Posts Tagged ‘Portugal’
Lescol XL (Fluvastatin)
Lescol XL 80 mg prolonged-release tablets
Fluvastatin
1. WHAT LESCOL XL IS AND WHAT IT IS USED FOR
Lescol XL contains the active fluvastatin sodium which belongs to a group of medicines known as statins, which are lipid-lowering medicines: they lower the fat (lipids) in your blood. They are used in patients whose conditions cannot be controlled by diet and exercise alone.
- Lescol XL is a medicine used to treat raised levels of fats in the blood in adults, in
particular total cholesterol and so called “bad” or LDL cholesterol, which is associated with an increased risk of heart disease and stroke.
- in adult patients with high blood levels of cholesterol
- in adult patients with high blood levels of both cholesterol and triglycerides (another sort of blood lipid)
- Your doctor can also prescribe Lescol XL to prevent further serious cardiac events (e.g. heart attack) in patients after they already went through a heart catheterisation, with an intervention in the heart vessel.
2.BEFORE YOU TAKE LESCOL XL
Follow all instructions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
Read the following explanations before you take Lescol XL.
Do not take Lescol XL
- if you are allergic (hypersensitive) to fluvastatin or any of the other ingredients of Lescol XL listed in section 6 of this leaflet.
- if you currently have liver problems, or if you have unexplained, persistently high level of certain liver enzymes (transaminases).
- if you are pregnant or breast-feeding.
If any of these apply to you, do not take Lescol XL and tell your doctor.
Take special care with Lescol XL
- if you previously had a liver disease. Liver function tests will normally be done before you start Lescol XL, when your dose is increased and at various intervals during treatment to check for side effects.
- if you have a kidney disease.
- if you have a thyroid disease (hypothyroidism).
- if you have a medical history of muscle diseases yourself or in your family.
- if you had muscle problems with another lipid-lowering medicine.
- if you regularly drink large amounts of alcohol.
Check with your doctor or pharmacist before taking Lescol XL:
if you have severe respiratory failure
If any of these apply to you, tell your doctor before you take Lescol XL. Your doctor will take a blood test before prescribing Lescol XL.
Lescol XL and people over 70 years
If you are over 70 years your doctor may want to check if you have risk factors for muscular diseases. You may need specific blood tests.
Lescol XL and children/adolescents
Lescol XL has not been investigated and is not intended for the use in children below 9 years. For dose information in children and adolescents over 9 years, see section 3.
There is no experience with the use of Lescol in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.
Lescol XL can be taken on its own or with other cholesterol-lowering medicines prescribed by your doctor.
After intake of a resin, e.g. cholestyramine (primarily used to treat high cholesterol) wait at least 4 hours before taking Lescol XL.
Tell your doctor and pharmacist if you are taking any of the following:
- Ciclosporin (a medicine used to suppress the immune system).
- Fibrates (e.g. gemfibrozil), nicotinic acid or bile acid sequestrants (medicines used to
- lower bad cholesterol levels).
- Fluconazole (a medicine used to treat fungal infections).
- Rifampicin (an antibiotic).
- Phenytoin (a medicine used to treat epilepsy).
- Oral anticoagulants like warfarin (medicines used to reduce blood clotting).
- Glibenclamide (a medicine used to treat diabetes).
- Colchicines (used to treat gout).
Taking Lescol XL with food and drink
You can take Lescol XL with or without food.
Pregnancy and breast-feeding
Do not take Lescol XL if you are pregnant or breast-feeding as the active ingredient may lead to harm to your unborn child, and it is not known whether the active ingredient is excreted in human breast milk. If you are pregnant, consult your doctor or pharmacist before taking Lescol XL. Use reliable contraception for the whole time that you are taking Lescol XL.
If you become pregnant while taking this medicine, stop taking Lescol XL and see your doctor.
Driving and using machines
There is no information on the effects of Lescol XL on your ability to drive and use machines.
3. HOW TO TAKE LESCOL XL
Follow your doctor’s instructions carefully. Do not exceed the recommended dose.
Your doctor will recommend you to follow a low-cholesterol diet. Stay on this diet while taking Lescol XL.
How much Lescol XL to take
- The dose for adults is 80 mg per day. Dose adjustments may be made by your doctor at 4-week or longer intervals.
- For children (aged 9 years and older) the maximum daily dose is 80 mg. Dose adjustments may be made by your doctor at 6-week intervals.
Your doctor will tell you exactly how many tablets of Lescol XL to take.
Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.
- When to take Lescol XL
You can take your Lescol XL dose at any time of the day.
Lescol XL can be taken with or without meals. Swallow whole with a glass of water.
- If you take more Lescol XL than you should
If you have accidentally taken too much Lescol XL, talk to your doctor straight away. You may need medical attention.
- If you forget to take Lescol XL
Take one dose as soon as you remember. However, do not take it if there is less than 4 hours before your next dose. In this case take your next dose at the usual time. Do not take a double dose to make up for the one that you missed.
- If you stop taking Lescol XL
To maintain the benefits of your treatment, do not stop taking Lescol XL unless your doctor tells you to. You must continue to take Lescol XL as directed to keep the levels of your ‘bad’ cholesterol down. Lescol XL will not cure your condition but it does help control it. Your cholesterol levels need to be checked regularly to monitor your progress. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lescol XL can cause side effects, although not everybody gets them. Very common: affects more than 1 user in 10 Common: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data.
Some rare or very rare effects could be serious: get medical help immediately.
if you have unexplained muscle pain, tenderness or weakness. These might be early signs of a potentially severe muscle degradation. This can be avoided if your doctor stops your treatment with fluvastatin as quickly as possible. These side effects have also been found with similar medicines of this class (statins).
if you have unusual tiredness or fever, yellowing of the skin and eyes, dark coloured urine (signs of hepatitis).
if you have signs of skin reactions such as skin rash, hives, redness, itching, swelling of the face, eyelids, and lips.
if you have skin swelling, difficulty in breathing, dizziness (signs of severe allergic reaction).
if you bleed or bruise more easily than normal (signs of decreased number of blood platelets).
if you have red or purple skin lesions (signs of blood vessel inflammation).
if you have red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematous-like reaction).
if you have severe upper stomach pain (signs of inflamed pancreas). If you experience any of these, tell your doctor straight away.
Other side effects: tell your doctor if they worry you.
Common:
- Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea.
Very rare:
- Tingling or numbness of the hands or feet, disturbed or decreased sensitivity.
Other possible side effects
- Sleep disturbances, including insomnia and nightmares
- Memory loss
- Sexual difficulties
- Depression
- Breathing problems including persistent cough and/or shortness of breath or fever
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE LESCOL XL
Keep your tablets in their original pack at a temperature below 30°C. Keep Lescol XL out of the reach and sight of children.
Do not use Lescol XL after the expiry date which is stated on the carton and blister. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
- What Lescol XL contains
The active substance is fluvastatin sodium
Each Lescol XL 80 mg tablet contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid.
The tablets also contain the inactive ingredients microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, potassium hydrogen carbonate, povidone, magnesium stearate, yellow iron oxide (E172), titanium dioxide (E171) and macrogol 8000.
- What Lescol XL looks like and contents of the pack
Lescol XL 80 mg prolonged release tablets are round, yellow tablets marked ‘LE’ on one side and ‘NVR’ on the other. They come in packs of 28 tablets.
This medicinal product is authorised in the Member States of the EEA under the following names:
| Member State | Medicinal Product |
| Estonia, Bulgaria, Cyprus, Czech Republic, Greece, Hungary, Ireland, Latvia, Lithuania, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, United Kingdom | Lescol XL |
| Demark, Finland, Iceland, Norway, Sweden | Lescol Depot |
| Austria, Germany | Fluvastatin Novartis |
| Austria | Lescol MR |
| Belgium | Lescol Exel |
| France | Lescol LP |
| Germany, Luxembourg | Locol |
| Italy | Lescol, Lipaxin, Primesin |
| Portugal | Cardiol XL, Canef |
| Spain | Lescol Prolib, Leposit Prolib, Vaditon Prolib, Digaril Prolib |
Clofarabine
(British Approved Name, US Adopted Name, rINN)
Drug Nomenclature
International Nonproprietary Names (INNs) in main languages (French, Latin, Russian, and Spanish):
Adverse Effects, Treatment, and Precautions
As for Fludarabine Phosphate, although neurotoxicity is less severe. Capillary leak syndrome resulting from cytokine release has occurred with clofarabine, causing respiratory distress, hypotension, pleural and pericardial effusions, and multi-organ failure. Prophylactic corticosteroids may be useful, but clofarabine must be stopped immediately if signs or symptoms of capillary leak syndrome develop (respiratory status and blood pressure should be monitored during infusion). Other adverse effects include anxiety, flushing, tachycardia, hypotension, hepatotoxicity, haematuria, myalgia, arthralgia, and headache. Renal and hepatic function, and complete blood counts, should be monitored during clofarabine therapy. Hydration should be maintained during treatment to minimise the risk of tumour lysis syndrome and other adverse effects.
Pharmacokinetics
Clofarabine is about 47% bound to plasma proteins. About 50 to 60% of a dose is excreted unchanged in the urine and it has a terminal half-life of about 5 hours.
Uses and Administration
Clofarabine, a purine nucleoside analogue, is used as an antimetabolite antineoplastic in the treatment of relapsed or refractory acute lymphoblastic leukaemia in patients aged 1 to 21 years. A dose of 52 mg/m is given daily for 5 days, by intravenous in fusion over 2 hours. A longer infusion time should be considered in children weighing less than 20 kg to reduce anxiety and irritability, and to avoid high clofarabine concentrations. The course may be repeated every 2 to 6 weeks, depending on the patient’s recovery from bone-marrow depression and other adverse effects. Treatment is usually assessed after 2 treatment cycles. Clofarabine is under investigation for the treatment of acute myeloid leukaemia, myelodysplastic syndrome, and solid tumours.
Proprietary Preparations
Czech Republic: Evoltra;
France: Evoltra;
Portugal: Evoltra;
United Kingdom (UK): Evoltra;
United States of America (US and USA): Clolar
Comments Closed
Luteinising Hormone
Lutropin Alfa
Drug Approvals
(British Approved Name, US Adopted Name, rINN)
Units
35 units of human pituitary luteinising hormone are contained in about 5.8 micrograms (with 1 mg of human albumin, 5 mg of mannitol, and 1 mg of sodium chloride) in one ampoule of the second International Standard (1988).
10 units of the alpha subunit of human pituitary luteinising hormone are contained in about 10 micrograms (with 0.5 mg of human albumin, 2.5 mg of lactose, and 45 micrograms of sodium chloride) in one ampoule of the first International Standard (1984).
10 units of the beta subunit of human pituitary luteinising hormone are contained in 10 micrograms (with 0.5 mg of human albumin, 2.5 mg of lactose, and 45 micrograms of sodium chloride) in one ampoule of the first International Standard (1984). 189 units of recombinant human luteinising hormone are contained in about 8.8 micrograms (with 2 mg of human albumin, 10 mg of lactose, and 8.9 mg of sodium chloride) in one ampoule of the first International Standard (2003).
Adverse Effects and Precautions
As for Human Menopausal Gonadotrophins.
Pharmacokinetics
The absolute bioavailability of lutropin alfa after subcutaneous doses is about 60%, and the terminal half-life is at least 10 to 12 hours.
Uses and Administration
Luteinising hormone (LH) is secreted with follicle-stimulating hormone (FSH), another gonadotrophin, by the anterior pituitary lobe.
These gonadotrophins stimulate the normal functioning of the gonads and the secretion of sex hormones in both men and women. In women, follicle-stimulating hormone stimulates the development and maturation of the follicles and ova. As the follicle develops it produces oestrogen in increasing amounts which at mid-cycle stimulates the release of LH. This causes rupture of the follicle with ovulation and converts the follicle into the corpus luteum which secretes progesterone. In men, luteinising hormone stimulates the interstitial cells of the testis to secrete testosterone, which in turn has a direct effect on the seminiferous tubules.
Gonadotrophic substances with luteinising or follicle-stimulating activity or both are used in the treatment of infertility, chiefly in females but also in males. Such substances include chorionic gonadotrophin which possesses LH activity and human menopausal gonadotrophins which possess both LH and FSH activity.
Lutropin alfa is a recombinant human luteinising hormone used to induce ovulation in women with severe deficiency of luteinising and follicle-stimulating hormones. It is used at the same time as a preparation with follicle-stimulating activity, usually folli-tropin alfa. The dosage and schedule of treatment must be determined according to the needs of each patient it is usual to monitor response by studying the patient’s urinary oestrogen excretion or by ultrasonic visualisation of follicles or both. Treatment is usually begun with 75 units of lutropin alfa daily by subcutaneous injection for 7 to 14 days, accompanied by FSH. If there is no response, the FSH dosage may be increased at 7- or 14-day intervals until an adequate but not excessive response is achieved. A treatment cycle of up to 5 weeks may be needed. Treatment is then stopped and followed after 1 or 2 days by a single dose of chorionic gonadotrophin 5000 to 10 000 units to induce ovulation. These patients are generally amenorrhoeic and treatment may be started at any time.
Preparations
Proprietary Preparations
Argentina: Luveris
Australia: Luveris
Belgium: Luveris
Brazil: Luveris
Chile: Luveris
Czech Republic: Luveris
Denmark: Luveris
Finland: Luveris
France: Luveris
Germany: Luveris
Greece: Luveris
Hong Kong: Luveris
Hungary: Luveris
Indonesia: Luveris
Ireland: Luveris
Israel: Luveris
Italy: Luveris
Malaysia: Luveris
Mexico: Luveris
The Netherlands: Luveris
Norway: Luveris
New Zealand: Luveris
Philippines: Luveris
Poland: Luveris
Portugal: Luveris
Russia: Luveris
Singapore: Luveris
Spain: Luveris
Sweden: Luveris
Switzerland: Luveris
Thailand: Luveris
Turkey: Luveris
UK: Luveris
USA: Luveris
Venezuela: Luveris
Multi-ingredient
Czech Republic: Pergoveris
Portugal: Pergoveris
UK: Pergoveris
Follicle-stimulating Hormone
Folitropina FSH.
ATC Vet — QG03GA90.
Follitropin Alfa
Drug Approvals
(British Approved Name, rINN)
Folitropin Alfa; Folitropina alfa; Follitropine Alfa; Follitropinum Alfa.
Фоллитропин Альфа
Follitropin Beta
Drug Approvals
(British Approved Name, rINN)
Folitropin Beta; Folitropina beta; Follitropine Bêta; FollitropinumBeta; Org-32489.
Фоллитропин Бета
Units
80 units of human pituitary follicle-stimulating hormone are contained in about 4.17micrograms (with 5 mg of mannitol and 1 mg human serum albumin) in one ampoule ofthe first International Standard (1986). 138 units of recombinant human follicle-stimulating hormone for bioassay are contained in one ampoule of the first International Standard (1995).
Adverse Effects and Precautions
As for Human Menopausal Gonadotrophins.
Spongiform encephalopathies. In a few countries, gonadotrophins derived from cadaver pituitary glands have been used in the treatment of infertility, and a small number of patients are reported to have acquired Creutzfeldt-Jakob disease from such preparations.l However, most countries have preferred to use gonadotrophins derived from urine, and these in their turn are being replaced with recombinant products such preparations appear to carry negligible risk of transmitting prion disease.
Pharmacokinetics
Follitropins alfa and beta are slowly absorbed after subcutaneous or intramuscular injection, with an absolute bioavailability of about 70 to 80%. Peak plasma concentrations of follitropin beta have been stated to occur about 12 hours after subcutaneous or intramuscular injection. Accumulation occurs with repeated doses, reaching a steady state within 3 to 5 days. Follitropins are slowly eliminated from the body, with a terminal half-life ranging from 12 to 70 hours. About one-eighth of a dose of follitropin alfa is reported to be excreted in the urine.
Uses and Administration
Follicle-stimulating hormone is secreted by the anterior lobe of the pituitary gland, with another gonadotrophin, luteinising hormone. These gonadotrophins stimulate the normal functioning ofthe gonads and the secretion of sexhormones in both men and women. In women, follicle-stimulating hormone stimulates the development and maturation ofthe follicles and ova in men it has a role in sperma-togenesis.
Recombinant human follicle-stimulating hormones (follitropins alfa or beta) are used in the treatment of female infertility due to anovulation, in women who have not responded to clomifene therapy. Follitropins are also used for the stimulation of spermatogenesis in the management of male infertility caused by hypogonadotrophic hypogonadism (see Infertility). The dosage and schedule of treatment for female infertility must be determined according to the needs of each patient it is usual to monitor response by studying the patient’s urinary oestrogen excretion or by ultrasonic visualisation of follicles or both. In menstruating patients treatment should be started within the first 7 days ofthe menstrual cycle.
• Treatment is usually begun with 75 to 150 units daily by subcutaneous or intramuscular injection for 7 or 14 days if there is no response, dosage is increased at 7- or 14-day intervals until an adequate but not excessive response is achieved.
• Treatment is then stopped and followed after 1 or 2 days by a single dose of chorionic gonadotrophin 5000 to 10 000 units to induce ovulation.
It has been suggested in UK licensed product information for follitropin alfa that a daily dose of 225 units is the usual maximum, and that if a patient fails to respond adequately after 4 weeks of treatment that cycle should be abandoned and the patient should subsequently begin the next cycle at a higher starting dose. Follitropins are also used as part of IVF or other assisted reproductive technologies.
• For this purpose doses of 150 to 225 units daily are generally given, for at least 4 days, commencing on the second or third day ofthe menstrual cycle. Thereafter the dose may be adjusted individually based on ovarian response to a usual maximum of about 450 units adequate follicular development generally occurs within about 5 to 10 days of treatment.
• Pituitary downregulation with a gonadorelin analogue may be used with follitropin therapy, in which case the gonadorelin analogue is generally begun about 2 weeks before follitropin, and the 2 are then continued together until follicular development is adequate.
• A single dose of up to 10 000 units of chorionic gonadotrophin is then given to induce final follicular maturation and oocyte retrieval performed about 35 hours later.
Follitropins are used for the stimulation of spermatogenesis in the management of male infertility caused by hypogonadotrophic hypogonadism. Before starting follitropin therapy, chorionic gonadotrophin is given to raise serum testosterone concentrations to the normal range, which may take 3 to 6 months. A dose of follitropin alfa or beta of 150 units subcutaneously three times weekly is then used, with continued chorionic gonadotrophin doses of follitropin alfa up to 300 units three times weekly may be required. Treatment is continued for at least 4 months, and more than 18 months of treatment may be needed. A dose of follitropin beta 75 units daily or two or three times weekly, by subcutaneous or intramuscular injection, has been used similarly.
Other substances with follicle-stimulating activity are used similarly: these include human menopausal gonadotrophins, which have both luteinising and follicle-stimulating activity, and urofollitropin.
Preparations
Proprietary Preparations
Argentina: Gonal † Puregon
Australia: Gonal † Puregon
Austria: Gonal † Puregon
Belgium: Gonal † Puregon
Brazil: Gonal † Puregon
Canada: Gonal † Puregon
Chile: Gonal-F Puregon
Czech Republic: Gonal † Puregon
Denmark: Gonal † Puregon
Finland: Gonal † Puregon
France: Gonal † Puregon
Germany: Gonal † Puregon
Greece: Gonal † Puregon
Hong Kong: Gonal † Puregon
Hungary: Gonal † Puregon
India: Gonal †
Indonesia: Gonal † Puregon
Ireland: Gonal † Puregon
Israel: Gonal † Puregon
Italy: Gonal † Puregon
Malaysia: Gonal † Puregon
Mexico: Gonal † Puregon
The Netherlands: Gonal † Puregon
Norway: Gonal † Puregon
New Zealand: Gonal † Puregon
Philippines: Gonal † Puregon
Poland: Gonal † Puregon
Portugal: Gonal † Puregon
Russia: Gonal † Puregon
South Africa: Gonal † Puregon
Singapore: Gonal † Puregon
Spain: Gonal † Puregon
Sweden: Gonal † Puregon
Switzerland: Gonal † Puregon
Thailand: Gonal † Puregon
Turkey: Gonal † Puregon
United Kingdom: Gonal † Puregon
USA: Follistim Gonal †
Venezuela: Gonal † Puregon
Multi-ingredient
Czech Republic: Pergoveris
Portugal: Pergoveris
UK: Pergoveris