كسترال XL ١٠ ملغ

المعلومات الرئيسية

  • اسم تجاري:
  • كسترال XL ١٠ ملغ
  • الشكل الصيدلاني:
  • TABLETS PROLONGED RELEASE
  • طريقة التعاطي:
  • PER OS
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • SANOFI WINTHROP INDUSTRIE, FRANCE

المستندات

الأقلمة

  • متاح في:
  • كسترال XL ١٠ ملغ
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • ALFUZOSIN
  • الخصائص العلاجية:
  • Treatment of certain functional symptoms of benign prostatic hypertrophy particularly if surgery has to be delayed for some reason. Adjuvant treatment to a catheter in acute urinary retention related to benign prostatic hypertrophy.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 123013014000
  • تاريخ الترخيص:
  • 01-07-2011
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة

Patient Package insert in accordance 

with the Pharmacists’ regulations 

(PreParations) – 1986

the medicine is dispensed with  

a doctor’s prescription only

Xatral Xl 10 mg

Prolonged release tablets

Each prolonged release tablet contains:

ALFUZOSIN HCl 10 mg

Inactive ingredients – see Section 6.

read this leaflet carefully in its entirety 

before using the medicine.

Keep this leaflet; you may need to read it 

again.

This leaflet contains concise information about 

the medicine.

If you have further questions, refer to the 

doctor or pharmacist.

This medicine was prescribed to treat you. Do 

not pass it on to others. It may harm them even 

if it seems to you that their medical condition 

is similar.

The medicine is intended for men.

If a side effect worsens or if a side effect not 

mentioned in this leaflet occurs, please refer 

to the doctor or pharmacist.

1. what is the medicine intended For?

Xatral is used for the treatment of symptoms 

associated with benign prostatic hypertrophy 

and as an adjuvant treatment to catheter 

withdrawal in urinary retention resulting from 

benign prostatic hypertrophy.

therapeutic  group:  Xatral  belongs  to  a 

group of preparations called alpha blockers 

and is a selective blocker of the a1 (alpha one) 

receptor.

2. BeFore using the medicine

 do not use the medicine if:

You  are  sensitive  to  alfuzosin  or  to  any 

of  the  ingredients  of  the  medicine  (see  

Section 6). Signs of an allergic reaction include: 

rash, swallowing or breathing problems, 

swelling of the lips, throat or tongue.

You suffer from a sudden drop in blood 

pressure  when  you  get  up  (postural 

hypotension).

You suffer from a problem in liver function.

You  suffer  from  severe  kidney  failure 

(creatinine clearance below 30 mL/min).

You are being treated with other a (alpha) 

blockers.

special warnings relating to use of the 

medicine

Before treatment with the medicine, tell your 

doctor if:

• You are being treated with medicines for 

treatment of hypertension or with nitrate 

derivatives

• You are suffering from disturbed blood flow 

to the brain

• You  are  suffering  from  coronary  heart 

• You experienced a significant drop in blood 

pressure after taking another medicine from 

the a (alpha) blocker group

Warnings:

When taking the medicine, some people may 

experience a sudden drop in blood pressure 

when they sit up or stand up quickly. This 

effect may occur within a few hours of taking 

the medicine and may be accompanied by 

dizziness, sweating, a feeling of tiredness, 

or even fainting. The patient must lie down 

until the symptoms pass. It is therefore also 

recommended to take the first dose before 

going to sleep.

If you suffer or have suffered from prolonged 

QT  intervals  in  ECG  or  if  you  are  taking 

medicines that cause prolonged QT intervals 

in ECG, you must be monitored before and 

while taking the medicine.

 if you are taking or have recently taken 

other medicines, including non-prescription 

medicines and food supplements, tell the 

doctor or pharmacist.

Do not take Xatral if you are taking: other a 

(alpha) blockers.

Check with the doctor or pharmacist if you are 

taking: medicines for treatment of impotence 

(such  as  sildenafil),  antihypertensives, 

medicines for treatment of angina pectoris 

(nitrates), antifungals (such as: ketoconazole, 

itraconazole), medicines for treatment of HIV 

(such as: ritonavir), antibiotics of the macrolide 

family (such as: clarithromycin, erythromycin).

Nitrates for the treatment of symptoms of 

chest pains when taken together with Xatral 

may cause a drop in blood pressure.

General anesthetics may cause a severe drop 

in blood pressure.

 surgery and tests while taking Xatral

While taking Xatral, blood pressure must be 

monitored, especially at the beginning of 

treatment with Xatral.

If you are due to undergo surgery under general 

anesthesia, tell the anesthesiologist that you 

are taking Xatral. The doctor may decide to stop 

Xatral treatment 24 hours before the surgery.

If you are due to undergo cataract eye surgery, 

tell the surgeon if you are taking or have taken 

Xatral,  in  order  to  prevent  complications 

during surgery.

 use of Xatral with food

Xatral  should  be  taken  immediately  after 

dinner.

 use of Xatral and alcohol consumption

You may feel dizzy or weak when taking Xatral; 

if these effects occur, do not drink alcohol.

 driving and use of machinery

Use of this medicine may cause dizziness, 

exhaustion and disturbed vision. If these effects 

occur, do not drive or operate machinery or 

dangerous tools.

 important information regarding some of 

the ingredients of the medicine

Xatral contains hydrogenated castor oil that 

3. how should You use the medicine?

Always  use  according  to  the  doctor's 

instructions.  Check  with  the  doctor  or 

pharmacist if you are unsure.

Swallow the tablet whole, with plenty of water, 

after dinner. Do not break, crush or chew the 

tablet, as it may impact the absorption of the 

medicine in the body.

The dosage and treatment regimen will be 

determined by the doctor only.

The usual dosage is generally:

For benign prostatic hypertrophy – one tablet, 

once a day.

For adjuvant treatment to catheter withdrawal 

in urinary retention resulting from benign 

prostatic hypertrophy – one tablet, once a day. 

Treatment is initiated on the day the catheter 

is inserted and stopped the day after removal 

of the catheter (a total of 3-4 days).

do not exceed the recommended dose.

if you mistakenly took a higher dosage of 

Xatral or if a child has mistakenly swallowed 

the medicine, refer immediately to a hospital 

emergency room and bring the medicine 

package with you. Remain in a lying position 

as much as possible, to stop the side effects. Do 

not drive to the hospital by yourself.

if you forgot to take Xatral at the required 

time, do not take a double dose to compensate 

for the forgotten dose. Skip this dose and take 

the next dose at the regular time.

Adhere  to  the  treatment  regimen  as 

recommended by the doctor.

if you stop taking Xatral

Continue taking Xatral even if there has been 

an improvement in your health. Stop the 

treatment only if instructed to do so by the 

doctor.

Do not take medicines in the dark! Check 

the label and the dose each time you take 

medicine. Wear glasses if you need them.

If  you  have  further  questions  regarding 

use of the medicine, consult the doctor or 

pharmacist.

4. side eFFects

As with any medicine, use of Xatral may cause 

side effects in some users. It is likely that these 

effects will occur at the start of treatment. 

Do not be alarmed when reading the list of 

side effects. You may not suffer from any of 

them.

chest pain (angina) - usually occurs if you 

have suffered from angina in the past.  if 

you suffer from chest pain, stop Xatral 

treatment  and  refer  to  the  doctor  or 

hospital immediately. This effect occurs in 

less than 1 in 10,000 people.

allergic reactions - you can notice signs of 

angioedema, such as, skin redness or rash, 

swelling (of the eyes, face, lips, mouth and 

tongue), difficulty breathing and swallowing. 

These are signs of an allergic reaction. If these 

effects occur, stop Xatral treatment and refer 

to the doctor or hospital immediately. This 

effect occurs in less than 1 in 10,000 people.

SENS  DE  DER OULEMENT

other side effects

occur frequently (occur in less than 1 in 10 

people):

Dizziness, weakness, fainting, headache, nausea, 

abdominal pain, feeling ill, a drop in blood 

pressure when switching from a lying position 

to standing or sitting (postural hypotension).

occur infrequently (occur in less than 1 in 

100 people): 

Vertigo, drowsiness, syncope, rapid heart rate 

(tachycardia), palpitations, allergic rhinitis, 

diarrhea, dryness in the mouth, skin rash, 

itchiness, edema, chest pain, flushing.

occur very rarely (occur in less than 1 in 10,000 

people): Allergic skin reaction, angioedema.

other  side  effects  that  may  occur  (of 

unknown frequency): 

Cerebral events in patients with disturbed 

blood flow to the brain, atrial fibrillation, 

eye problems in patients who are undergoing 

tests while taking Xatral), vomiting, liver injury, 

cholestatic liver inflammation, prolonged 

erection, a decrease in the number of white 

blood cells and platelets.

If any of the side effects worsens or if you suffer 

from a side effect not mentioned in this leaflet, 

consult with the doctor.

5. how should Xatral Be stored?

Avoid poisoning! This medicine and all other 

medicines must be stored in a closed place, out 

of the reach of children and/or infants in order to 

avoid poisoning. Do not induce vomiting unless 

explicitly instructed to do so by a doctor.

Do not use the medicine after the expiry date 

(exp. date) that appears on the package. The 

expiry date refers to the last day of that month.

Store at a temperature below 30°C.

6. additional inFormation

In addition to the active ingredient, the medicine  

Castor Oil, Ethylcellulose, Magnesium Stearate, 

Mannitol, Povidone, Microcrystalline Cellulose, 

Yellow Iron Oxide, Colloidal Hydrated Silica

What does the medicine look like and what is 

included in the pack: Round, biconvex, three 

layer tablet: one white layer between two yellow 

layers. Packs of 10 and 30 tablets are available 

(not all pack sizes may be marketed).

This leaflet does not contain all the information 

about your medicine; if you have any questions 

or are not sure about anything, please ask your 

doctor.

License holder and address: sanofi-aventis 

Israel ltd., P.O.Box 8090, Netanya 4250499.

Manufacturer's name and address: Sanofi 

Winthrop Industrie, France.

This leaflet was checked and approved by the 

Ministry of Health in May 2013.

Registration number of the medicine in the 

National Drug Registry of the Ministry of Health: 

123.01.30140

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:)העודי הניא ןתוחיכש(

 תמירזב תוערפה םע םילוחב םייחומ םיעורא

 םייניעב תויעב ,םירודזורפ רופרפ ,חמל םדה

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 :םג

Hypromellose,  Hydrogenated  Castor  Oil, 

Ethylcellulose, Magnesium Stearate, Mannitol, 

Povidone, Microcrystalline Cellulose, Yellow 

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123.01.30140

XATR 10 TAB PL SH 020613

SENS  DE  DER OULEMENT

 םיחקורה תונקת יפל ןכרצל ןולע

1986 - ו"משתה )םירישכת(

 יפ לע תקוושמ הפורתה 

דבלב אפור םשרמ

 ג"מ 10  Xl  לרטסק

ךשוממ רורחשל תוילבט

:הליכמ ךשוממ רורחשל הילבט לכ

ALFUZOSIN HCI 10 mg

.6 ףיעס האר - םיליעפ אל םיביכרמ

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.הפורתב שמתשת

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.תינומרעה

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הפורתב שומיש ינפל  .2

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.ןושלב

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 שומישל  תועגונה  תודחוימ  תורהזא

הפורתב

:םא אפורל רפס הפורתב לופיטה ינפל

 ץחל רתיב לופיטל תופורתב לפוטמ ךנה   •

םיטרטינ לש תורזגנ וא םד

 חמל םדה תמירזב תוערפהמ לבוס ךנה •

 תילילכ בל תלחממ לבוס ךנה •

 תובקעב םדה ץחלב תיתועמשמ הדירי תיווח •

α םסוח תצובקמ תרחא הפורת תליטנ

)אפלא(

:תורהזא

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 תחיקל רחאל תועש רפסמ ךות תורקל הלולע

 ,תרוחרחסב הוולמ תויהל הלולעו הפורתה

 הלוחה לע .ןופלעל דע ,תופייע תשגרה ,העזה

 יוצר םג ןכל .םימוטפמיסה ומלעייש דע בכשל

 .הנישה ינפל הנושארה הנמה תא תחקל

 עטקמ תכראהמ תלבס וא לבוס ךנה םא

 תומרוגה תופורת לטונ ךנה וא גקאב  QT  -ה

 תויהל ךילע גקאב  QT  -ה עטקמ תכראהל

 .הפורתה תליטנ ןמזבו ינפל בקעמב

 ,הנורחאל תחקל םא וא ,חקול התא םא  

 םשרמ אלל תופורת ללוכ תורחא תופורת

 וא  אפורל  ךכ  לע  רפס  ,הנוזת  יפסותו

 .חקורל

α ימסוח :חקול התא םא לרטסק תחקל ןיא

.םירחא )אפלא(

 :חקול התא םא חקורה וא אפורה םע אדו

 ,)ליפאנדליס ןוגכ( תונוא ןיאב לופיטל תופורת

 לופיטל תופורת ,םד ץחל רתיב לופיטל תופורת

 לופיטל תופורת ,)םיטרטינ( סירוטקפ הניגנאב

 ,)לוזאנוקרטיא ,לוזאנוקוטק :ןוגכ( תוירטפב

 ,)ריבאנוטיר :ןוגכ(  HIV  -ה ףיגנב לופיטל תופורת

 :ןוגכ( םידילורקמה תחפשממ תוקיטויביטנא

.)ןיצימורתירא ,ןיצימורתירלק

 םיבאכ לש םימוטפמיסב לופיטל םיטרטינ

 םורגל םילולע לרטסק םע דחי החיקלב הזחב

.םדה ץחלב הדיריל

 הדיריל םורגל םילולע תיללכ המדרהל םירמוח

.םדה ץחלב הפירח

לרטסק תחיקל ןמזב תוקידבו םיחותינ  

 ץחל רחא בוקעל שי לרטסקב לופיטה תפוקתב

.לרטסקב לופיטה תליחתב דחוימב םד

 המדרהב חותינ רובעל דמוע התאו הדימב

 חקול  התאש  םידרמל  עידוהל  שי  ,האלמ

 תקספה לע טילחי אפורהו ןכתיי .לרטסק

.חותינה ינפל תועש 24 לרטסקה תחיקל

 טקרטק חותינ רובעל דמוע התאו הדימב

 ךנה םא חתנמה אפורל עידוהל שי ,םייניעב

 םיכוביס עונמל תנמ לע לרטסק תחקל וא חקול

.חותינה ןמזב

ןוזמ םע לרטסקב שומיש  

 .ברעה תחורא רחאל דימ לרטסק תחקל שי

לוהוכלא תכירצו לרטסקב שומיש  

 ןמזב השלוח וא תרוחרחס שיגרתש ןכתיי

 ולא תועפות תועיפומ םא ,לרטסק תחיקל

 .לוהוכלא תותשל ןיא

תונוכמב שומישו הגיהנ  

 ,תורוחרחסל םורגל לולע וז הפורתב שומישה

 תועפות תועיפומ םא .היאר תוערפהו תושישת

 םירישכמ וא תונוכמ ליעפהל וא גוהנל ןיא ולא

.םינכוסמ

 לש םיביכרמהמ קלח לע בושח עדימ  

הפורתה

 רשא  hydrogenated   Castor   oil  הליכמ לרטסק

.לשלשמ לש העפשה ול תויהל היושע

?הפורתב שמתשת דציכ  .3

 ךילע .אפורה תוארוה יפל שמתשהל שי דימת

.חוטב ךניא םא חקורה וא אפורה םע קודבל

 הברה םע התומלשב הילבטה תא עולבל שי

 קסרל ,רובשל ןיא .ברעה תחורא ירחא םימ

 עיפשהל לולע רבדה יכ הילבטה תא סועלל וא

.ףוגב הפורתה תגיפס לע

 אפורה ידי לע ועבקי לופיטה ןפואו ןונימה

:אוה ללכ ךרדב לבוקמה ןונימה

 תחא הילבט - תינומרעה לש הריפש הלדגהל

.םויב םעפ

 ,)רטטק(  רתנצמ  הלימגל  םילשמ  לופיטל

 לש הריפש הלדגהמ האצותכ ןתש תריצאב

 תלחתה .םויב םעפ תחא הילבט - תינומרעה

 לופיטה תקספהו רטטקה תסנכה םויב לופיטה

 3-4 לכה ךסב( רטטקה תאצוה רחאל םוי

.)םימי

.תצלמומה הנמה לע רובעל ןיא

 לש רתוי הובג ןונימ תועטב תלטנ םא

 ,הפורתה ןמ דלי עלב תועטב םא וא לרטסק

 אבהו םילוח תיב לש ןוימ רדחל דימ הנפ

 ןתינש לככ בכשל שי .ךתיא הפורתה תזירא

 גהנת לא .יאוולה תועפות תא רוצעל תנמ לע

.ךמצעב םילוחה תיבל

 ןיא ,שורדה ןמזב לרטסק לוטיל תחכש םא

 .החכשנש הנמה לע יוציפל הלופכ הנמ לוטיל

 ןמזב האבה הנמה תא חקו וז הנמ לע גלד

 .ליגרה

 ידי לע ץלמוהש יפכ לופיטב דימתהל שי

.אפורה

לרטסק תליטנ תא קיספמ התא םא

 רופיש לח םא םג לרטסק לוטיל ךישמהל שי

 םא קר לופיטה תא קספה .ךתואירב בצמב

.ךכ תושעל ךל הרוה אפורה

 הנמהו תיוותה קודב !ךשוחב תופורת לוטיל ןיא

 םייפקשמ בכרה .הפורת לטונ ךנהש םעפ לכב

.םהל קוקז ךנה םא

 שומישל עגונב תופסונ תולאש ךל שי םא

.חקורב וא אפורב ץעוויה ,הפורתב

יאוול תועפות  .4

 לולע לרטסקב שומישה ,הפורת לכב ומכ

 .םישמתשמהמ קלחב יאוול תועפותל םורגל

 .לופיטה תליחתב ועיפוי ולא תועפותש ריבס

 .יאוולה תועפות תמישר ארקמל להבית לא

.ןהמ תחא ףאמ לובסת אלו ןכתיי

 שחרתמ ללכ ךרדב - )הניגנא( הזחב באכ

 לבוס ךנה םא .רבעב הניגנאמ תלבס םא

 לרטסקב  לופיטה  קספה  הזחב  באכמ

 העפות .דימ םילוח תיבל וא אפורל הנפו

 10,000 ךותמ 1 -מ תוחפב תשחרתמ וז

.םישנא

 םינמיסב ןיחבהל לוכי ךנה - תויגרלא תובוגת

 החירפ וא תוימומדא ןוגכ המדאויגנא לש

 ,םייתפשב ,םינפב ,םייניעב( תוחיפנ ,רועב

 ולא .העילבבו המישנב םיישק ,)ןושלבו הפב

 תועפות םא .תיגרלא הבוגת לש םינמיס

 לרטסקב לופיטה קספה תושחרתמ ולא

 העפות .דימ םילוח תיבל וא אפורל הנפו

 10,000 ךותמ 1 -מ תוחפב תשחרתמ וז

.םישנא

תופסונ יאוול תועפות

 תושחרתמ(  תובורק  םיתיעל  תועיפומ

 :)םישנא 10 ךותמ 1 -מ תוחפב

 ,שאר באכ ,תופלעתה ,השלוח ,תרוחרחס

 תדירי  ,הלחמ  תשוחת  ,ןטב  באכ  ,הליחב

 הבישי וא הדימעל הביכשמ רבעמב םד ץחל

 .) postural   hypotension (

 תושחרתמ(  תוקוחר  םיתיעל  תועיפומ

:)םישנא 100 ךותמ 1 -מ תוחפב

 ,) syncope ( תופלעתה ,םונמנ ,)וגיטרו( רורחס

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

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

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

Recently Updated Records for the Week of July 25, 2018 Last Modified Date: Friday, August 10, 2018

FDA - U.S. Food and Drug Administration

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety