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Farcolin Respirator Solution is the mainstay of the symptomatic treatment of respiratory distress due to bronchospasm. Salbutamol, the active ingredient of Farcolin Respirator Solution, is a potent selective B2 -adrenoceptor agonist. It is the bronchodilator of first choice with a rapid maximal relaxation of bronchial smooth muscles for patients with asthma and other forms of reversible airway obstruction. It also has an antiallergic effect on mast cells causing inhibition of release of bronchoconstrictor mediators such as histamine, neutrophil chemotactive factor and prostaglandins.
Farcolin Respirator Solution, in nebulized form, is preferred in urgent cases of bronchospasm because the drug is delivered directly to the respiratory airways and is effective in smaller doses. Thus, it provides a more rapid relief of symptoms and causes fewer side effects than by other routes of administration. Salbutamol has the advantage of having longer duration of action than isoprenaline with a minimal effect on the heart.
Indications :
- As a bronchodilator for the management of acute cases of
bronchial asthma.
- For treatment of severs reversible bronchospasm associated
with bronchitis and emphysema.
- For management of status asthmaticus.
Although Salbutamol should be given with caution to patients with coronary insufficiency, severe hypertension hyperthyroidism and diabetes mellitus, the nebulized form is safer in these conditions due to the resultant low plasma concentration. Salbutamol therapy is not recommended during the first three months of pregnancy unless strictly indicated.
Farcolin Respirator Solution is inhaled from any efficient nebulizing device to achieve rapidly effective bronchodilatation.
1 - intermittent administration :
Adults :
A - Dilute solution : Farcolin Respirator Solution 0.5 - 1.0 ml ( 2.5 - 5.0 mg of Salbutamol ) should be diluted to a final volume of 2.0 to 4.0 ml with normal saline or water for injection.
The resulting solution is inhaled from a suitably driven nebulizer until aerosol generation ceases. This will take about 10 minutes, on using a correctly matched nebulizer and driving source.
B - undiluted solution : Farcolin Respirator Solution may be used undiluted for intermittent administration. In this respect, 2.0 ml of Farcolin Respirator Solution (10.0 mg of Salbutamol )
is placed in the nebulizer and inhaled by the patient until bronchodilation is achieved.
In severe cases, nebulization of the undiluted solution should be continued until aerosol generation ceases.
Children :
The same mode of intermittent administration is also applicable to children. The usual dosage for children up to the age of 12 years is 0.5 ml of Farcolin Respirator Solution ( 2.5 mg of Salbutamol ) diluted to 2.0 to 4.0 ml with normal saline or water for injection. Severe cases may require the use of higher doses of Salbutamol ( up to 5 mg ).
N.B. The intermittent treatment may be repeated up to four times daily, or as prescribed by the physician
If your breathing or wheezing gets worse straight after taking this medicine, stop using it immediately, and tell your doctor as soon as possible.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Allergic Reactions (may affect up to 1 in 10,000 people)
If you have an allergic reaction, stop taking Farcolin Respirator Solution and see a doctor straight away. Signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed, and collapse.
Talk to your doctor as soon as possible if: you feel your heart is beating faster or stronger than usual (palpitations). This is usually harmless, and usually stops after you have used the medicine for a while. you may feel your heartbeat is uneven or it gives an extra beat. these may affect up to 1 in 10 people.
If any of these happen to you, talk to your doctor as soon as possible. Do not stop using this medicine unless told to do so.
Tell your doctor if you have any of the following side effects which may also happen with this medicine:
Common (may affect up to 1 in 10 people) feeling shaky. . headache.
Uncommon (may affect up to 1 in 100 people) mouth and throat irritation. . muscle cramps.
Rare (may affect up to 1 in 1,000 people) a low level of potassium in your blood. increased blood flow to your extremities (peripheral dilatation). Very rare (may affect up to 1 in 10,000 people) changes in sleep patterns and changes in behaviour, such as restlessness and excitability). The following side effects can also happen but the frequency of these are not known:
chest pain, due to heart problems such as angina. Tell your doctor or pharmacist if this occurs. Do not stop using this medicine unless told to do so.
a condition known as lactic acidosis which may cause stomach pain, hyperventilation, shortness of breath, cold feet and hands, irregular heartbeat or thirst.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Store below 25o C, away from light.
Each 20 ml contains :
Salbutamol sulphate 0.121 g
PHARCO PHARMACEUTICAL
ALESKANDIRA - Eygpt .
فاركولين علاج فعال وأساسى لحالات ضيق التنفس الناشئة عن تقلصات الشعب الهوائية. وسالبيوتامول- المادة الفعالة فى محلول فاركولين التنفسى - يعمل بقوة وتأثير خاص على مستقبلات العصب السمبثاوى من نوع بيتا - 2 التى تتحكم فى إرتخاء عضلات الشعب الهوائية ويصاحب ذلك تحسن ملحوظ فى الوظائف التنفسية للرئتين - كما أن سالبيوتامول ذو فعالية عالية فى تثبيط إفراز المواد التى تسبب تقلصات العضلات اللاإرادية بجدار الشعب الهوائية مثل الهيستامين وبعض أنواع بروستاجلاندين - وبالمقارنة بمادة إيزوبرينالين والتى تستخدم لنفس الغرض كموسع للشعب الهوائية فإن تأثير سالبيوتامول يمتد لفترة أطول كما أن تأثيراته الجانبية على عضلة القلب نادرة الحدوث.
ويؤدى إستعمال محلول فاركولين التنفسى عن طريق الإستنشاق إلى وصول الرذاذ إلى الشعب الهوائية والتأثير على عضلاتها اللاإرادية وينتج عن ذلك سرعة إتساعها وزوال أعراض ضيق التنفس - ونتيجة لهذا التأثير المباشر فإن إتساع الشعب الهوائية يحدث بجرعات صغيرة من سالبيوتامول أقل مما يتطلبه إستخدام نفس الدواء بالطرق الأخرى.
دواعى الإستعمال:
- كمـوسع للشعب الهوائية فى الحالات الحادة للربو الشعبى.
- لـعـلاج التقلصـات الحـادة للشــعب الهـوائيــة المصـاحبــة لإلتهابـات الشـعـب الهوائيـة
المزمنـة.
- لعلاج نوبات الربو الحادة التي لا تستجيب للعلاج بأدوية أخرى.
- علـى الرغم مـن أن مستحضرات سالبيوتامـول تعطـى بحـذر للمرضى الـذيـن يعـانون
من قصور فى الدورة الدموية بالقلب وإرتفاع ضغط الدم الشديد وزيادة نشاط الغدة
الدرقية ومرضى البول السكرى - فإن التأثير الفعـال للجرعات الصغيـرة عن طريق
الرذاذ يجعل إستعـمال محلـول فاركولين التنفسـى أكثر أمناً فى هذه الحالات.
- ينصح بعدم إستعمال سالبيوتامول خلال الثلاثة أشـهر الأولـى من الحمل.
يسـتعمل محـلـول فاركولين التنفسى من خلال جهاز الإستنشاق وذلك لتوسيع الشعب الهوائية طبقاً للطرق الآتية حسب إرشادات الطبيب
أولاً : التعاطى المتقطع :
الكـبــار :
(أ) إستعمال محلول فاركولين بعد التخفيف : يخفف من 0.5 إلى 1 ملليـلتر
من محـلول فاركولين التنفسـى ( 2.5 - 5 مجم سالبيوتامول ) إلى حجم نهائـى
2 - 4 ملليلتر بمحلول ملحى معادل أو مـاء الحقن ويستنشق المحلول الـنـاتج مـن
خـلال جهاز الإستنشاق حتى يتوقف الرذاذ ويستغرق ذلك حـوالى 10 دقائـق.
(ب) إستعمال محلول فاركولين بـدون تخفـيف : يستعمل محلول فاركولين
بــدون تخفيـف بالتعاطـى المتقطع - وفـى هـذه الحـالة يوضـع 2 ملليلتـر مــن محـلـول
فــاركـولـين التنفسـى ( 10 مجم سالبيوتامول ) فــى الجهــاز ويســتمر الإستنشـاق
حتـى يتم توسيع الشعب الهوائية. وفـى الحالات الشديدة يسـتمر إستنشاق المحلول
الغير مخفف حتى يتوقف إنبعاث الرذاذ.
الأطفـــال:
نفـس طريقـة الإستعمـال المتقطـع :
للأطفال حتى سن 12 سنة : تخفف جرعة تساوى 0.5 ملليلتر من محلول فاركـولـين التنفسـى ( 2.5 مجم سالبيوتامول ) إلـى 2 - 4 ملليلتر بمحلول ملحى معادل أو ماء الحقن - وقد يحتاج بعض الأطفال إلى جرعة عالية قد تصل إلى 5 مجم من سالبيوتامول.
ملحوظة : يمكن تكرار العلاج المتقطع حتى أربع مرات يومياً أو حسب إرشادات الطبيب.
ثانياً : التعاطى المستمر فى المستشفيات :
فى حالة التعاطى المستمر يخفف 1 ملليلتر من محلول فاركولين التنفسى إلى 100 ملليلتر بمحلول ملحى معادل أو ماء الحقن ليصبح تركيزه 50 ميكروجرام سالبيوتامول لكل ملليلتر من المحلول المخفف ويستنشق المحلول المخفف عن طريق جهاز يعمل بضغط الهواء المشبع بالأكسچين أو الهواء العادى المضغوط حسب حالة المريض ويستمر إستنشاق المحلول المخفف حتي يتم توسيع الشعب الهوائية وقد يحدث هذا فى الحال إلا أن أقصى تأثير يحدث خلال 15 دقيقة من بدء الإستنشاق.
ملاحظات :
- لا يستعمل محلول فاركولين التنفسي للإستنشاق بعد 3 شهور من فتح الزجاجة.
- يحضر المحلول المخفف قبل إستنشاقه مباشـرة وبعد الإستعمال يتم التخلص من أى
كمية متبقية فى جهاز الإستنشاق.
- لتجنب تلوث الجهاز يجب أن ينظف جيداً حسب التعليمات.
- علـى الرغم مـن أن مستحضرات سالبيوتامـول تعطـى بحـذر للمرضى الـذيـن يعـانون
من قصور فى الدورة الدموية بالقلب وإرتفاع ضغط الدم الشديد وزيادة نشاط الغدة
الدرقية ومرضى البول السكرى - فإن التأثير الفعـال للجرعات الصغيـرة عن طريق
الرذاذ يجعل إستعـمال محلـول فاركولين التنفسـى أكثر أمناً فى هذه الحالات.
- ينصح بعدم إستعمال سالبيوتامول خلال الثلاثة أشـهر الأولـى من الحمل.
يحفظ فــى درجــة حــرارة أقل من 25 oم، بعيداً عــــــــــــن الـضــــــــوء.
تحفظ الأدوية بعيداً عـن متنـاول الأطفـال.
يحتوى كل 20 ملليلتر من المحلول علي :
كبريتات السالبيوتامول 0.121 جم
يحتوى كل 20 ملليلتر من المحلول علي :
كبريتات السالبيوتامول 0.121 جم
مجموعة فاركو للصناعات الدوائية
- Farcolin Respirator Solution contains a medicine called salbutamol. This belongs to a group of medicines called fast-acting bronchodilators.
- Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get in and out.
- They help to relieve chest tightness, wheezing and cough.
- Farcolin Respirator Solution is used to treat breathing problems in people with asthma and other chest illnesses. It is usually given to people who suffer quite badly from these conditions when other forms of treatment do not help enough.
- Farcolin Respirator Solution is also used to treat severe attacks of asthma.
- Farcolin Respirator Solution must only be used by inhalation from a nebuliser and must not
be injected or swallowe
- Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- Farcolin Respirator Solution must only be used by inhalation from a nebuliser, and must not be injected or swallowed. The nubuliser produces a fine mist which you breath in through a face mask or a mouthpiece. Make sure that you know how to use it properly. If you have problems ask your doctor or pharmacist.
- Do not let the Farcolin Respirator Solution, or the mist produced by the nebuliser, get into your eyes.
- Use your nebuliser in a well ventilated room as some of the mist will be released into the air and may
be breathed in by others.
- Make sure you know how, when and how much solution you should use.
- Your doctor may have prescribed either intermittent (occasional short bursts) or continuous treatment with Farcolin Respirator Solution.
- Intermittent Treatment:
• Adults and adolescents aged 12 years and over- The usual dose is 0.5 ml to 1 ml of Farcolin Respirator Solution (2.5 to 5 mg salbutamol). Some patients may require up to 2 ml (10 mg salbutamol).
• Children aged 18 months to 12 years - The usual dose is 0.5 ml to 1 ml (2.5 to 5 mg salbutamol) of Farcolin Respirator Solution, given four times daily.
• Your doctor may have told you to dilute the Farcolin Respirator Solution with s sterile normal saline solution before using it in the nebuliser. Remember to follow the instructions for dilution.
- Continuous Treatment:
• The usual dose is 1 to 2 mg of salbutamol per hour.
• This dose can be obtained by diluting 1 or 2 ml of Farcolin Respirator Solution to
100 ml with sterile normal saline solution to produce a solution containing 50 or 100 micrograms/ml of salbutamol, and inhaling the mist from a suitable nebuliser.
Do not take Farcolin Respirator Solution if:
you are allergic to salbutamol sulphate or any of the other ingredients of this medicine. you unexpectedly go into early labour (premature labour) or threatened abortion.
Take special care with Farcolin Respirator Solution if:
your asthma is active (for example you have frequent symptoms or flare ups or limited physical ability). Your doctor may start or increase the dose of a medicine to control your asthma such as an inhaled corticosteroid. you have high blood pressure. you are diabetic. you have an overactive thyroid gland. you have a history of heart problems such as an irregular or fast heartbeat or angina.
you use another nebuliser solution e.g. ipratropium bromide, make sure the mist does not get in your eyes. This can be prevented by using a mouthpiece instead of a face mask or goggles. you are taking xanthine derivatives (such as theophylline) or steroids to treat asthma.
you are taking water tablets (diuretics), sometimes used to treat high blood pressure or a heart condition.
you have taken other drugs used to relieve stuffy nose (such as ephedrine or pseudo-ephedrine) or other medicines used to treat asthma.
Instructions and Precaution for use:
1- It is important that you use Farcolin Respirator Solution properly. This will ensure that you receive the maximum benefit from your medicine.
1- Make sure you know how, when and how much solution you should use. Follow your doctor's instructions carefully. If you are not sure, ask your doctor.
2- To avoid contamination, proper cleaning and drying technique should be done for the nebuliser parts after each use.
3- Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface.
4- If the solution changes color or becomes cloudy, it should not be used.
5- Nebuliser devices should not be shared between patients.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. Remember to take this medicine with you if you go to the hospital. In particular tell your doctor or pharmacist if you are taking:
- medicines for an irregular or fast heartbeat.
- other medicines for your asthma.
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 taking this medicine.
Farcolin Respirator Solution is not likely to affect you being able to drive or use any tools or machines
If your breathing or wheezing gets worse straight after taking this medicine, stop using it immediately, and tell your doctor as soon as possible.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Allergic Reactions (may affect up to 1 in 10,000 people)
If you have an allergic reaction, stop taking Farcolin Respirator Solution and see a doctor straight away. Signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed, and collapse.
Talk to your doctor as soon as possible if: you feel your heart is beating faster or stronger than usual (palpitations). This is usually harmless, and usually stops after you have used the medicine for a while. you may feel your heartbeat is uneven or it gives an extra beat. these may affect up to 1 in 10 people.
If any of these happen to you, talk to your doctor as soon as possible. Do not stop using this medicine unless told to do so.
Tell your doctor if you have any of the following side effects which may also happen with this medicine:
Common (may affect up to 1 in 10 people) feeling shaky. . headache.
Uncommon (may affect up to 1 in 100 people) mouth and throat irritation. . muscle cramps.
Rare (may affect up to 1 in 1,000 people) a low level of potassium in your blood. increased blood flow to your extremities (peripheral dilatation). Very rare (may affect up to 1 in 10,000 people) changes in sleep patterns and changes in behaviour, such as restlessness and excitability). The following side effects can also happen but the frequency of these are not known:
chest pain, due to heart problems such as angina. Tell your doctor or pharmacist if this occurs. Do not stop using this medicine unless told to do so.
a condition known as lactic acidosis which may cause stomach pain, hyperventilation, shortness of breath, cold feet and hands, irregular heartbeat or thirst.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you take more than you should, talk to a doctor as soon as possible.
The following effects may happen: your heart beating faster than usual. you feel shaky. hyperactivity.
These effects usually wear off in a few hours.
FARCOLIN Respirator Solution is the mainstay of the symptomatic treatment of Respiratory distress due to bronchospasm. Salbutamol, the active ingredient of FARCOLIN Respirator Solution, is a potent selective β-adrenoceptor agonist. Salbutamol is the bronchodilator of first choice with a rapid maximal relaxation of bronchial smooth muscles for patients with asthma and other forms of reversible airway obstruction.
Salbutamol also has an antiallergic effect on mast cells causing inhibition of release of bronchoconstrictor mediators such as histamine neutrophil chemotactive factor and prostaglandins.
FARCOLIN Respirator Solution in nebulized form is preferred in urgent cases of bronchospasm because the drug is delivered directly to the Respiratory airways and is effective in smaller doses. Thus, it provides a more rapid relief of symptoms and causes fewer side effects than by other routes of administration. Salbutamol has the advantage of having longer duration of action than isoprenaline with a minimal effect on the heart
It has a local effect.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.
Sodium Metabisulfite |
Disodium Edetate |
Citric Acid Anhydrous |
Sodium Citrate Dihydrate |
Benzalkonium Chloride |
Water |
None.
A mixture of both APIs and Excipients are compatible.
Keep at temperature below 25°C, away from light. Keep out of the reach of children.
One opaque white plastic (LDPE) bottle fitted in with a transparent plastic (LDPE) plug, closed with a yellow plastic (HDPE) pilfer-proof cap and bears a label sticker. The bottle and a pamphlet are packed in a chromo-duplex carton box
Unnecessary.
