كسالاتان

المعلومات الرئيسية

  • اسم تجاري:
  • كسالاتان
  • الشكل الصيدلاني:
  • EYE DROPS
  • طريقة التعاطي:
  • OCULAR
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • PFIZER MANUFACTURING BELGIUM NV/SA

المستندات

الأقلمة

  • متاح في:
  • كسالاتان
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • LATANOPROST
  • الخصائص العلاجية:
  • Reduction of elevated intraocular pressure as a first line treatment in patients with open-angle galucoma and ocular hypertension.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 109362926405
  • تاريخ الترخيص:
  • 01-02-2011
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة: نشرة المعلومات, خصائص المنتج

Xalatan,Israel30 August2011

םיחקורהתונקתיפלןכרצלןולע ) םירישכת ( משתה " ו 1986

אפורםשרמבתבייחוזהפורת

ארק / שמתשתםרטבופוסדעןולעהתאןויעבי / הפורתבי

עעבקנהזןולעטמרופ " ודילערשואוקדבנונכותותואירבהדרשמי

ןטלאסק םייניעתופיט

בכרה : Latanoprost50mcg/ml

םיליעפיתלבםירמוח : Disodiumphosphateanhydrous, Sodiumdihydrogenphosphatemonohydrate,

Benzalkoniumchloride,Sodiumchloride,Waterforinjection.

תיטאופרתתוצובק : ןידנלגטסורפגולנא F2

תיאופרתוליעפ : וסהםילוחביניעךותץחלתדרוהל םילב תיקרבמ ) המוקואלג ( יניעךותץחלמוהחותפהתיווזהסופיטמ

רבגומ

רישכתבשמתשהלןיאיתמ ?

הפורתהיביכרממדחאלתושיגרךלהעודיםאשמתשהלןיא .

הרוכעלתכפוהאיהשואהסימתהעבצביונישלחשכוזהפורתבשמתשהלןיא .

שמתשהלןיא לופיטהתלחתהינפלאפורבץעוויהלילבמהפורתב :

ןוירהבךניהםא הקינמוא , לבוסךניהםא / יוקילמרבעבתלבסואת ב םייניע ) תקלד , םוהיז ספרהןוגכ , המוקואלג תרצ

הרומחתיוז , םייניעהתושדעבהעיגפ וכו '( , בלה , דבכה . המטסאמלבוסךנהםא .

לבוסךניהםא / ניעמרבעבתלבסואת תושביםיי , טקארטקתרסהלחותינהנורחאלתרבעםא .

ןיעבחותינרובעלדמועךניהםא - הפורתבשומישהלעחוודלשי .

תורהזא : ןיעהתיתשקבהיצטנמגפרחאבוקעלשיוזהפורתבלופיטהתפוקתב .

שיגרךניהםא / יהשלכהפורתלואוהשלכןוזמלה , רתהתליטנינפלאפורלךכלעעידוהלךילע הפו .

דירולכםוינוקלזנבליכמרישכתה , עגמתושדעםעשמתשהלןיא ) האר / שומישתוארוהי .(

ףלוחהיארשוטשטלםורגללולעםייניעתופיטבשומישה . והגיהנמענמהלשי / וא דועלכתונכוסמתונוכמבשומיש

תשטשוטמךתייאר .

תויתפורתןיבתובוגת : לטונךניהםא / תפסונהפורתת , גםאוא תרחאהפורתבלופיטהתעהזתרמ , חוודלךילע

יאואםינוכיסעונמלידכלפטמהאפורל - תויתפורתןיבתובוגתמםיעבונהתוליעי , תוצובקהמתופורתיבגלדחוימב

תואבה : דימאלוזאטצא - םינתשמ , םייגרנילוכםירישכת ) ןיפרקוליפ ( , אטבימסוח - לולומיט , ןירפביפיד , ןירפניפא - טסינוגא

יגרנרדא , םינידנלגטסורפ , םיגולנא תורזגנוא ןידנלגטסורפל .

יאוולתועפות : הפורתהלשהיוצרהתוליעפלףסונב , יאוולתועפשהעיפוהלתולולעהבשומישהןמזב , ןוגכ : יוניש

תיתשקהלשהיצטנמגפב יונישלםורגיש , ידימתםיתיעל , םייניעהעבצב , החירפ , היארשוטשיט , ןיעבםדוא , הבירצ

ריגו ןיעביו ) ןוגכ : דרג , ץוצקע , תשגרה " רזףוג " ןיעב ( , רתיתעימד , באכ שבויוא ןיעב , תקצב ואףעפעב ןיעב , היבופוטופ

רואלתוליבסיא , יוניש םי םיסירב ) ןוגכ : ןוויכ , ךרוא , יבוע , עבצ א ו רפסמ ( , ףעפעהרועתוהכתה םייונישוא וב םימרוגה

תקמעהל ףעפעהץירח , המתסא , מתסאיפקתה ה םיפירח , הפרחה המישנרצוקותמייקהמתסאב , תרוחרחס , באכ

שאר , םייניעהןיבעבצילדבה , תימחלבםדץחלרתי .

תדחוימתוסחיתהתובייחמהתועפות : תוררקתה , תעפש , םירירשבבאכ םיקרפבוא , הזחבבאכ , בלתוקיפד

תויצטיפלפ ( , החירפןוגכרועברתיתושיגר ) רידנ :( קספה / לופיטהי הנפו / אפורלי .

םוהיזחתפתמוהדימב , המוארט , תקלד ףעפעב , תינרקבואןיעב אפורלדימתונפלשי .

הזןולעבוניוצאלשיאוולתועפותהשיגרמךניהובשהרקמלכב , םעץעייתהלךילעתיללכהךתשגרהביונישלחםאוא

דימאפורה .

אפורמתרחאהארוהרדעהבלבוקמןונימ :

ןיעבתחאהפיט / ניע תלפוטמהםיי / םויבםעפתו , ברעב .

וני ן דבלבאפורהתוארוהיפל . תצלמומההנמהלערובעלןיא .

תוקוניתוםידלילללכךרדבתדעוימהניאוזהפורת . בוצקןמזבוזהפורתלוטילתחכשםא , דימהנמלוטילשי

תרכזנשכ , דחיבתונמיתשלוטילןיאןפואםושבךא !

םיש / בלי : תעולבלאל דבלבינוציחשומישלתדעוימוזהפור .

Xalatan,Israel30 August2011

שומישהןפוא : ץחר / ךידיתאבטיהי . הטה / בכשוארוחאלךשארי / קחרהעבצאהתרזעבוהטימלעי / ףעפעהתאטעמי

ןיעהןמןותחתה . ףטפטרצווישחוורמהךותל / הפורתהתאי . הקדכךשמלףאלהבורקהןיעהתניפלעעבצאהםעץחל

ןיעהתמיצעידכךות . ףפעתלא /י .

דפקההסימתהםוהיזתעינמל / רוגסוןיעהואעבצאהללוכוהשלכחטשמםעעגמבאובתאלקובקבהתייפשי / קובקבהי

בטיה .

הנושארלקובקבהתחיתפרחאלםימישדוחמרתויהפורתבשמתשהלןיא .

תוכחלשיתורחאםייניעתופיטםעבלושמלופיטב 5 םילופיטהןיבתוקד .

ליכמרישכתה דירולכםוינוקלזנברמשמרמוח , לעגפסיהללולעה - עגמתושדעידי , רשאכהזרישכתבשמתשהלןיא

תא / ביכרמה / עגמתושדעה . רישכתבשומישהינפלתושדעהריסהלשי , מתוחפאלרובעכןריזחהלןתינו - 15 תוקד

ןיעלהפורתהתפלזהמ .

--------------------------------------------

תדציכ לכו / לופיטהתחלצהלעייסלי ?

--------------------------------------------

אפורהידילעץלמוהשלופיטהתאםילשהלךילע .

אפורםעתוצעייתהאללהפורתבלופיטהתאקיספהלןיאךתואירבבצמברופישלחםאםג .

ענמ / הלערהי ! ץוחמרוגסםוקמברומשלשיתרחאהפורתלכווזהפורת וםידלילשםדיגשיהל / ידילעותוקוניתוא כ ך

ענמת / הלערהי . הפורתהןמדליעלבתועטבםאוארתיתנמתלטנםא , הנפ / אבהוםילוחתיבלשןוימרדחלדימי / י

ךתיאהפורתהתזירא .

האקהלםורגלןיא אפורמתשרופמהארוהאלל !

ךתלחמבלופיטלהמשרנוזהפורת , רחאהלוחב / להלולעאיהת קיזה . ןתיתלא / ךיבורקלוזהפורתי , ךירכמואךינכש .

ךשוחבתופורתלוטילןיא ! הנמהותויוותהקודבלשי םעפלכב לטונךניהש / הפורתת . ךניהםאםייפקשמביכרהלשי

םהלקוקז .

הנסחא : הרוטרפמטבררקמבןסחאלשי C 2 0 -8 0 , רואמןגומ .

רדחהתרוטרפמטברומשלןתינהחיתפהרחאל ) תמ לתח - ºC 25 ( דעךשמל 4 תועובש .

תיראשהתאקורזלשי .

הזיראהיאנתיפלםג / םיצלמומההנסחאה , דבלבתלבגומהפוקתלתורמשנתופורת . ךיראתלבלםישלאנ לשהגופתה

רישכתה ! קפסלשהרקמלכב , הפורתהתאךלקפיסשחקורבץעוויהלךילע . הזיראהתואבתונושתופורתןסחאלןיא .

סמ ' יר הפורתהםוש : 05 29264 36 109

ןרצי : רוציירזייפ NV , היגלב .

רובע : עבלארשיהקיטבצמרפרזייפ " מ , חר ' רקנש 9 , חותיפהילצרה 46725

3-1-2019

Loblaw Companies Limited recalls Life at Home 50 Count Indoor LED Microdot Icicle Lights

Loblaw Companies Limited recalls Life at Home 50 Count Indoor LED Microdot Icicle Lights

Due to a potential manufacturing defect the lights may overheat, posing a burn and fire hazard.

Health Canada

21-12-2018

Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts

Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts

Funky Chunky, LLC of Eden Prairie, MN is recalling 10 oz Nutty Choco Pop Gift Box, 50 oz. Holiday Crowd Pleaser and 50 oz. Crowd Pleaser, because it may contain undeclared Almond and Cashew Tree Nut. People who have an allergy or severe sensitivity to Almonds and Cashews run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

29-11-2018

ANSES Newsletter in English - N°50 - November 2018

ANSES Newsletter in English - N°50 - November 2018

France - Agence Nationale du Médicament Vétérinaire

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

19-11-2018

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

One lot each of Option Family Sunscreen Lotion SPF 50 and Personnelle Sport Sunscreen Lotion SPF 50 have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination.

Health Canada

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

5-7-2018

Blokhuis: jaarlijks 4 miljoen euro naar onderzoek Lifelines tot 2024

Blokhuis: jaarlijks 4 miljoen euro naar onderzoek Lifelines tot 2024

Derde onderzoeksronde Lifelines in 2019 van start Lifelines, de data- en biobank waarin informatie over de gezondheid van drie generaties inwoners in de noordelijke provincies gedurende dertig jaar wordt verzameld, start in 2019 met de derde onderzoeksronde onder alle Lifelines-deelnemers. Dit wordt mogelijk gemaakt door het Ministerie van VWS, de RUG en het UMCG en de provincies Groningen, Friesland en Drenthe. Deze gezamenlijke inzet weerspiegelt het belang van Lifelines voor zowel volksgezondheid, wet...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

29-5-2018

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal...

FDA - U.S. Food and Drug Administration

27-4-2018

EpiPen 300 mcg adrenaline auto-injector

EpiPen 300 mcg adrenaline auto-injector

Medicine shortages

Therapeutic Goods Administration - Australia

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

4-6-2018

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Active substance: apixaban) - Centralised - 2-Monthly update - Commission Decision (2018)3616 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2148/II/50

Europe -DG Health and Food Safety