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xml053銀蟲 (小有名氣)
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刁刁8888
金蟲 (小有名氣)
制劑君
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感謝參與，應(yīng)助指數(shù) +1
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最新版本的 Summary of Product Characteristics last updated on the eMC: 04/04/2012 SPC Salofalk 1.5g gastro-resistant prolonged-release granules Table of Contents 1. Name of the medicinal product 2. Qualitative and quantitative composition 3. Pharmaceutical form 4. Clinical particulars 4.1 Therapeutic indications 4.2 Posology and method of administration 4.3 Contraindications 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction 4.6 Fertility, pregnancy and lactation 4.7 Effects on ability to drive and use machines 4.8 Undesirable effects 4.9 Overdose 5. Pharmacological properties 5.1 Pharmacodynamic properties 5.2 Pharmacokinetic properties 5.3 Preclinical safety data 6. Pharmaceutical particulars 6.1 List of excipients 6.2 Incompatibilities 6.3 Shelf life 6.4 Special precautions for storage 6.5 Nature and contents of container 6.6 Special precautions for disposal and other handling 7. Marketing authorisation holder 8. Marketing authorisation number(s) 9. Date of first authorisation/renewal of the authorisation 10. Date of revision of the text Go to top of the page1. Name of the medicinal product Salofalk 1.5g gastro-resistant prolonged-release granules Go to top of the page2. Qualitative and quantitative composition Each sachet of Salofalk 1.5g granules contains 1.5g mesalazine. Excipient: Each sachet of Salofalk 1.5g granules contains 3.0mg aspartame. For a full list of excipients, see section 6.1. Go to top of the page3. Pharmaceutical form Gastro-resistant prolonged-release granules. Description: Stick-formed or round, greyish white granules. Go to top of the page4. Clinical particulars Go to top of the page4.1 Therapeutic indications For the treatment of acute episodes and the maintenance of remission of ulcerative colitis. Go to top of the page4.2 Posology and method of administration Posology Adults and elderly: For the treatment of acute episodes of ulcerative colitis: Once daily 1 sachet of Salofalk 3g granules, 1 or 2 sachets of Salofalk 1.5g granules, 3 sachets of Salofalk 1000mg granules or 3 sachets of Salofalk 500mg granules (equivalent to 1.5 – 3.0g mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement. It is also possible to take the prescribed daily dose in three divided doses (1 sachet of Salofalk 500mg granules three times daily or 1 sachet of Salofalk 1000mg granules three times daily) if this is more convenient to the patient. For the maintenance of remission of ulcerative colitis: The standard treatment is 0.5g mesalazine three times daily (in the morning, at midday and in the evening) corresponding to a total dose of 1.5g mesalazine per day. For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of three daily doses the dosing schedule can be adapted to 3.0g mesalazine given as a single daily dose preferably in the morning. Paediatric population: There is only limited documentation for an effect in children (age 6-18 years). Children 6 years of age and older: Active disease: To be determined individually, starting with 30-50mg/kg/day once daily preferably in the morning or in divided doses. Maximum dose: 75mg/kg/day. The total dose should not exceed the maximum adult dose. Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed the recommended adult dose. It is generally recommended that half the adult dose may be given to children up to a body weight of 40kg and the normal adult dose to those above 40kg. Method of administration: The contents of the sachets of Salofalk granules should not be chewed. The granules should be taken on the tongue and swallowed, without chewing, with plenty of liquid. Both in the treatment of acute inflammatory episodes and during long term treatment, Salofalk granules should be used on a regular basis and consistently in order to achieve the desired therapeutic effects. The duration of use is determined by the physician. Go to top of the page4.3 Contraindications Salofalk granules are contra-indicated in cases of: • Known hypersensitivity to salicylates or any of the excipients. • Severe impairment of hepatic or renal function. Go to top of the page4.4 Special warnings and precautions for use Blood tests (differential blood count; liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip sticks) should be determined prior to and during treatment, at the discretion of the treating physician. As a guideline, follow up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks. If the findings are normal, follow up tests should be carried out every 3 months. If additional symptoms occur, these tests should be performed immediately. Caution is recommended in patients with impaired hepatic function. Salofalk granules should not be used in patients with impaired renal function. Mesalazine-induced renal toxicity should be considered if renal function deteriorates during treatment. Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment with Salofalk granules. Patients with a history of adverse drug reactions to preparations containing sulphasalazine should be kept under close medical surveillance on commencement of a course of treatment with Salofalk granules. Should Salofalk granules cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately. In patients with phenylketonuria it should be kept in mind that Salofalk 1.5g granules contain aspartame as a sweetening agent, equivalent to 1.68mg phenylalanine. Go to top of the page4.5 Interaction with other medicinal products and other forms of interaction Specific interaction studies have not been performed. Lactulose or similar preparations, which lower stool pH: • possible reduction of mesalazine release from granules due to decreased pH caused by bacterial metabolism of lactulose. In patients who are concomitantly treated with azathioprine, 6-mercaptopurine or thioguanine, a possible increase in the myelosuppressive effects of azathioprine, 6-mercaptopurine or thioguanine should be taken into account. There is weak evidence that mesalazine might decrease the anticoagulant effect of warfarin. Go to top of the page4.6 Fertility, pregnancy and lactation Pregnancy There are no adequate data on the use of Salofalk granules in pregnant women. However, data on a limited number of exposed pregnancies indicate no adverse effect of mesalazine on pregnancy or on the health of the foetus/newborn child. To date no other relevant epidemiologic data are available. In one single case after long-term use of a high dose of mesalazine (2-4g, orally) during pregnancy, renal failure in a neonate was reported. Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. Salofalk granules should only be used during pregnancy if the potential benefit outweighs the possible risk. Breastfeeding N-acetyl-5-aminosalicylic acid and to a lesser degree mesalazine are excreted in breast milk. Only limited experience during lactation in women is available to date. Hypersensitivity reactions such as diarrhoea in the infant cannot be excluded. Therefore, Salofalk granules should only be used during breast-feeding if the potential benefit outweighs the possible risk. If the infant develops diarrhoea, breast-feeding should be discontinued. Go to top of the page4.7 Effects on ability to drive and use machines No effects on the ability to drive and use machines have been observed. Go to top of the page4.8 Undesirable effects Organ Class System Frequency According to MedDRA Convention rare ( ≥ 1/10,000; <1/1,000) very rare (< 1/ 10,000) Blood and lymphatic system disorders Altered blood counts (aplastic anaemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia) Nervous system disorders Headache, dizziness peripheral neuropathy Cardiac disorders Myocarditis, pericarditis Respiratory, thoracic and mediastinal disorders Allergic and fibrotic lung reactions (including dyspnoea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis) Gastrointestinal disorders Abdominal pain, diarrhoea, flatulence, nausea, vomiting Acute pancreatitis Renal and urinary disorders Impairment of renal function including acute and chronic interstitial nephritis and renal insufficiency Skin and subcutaneous tissue disorders Alopecia Musculoskeletal and connective tissue disorders Myalgia, arthralgia Immune system disorders Hypersensitivity reactions such as allergic exanthema, drug fever, lupus erythematosus syndrome, pancolitis Hepatobiliary disorders Changes in liver function parameters (increase in transaminases and parameters of cholestasis), hepatitis, cholestatic hepatitis Reproductive system disorders Oligospermia (reversible) Go to top of the page4.9 Overdose There are rare data on overdosage (e.g. intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity. There is no specific antidote and treatment is symptomatic and supportive. Go to top of the page5. Pharmacological properties Go to top of the page5.1 Pharmacodynamic properties Pharmacotherapeutic group: Aminosalicylic acid and similar agents. ATC code: A07EC02 The mechanism of the anti-inflammatory action is unknown. The results of in vitro studies indicate that inhibition of lipoxygenase may play a role. Effects on prostaglandin concentrations in the intestinal mucosa have also been demonstrated. Mesalazine (5-aminosalicylic acid / 5-ASA) may also function as a radical scavenger of reactive oxygen compounds. Mesalazine, orally administered, acts predominantly locally at the gut mucosa and in the submucous tissue from the luminal side of the intestine. It is important, therefore, that mesalazine is available at the regions of inflammation. Systemic bioavailability/plasma concentrations of mesalazine therefore are of no relevance for therapeutic efficacy, but rather a factor for safety. In order to realise this, Salofalk granules are gastric juice resistant and release mesalazine in a pH dependent manner due to an Eudragit L coating, and prolonged manner due to the matrix granule structure. Go to top of the page5.2 Pharmacokinetic properties General considerations of mesalazine: Absorption: Mesalazine absorption is highest in proximal gut regions and lowest in distal gut areas. Biotransformation: Mesalazine is metabolised both pre-systemically by the intestinal mucosa and the liver to the pharmacologically inactive N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). The acetylation seems to be independent of the acetylator phenotype of the patient. Some acetylation also occurs through the action of colonic bacteria. Protein binding of mesalazine and N-Ac-5-ASA is 43 % and 78 %, respectively. Elimination: Mesalazine and its metabolite N-Ac-5-ASA are eliminated via the faeces (major part), renally (varies between 20 and 50 %, dependent on kind of application, pharmaceutical preparation and route of mesalazine release, respectively), and biliary (minor part). Renal excretion predominantly occurs as N-Ac-5-ASA. About 1 % of total orally administered mesalazine dose is excreted into the breast milk mainly as N-Ac-5-ASA. Salofalk Granules specific: Distribution: Owing to the granule size of about 1 mm, transit from the stomach to the small intestine is fast. A combined pharmacoscintigraphic/pharmacokinetic study showed that the compound reaches the ileocaecal region within approx. 3 hours and the ascending colon within approx. 4 hours. The total transit time in the colon amounts to about 20 hours. Approximately 80 % of an administered oral dose is estimated to be available in the colon, sigmoid and rectum. Absorption: Mesalazine release from Salofalk granules starts after a lag phase of about 2-3 hours, peak plasma concentrations are reached at about 4-5 hours. The systemic bioavailability of mesalazine after oral administration is estimated to be approximately 15-25 %. Food intake delays absorption for 1 to 2 hours but does not change the rate and extent of absorption. Elimination: From a 3 x 500 mg daily mesalazine dose, a total renal elimination of mesalazine and N-Ac-5-ASA under steady state condition was calculated to be about 25 %. The un-metabolised excreted mesalazine part was less than 1 % of the oral dose. The elimination half-life in this study was 4.4 hours. Go to top of the page5.3 Preclinical safety data Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenicity (rat) or toxicity to reproduction. Kidney toxicity (renal papillary necrosis and epithelial damage in the proximal convoluted tubule or the whole nephron) has been seen in repeat-dose toxicity studies with high oral doses of mesalazine. The clinical relevance of this finding is unknown. Go to top of the page6. Pharmaceutical particulars Go to top of the page6.1 List of excipients Aspartame (E 951) Carmellose sodium Cellulose, microcrystalline Citric acid, anhydrous Hypromellose Magnesium stearate Methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100) Methylcellulose Polyacrylate dispersion 40 % (Eudragit NE 40 D containing 2 % Nonoxynol 100) Povidone K 25 Silica, colloidal anhydrous Simeticone Sorbic acid Talc Titanium dioxide (E 171) Triethyl citrate Vanilla custard flavouring (containing propylene glycol) Go to top of the page6.2 Incompatibilities Not applicable. Go to top of the page6.3 Shelf life 4 years. Go to top of the page6.4 Special precautions for storage This medicinal product does not require any special temperature storage condition. Go to top of the page6.5 Nature and contents of container Sachet of polyester/aluminium/polyethylene-foil Each sachet of Salofalk 1.5g granules contains 2.79g granules Package sizes: 20, 30, 35, 45, 50, 60, 70, 90, 100 and 150 sachets Salofalk 1.5g granules Not all package sizes may be marketed. Go to top of the page6.6 Special precautions for disposal and other handling No special requirements. Go to top of the page7. Marketing authorisation holder Dr. Falk Pharma GmbH Leinenweberstr. 5 79108 Freiburg Germany Tel: +49 (0)761 1514-0 Go to top of the page8. Marketing authorisation number(s) PL08637/0016 Go to top of the page9. Date of first authorisation/renewal of the authorisation Date of first authorisation: 17 June 2008 Go to top of the page10. Date of revision of the text 03/2012 |
2樓2013-08-08 16:06:03
xml053
銀蟲 (小有名氣)
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3樓2013-08-09 08:45:08
fengzi913
木蟲 (正式寫手)
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4樓2013-08-13 11:50:31
xml053
銀蟲 (小有名氣)
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5樓2013-08-13 13:03:01
fengzi913
木蟲 (正式寫手)
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【答案】應(yīng)助回帖
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沒有一個(gè)產(chǎn)品是顆粒劑的，歐洲和日本是沒有的，美國的都在這，你看嘛http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm |
6樓2013-08-13 13:50:46
xml053
銀蟲 (小有名氣)
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7樓2013-08-13 15:25:20
sjz_zhaonan
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- 專業(yè): 藥物學(xué)
8樓2013-08-14 13:18:37
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