Advertisement

اتروڤنت

المعلومات الرئيسية

  • اسم تجاري:
  • اتروڤنت
  • متاح من:
  • BOEHRINGER INGELHEIM ISRAEL LTD.
  • الشكل الصيدلاني:
  • INHALER
  • طريقة التعاطي:
  • INHALATION
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • BOEHRINGER INGELHEIM PHARMA GmbH & CO.KG
Advertisement

المستندات

الأقلمة

  • متاح في:
  • اتروڤنت
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • IPRATROPIUM BROMIDE
  • الخصائص العلاجية:
  • For the relief of symptoms of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 130013093400
  • تاريخ الترخيص:
  • 01-01-2009
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة


רשואוקדבנונכותותואירבהדרשמי"עעבקנהזןולעטמרופ

1986-ו"משתה(םירישכת)םיחקורהתונקתיפלןכרצלןולע

אפורםשרמבתבייחוזהפורת

הפורתבי/שמתשתםרטבופוסדעןולעהתאןויעבי/ארק

טנבורטא

CFC -מישפוח

ףאשמ

בכרה

:תררחשמהפיאשלכ

Ipratropium Bromide   20 mcg

םיליעפיתלבםיביכרמ

1,1,1,2-tetrafluoroethane (propellant HFA 134a), ethanol absolute (99%),

purified water, citric acid anhydrous.

תיטיופרתהצובק

.יגרנילוכיטנא

תיאופרתוליעפ

.המישנהיכרדבתונופמיסביחרמ

.המישנרצוקלתמרוגהתונופמיסהתיוועמםילבוסהםילוחבהלקהלתדעוימהפורתה

?רישכתבשמתשהלןיאיתמ

םימודםירישכתלואהזרישכתלתושיגרהעודיםאוזהפורתבשמתשהלןיא

.ןיפורטאםיליכמה

ןוירהבךניהםאלופיטהתלחתהינפלאפורבץעוויהלילבמהפורתבשמתשהלןיא

לופיטהתלחתהינפלאפורבץעוויהלילבמהפורתבשמתשהלןיא,ןכומכ.הקינמוא

תוימומדא,תוחוניאןוגכ)םייניעהדוקפיתביוקילמרבעבתלבסואת/לבוסךניהםא

,(המוקואלג,תוינועבצתויומדואתוליהתייאר,הייארשוטשט,םייניעבבאכוא

הלחמהמלבוסךניהםאוא,ןתשהיכרדבהמיסח/תינומרעהתטולבתלדגהמ

תעבהלוחהתבוגתירחאבקעמםייקליוצר.(CF)סיזורביפקיטסיסתיתשרותה

.לופיטהתליחת

?ךלשםויםויהייחלעהפורתהעיפשתךיא

תלוכי)היצדומוקאבישוק,תורוחרחסןוגכיאוולתועפותשוחלה/לולעךניה

.וזהפורתבלופיטהתפוקתךשמבהייארשוטשטוןושיאהתובחרתה,(דקמתהל

תנכוסמתוליעפמענמיהלךילעל"נהיאוולתועפותבה/שיגרמךניהוהדימבןכלע

.תונוכמתלעפהובכרבהגיהנןוגכ

שיבכהתברקבםיקחשממואםיינפואלעהביכרמםריהזהלשי,םידלילרשאב

.המודכו

תורהזא

אפורבץעוויהלשי)תונופמיסהתיוועלשדחףקתהבלופיטלדעוימאלרישכתה

.(הלאםירקמלםיאתמרישכתיבגל

החירפןוגכ,וזהפורתבשומישהרחאלשחרתהלתולולעתוידיימתויגרלאתובוגת

המישניישקלםורגללולעה,תירירהוארועהלשהריהמתוחפנתה,תלרח,רועב

הריהמתוחתפתהואןורגבוהפבתוחיפנ,המישנהיכרדלשתורציה,(angioedema)

.(anaphylaxis)םייחתונכסמהתויגרלאתובוגתלש

לעךלשאפורבץעוויהלךילע,תורימחמואתוכשמתמךלשהמישנהתויעבוהדימב

.לופיטהתטישתאןוחבלתנמ

בטיהףוטשלשיםייניעהםעעגמלשהרקמב.םייניעהםערישכתהעגמעונמלשי

.םימב

תויתפורת-ןיבתובוגת

ללוכ,תרחאהפורתבלופיטההתעהזתרמגםאוא,תפסונהפורתת/לטונךניהםא

ידכלפטמהאפורלחוודלךילע,הנוזתיפסותואאפורםשרמאללתשכרשתופורת

תופורתיבגלדחוימב,תויתפורת-ןיבתובוגתמםיעבונהתוליעי-יאואםינוכיסעונמל

ןיליפואתןוגכ)םיניטנסקםיליכמהםירישכתוהמטסאדגנתופורת:תואבהתוצובקהמ

.(ויתורזגנו

יאוולתועפות

תועפשהעיפוהלתולולעהבשומישהןמזב,הפורתהלשהיוצרהתוליעפלףסונב

ללוכ)לוכיעהתכרעמבתויעב,שארבאכ,הליחב,לועישואןורגביוריג:ןוגכיאוול

ידכ.הפבשבויואתונבצע,תרוחרחס,הליחב,רועביוריג,(האקהו,לושלש,תוריצע

תסיעלואםינטקחרקישוג,הירכוסתציצמברזעהלןתינהפבשבויהלעלקהל

.אפורל י/הנפ םייעובש ירחא תפלוח הניא העפותה םא .קיטסמ

:תורחאיאוולתועפות

,(תשקהיעבצ)תינועבצהייאר,םיבחרומםינושיא,רידסאלוא/וריהמבלקפוד

,(היצלהניאבשומישמהאצותכםג)המישנהיכרדבתורציה,םייניעבתוימומדא

תוחיפנ,רובידהוהמישנהלעעיפשהלתולולעהלוקהירתימבתוימואתפתויוצווכתה

לשהריהמתוחפנתה,יוריג,החירפ,הפהללחבתוחיפנותקלד,ןורגבשבוי,עולב

,המישניישקלםורגללולעה(angioedema)ןושלהוא/וםייתפשה,םינפה,רועה

םייחתונכסמהתויגרלאתובוגתלשהריהמתוחתפתהוא,רתיתושיגר,תלרח

.(anaphylaxis)

תדחוימתוסחייתהתובייחמהתועפות

יבאכוא,(דקמתהלתלוכי)היצדומוקאבישוק,הייארשוטשטןוגכהמוקואלגינמיס

.אפורלי/הנפ:םייניע

ריהמקפודוא(תוקזחבלתוקיפד)תויצטיפלפ,םייתפשבוהפבםיביכ,רועבהחירפ

(המישניישק,הזחבץחלתלדגה)תונופמיסתיוועתרמחה,ןתשתריצע,(רידנ)

!דימאפורלי/הנפולופיטהי/קספה:(רידנ)

לחםאוא,הזןולעבונייוצאלשיאוולתועפותה/שיגרמךניהובשהרקמלכב

.דימאפורהםעץעייתהלךילע,תיללכהךתשגרהביוניש

םידליבתויתפורתןיבתובוגתויאוולתועפות

תפסונהפורתלכלעןכויאוולתועפותלכלעלפטמהאפורלחוודלםירוההלע

.ה/דלילתנתינה

.וטרופשתודחוימתויתפורת-ןיבתובוגתויאוולתועפותליעלהאר

ןונימ

.דבלבאפורהתוארוהיפל

.תצלמומההנמהלערובעלןיא

.דבלבאפורהתוארוהיפל:םידלילןונימ

.םינש6ליגלתחתמםידלילתדעוימהניאוזהפורת

!בלי/םיש

.םימהברהבבטיהףוטשלשיןיעבהעיגפלשהרקמב.םייניעםעעגממענמיהלשי

שומישהןפוא

"ףאשמטנבורטאבשמתשהלדציכ"י/האר

.תוליעיהתרבגהל-הפיאשלהפיאשןיבהקדי/ןתמה-תפסונהפיאשבךרוצשיםא

!הלערהי/ענמ

וא/וםידלילשםדיגשיהלץוחמרוגסםוקמברומשלשיתרחאהפורתלכווזהפורת

.הלערהענמתךכידילעותוקונית

לשןוימרדחלדימי/הנפ,הפורתהןמדליףאשתועטבםאוארתיתנמתלטנםא

.ךתיאהפורתהתזיראי/אבהו,םילוחתיב

!אפורהמתשרופמהארוהאללהאקהלי/םורגתלא

.קיזהל הלולע איה ,(ת)רחא הלוחב ;ךתלחמב לופיטל המשרנ וז הפורת

.ךירכמואךינכש,ךיבורקלוזהפורתי/ןתיתלא

.הפורתת/לטונךניהשםעפלכבהנמהותיוותהי/קודב!ךשוחבתופורתלוטילןיא

.םהלה/קוקזךניהםאםייפקשמי/בכרה

הנסחה

-לתחתמןסחאלשי

!רואינפמי/נגהוםוחושאמי/קחרה:קילדרמוח!תוריהז

.קירלכימהרשאכםגףורשלוארובשל,בקנלןיא:ץחללכימ!תוריהז

.דבלבתלבגומהפוקתלתורמשנתופורת,םיצלמומההנסחה/הזיראהיאנתיפלםג

ץעוויהלךילע,קפסלשהרקמלכב!רישכתהלשהגופתהךיראתלבלםישלאנ

.הפורתהתאךלקפיסשחקורב

.הזיראהתואבתונושתופורתןסחאלןיא

130013093400:הפורתהםושיר.סמ

ןרצי

ינפמוק & מ"עבהמרפםייהלגניארגנירב

הינמרג,ןייר/םייהלגניא

םושירהלעב

,מ"עבןייטשלאוןיול,ןומולס

.49131הוקת-חתפ,3696ד"ת

.ריואלתוציחל2רורחישי"עי/לחתה,רישכמבןושארהשומישהינפל:בלי/םיש

.ריואלתחאהציחלרורחשי"עי/לחתה,םימי3ךשמבףאשמבשומישהשענאלםא

This leaflet format has been determined by the Ministry of Health and the content

thereof has been checked and approved

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'

REGULATIONS (PREPARATIONS) - 1986

This medicine should be dispensed on a doctor's prescription.

Carefully read the package insert in its entirety before using the medicine.

ATROVENT

CFC- Free

Metered aerosol

COMPOSITION

Each metered dose delivers:

Ipratropium Bromide 20 mcg

Inactive Ingredients

1,1,1,2-tetrafluoroethane (propellant HFA 134a), ethanol absolute (99%),

purified water, citric acid anhydrous.

THERAPEUTIC GROUP

Anticholinergic.

THERAPEUTIC ACTIVITY

Bronchodilator of the airways.

This product is intended for relief in patients who suffer from bronchospasm

which causes difficulty breathing.

WHEN SHOULD THE PREPARATION NOT BE USED?

Do not use this medicine if you have a sensitivity to this preparation or

to similar preparations containing atropine.

Do not take this medicine without consulting a doctor before starting

treatment if you are pregnant or breastfeeding. The same applies for

patients who are suffering, or have suffered in the past, from impaired

function of the eyes (e.g., eye pain, redness or discomfort, blurred vision,

visual halos or colored images, glaucoma), from enlarged prostatic

gland/urinary tract obstruction, or if you are suffering from hereditary

disease cystic fibrosis (CF).

It is advisable that patient's response be kept under medical supervision

at the start of treatment.

HOW WILL THIS MEDICINE AFFECT YOUR DAILY LIFE?

You may experience side effects such as dizziness, accommodation

disorder (difficulty to focus), mydriasis and blurred vision during treatment

with this medicine. Therefore, if you experience the above mentioned

side effects you should avoid potentially hazardous tasks such as driving

or operating machinery.

Children should be cautioned against engaging in activities such as

bicycle riding or playing near roads and the like.

WARNINGS

The preparation is not indicated for acute bronchospasm attacks (in these

cases, you must consult a doctor for suitable treatment).

Immediate hypersensitivity reactions may occur after administration of the

product such as rash, nettle rash, angio-oedema (a rapid swelling of the

skin or mucous membranes which may cause difficulty breathing), narrowing

of the airways, swelling  of mouth and throat or rapidly progressing, life

threatening allergic reactions (anaphylaxis).

If your breathing problems persist or even worsen: you should consult

your doctor, as your treatment has to be checked.

Avoid contact with the eyes. In case of contact with the eyes, wash them

thoroughly with water.

DRUG INTERACTIONS

If you are taking another drug concomitantly or if you have just finished

treatment with another medicine, including medicines you have bought

without prescription or food supplements, inform the attending doctor, in

order to prevent hazards or lack of efficacy arising from drug interactions.

This is especially important for medicines belonging to the following

groups: antiasthmatics and xanthine-containing preparations (such as

theophylline and its derivatives).

SIDE EFFECTS

In addition to the desired effect of the medicine, adverse reactions may

occur during the course of taking this medicine such as  cough or throat

irritation, nausea, headache, gastrointestinal motility disorders (including

consitipation, diarrhea and vomiting), skin irritation, nausea, dizziness or

nervousness, dry mouth.

Note: Before the apparatus is used for the first time, prime it by activating twice into the atmosphere.

For the relief of dry mouth, you may suck candy or small bits of ice in your

mouth or chew gum. However, if dry mouth continues for more than 2

weeks, refer to your doctor.

Other side effects include: fast and/or abnormal heart rate, widened pupils,

halo-vision (rainbow colors), redness of the eye, narrowing of the airways

(including inhalation induced narrowing), laryngospasm (sudden contractions

of the vocal cords -may impact breathing and speech) , pharyngeal edema

(swelling of the upper throat), dry throat, inflammation of the lining of the

mouth, swelling in the mouth, rash, itching,

angioedema - a rapid swelling of the skin or mucous membranes, the

tongue, lips and face which may cause difficulty breathing, nettle rash,

hypersensitivity or rapidly progressing, life threatening allergic reactions

(anaphylaxis).

Side effects that require special attention:

Signs of glaucoma such as blurred vision, accommodation disorder

(difficulty to focus) or eye pain: refer to your doctor.

Skin rash, ulcers in mouth and on lips, palpitations (strong heart beat) or

increased heart rate (rare), urinary retention, worsening of bronchospasm

(increase in chest pressure, breathing difficulties) (rare): stop treatment

and refer to your doctor immediately!

In the event that you experience side-effects not mentioned in this

insert, or if there is a change in your general feeling, you must consult

your doctor immediately.

Adverse Reactions and Drug Interactions in Children

Parents must inform their doctor on any side-effects, as well as any

additional medicine given to the child.

See above for details of specific side-effects and drug interactions.

DOSAGE

According to doctor’s instructions only.

Do not exceed the recommended dosage.

Dosage for children: according to doctor’s instructions only. This medicine

is not recommended for use in children under 6 years of age.

Attention!

Avoid contact with the eyes. In case of contact with the eyes, wash with

a large amount of water.

DIRECTIONS FOR USE

Refer to "How to use Atrovent Metered Aerosol".

If more than one inhalation is required, wait one minute between inhalations

for maximum benefit.

AVOID POISONING!

This medicine, and all other medicines, must be stored in a safe place out

of the reach of children and/or infants, in order to avoid poisoning.

If you have taken an overdose, or if a child has accidentally inhaled the

medicine, proceed immediately to a hospital emergency room and bring

the package of the medicine with you.

Do not induce vomiting unless explicitly instructed to do so by a doctor!

This medicine has been prescribed for the treatment of your ailment; in

another patient it may cause harm. Do not give this medicine to your

relatives, neighbours or acquaintances.

Do not take medicines in the dark! Check the label and the dose each

time you take your medicine. Wear glasses if you need them.

STORAGE

This medicine should be stored below 30 °C.

Caution! Inflammable, keep away from fire and heat and protect from light.

Warning! Pressure container: Do not puncture, break or burn even when

empty.

Even if kept in their original container and stored as recommended,

medicines may be kept for a limited period only. Please note the expiry

date of the medicine! In case of doubt, consult the pharmacist who

dispensed the medicine to you.

Do not store different medications in the same package.

Drug Reg. No.: 130 01 30934 00

Manufacturer

Boehringer Ingelheim

Pharma GmbH & Co. KG

Ingelheim/Rhein, Germany

Licence Holder

Salomon, Levin & Elstein Ltd.,

:ןמקלדכעובשבםעפףאשמהתאתוקנלשי

םתומלעיהחיטבהלידכהייקנףאשמתייפלערומשלבושח

.סיסרתהתאםוסחלםילולעההפורתהלשםיעקשמלש

הסכמתאריסהלךילעתישאר,ףאשמהתאתוקנלתנמלע

.היפהמ לכימה תא דירפהל ןכמ רחאלו קבאה דגנ ןגמה

ךולכלתוארלהיהיןתינאלשדעםימחםימבהיפהתאי/ץחר

.והשלכ

.ףסונםוחבשומישאללריוואבי/שביויוקינרחאלהיפהתארענ

ינפמןגמההסכמתאולכימהתאי/רזחה,היפהשוביירחאל

.קבא

הפישנמתוענמיהי"עתולקרתיבהיפהןויקינלערומשלןתינ

.היפהךותלא

ותואףושחלוא,חוכבותואחותפל,לכימהתאבקנלןיא

.50°Cלעמתורוטרפמטל

:בושח

הזףאשמםעשומישלדחוימןפואבהמאתוהוהחתופהיפה

ןיאןכל.עובקןפואבןוכנהןונימהלשרורחשחיטבהלתנמלע

שמתשהלןיאןכומכ.םירחאםיפאשמםעדחיהבשמתשהל

.רצומהםעהקפוסרשאוזדבלמהזףאשמםעתורחאתויפב

The metered dose inhaler should be cleaned once a week as follows:

It is important that you keep the mouthpiece of the metered dose inhaler

clean in order to ensure that no deposits of the medicine block the spray.

To clean the inhaler, please first remove the protective dust cap then

remove the container from the mouthpiece.

Rinse the mouthpiece under warm water until no more dirt is visible.

Shake the mouthpiece after cleaning and allow to air dry without using

additional heat. Once the mouthpiece is dry, replace the container and

the protective dust cap.

It is easier to keep the mouthpiece clean by avoiding breathing into the

inside of the mouthpiece.

The pressurized container should not be forced open, punctured or exposed

to temperatures above 50 °C.

IMPORTANT:

The mouthpiece was developed specifically for use with this inhaler to

ensure that the correct dose is always released. It should not therefore

be used with any other metered dose inhalers. Likewise, no mouthpieces

should be used with the inhaler other than the one provided.

31-8-2017

Hospira Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial Due to The Presence of Particulate Matter Within a Single Vial

Hospira Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial Due to The Presence of Particulate Matter Within a Single Vial

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial.

FDA - U.S. Food and Drug Administration

4-8-2017

FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor

FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor

[02-17-2011] The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death.

FDA - U.S. Food and Drug Administration

4-8-2017

FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blockers (ARBs)

FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blockers (ARBs)

[06-02-2011] The U.S. Food and Drug Administration (FDA) has completed a review of the potential risk of cancer associated with the class of medications known as angiotensin receptor blockers (ARBs). FDA has concluded that treatment with an ARB medication does not increase a patient’s risk of developing cancer.

FDA - U.S. Food and Drug Administration

13-12-2017

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Solution [Mylan Pharmaceuticals, Inc.]

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Solution [Mylan Pharmaceuticals, Inc.]

Updated Date: Dec 13, 2017 EST

US - DailyMed

13-12-2017

K-BROVET (Potassium Bromide) Solution [Pegasus Laboratories, Inc.]

K-BROVET (Potassium Bromide) Solution [Pegasus Laboratories, Inc.]

Updated Date: Dec 13, 2017 EST

US - DailyMed

12-12-2017

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE Capsule [A-S Medication Solutions]

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE Capsule [A-S Medication Solutions]

Updated Date: Dec 12, 2017 EST

US - DailyMed

12-12-2017

AMMONIUM BROMATUM (Ammonium Bromide) Liquid [Washington Homeopathic Products]

AMMONIUM BROMATUM (Ammonium Bromide) Liquid [Washington Homeopathic Products]

Updated Date: Dec 12, 2017 EST

US - DailyMed

12-12-2017

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Solution [Ritedose Pharmaceuticals, LLC]

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Solution [Ritedose Pharmaceuticals, LLC]

Updated Date: Dec 12, 2017 EST

US - DailyMed

11-12-2017

RADIUM BROMATUM (Radium Bromide) Pellet [Laboratoires Boiron]

RADIUM BROMATUM (Radium Bromide) Pellet [Laboratoires Boiron]

Updated Date: Dec 11, 2017 EST

US - DailyMed

16-11-2017

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Solution [Nephron SC Inc.]

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Solution [Nephron SC Inc.]

Updated Date: Nov 16, 2017 EST

US - DailyMed

16-11-2017

IPRATROPIUM BROMIDE Solution [Nephron SC Inc.]

IPRATROPIUM BROMIDE Solution [Nephron SC Inc.]

Updated Date: Nov 16, 2017 EST

US - DailyMed

2-11-2017

Menveo (GSK Vaccines S.r.l.)

Menveo (GSK Vaccines S.r.l.)

Menveo (Active substance: Meningococcal Group A, C, W135 and Y Conjugate Vaccine) - Rectificative Decision - Commission Decision (2017)7395 of Thu, 02 Nov 2017

Europe -DG Health and Food Safety

2-11-2017

Multaq (Sanofi-Aventis groupe)

Multaq (Sanofi-Aventis groupe)

Multaq (Active substance: dronedarone) - Centralised - Yearly update - Commission Decision (2017)7407 of Thu, 02 Nov 2017

Europe -DG Health and Food Safety

2-11-2017

Ibandronic Acid Teva (Teva B.V.)

Ibandronic Acid Teva (Teva B.V.)

Ibandronic Acid Teva (Active substance: Ibandronic acid) - Centralised - Yearly update - Commission Decision (2017)7169 of Thu, 02 Nov 2017

Europe -DG Health and Food Safety

1-11-2017

Ultibro Breezhaler (Novartis Europharm Limited)

Ultibro Breezhaler (Novartis Europharm Limited)

Ultibro Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Yearly update - Commission Decision (2017)7400 of Wed, 01 Nov 2017

Europe -DG Health and Food Safety

31-10-2017

Spiriva vs. Symbicort

Spiriva vs. Symbicort

Spiriva HandiHaler (tiotropium bromide) and Symbicort (budesonide and formoterol fumarate dihydrate) are prescribed to prevent bronchospasm (narrowing of the airways in the lungs) in people with bronchitis, emphysema, or COPD (chronic obstructive pulmonary disease).

US - RxList

31-10-2017

VECURONIUM BROMIDE Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]

VECURONIUM BROMIDE Injection, Powder, Lyophilized, For Solution [Hospira, Inc.]

Updated Date: Oct 31, 2017 EST

US - DailyMed

30-10-2017

Scientific guideline:  Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products, draft: consultation open

Scientific guideline: Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products, draft: consultation open

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor VIII products, which are indicated for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). In case of an indication claim in von Willebrand’s disease, see also core SmPC for von Willebrand factor products (CPMP/BPWG/278/02).

Europe - EMA - European Medicines Agency

26-10-2017

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Solution [Golden State Medical Supply, Inc.]

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Solution [Golden State Medical Supply, Inc.]

Updated Date: Oct 26, 2017 EST

US - DailyMed

24-10-2017

Sleep Quiz: Sleep Hygiene & Sleep Facts

Sleep Quiz: Sleep Hygiene & Sleep Facts

Title: Sleep Quiz: Sleep Hygiene & Sleep FactsCategory: MedicineNet QuizCreated: 7/21/2010 12:00:00 AMLast Editorial Review: 10/24/2017 1:41:02 PM

US - MedicineNet

23-10-2017

SPIRIVA (Tiotropium Bromide) Capsule [Boehringer Ingelheim Pharmaceuticals Inc.]

SPIRIVA (Tiotropium Bromide) Capsule [Boehringer Ingelheim Pharmaceuticals Inc.]

Updated Date: Oct 23, 2017 EST

US - DailyMed

19-10-2017

IPRATROPIUM BROMIDE Solution [A-S Medication Solutions]

IPRATROPIUM BROMIDE Solution [A-S Medication Solutions]

Updated Date: Oct 19, 2017 EST

US - DailyMed

17-10-2017

Ulunar Breezhaler (Novartis Europharm Limited)

Ulunar Breezhaler (Novartis Europharm Limited)

Ulunar Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Yearly update - Commission Decision (2017)7025 of Tue, 17 Oct 2017

Europe -DG Health and Food Safety

17-10-2017

LUMASILK EMULSION LEVEL 02 Emulsion [The Skin Atelier, Inc.]

LUMASILK EMULSION LEVEL 02 Emulsion [The Skin Atelier, Inc.]

Updated Date: Oct 17, 2017 EST

US - DailyMed

2-10-2017

Versican Plus Pi/L4 (Zoetis Belgium S.A.)

Versican Plus Pi/L4 (Zoetis Belgium S.A.)

Versican Plus Pi/L4 (Active substance: Canine parainfluenza type 2 virusLeptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088) - Centralised - Yearly update - Commission Decision (2017)6707 of Mon, 02 Oct 2017

Europe -DG Health and Food Safety

2-10-2017

Versican Plus L4 (Zoetis Belgium S.A.)

Versican Plus L4 (Zoetis Belgium S.A.)

Versican Plus L4 (Active substance: Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088) - Centralised - Yearly update - Commission Decision (2017)6709 of Mon, 02 Oct 2017

Europe -DG Health and Food Safety

2-10-2017

Versican Plus Pi (Zoetis Belgium S.A.)

Versican Plus Pi (Zoetis Belgium S.A.)

Versican Plus Pi (Active substance: Canine parainfluenza type 2 virus) - Centralised - Yearly update - Commission Decision (2017)6708 of Mon, 02 Oct 2017

Europe -DG Health and Food Safety

2-10-2017

ProZinc (Boehringer Ingelheim Vetmedica GmbH)

ProZinc (Boehringer Ingelheim Vetmedica GmbH)

ProZinc (Active substance: Insulin human) - Centralised - Yearly update - Commission Decision (2017)6710 of Mon, 02 Oct 2017

Europe -DG Health and Food Safety

2-10-2017

Neupro (UCB Pharma S.A.)

Neupro (UCB Pharma S.A.)

Neupro (Active substance: Rotigotine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2017)6704 of Mon, 02 Oct 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/000626/T/0080

Europe -DG Health and Food Safety

2-10-2017

Ristempa (Amgen Europe B.V.)

Ristempa (Amgen Europe B.V.)

Ristempa (Active substance: pegfilgrastim) - Withdrawal - Commission Decision (2017)6702 of Mon, 02 Oct 2017

Europe -DG Health and Food Safety

28-9-2017

Xoterna Breezhaler (Novartis Europharm Limited)

Xoterna Breezhaler (Novartis Europharm Limited)

Xoterna Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Yearly update - Commission Decision (2017)6643 of Thu, 28 Sep 2017

Europe -DG Health and Food Safety

7-9-2017

EU/3/03/182 (Idorsia Pharmaceuticals Deutschland GmbH)

EU/3/03/182 (Idorsia Pharmaceuticals Deutschland GmbH)

EU/3/03/182 (Active substance: 5-methyl-pyridine-2-sulfonic acid {6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-[2-(1H-tetrazol-5-yl)-pyridin-4-yl]-pyrimidin-4-yl}-amide sodium salt) - Transfer of orphan designation - Commission Decision (2017)6106 of Thu, 07 Sep 2017 European Medicines Agency (EMA) procedure number: EMEA/OD/057/03/T/02

Europe -DG Health and Food Safety

1-9-2017

ROCURONIUM BROMIDE Injection [Mylan Institutional LLC]

ROCURONIUM BROMIDE Injection [Mylan Institutional LLC]

Updated Date: Sep 1, 2017 EST

US - DailyMed

30-8-2017

EU/3/06/364 (Bayer AG)

EU/3/06/364 (Bayer AG)

EU/3/06/364 (Active substance: Sorafenib tosylate) - Transfer of orphan designation - Commission Decision (2017)5981 of Wed, 30 Aug 2017 European Medicines Agency (EMA) procedure number: EMEA/OD/109/05/T/02

Europe -DG Health and Food Safety

30-8-2017

EU/3/07/518 (Bayer AG)

EU/3/07/518 (Bayer AG)

EU/3/07/518 (Active substance: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate) - Transfer of orphan designation - Commission Decision (2017)5980 of Wed, 30 Aug 2017 European Medicines Agency (EMA) procedure number: EMEA/OD/088/07/T/02

Europe -DG Health and Food Safety

21-8-2017

EU/3/07/469 (Bayer AG)

EU/3/07/469 (Bayer AG)

EU/3/07/469 (Active substance: Ciprofloxacin (inhalation use)) - Transfer of orphan designation - Commission Decision (2017)5795 of Mon, 21 Aug 2017 European Medicines Agency (EMA) procedure number: EMEA/OD/092/06/T/02

Europe -DG Health and Food Safety

21-8-2017

Ipratropium

Ipratropium

Ipratropium is used to treat a runny nose caused by the common cold or seasonal allergies. It works by reducing the amount of fluid/mucus released from inside your nose.

US - RxList

بنفس العنصر النشط

من نفس المنتِج

Advertisement