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xml053

银虫 (小有名气)

[求助] 求助原研说明书

求助美沙拉嗪缓释颗粒的上市公司说明书或原研说明书，重谢！
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1楼 2013-08-08 15:39:47
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刁刁8888

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制剂君

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感谢参与，应助指数 +1
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
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2楼2013-08-08 16:06:03
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xml053

银虫 (小有名气)
引用回帖:
2楼: Originally posted by 刁刁8888 at 2013-08-08 16:06:03
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 pr ...

请问这是缓释颗粒的说明书吗？在网上搜的都是法国爱的发医药生产的，而且规格都是250mg，500mg的，跟这个不一样呢。还有缓释的英文是prolonged-release还是extended release 呢？新手不懂，请指教O(∩_∩)O~
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3楼2013-08-09 08:45:08
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fengzi913

木虫 (正式写手)

【答案】应助回帖

http://wenku.baidu.com/view/1a2564c0d5bbfd0a795673e2.html是这个吗？胶囊
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4楼2013-08-13 11:50:31
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xml053

银虫 (小有名气)
引用回帖:
4楼: Originally posted by fengzi913 at 2013-08-13 11:50:31
http://wenku.baidu.com/view/1a2564c0d5bbfd0a795673e2.html是这个吗？胶囊

不是，不是胶囊的，是颗粒的
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5楼2013-08-13 13:03:01
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fengzi913

木虫 (正式写手)

【答案】应助回帖

引用回帖:
5楼: Originally posted by xml053 at 2013-08-13 13:03:01
不是，不是胶囊的，是颗粒的...

没有一个产品是颗粒剂的，欧洲和日本是没有的，美国的都在这，你看嘛http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
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6楼2013-08-13 13:50:46
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xml053

银虫 (小有名气)
引用回帖:
6楼: Originally posted by fengzi913 at 2013-08-13 13:50:46
没有一个产品是颗粒剂的，欧洲和日本是没有的，美国的都在这，你看嘛http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm...

有的
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7楼2013-08-13 15:25:20
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sjz_zhaonan

木虫 (小有名气)

【答案】应助回帖

引用回帖:
3楼: Originally posted by xml053 at 2013-08-09 08:45:08
请问这是缓释颗粒的说明书吗？在网上搜的都是法国爱的发医药生产的，而且规格都是250mg，500mg的，跟这个不一样呢。还有缓释的英文是prolonged-release还是extended release 呢？新手不懂，请指教O(∩_∩)O~...

http://drugs.dxy.cn/drug/91527.htm
Mesalazine SR Granules
其中SR=Sustained Release
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8楼2013-08-14 13:18:37
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