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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

LUMIFY eye drops is an OTC drug topically applied on the eye(s). The product contains brimonidine tartrate as an active substance. Brimonidine tartrate is an α2-adrenoceptors agonist (sympathomimetic) displaying potent blood-vessel constricting properties thus provides the eye blanching activity on the conjunctiva.LUMIFY eye drops is an OTC drug topically applied on the eye(s). The product contains brimonidine tartrate as an active substance. Brimonidine tartrate is an α2-adrenoceptors agonist (sympathomimetic) displaying potent blood-vessel constricting properties thus provides the eye blanching activity on the conjunctiva.

 

Therapeutic indications
LUMIFY, Eye drops, relieves redness of the eyes due to minor eye irritations.Therapeutic indications
LUMIFY, Eye drops, relieves redness of the eyes due to minor eye irritations.


Do not use LUMIFY eye drops:
- if you are allergic to brimonidine or any of the other
ingredients of this medicine (listed in section 6).
- in prolonged ocular hyperaemia (ocular redness)
- in prolonged eye irritation
- in bacterial, viral and fungal ocular infections (manifest
ing e.g. with the eye mucous or purulent discharge)
- in eye(s) pain
- in cases of vision changes or disturbances.Do not use LUMIFY eye drops:
- if you are allergic to brimonidine or any of the other
ingredients of this medicine (listed in section 6).
- in prolonged ocular hyperaemia (ocular redness)
- in prolonged eye irritation
- in bacterial, viral and fungal ocular infections (manifest
ing e.g. with the eye mucous or purulent discharge)
- in eye(s) pain
- in cases of vision changes or disturbances.

Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using LUMIFY eye drops.
Warnings and precautions
Talk to your doctor, pharmacist before using LUMIFY eye drops.
For external use only.
LUMIFY is designed only for intermittent or occasional use.
If after the use of LUMIFY eye drops the condition worsens or persists for more than 3 days, stop using this product and refer to ophthalmologist immediately. For children 5 years of age and older, careful observation of the treatment response should be performed by parents and/or caregivers.Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using LUMIFY eye drops.
Warnings and precautions
Talk to your doctor, pharmacist before using LUMIFY eye drops.
For external use only.
LUMIFY is designed only for intermittent or occasional use.
If after the use of LUMIFY eye drops the condition worsens or persists for more than 3 days, stop using this product and refer to ophthalmologist immediately. For children 5 years of age and older, careful observation of the treatment response should be performed by parents and/or caregivers.

If after the use of LUMIFY eye drops you experience eye pain, changes in vision, skin or eye allergy, continued redness or irritation of the eye, stop using the product and refer to ophthalmologist immediately.
Eye irritation or redness caused by a serious ocular condition, such as infection, foreign body or damage to the cornea, acute glaucoma or iritis (inflammation of the iris) requires immediate medical attention.
In the case of infection at the site of application of the medicinal product, you should refer to ophthalmologist who will decide about appropriate antibacterial and/or antifungal treatment introduction. Any spread of infection requires referring to ophthalmologist who will decide about LUMIFY eye drops withdrawal till the time of infection cure.
If you suffer from cardiovascular diseases such as: severe or unstable and uncontrolled cardiovascular disease, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension or thromboangitis obliterans (inflammation and clotting of arteries and veins of hands and feet), you should take special care when using this product since brimonidine if absorbed (when used incorrectly or for prolonged time) may affect circulatory functions and worsen disease symptoms.If after the use of LUMIFY eye drops you experience eye pain, changes in vision, skin or eye allergy, continued redness or irritation of the eye, stop using the product and refer to ophthalmologist immediately.
Eye irritation or redness caused by a serious ocular condition, such as infection, foreign body or damage to the cornea, acute glaucoma or iritis (inflammation of the iris) requires immediate medical attention.
In the case of infection at the site of application of the medicinal product, you should refer to ophthalmologist who will decide about appropriate antibacterial and/or antifungal treatment introduction. Any spread of infection requires referring to ophthalmologist who will decide about LUMIFY eye drops withdrawal till the time of infection cure.
If you suffer from cardiovascular diseases such as: severe or unstable and uncontrolled cardiovascular disease, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension or thromboangitis obliterans (inflammation and clotting of arteries and veins of hands and feet), you should take special care when using this product since brimonidine if absorbed (when used incorrectly or for prolonged time) may affect circulatory functions and worsen disease symptoms.

If you suffer from depression, you should special attention when using this product since brimonidine, if absorbed (when used incorrectly or for prolonged time), easily passes the blood-brain barrier and attenuates the central nervous system functions. Dizziness, somnolence, sedation and other similar symptoms may occur. If you notice worsening of disease symptoms, you should refer to a doctor.
If you use contact lenses you should avoid contact them with the drug solution as it may cause lenses discolouration. After ocular installation of LUMIFY eye drops you should maintain at least 10-minute interval before lenses reinsertion.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.If you suffer from depression, you should special attention when using this product since brimonidine, if absorbed (when used incorrectly or for prolonged time), easily passes the blood-brain barrier and attenuates the central nervous system functions. Dizziness, somnolence, sedation and other similar symptoms may occur. If you notice worsening of disease symptoms, you should refer to a doctor.
If you use contact lenses you should avoid contact them with the drug solution as it may cause lenses discolouration. After ocular installation of LUMIFY eye drops you should maintain at least 10-minute interval before lenses reinsertion.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

Children and adolescents
LUMIFY eye drops should not be used in paediatric patients younger than 5 years of age.
Other medicines and LUMIFY eye drops
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
No interactions are known for ocular use of brimonidine tartrate in combination with other drugs used onto the eye. However, if brimonidine is absorbed to the blood circulation after application onto the eye, it may interfere with activity of several groups of medicines administered orally or parenterally. These groups include antidepressant medicines (attenuated activity), CNS depressants (enhanced activity), hypotensive and other cardiovascular-active drugs (decreased or enhanced activity).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.Children and adolescents
LUMIFY eye drops should not be used in paediatric patients younger than 5 years of age.
Other medicines and LUMIFY eye drops
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
No interactions are known for ocular use of brimonidine tartrate in combination with other drugs used onto the eye. However, if brimonidine is absorbed to the blood circulation after application onto the eye, it may interfere with activity of several groups of medicines administered orally or parenterally. These groups include antidepressant medicines (attenuated activity), CNS depressants (enhanced activity), hypotensive and other cardiovascular-active drugs (decreased or enhanced activity).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
LUMIFY 0.025%, eye drops, medicinal product has minor influence on the ability to drive and use machines. As all products administered to eye, it may cause transient blurred vision, which may impair the ability to drive or to use machinery, especially at night or in reduced lighting. If you experience such disturbances, you should wait until these symptoms have cleared before driving or using machinery.
LUMIFY eye drops contains benzalkonium chloride
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 10 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.Driving and using machines
LUMIFY 0.025%, eye drops, medicinal product has minor influence on the ability to drive and use machines. As all products administered to eye, it may cause transient blurred vision, which may impair the ability to drive or to use machinery, especially at night or in reduced lighting. If you experience such disturbances, you should wait until these symptoms have cleared before driving or using machinery.
LUMIFY eye drops contains benzalkonium chloride
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 10 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

 

 

 


Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The drug should not be used longer than it was recommended by a doctor.
You should use the medicine locally onto the eye(s).
Do not apply LUMIFY eye drops simultaneously with other ophthalmic medicinal products used topically. If you use other topical ophthalmic medicinal products, you should keep the 5-minute interval between application of your medicines.
Wash your hands and remove your contact lenses before application of the product.Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The drug should not be used longer than it was recommended by a doctor.
You should use the medicine locally onto the eye(s).
Do not apply LUMIFY eye drops simultaneously with other ophthalmic medicinal products used topically. If you use other topical ophthalmic medicinal products, you should keep the 5-minute interval between application of your medicines.
Wash your hands and remove your contact lenses before application of the product.

The cap of the bottle should be pushed down while turning then taken off.
The patient’s head must be tilted back, and the lower eyelid must be pulled gently down to form a small pocket between the eyelid and the eye.
The bottle should be inverted and squeezed until a single drop is dispensed into the eye.
Adults and Children 5 years of age and over:
Apply one drop in the affected eye(s) every 6 – 8 hours, no more than four times daily. The tip of the dispensing container should not contact with the eye or surrounding structures in order to prevent contamination.
After application of the LUMIFY eye drops in the affected eye(s), you should press the corner(s) of the eye near the nose and close the eyelids for 2 minutes.
The cap must be put back on and the bottle must be closed tightly straight after it has been used.
Wash your hands thoroughly after using the product.
Renal/hepatic impairment
Brimonidine has not been studied in patients with hepatic or renal impairment.
Use in children and adolescents
LUMIFY eye drops should not be used in paediatric patients younger than 5 years of age.The cap of the bottle should be pushed down while turning then taken off.
The patient’s head must be tilted back, and the lower eyelid must be pulled gently down to form a small pocket between the eyelid and the eye.
The bottle should be inverted and squeezed until a single drop is dispensed into the eye.
Adults and Children 5 years of age and over:
Apply one drop in the affected eye(s) every 6 – 8 hours, no more than four times daily. The tip of the dispensing container should not contact with the eye or surrounding structures in order to prevent contamination.
After application of the LUMIFY eye drops in the affected eye(s), you should press the corner(s) of the eye near the nose and close the eyelids for 2 minutes.
The cap must be put back on and the bottle must be closed tightly straight after it has been used.
Wash your hands thoroughly after using the product.
Renal/hepatic impairment
Brimonidine has not been studied in patients with hepatic or renal impairment.
Use in children and adolescents
LUMIFY eye drops should not be used in paediatric patients younger than 5 years of age.

If you use more LUMIFY eye drops than it is recommended
After long-term use of LUMIFY eye drops overdose or after accidental oral ingestion, the following symptoms may
occur: decreased blood pressure, weakness, vomiting,
lethargy, sedation, slow or irregular heart rhythm,
excessive constriction of the pupil, difficulty breathing or no breath, decreased muscle tone, decreased body temperature or seizures.
If overdose symptoms occur, talk to your doctor or go to hospital as soon as possible.
If you forget to use LUMIFY eye drops
Do not take a double dose to make up for a forgotten dose.
If you stop using LUMIFY eye drops
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.If you use more LUMIFY eye drops than it is recommended
After long-term use of LUMIFY eye drops overdose or after accidental oral ingestion, the following symptoms may
occur: decreased blood pressure, weakness, vomiting,
lethargy, sedation, slow or irregular heart rhythm,
excessive constriction of the pupil, difficulty breathing or no breath, decreased muscle tone, decreased body temperature or seizures.
If overdose symptoms occur, talk to your doctor or go to hospital as soon as possible.
If you forget to use LUMIFY eye drops
Do not take a double dose to make up for a forgotten dose.
If you stop using LUMIFY eye drops
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies, LUMIFY medicinal product has been shown to possess similar safety profile as the product without active substance (Placebo).
Common local adverse reactions (may occur in 1 to 10 patients per 100 treated patients):
- Ocular hyperaemia (also known as ocular redness -
small dilated blood vessels)
- Installation site pain.
Uncommon local adverse reactions (may occur in 1 to 10 patients per 1000 treated patients):
- Dry eye
- Photophobia
- Eye discharge
- Eye irritation
- Eye pain
- Foreign body sensation in eyes
- Installation site irritation, burning or itching.Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies, LUMIFY medicinal product has been shown to possess similar safety profile as the product without active substance (Placebo).
Common local adverse reactions (may occur in 1 to 10 patients per 100 treated patients):
- Ocular hyperaemia (also known as ocular redness -
small dilated blood vessels)
- Installation site pain.
Uncommon local adverse reactions (may occur in 1 to 10 patients per 1000 treated patients):
- Dry eye
- Photophobia
- Eye discharge
- Eye irritation
- Eye pain
- Foreign body sensation in eyes
- Installation site irritation, burning or itching.

Uncommon systemic adverse reactions (may occur in 1 to 10 patients per 1000 treated patients):
- Headache
- Palpitations
- Muscle twitching
- Lymphocytosis, monocytosis (high count of lymphocytes
or monocytes in blood)
- Nasal discomfort
- Hypotension (decreased blood pressure).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
Website: www.sfda.gov.sa/npUncommon systemic adverse reactions (may occur in 1 to 10 patients per 1000 treated patients):
- Headache
- Palpitations
- Muscle twitching
- Lymphocytosis, monocytosis (high count of lymphocytes
or monocytes in blood)
- Nasal discomfort
- Hypotension (decreased blood pressure).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
Website: www.sfda.gov.sa/np


Keep this medicine out of the sight and reach of children.
Store below 30°C. After opening, it can be used up to
121 days when stored below 30°C.
Do not use this medicine after the expiry date which is stated on the bottle label and carton. The expiry date refers to the last day of that month.
Do not use this medicine if solution changes colour or becomes cloudy.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.Keep this medicine out of the sight and reach of children.
Store below 30°C. After opening, it can be used up to
121 days when stored below 30°C.
Do not use this medicine after the expiry date which is stated on the bottle label and carton. The expiry date refers to the last day of that month.
Do not use this medicine if solution changes colour or becomes cloudy.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


- The active substance is: Brimonidine tartrate (0.025%)
- The other ingredients are: glycerin, sodium borate decahydrate, boric acid, potassium chloride, calcium chloride dihydrate, sodium chloride, benzalkonium chloride, Hydrochloric acid and/or sodium hydroxide may be used to adjust pH, and water for injection.- The active substance is: Brimonidine tartrate (0.025%)
- The other ingredients are: glycerin, sodium borate decahydrate, boric acid, potassium chloride, calcium chloride dihydrate, sodium chloride, benzalkonium chloride, Hydrochloric acid and/or sodium hydroxide may be used to adjust pH, and water for injection.


LUMIFY, Brimonidine Tartrate Ophthalmic Solution, 0.025% drug product is a clear, colorless to slightly yellow, sterile, preserved ophthalmic solution formulated for topical delivery to the eye. The multi-dose drug product is packaged in as nominal of 2.5ml or 7.5 mL fill volumes in 10 mL LDPE bottles using LLDPE tips and two-piece child-resistant closures.

Marketing Authorisation Holder
Bausch & Lomb Incorporated, 400 Somerset Corporate Boulevard, Bridgewater, NJ 08807 United States of America
Manufacturer
Bausch & Lomb Incorporated, 8500 Hidden River Parkway, Tampa, FL 33637, United StatesMarketing Authorisation Holder
Bausch & Lomb Incorporated, 400 Somerset Corporate Boulevard, Bridgewater, NJ 08807 United States of America
Manufacturer
Bausch & Lomb Incorporated, 8500 Hidden River Parkway, Tampa, FL 33637, United States


09/2019
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

لوميفاي عبارة عن قطرات عين متوفرة بدون وصفة طبية للاستخدام
الموضعي على العين (العينين). يحتوي هذا المنتج على مادة طرطرات
البريمونيدين كمادة فعالة. طرطرات البريمونيدين هي محفزات مستقبلات
الأدرينالين ألفا 2 (مقلّدات الودي) التي تزيد من الخصائص الانقباضية
للأوعية الدموية مما يزيد من نشاط تبيض ملتحمة العين.لوميفاي عبارة عن قطرات عين متوفرة بدون وصفة طبية للاستخدام
الموضعي على العين (العينين). يحتوي هذا المنتج على مادة طرطرات
البريمونيدين كمادة فعالة. طرطرات البريمونيدين هي محفزات مستقبلات
الأدرينالين ألفا 2 (مقلّدات الودي) التي تزيد من الخصائص الانقباضية
للأوعية الدموية مما يزيد من نشاط تبيض ملتحمة العين.

دواعي الاستعمال العلاجية
قطرة العين لوميفاي تخفف الاحمرار الناتج من التهيج الطفيف في العين.

موانع استعمال قطرة العين لوميفاي:
- إذا كنت تعاني من حساسية من مادة البريمونيدين أو أي مادة من
) المكونات الأخرى المحتوي عليها هذا الدواء )المبينة في القسم 6
- في حالة فرط الدم بالعينين لمدة طويلة (احمرار العينين)
- في حالة تهيج العينين لمدة طويلة
- في حالة الإصابة بعدوى بكتيريه أو فيروسيه أو فطريات في العين (أي على
سبيل المثال، في مخاط العين أو التفريغ القيحي)
- الإصابة بألم في العين (العينين)
- في حالة تغيير الرؤية أو اضطرابات الرؤية
يحظر استخدام هذا الدواء في حال انطبقت عليك أي من الحالات السابقة.
وإذا كنت غير متيقن، فعليك استشارة الطبيب أو الصيدلي قبل استخدام
لوميفاي.
تحذيرات واحتياطات
يجب استشارة الطبيب أو الصيدلي قبل استخدام لوميفاي
للاستعمال الخارجي فقط.
لوميفاي مخصص للاستعمال المتقطع أو العرضي.

إذا ساءت الحالة بعد استخدام قطرة العين لوميفاي أو ظلت كما هي
لأكثر من 3 أيام، فتوقف عن استخدام هذا المنتج وعليك استشارة طبيب
العيون في الحال. أما بخصوص الأطفال سن 5 سنوات وما فوق، فيجب على
الوالدين و/أو مقدمي العناية ملاحظة الاستجابة للعلاج بعناية شديدة.
في حالة الإحساس بألم في العينين بعد استخدام لوميفاي أو حدوث تغيير في
الرؤية أو البشرة أو حساسية بالعينين أو استمرار الاحمرار أو تهيج بالعين،
فتوقف عن استخدام المنتج وعليك استشارة طبيب العيون في الحال.
عناية طبية فورية مطلوبة عند الشعور بتهيج في العينين أو احمرارهما
بسبب الإصابة بمرض شديد بالعينين مثل العدوى أو الأجسام الغريبة أو
تلف القرنية أو المياه الزرقاء الحادة أو التهاب القزحية (التهاب قزحية
العين).
في حالة الإصابة بعدوى في موضع استعمال المنتج الدوائي، يجب عليك
استشارة طبيب العيون الذي بدوره سيقرر استعمال العلاج المناسب المضاد
للبكتيريا/ الفطريات. انتشار أي عدوى يستلزم استشارة طبيب العيون
الذي بدوره سيقرر بشأن الامتناع عن استعمال قطرة العين لوميفاي حتى
تتم معالجة العدوى.

يجب عليك اتخاذ الاحتياطات الخاصة إذا كنت تعاني من أمراض قلبية
وعائية مثل الأمراض القلبية الوعائية غير المسيطر عليها أو غير المستقرة
أو المزمنة، قصور الدماغ أو الشريان التاجي، أو ظاهرة رينو، أو انخفاض
ضغط الدم الانتصابي، أو مرض بيورجر )التهاب الشرايين والأوردة
باليدين والقدمين وتجلطها(، عند استعمال هذا المنتج، إذ قد تؤثر مادة
البريمونيدين عند امتصاصها )عند استعمالها على نحو غير صحيح أو لمدة
طويلة( على وظائف نظام الدورة الدموية وتؤدي إلى تفاقم أعراض المرض.
إذا كنت تعاني من الاكتئاب، فيجب عليك اخذ الاحتياطات الخاصة عند
استعمال هذا المنتج، لأن مادة البريمونيدين، عند امتصاصها )عند استعمالها
على نحو غير صحيح أو لفترة طويلة( تجتاز الحاجز الدموي الدماغي
بسهولة وتُضعف وظائف الجهاز العصبي المركزي، مما قد يسبب الشعور
بالدوار والنعاس والتخدير أو أعراض أخرى مماثلة. وفي حال لاحظت تفاقم
أعراض المرض، يجب عليك استشارة الطبيب.

إذا كنت تستخدم العدسات اللاصقة، فيجب عليك تجنب ملامستها بهذا
المحلول الدوائي، فقد يسبب تغيير ألوان العدسات، وبعد وضع لوميفاي،
يجب عليك الانتظار لمدة 10 دقائق على الأقل قبل إعادة وضع العدسات.
في حالة عدم تاكدك إذا ما كانت الحالات السابقة تنطبق عليك أم لا،
فعليك استشارة الطبيب أو الصيدلي قبل استخدام هذا الدواء.

الأطفال والمراهقين
يُحظر استعمال قطرة العين لوميفاي لمعالجة الأطفال دون سن 5 سنوات.
لوميفاي والأدوية الأخرى
أخبر الطبيب أو الصيدلي إذا كنت تستخدم أو استخدمت مؤخرًا أو قد
تستخدم أي أدوية أخرى.

لا توجد تفاعلات معروفه كنتيجة لاستخدام طرطرات البريمونيدين بالعينين
مع أدوية أخرى، ومع ذلك، إذا اُمتصت مادة البريمونيدين بالدم بعد
استعمالها بالعينين، فقد تتعارض مع فعالية العديد من مجموعات الأدوية
المتناولة عن الطريق الفم أو الحقن، تتضمن هذه المجموعات الأدوية
المضادة للاكتئاب (فعالية مخففة) والعقاقير المسببة للاكتئاب (فعالية
معززة) وأدوية علاج انخفاض ضغط الدم والأدوية النشطة لعلاج الأمراض
الوعائية القلبية (فعالية مخفضة أو معززة)

الحمل والرضاعة والخصوبة
إذا كنتِ حامل أو ترضعين رضاعة طبيعية، أو تعتقدين أنك حامل أو
تخططين للإنجاب، فعليك استشارة الطبيب أو الصيدلي قبل استخدام
هذا الدواء.
القيادة واستخدام الآلات
تؤثر قطرة العين لوميفاي 0.025 %، على القدرة على قيادة الآلات
واستخدامها تأثيرًا طفيفًا. و كحال جميع المنتجات المستخدمة لمعالجة
العينين، قد تسبب تغيم مؤقت بالرؤية مما يعيق القدرة على القيادة
أو استخدام الآلات خاصة بالليل أو في حالة الإضاءة الضعيفة. وفي حال
شعرت بتلك الاضطرابات، فعليك الانتظار حتى زوال تلك الأعراض قبل
القيادة أو استخدام الآلات.
تحتوي لوميفاي على كلوريد البنزالكونيوم
قد تمتص العدسات اللاصقة الرقيقة كلوريد البنزالكونيوم وقد يغير لون
العدسات اللاصقة. لذا يجب عليك إزالة العدسات اللاصقة قبل استخدام
هذا الدواء ووضعها مرة أخرى بعد 10 دقائق.

كما يمكن أن يسبب كلوريد البنزالكونيوم تهيج العينين خاصة في حال
كانت عيناك مصابة بالجفاف أو كنت تعاني من اضطرابات بالقرنية
)الطبقة الشفافة في مقدمة العينين(. وإذا كنت تشعر بإحساس غير طبيعي
أو وجع أو ألم بالعينين بعد استخدام هذا الدواء، فعليك استشارة الطبيب.

https://localhost:44358/Dashboard

احرص دائمًا على استخدام هذا الدواء تمامًا كما أخبرك الطبيب أو الصيدلي،
واستشر الطبيب أو الصيدلي إن كنت غير متأكد من ذلك. إذ يحظر
استعمال الدواء لمدة أطول من التي أوصى بها الطبيب.
يجب استخدام الدواء موضعيًا على العين )العينين(.
يحظر استخدام قطرة العين لوميفاي مع أدوية أخري تُستخدم موضعيًا
للعينين في آن واحد. وفي حالة استخدامك أدوية موضعية أخرى للعينين،
يجب عليك الانتظار لمدة 5 دقائق بين استخدام الدواء و الأخر.
يجب غسل اليدين وإزالة العدسات اللاصقة قبل استخدام المنتج.
يجب الضغط على غطاء الزجاجة لأسفل أثناء التدوير وإزالته بعد ذلك.
يجب إمالة رأس المريض للخلف وسحب جفن العين السفلي للأسفل قلي ل
بحيث تُشكل فتحة جيبية صغيرة بين جفن العين والعين.
يجب قلب الزجاجة والضغط عليها حتى تنزل قطرة واحدة في العين.

البالغين والأطفال من سن 5 سنوات وما فوق:
6 ساعات، لكن ليس - ضع قطرة واحدة في العين )العينين( المصابة كل 8
أكثر من أربع مرات يوميًا. يُحظر ملامسة طرف القطارة للعينين أو
الأنسجة المحيطة لتجنّب التلوث.
بعد وضع قطرة العين لوميفاي في العين )العينين( المصابة، يجب عليك الضغط على زاوية (زاويا) العين القريبة من الأنف وإغلاق جفون العين
لدقيقتين.
يجب إعادة وضع الغطاء وغلق الزجاجة بإحكام بعد الاستخدام مباشرة.
يجب غسل اليدين تمامًا بعد استعمال المنتج.

مشاكل الكبد/ الكلى
لم تُدرس مادة البريمونيدين على المرضى الذين يعانون من مشاكل بالكبد/
الكلى.
الاستخدام لمعالجة الأطفال والمراهقين
يُحظر استعمال قطرة العين لوميفاي لمعالجة الأطفال دون سن 5 سنوات.
في حالة استعمال قطرة العين لوميفاي أكثر من الحد الموصى به
بعد مدة طويلة من استعمال الجرعة الزائدة من قطرة العين لوميفاي
أو بعد ابتلاعها بالخطأ، قد تظهر الأعراض التالية: انخفاض ضغط الدم أو
الإجهاد أو القيء أو الخمول أو السبات أو بطء نبضات القلب أو عدم
انتظامها أو الإفراط في انقباض حدقة العين أو صعوبة التنفس أو انقطاع
النفس أو انخفاض وتيرة أداء العضلات أو انخفاض درجة حرارة الجسم أو
التعرض لنوبات.
في حالة ظهور أعراض الجرعة الزائدة، يجب عليك استشارة الطبيب أو
الذهاب إلى المستشفى في أقرب وقت ممكن.

في حالة نسيان استعمال قطرة العين لوميفاي
يُحظر أخذ جرعة مضاعفة لتعويض جرعة فائتة.
في حالة التوقف عن استعمال قطرة العين لوميفاي
إذا كانت لديك أي استفسارات أخرى عن استعمال هذا الدواء، فعليك
استشارة الطبيب أو الصيدلي.

مثل جميع الأدوية، يمكن أن يسبب هذا الدواء أعراض جانبية، بالرغم من
أنها لا تحدث للجميع.
في الدراسات السريرية، أثبت المنتج الدوائي لوميفاي أنه يتمتع بملف
سلامة مماثل للمنتج الخالي من المادة الفعّالة (علاج وهمي).

الأعراض الجانبية الموضعية الشائعة (قد تحدث لمريض حتى 10 مرضي من
بين كل 100 مريض يُجرى معالجتهم):
- فرط الدم بالعينين (يُعرف أيضًا باحمرار العينين- اتساع طفيف بالأوعية
الدموية)
- ألم في موضع الاستعمال

 

الأعراض الجانبية الموضعية غير الشائعة (قد تحدث لمريض حتى 10 مرضي
من بين كل 1000 مريض يُجرى معالجتهم):
- جفاف العينين
- رهاب الضوء
- افرازات العينين
- تهيج العينين
- ألم العينين
- الشعور بأجسام غريبة بالعينين
- تهيج في موضع الاستعمال أو الحرقة أو الحكة.

 

الأعراض الجانبية غير الموضعية غير الشائعة (قد تحدث لمريض حتى 10
مرضي من بين كل 1000 مريض يُجرى معالجتهم):
- صداع
- خفقان القلب
- الوخز العضلي
- كثرة اللمفاويات وكثرة الخلايا وحيدات النواة في الدم (كثرة عدد الخلايا
اللمفاوية أو الخلايا وحيدة النواة في الدم)
- الشعور بعدم ارتياح بالأنف
- انخفاض الضغط (انخفاض ضغط الدم)

 

الإبلاغ عن الآثار الجانبية
يجب استشارة الطبيب أو الصيدلي أو الممرضة في حالة الإصابة بأي أعراض
جانبية، ويشمل ذلك أي أعراض جانبية غير واردة في هذه النشرة. فإبلاغك
عن الأعراض الجانبية، قد يساعد في توفير المزيد من المعلومات حول سلامة
هذا الدواء.

يجب حفظ هذا الدواء بعيدًا عن مرمي بصر الأطفال ومتناول أيديهم.
ييُخزن في درجة حرارة أقل من 30 درجة مئوية. بعد فتح العبوة، يمكن
استخدام الدواء لمدة 121 يوم بشرط تخزينه عند أقل من 30 درجة مئوية.
يُحظر استخدام هذا الدواء بعد انتهاء تاريخ الصلاحية المدون على
الزجاجة والعبوة. يشير تاريخ انتهاء الصلاحية إلى أخر يوم من ذلك الشهر
يُحظر استخدام هذا الدواء إذا تغير لون المحلول أو أصبح معتم.
يُحظر التخلص من أي أدوية عن طريق نفايات الصرف الصحي أو النفايات
المنزلية. ويجب استشارة الصيدلي عن كيفية التخلص من الأدوية التي لم
تعد تستعملها. تلك الإجراءات تساعد على حماية البيئة.


- المادة الفعالة: طرطرات البريمونيدين (0.025%)
- المكونات الأخرى: جليسرين، عشاري هيدرات بورات الصوديوم، حمض
البوريك، كلوريد البوتاسيوم، ثنائي هيدرات كلوريد الكالسيوم، كلوريد
الصوديوم، كلوريد البنزالكونيوم، ويمكن استخدام حمض الهيدروكلوريك و/
أو هيدروكسيد الصوديوم لتعديل الأس الهيدروجيني، ومياه معدّة للحقن

لوميفاي، طرطرات بريمونيدين محلول للعينين، 0.025 % عبارة عن محلول
صاف، قوامه إما شفاف أو مائل للاصفرار، ومعقم، محلول عيني بتركيبة
مصنوعة باستخدام مواد حافظة للاستخدام الموضعي على العين.
تمت تعبئة المنتج متعدد الجرعات بأحجام صغيرة هي 2.5 أو 7.5 مللي
لتر في عبوة حجمها 10 مللي لتر، تُصنع العبوات من البولي إيثلين منخفض
الكثافة المصنعة باستخدام أليفا البولي إيثلين الخطي منخفض الكثافة
وقطعتي غلق مقاومة لعبث الأطفال.
قد لا تكون جميع أحجام العبوات متاحة في الاسواق.

حامل حق التسويق
بوش آند لومب إنكوربوريتد، 400 سومرسيت كوربوريت بوليفارد،
بريدجووتر، نيوجيرسي 08807 ، الولايات المتحدة الأمريكية
المصنع
بوش آند لومب إنكوربوريتد، 8500 هيدن ريفر باركواي، تامبا، فلوريدا
33637 ، الولايات المتحدة الأمريكية.

09/2019
 Read this leaflet carefully before you start using this product as it contains important information for you

Lumify, 0.025%, Ophthalmic Solution, Eye drops

For the full list of excipients, see section 6.1.

Lumify, Brimonidine Tartrate Ophthalmic Solution, Eye drops, 0.025% drug product is a is clear, colorless to slightly yellow, sterile, preserved ophthalmic solution as eye drops formulated for topical delivery to the eye.

Lumify, eye drops, relieves redness of the eye due to minor eye irritations.


Posology for Adults and children 5 years of age and over:
One drop in the affected eye(s) every 6 – 8 hours, no more than four times daily.
Method of administration
Ocular use only.
Lumify should be applied in the affected eye(s) with pressing nasolacrimal duct and closing the
eyelids for 2 minutes. These procedures enable to reduce the systemic absorption of the drug what
result in a decrease in systemic side effects occurrence and an increase in local (ocular) activity.
If Lumify is used with other topical ophthalmic medicinal product, the 5-minute interval should
be maintained.
Hands should be thoroughly washed before and after using the product.
The tip of the dispensing container should not contact with the eye or surrounding structures in
order to prevent contamination

Renal / Hepatic Impairment
Lumify 0.025%, eye drops, solution has not been studied in patients with renal or hepatic impairment
(see section 4.4).


Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Lumify should not be used in the following conditions: - prolonged hyperaemia of the eye - prolonged irritation of the eye - ocular infections - mucopurulent discharge from the ocular tissues - eye pain - vision changes/disturbances

Lumify 0.025%, eye drops, solution is for intermittent or occasional use only.
If the condition worsens or persists for more than 72 hours, the use of the product should be
discontinued and the patient should be reevaluated. For children 5 years of age and older, careful
observation of the treatment response should be performed by parents and/or caregivers.
Eye irritation or redness caused by a serious ocular disease, such as infection, foreign body or damage
to the cornea, acute glaucoma or iritis requires immediate medical attention.

Cardiovascular disorders
In case of systemic absorption of brimonidine (when used incorrectly or for prolonged time)
cardiovascular disturbances may be observed and thus special caution should be applied in patients
with:
- severe or unstable and uncontrolled cardiovascular disease
- cerebral or coronary insufficiency
- Raynaud’s phenomenon
- orthostatic hypotension
- thromboangiitis obliterans

CNS depression
In case of systemic absorption of brimonidine (when used incorrectly or for prolonged time) which
easily pass the blood-brain barrier, the attenuation of central nervous system functions may be
observed (dizziness, somnolence, sedation etc.). Such activity may result in the increase of disease
symptoms and thus special caution should be applied in such patients treated with the product.
Simultaneous use of other ophthalmic topical drugs
If Lumify is used with other topical ophthalmic medicinal product simultaneously, the 5-minute
interval should be maintained.
Hepatic / Renal Impairment
Brimonidine has not been studied in patients with hepatic or renal impairment, therefore special
caution should be used in treating such patients.
Paediatric population
Lumify 0.025%, eye drops, solution should not be used in paediatric patients younger than 5 years of
age.

Excipients-specific
The medicinal product contains benzalkonium chloride and may cause eye irritation.
Benzalkonium chloride is known to discolour soft contact lenses. The contact of the drug with contact
lenses should be avoided. Contact lenses should be removed prior the application and 10-minute
interval maintained before lenses reinsertion.


No interaction studies have been performed.
Other ocular medication:
Currently there is no information regarding the use of Lumify 0.025%, eye drops, medicinal product
and the absorption of concomitant ocular products. However, a short, 5-minute interval between the
application of Lumify 0.025%, eye drops, medicinal product and other ocular products should be
maintained.

Systemic medication:
There is no information available regarding the use of Lumify 0.025%, eye drops medicinal product
with other systemically administered drugs. Systemic absorption of brimonidine after topical
ophthalmic application of the Lumify 0.025%, eye drops is limited and such amount of the drug is
unlikely to pose a systemic threat to the use of other systemically administered drugs (see section 5.2).
Caution has been, however, expressed when using brimonidine eye drops at a higher concentration
(0.2%) for the treatment of glaucoma concomitantly with the classes of drugs mentioned below.
Monoamine oxydase (MAO) inhibitors
Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine
and potentially result in an increased systemic side effect such as hypotension. Caution is advised in
patients taking MAO inhibitors, which can affect the metabolism and uptake of circulating amines.
Tricyclic or tetracyclic antidepressants
Caution is advised in patients taking antidepressants which can affect the noradrenergic transmission.

CNS depressants
Although specific drug interactions studies have not been conducted with brimonidine tartrate
ophthalmic solution, the possibility of an additive or potentiating effect with central nervous system
depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be taken into
consideration.
Betablockers, antihypertensives, cardiac glycosides
Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in using concomitant drugs
such as beta-blockers (ophthalmic and systemic), antihypertensives and/or cardiac glycosides is
advised.
Adrenoceptor agonists/antagonists
Caution is required during initial concomitant use (or with a change in dosage) of a systemic drug
(regardless of pharmaceutical form) that can cause interactions with α-adrenergic agonists or that can
affect their effectiveness such as adrenoceptor agonists or antagonists (e.g. isoprenaline, prazosin).

Clonidine, chlorpromazine, methylphenidate, reserpine
Although no actual data on the level of circulating catecholamines after administration of brimonidine
tartrate ophthalmic solution as eye drops are available, caution is advised when using the eye drops in
patients who are taking medications such as chlorpromazine, methylphenidate and reserpine, which
can affect the metabolism and uptake of circulating amines.


Pregnancy
Ther are no or limited amount of data from the use of brimonidine in pregnant women. Brimonidine,
at plasma levels higher than are achieved during therapy in humans, has been shown to cause postnatal
growth reduction in rabbits (see section 5.3). As a precautionary measure, the use of the Lumify
0.025%, eye drops medicinal product should be avoided during pregnancy.
Lactation
It is not known to what extent brimonidine tartrate may pass to the milk of breastfeeding women after
ocular use. Studies on animals have shown that brimonidine and its metabolites are excreted with milk
(for details see 5.3). A risk to the newborns/infants cannot be excluded. Therefore, the use of the
Lumify 0.025%, eye drops medicinal product should be avoided during lactation.
Fertility
There is no human data indicating that topically applied brimonidine tartrate affects the fertility. Brimonidine,
at plasma levels higher than are achieved during therapy in humans, has been shown to cause increased preimplantation
loss in rabbits (see section 5.3).


Lumify 0.025%, eye drops, medicinal product has minor influence on the ability to drive and use
machines. As all products administered to eye, it may cause transient blurred vision, which may impair
the ability to drive or to use machinery, especially at night or in reduced lighting. The patient should
wait until these symptoms have cleared before driving or using machinery.


The frequency of occurrence of side effects was arranged as specified below:
Very Common: (≥ 1/10)
Common: (≥ 1/100, < 1/10)
Uncommon: (≥ 1/1000 < 1/100)
Rare: (≥ 1/10,000 < 1/1000)
Very rare: (< 1/10,000)
Frequency unknown (cannot be estimated from the available data).
The safety profile of Lumify 0.025%, eye drops was shown to be similar to the safety profile of the
placebo.

System Organ ClassFrequency of OccurenceSide Effect
Eye disordersCommonOcular Hyperemia
UncommonDry eye, photophobia, eye discharge, eye irritation, eye pain, foreign body sensation in eyes
General disorders and administration site conditionsCommonInstillation site pain
UncommonInstillation site burn, instillation site irrittion instillation site pruritus
Nervous system disordersUncommonHeadache
Cardiac disordersUncommonPalpitations
Musculoskeletal and connective tissue disordersUncommonMuscle twitching
Blood and lymphatic system disordersUncommonLymphocytosis, monocytosis
Respiratory, thoracic and mediastinal disordersUncommonNasal discomfort
Vascular disordersUncommonHypotension

Due to the lower concentration of Lumify 0.025%, eye drops medicinal product, the potential risk of
occurrence of known pharmacological class effects is expected to be lower than with brimonidine 0.2%
eye drops, especially the systemic effects because of the negligible systemic exposure of Lumify
0.025%, eye drops medicinal product (see section 5.2).
In clinical studies with children treated with brimonidine eye drops at higher concentration (0.2%) as
part of the medical treatment of congenital glaucoma, symptoms of brimonidine overdose such as loss
of consciousness, lethargy, somnolence, hypotension, hypotonia, bradycardia, hypothermia, cyanosis,
pallor, respiratory depression and apnoea have been reported (see section 4.9). Taking into consideration
that 0.025% concentration of brimonidine in Lumify is 8-times lower than that used in the treatment of
glaucoma (0.2%), it may be assumed that the risk of serious side effects related to the CNS and
peripheral tissues should also be significantly lower for Lumify product.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via:

To report any side effect:

Saudi Arabia
The National Pharmacovigilance Centre (NPC):
- SFDA Call Center: 19999
- E-mail: npc.drug@sfda.gov.sa
- Website: https://ade.sfda.gov.sa/
Other GCC States:
Please contact the relevant competent authority.


Ophthalmologic overdose
There is no data available regarding any overdoses in adults following ophthalmological use
regardless on dosage.
Systemic overdose in the case of accidental ingestion
There is very limited information regarding accidental ingestion of brimonidine in adults. The only
adverse event reported to date was hypotension reported after ingestion of 0.2% solution of
brimonoidine. It was reported that the hypotensive episode was followed by rebound hypertension.
Treatment of an oral overdose includes supportive and symptomatic therapy - patient's respiratory
function should be maintained.
Oral overdoses of other alpha-2-agonists have been reported to cause symptoms such as hypotension,
asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia,
hypothermia, respiratory depression and seizure.
Paediatric population
Reports of serious adverse effects following inadvertent ingestion of 0.2% solution of brimonidine (8-
times higher than in the Lumify product) by paediatric subjects have been published or reported. The
subjects experienced symptoms of CNS depression, typically temporary coma or low level of
consciousness, lethargy, somnolence, hypotonia, bradycardia, hypothermia, pallor, respiratory
depression and apnoea, and required admission to intensive care with intubation if indicated. All
subjects were reported to have made a full recovery, usually within 6 -24 hours.


Pharmacotherapeutic group: Ophthalmologicals, ATC code: not yet assigned.
Mechanism of action
Brimonidine is an alpha-2 adrenergic receptor agonist that acts on sympathetic nerves to cause
vasoconstriction. It is 1000-fold more selective for the alpha-2 adrenoceptors than the alpha-1
adrenoceptors. Alpha-2-adrenoceptors are present both pre- and post-synaptically in vascular tissues.

Presynaptic α2-adrenoceptors act as a negative feedback mechanism; activation of these receptors
inhibits the release of norepinephrine. Activation of post-synaptic α2-adrenoceptors decreases
intracellular cAMP leading to tissue specific effects, including vasoactive effects. Brimonidine has
been shown to act on both pre- and post-synaptic α2-adrenoceptors in the ciliary body to mediate
intraocular pressure. The α2-adrenoceptor mediated vasoconstriction appears to occur primarily on the
venous-side.
In the eye, α2-adrenergic receptor agonism has been shown to regulate intraocular pressure by
modulating neurotransmitter release and ciliary blood vessel constriction in the ciliary body and
increasing the uveoscleral outflow.
Alpha-2-adrenergic receptors have been identified in human conjunctival biopsy samples, supporting
the vasoconstrictive (blanching) effects observed in the conjunctiva.
Pharmacodynamic effects
Lumify 0.025% eye drops medicinal product has a rapid onset of action for the relief of conjunctival
hyperaemia within 1 minute and a lasting effect of up to 8 hours.
Clinical efficacy and safety
Clinical studies with Lumify 0.025% eye drops medicinal product used 4 times a day have shown
superiority to placebo in consistently reducing ocular hyperaemia with no significant tachyphylaxis.
No clinically significant intra-ocular pressure changes were observed in patients without ocular
hypertension.
When used 4 times a day for four weeks, Lumify 0.025% eye drops medicinal product was safe and
well tolerated in paediatric (≥ 5 and < 18 years of age), adult, and geriatric (≥ 65 years of age)
populations. The incidence of adverse events was comparable to that in the placebo group for all age
categories. In the clinician assessed alertness evaluation, all subjects were deemed to be fully alert
prior to and 90-180 minutes following drop instillation at all visits. No clinically significant concerns
related to known brimonidine side effects were observed.


Absorption
After ocular administration, intraocular absorption is rapid. After a single topical administration of
0.5% brimonidine in rabbits, measurable levels of brimonidine were observed in all ocular tissues
assessed (conjunctiva, cornea, aqueous humor, iris, ciliary body and lens) as soon as 10 minutes postdosing.
Following oral administration to man, brimonidine is well absorbed.
Following topical ocular dosing of Lumify 0.025% eye drops medicinal product in 14 healthy
volunteers, systemic exposure was below the lower limit of quantification (LLOQ, i.e. < 0.0250
ng/mL) in all subjects but one who demonstrated a Cmax of 0.0253 ng/mL.
Distribution
Brimonidine has been shown to be distributed to all ocular tissues after ocular dosing in rabbits. In
humans, mean levels of brimonidine in aqueous humor samples obtained approximately 1 h after a
single 30 μL drop of 0.1% or 0.15% brimonidine were 59.4 ng/mL or 95.5 ng/mL, respectively.
Brimonidine binds to pigment resulting in higher levels in pigmented tissues (e.g., iris). However, long
term clinical studies in humans suggest that there are no adverse effects associated with binding to
pigmented tissues.
It is reported that after ocular administration of a 0.2% solution twice daily for 10 days, plasma
concentrations are low (mean Cmax 0.06 ng/ml). There is a slight accumulation in the blood after
multiple instillations (twice daily for 10 days). AUC0-12h at steady state is reported as 0.31 ng*hr/ml,
compared to 0.23 ng*hr/ml after the initial dose. The mean apparent half-life in the systemic
circulation after topical dosing in humans was approximately 3 hours. Plasma protein binding of
brimonidine after topical dosing in humans is approximately 29%.

Biotransformation
In-vitro studies, using animal and human liver, indicate that the metabolism is mediated largely by
aldehyde oxidase and cytochrome P450. Hence, the systemic elimination seems to be primarily hepatic
metabolism.
Elimination
Following oral administration to man, brimonidine is rapidly eliminated. The major part of the dose
(around 75%) is excreted as metabolites in urine within 5 days; no unchanged drug was detected in
urine.
Linearity/non-linearity
There is limited data available for ocular applied brimonidine tartrate pharmacokinetics and
no information about linearity or non-linearity are available.


Published non-clinical data reveal no special hazard for humans based on conventional studies of
safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to
reproduction and development.
There is no data available concerning the influence of ocularly applied brimonidine on animal
pregnancy. It is also not known if brimonidine is excreted in animal milk after ocular administration.
In published animal studies, brimonidine tartrate did not cause any teratogenic effects. The experiment
on pregnant rats showed that brimonidine 0.1 and 0.4 mg/kg/day were no effect doses (approximately
20 times and 77 times the human exposure); the doses of 1.0 mg/kg/day produced maternal
pharmacologic/toxic effect without fetotoxic or teratogenic effects (approximately 180 times the
human exposure); whereas 2.5 mg/kg/day resulted in maternal and foetal toxicity without any
teratogenic effect (approximately 470 times the human exposure).
In rabbits, brimonidine tartrate, at plasma levels higher than are achieved during therapy in humans,
has been shown to cause increased pre-implantation loss and postnatal growth reduction.The
compound is excreted in the milk of the lactating rat.


- Glycerin
- Sodium borate decahydrate
- Boric acid, potassium chloride
- Calcium chloride dihydrate
- Sodium chloride
- Benzalkonium chloride
- Hydrochloric acid and/or sodium hydroxide may be used to adjust pH
- Water for injection.


Not applicable.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
 


24 months

The proposed expiry period for drug product is 24 months for the 7.5 mL fill size when
stored below the defined label storage condition of 30°C. After opening, it can be used up to
121 days when stored below 30°C.


The multi-dose drug product is packaged in as nominal of 2.5ml or 7.5 mL fill volumes in 10
mL LDPE bottles using LLDPE tips and two-piece child-resistant closures. The childresistant
closure consists of an inner closure (natural polypropylene) and an outer closure
(purple HDPE).

Not all pack sizes may be marketed.


Lumify 0.025%, eye drops, solution should not be used in paediatric patients younger than 5 years of
age.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle label and carton. The expiry
date refers to the last day of that month.
Do not use this medicine if solution changes colour or becomes cloudy.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.


Bausch & Lomb, Inc., 8500 Hidden River Parkway, Tampa, FL 33637, United States

September 2019
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