeletal ossification were observed in various locations in fetuses of female rats that received sevelamer at the intermediate and high doses (human dose equivalent below the maximum clinical trial dose of 14.4 g). These effects may be secondary to the vitamin D depletion
In pregnant rabbits who received oral doses of sevelamer hydrochloride with gavage, there was an increase in early resorption in the high dose group during organogenesis (human equivalent dose twice the maximum dose in the high dose group). clinical studies).
Sevelamer hydrochloride did not compromise male or female fertility in rats, in a dietary administration study in which females were treated from 14 days before mating to gestation, and males for 28 days before gestation. The maximum dose in this particular study was 4.5 g / kg / day (human equivalent dose twice the maximum dose in clinical studies of 13 g / day, based on relative body surface area comparison).
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Tablet:
Microcrystalline cellulose
Sodium chloride
Zinc stearate
Coating film:
Hypromellose (E464)
Diacetylated monoglycerides
Printing ink:
Black iron oxide (E172)
Propylene glycol
Isopropyl alcohol
Hypromellose (E464)
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
3 years.
06.4 Special precautions for storage -
Keep the bottle tightly closed to protect the medicine from moisture.
This medicinal product does not require any special storage temperatures.
06.5 Nature of the immediate packaging and contents of the package -
HDPE bottles equipped with a polypropylene cap and an aluminum induction closure.
Each bottle contains 30 tablets or 180 tablets.
Packs of 30 or 180 tablets and a multipack containing 180 (6 bottles of 30) tablets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Genzyme Europe B.V.
Gooimeer 10
1411 DD Naarden
Netherlands
08.0 MARKETING AUTHORIZATION NUMBER -
EU / 1/09/521/001
039480013
EU / 1/09/521/002
039480025
EU / 1/09/521/003
039480037
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Date of first authorization: 10 June 2009
10.0 DATE OF REVISION OF THE TEXT -
March 2014
