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| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
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Adrenaline Injection belongs to a group of medicines called adrenergic and dopaminergic agents.
This medicine is used for:
- Treatment of cardiac arrest (unexpected loss of heart function, breathing and consciousness),
- Treatment of acute anaphylaxis in adults (serious shock or collapse produced by a severe allergic reaction).
You must not be given Adrenaline injection
If you are allergic (hypersensitive) to any ingredients of this medicine (listed in section 6) where an alternative presentation of Adrenaline or alternative vasopressor is available.
Warnings and precautions
Adrenaline injection is indicated for emergency treatment. Continuous medical supervision is necessary after administration.
Precautions for use
The risk of side effects is increased if you:
- have medical history of hyperthyroidism (disease of the thyroid gland),
- have severe renal insufficiency,
- suffer from hypercalcaemia (increase of calcium concentration in the blood),
- suffer from hypokalaemia (decrease of potassium concentration in the blood),
- have diabetes mellitus,
- have cardiac disease or arterial hypertension,
- have brain damage or hardening of the arteries in the brain,
- have glaucoma (increased pressure in the eye),
- have prostate disorders,
- are elderly,
- are pregnant.
Other medicines and Adrenaline injection
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Medicines that may interact with Adrenaline injection include:
- Volatile halogen anaesthetics (gas used during anaesthesia),
- Certain antidepressants,
- Drugs to treat high blood pressure, heart conditions,
- Drugs to treat diabetes.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you are given this medicine.
Driving and using machines
Having Adrenaline injection does not affect your ability to drive or use machines.
Adrenaline injection contains sodium
This medicinal product contains 3.54 mg of sodium per ml of solution for injection. This needs to be taken into consideration by patients on strict sodium diet.
| Adrenaline injection is administered to you by your doctor, nurse or paramedic. They will have to decide the correct amount for you and when and how this should be given. In case of life threatening allergic reactions (acute anaphylaxis): Adults will be given a dose of 0.05 mg (0.5 ml of Adrenaline 1:10,000 solution) repeated as necessary until the desired response is achieved. In case of cardiac arrest: Adults: 1 mg (10 ml of Adrenaline 1:10,000 solution) is given into a vein or into a bone every 3-5 minutes until the heart starts to work. Children above 5 kg: 10 micrograms/kg (0.1 ml/kg of Adrenaline 1:10,000 solution) is given into a vein or into a bone every 3-5 minutes every 3-5 minutes until the heart starts to work. This medicinal product is not suitable for delivering a dose of less than 0,5 ml and should therefore not be used in neonates and infants for which the body weight is less than 5 kg. |
| Like all medicines this medicine can cause side effects, although not everybody gets them. The following side effects have been reported: - anxiety, - dyspnoea (difficulty in breathing), - nervousness, - fear, - sweating, - palpitations (irregular or faster heart beat), - tachycardia (increased heart rate), - pallor, - tremors, - weakness, - dizziness, - headache, - nausea, - vomiting, - coldness of the extremities, - hallucinations, - syncopes, - hyperglycaemia (high blood sugar levels), - hypokalaemia (low potassium levels in the blood), - metabolic acidosis (increased acidity in the blood), - mydriasis (dilatation of the pupil). In high dosages or for patients sensitive to adrenaline, side effects are: - cardiac dysrhythmia (irregular heartbeats/cardiac arrest), - hypertension (with risk of cerebral haemorrhage), - vasoconstriction (narrowing of the blood vessels for example cutaneous, in the extremities or kidneys), - acute angina attacks, - risk of acute myocardial infarction. Repeated local injections may produce necrosis (tissue damage) at the site of injection as a result of vascular constriction (blood vessel constriction). In all cases, after administration of Adrenaline injection medical supervision is necessary. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. |
| Keep out of the sight and reach of children. You should not be given this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of the month. Your doctor or nurse will check this. Store in the aluminium pouch in order to protect from light and oxygen. Do not store above 25°C. Do not open the aluminium pouch until use. After opening the pouch the product must be used immediately. Do not freeze. Do not use sharp instruments to open the pouch. You should not be given Adrenaline injection if it has been partly used or shows signs of visible damage. 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 ingredient is adrenaline tartrate: Each ml of solution for injection contains 0.1 mg of adrenaline (as adrenaline tartrate). Each 10 ml pre-filled syringe contains 1 mg adrenaline (as adrenaline tartrate). The other ingredients are sodium chloride, hydrochloric acid, sodium hydroxide, water for injections. |
Laboratoire Aguettant
1, rue Alexander Fleming
69007 LYON
France
تنتمي حُقنة الأدرينالين إلى مجموعة من الأدوية تسمى الأدوية الأدرينالية والدوبامينية.
يُستخدم هذا الدواء في:
- علاج السكتة القلبية (فقدان غير متوقع لوظيفة القلب، والتنفس والوعي)،
- علاج الحساسية المُفرطة "التأق" عند البالغين (صدمة خطيرة أو انهيار ناتج عن رد فعل تحسسي شديد).
يجب أن لا تتلقى حقنة الأدرينالين
إذا كنت تعاني من الحساسية (فرط الحساسية) لأيّ من مكونات هذا الدواء (المُدرجة في الفقرة رقم 6)
في حال توفر شكل بديل للأدرينالين أو دواء بديل قابض للأوعية الدموية.
المحاذير والإحتياطات
حقنة الأدرينالين مُعدّة للاستخدام في حالات الطوارئ. الإشراف الطبي المستمر ضروري بعد تلقيه.
الاحتياطات اللازمة للاستخدام
يزداد خطر حدوث الأعراض الجانبية إذا:
- كان لديك تاريخ طبي من الإصابة بفرط نشاط الغدة الدرقية (مرض يُصيب الغدة الدرقية)،
- كنت تعاني من قصور كلوي حاد،
- كنت تعاني من فرط كالسيوم الدم (زيادة تركيز الكالسيوم في الدم)،
- كنت تعاني من نقص بوتاسيوم الدم (انخفاض تركيز البوتاسيوم في الدم)،
- كنت مصابًا بداء السكري،
- كنت مصابًا بمرض في القلب أو بارتفاع ضغط الدم،
- كنت مصابًا بتلف في الدماغ أو بتصلب الشرايين في الدماغ،
- كنت مصابًا بالجلوكوما (زيادة الضغط في العين)،
- كنت مصابًا باضطرابات البروستاتا،
- كنت من كبار السن،
- كنتِ حاملاً.
الأدوية الأخرى وحقنة الأدرينالين
أخبر طبيبك إذا كنت تتناول أو تناولت مؤخراً أو قد تتناول أي أدوية أخرى.
الأدوية التي قد تتفاعل مع حقنة الأدرينالين تشمل:
- تخدير الهالوجين المتطاير (غاز يُستخدم أثناء التخدير)،
- بعض مضادات الاكتئاب،
- الأدوية التي تُستخدم في علاج ارتفاع ضغط الدم وأمراض القلب،
- الأدوية التي تُستخدم في علاج مرض السكري.
الحمل والرضاعة الطبيعية
إذا كنتِ حاملاً أو مرضعة، تعتقدين أنك قد تكونين حاملاً أو تخططين لإنجاب طفل، استشيري طبيبك أو الصيدلي أو الممرض قبل تلقيكِ لهذا الدواء.
القيادة واستخدام الآلات
لا يؤثر استخدام حقنة الأدرينالين على قدرتك على القيادة أو استخدام الآلات.
حقنة الأدرينالين تحتوي على الصوديوم
يحتوي هذا المنتج الطبي على 3,54 مجم من الصوديوم في كل 1 مل من محلول الحقن. يجب أن يؤخذ ذلك في الاعتبار من قبل المرضى الذين يتبعون نظام غذائي قليل المحتوى من الصوديوم.
يتم إعطاء حقنة الأدرينالين لك من قبل طبيبك أو الممرض أو المُسعف. سيتعين عليهم تحديد الجرعة الصحيحة نيابة عنك ومتى وكيف ينبغي إعطاؤها لك.
في حالة الحساسية التي تهدد الحياة (التأق الحاد):
للبالغين: سيتم إعطاء جرعة مقدارها 0,05 مجم (0,5 مل من محلول الأدرينالين 1: 10,000) عند الضرورة حتى يتم تحقيق الاستجابة المطلوبة.
في حالة السكتة القلبية:
للبالغين: يتم إعطاء 1 مجم (10 مل من محلول الأدرينالين 1: 10,000) في الوريد أو في العظم كل 3-5 دقائق حتى يبدأ القلب في الانقباض.
الأطفال الذين تتجاوز أوزانهم 5 كجم: 10 ميكروجرام/كيلوجرام (0,1 مل/كجم من محلول الأدرينالين 1: 10,000) في الوريد أو في العظم كل 3-5 دقائق حتى يبدأ القلب في الانقباض.
هذا المنتج الطبي غير مناسب لإعطاء جرعة أقل من 0,5 مل، وبالتالي لا ينبغي استخدامه لدى المواليد والرضّع الذين تقلّ أوزانهم عن 5 كجم.
كما هو الحال مع سائر الأدوية، يمكن أن يسبب هذا الدواء أعراضًا جانبية، على الرغم من أنها لا تحدث لدى جميع من يستخدمه.
تم الإبلاغ عن الأعراض الجانبية التالية:
- القلق،
- ضيق التنفس (صعوبة في التنفس)،
- العصبية،
- الخوف،
- التعرق،
- الخفقان (عدم انتظام ضربات القلب أو تسارع القلب)،
- تسارع القلب (زيادة معدل ضربات القلب)،
- الشحوب،
- الارتعاش،
- ضعف،
- دوخة،
- صداع الراس،
- الغثيان،
- القيء،
- برودة الأطراف.
- الهلوسة،
- غشيان،
- ارتفاع سكر الدم (ارتفاع مستويات السكر في الدم) ،
- نقص بوتاسيوم الدم (انخفاض مستويات البوتاسيوم في الدم)،
- الحماض الأيضي (زيادة الحموضة في الدم)،
- توسع حدقة العين.
تم الإبلاغ عن الأعراض الجانبية التالية عند استخدام جرعات عالية أو مع المرضى الذين لديهم حساسية نحو الأدرينالين،
- عدم انتظام ضربات القلب (اضطراب نظم القلب/السكتة القلبية)،
- ارتفاع ضغط الدم (مع خطر النزيف الدماغي)،
- انقباض الأوعية (تضييق الأوعية الدموية على سبيل المثال في الجلد، الأطراف أو الكلى)،
- نوبات الذبحة الصدرية الحادة،
- خطر حدوث احتشاء عضلة القلب الحاد.
قد تُسبب الحقن الموضعية المتكررة نخرًا (تلف الأنسجة) في موضع الحقن نتيجة لانقباض الأوعية الدموية.
الإشراف الطبي ضروري في جميع الحالات بعد إعطاء حقن الأدرينالين.
يُرجى إخبار طبيبك أو الصيدلي إذا تفاقم أي من الأعراض الجانبية، أو إذا لاحظت أي أعراضٍ جانبية غير مدرجة في هذه النشرة.
- احفظها بعيدا عن مرأى وتناول الأطفال.
- يجب عدم إعطاؤك هذا الدواء بعد تاريخ انتهاء الصلاحية المدرج في الملصق. يشير تاريخ انتهاء
الصلاحية إلى اليوم الأخير من الشهر. سوف يتحقق طبيبك أو الممرض من ذلك.
- احفظها داخل كيس الألومنيوم من أجل حمايتها من الضوء والأكسجين.
- لا تحفظها في درجة حرارة تتجاوز 30 درجة مئوية.
- لا تفتح كيس الألومنيوم حتى موعد الاستخدام.
- يجب استخدام المنتج على الفور بعد فتح الكيس.
- لا تُجمدها.
- لا تستخدم الأدوات الحادة لفتح الكيس.
- ينبغي تجنّب استخدام حقنة الأدرينالين إذا تبيّن أنها استخدمت جزئيا أو إذا ظهرت عليها علامات تلف
واضحة.
- لا تتخلص من أي أدوية عن طريق مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن كيفية
التخلص من الأدوية التي لم تعد تستخدمها. سوف تساعد هذه التدابير في حماية البيئة.
العنصر الفعّال هو طرطرات الأدرينالين:
يحتوي كل مل من محلول الحقن على 0,1 مجم من الأدرينالين (على شكل طرطرات الأدرينالين).
تحتوي كل محقنة بحجم 10 مل مسبقة التعبئة على 1 مجم من الأدرينالين (على شكل طرطرات الأدرينالين).
المكونات الأخرى هي: كلوريد الصوديوم، حمض الهيدروكلوريك، هيدروكسيد الصوديوم، الماء المُخصّص للحقن.
حقنة الأدرينالين عبارة عن محلول صافٍ عديم اللون في محقنة بحجم 10 مل مصنوعة من البولي بروبيلين، ومعبأة بشكل فردي في بثرة شفافة وملفوفة في كيس من الألومنيوم.
تتوفّر المحاقن المسبقة التعبئة في علب يحتوي كلٍّ منها على 10 محاقن.
اجويتانت لابوراتوار
1 ، شارع الكسندر فليمنج
69007 ليون
فرنسا
Cardiopulmonary resuscitation
Acute anaphylaxis in adults
| Intravenous adrenaline should only be administered by those experienced in the use and titration of vasopressors in their normal clinical practice. Cardiopulmonary resuscitation: 10 ml of the 1:10,000 solution (1 mg) by the intravenous or intraosseous route, repeated every 3-5 minutes until return of spontaneous circulation. Endotracheal use should only be considered as a last resort if no other route of administration is accessible, at a dose of 20 to 25 ml of the 1:10,000 solution (2 to 2.5 mg). In cardiac arrest following cardiac surgery, Adrenaline should be administered intravenously in doses of 0.5 ml or 1 ml of 1:10,000 solution (50 or 100 micrograms) very cautiously and titrated to effect. Acute anaphylaxis Titrate using intravenous boluses of 0.5 ml 1:10,000 solution (0.05 mg) according to response. ADRENALINE 0.1mg/mL sulphite free, solution for injection in pre-filled syringe is not recommended for intramuscular use in acute anaphylaxis. For intramuscular administration, a 1 mg/ml (1:1000) solution should be used. Paediatric Population: This medicinal product is not suitable for delivering a dose of less than 0.5 ml and should therefore not be used by the intravenous or intraosseous route, in neonates and infants with body weight less than 5 kg. Cardiac arrest in children: Intravenous or intraosseous route (above 5 kg only): 0.1 ml/kg of 1:10,000 solution (10 micrograms/kg) to a maximum single dose of 10 ml of 1:10,000 solution (1 mg), repeated every 3-5 minutes until return of spontaneous circulation. Endotracheal use (any body weight) should only be considered as a last resort if no other route of administration is accessible, at a dose of 1 ml/kg of 1:10,000 solution (100 micrograms/kg) to a maximum of single dose of 25 ml of 1:10,000 solution (2.5 mg). |
| ADRENALINE 0.1mg/mL sulphite free, solution for injection in pre-filled syringe is indicated for emergency treatment. Medical supervision is necessary after administration. For intramuscular administration, a 1 mg/ml (1:1000) solution should be used. In the treatment of anaphylaxis and in other patients with a spontaneous circulation, intravenous adrenaline can cause life-threatening hypertension, tachycardia, arrhythmias and myocardial ischaemia. Intravenous adrenaline should only be used by those experienced in the use and titration of vasopressors in their normal clinical practice. Patients who are given IV adrenaline require continuous monitoring of ECG, pulse oximetry and frequent blood pressure measurements as a minimum. The risk of toxicity is increased if the following conditions are pre-existing • Hyperthyroidism • Hypertension • Structural cardiac disease, cardiac arrhythmias, severe obstructive cardiomyopathy, • Coronary insufficiency • Phaeochromocytoma, • Hypokalaemia • Hypercalcaemia • Severe renal impairment • Cerebrovascular disease, organic brain damage or arteriosclerosis • Patients taking Monoamine oxidase (MAO) inhibitors (see section 4.5) • Patients taking concomitant medication which results in additive effects, or sensitizes the myocardium to the actions of sympathomimetic agents (see section 4.5) Prolonged use of adrenaline can result in severe metabolic acidosis because of elevated blood concentrations of lactic acid. Adrenaline may increase intra-ocular pressure in patients with narrow angle glaucoma. Adrenaline should be used with caution in patients with prostatic hyperplasia with urinary retention. Adrenaline may cause or exacerbate hyperglycaemia, blood glucose should be monitored, particularly in diabetic patients. Adrenaline should be used with caution in elderly patients. Adrenaline should not be used during the second stage of labour (See Section 4.6). This medicinal product contains 3.54 mg of sodium per ml of solution for injection: to be taken into consideration by patients on strict sodium diet. |
| Volatile halogen anaesthetics: severe ventricular arrhythmia (increase in cardiac excitability). Imipramine antidepressants: paroxysmal hypertension with the possibility of arrhythmia (inhibition of the entry of sympathomimetics into sympathetic fibres). Serotoninergic-adrenergic antidepressants: paroxysmal hypertension with the possibility of arrhythmia (inhibition of the entry of sympathomimetics into sympathetic fibres). Sympathomimetic agents: concomitant administration of other sympathomimetic agents may increase toxicity due to possible additive effects. Non-selective MAO inhibitors: increased pressor action of adrenaline, usually moderate. Selective MAO-A inhibitors, Linezolid (by extrapolation from non-selective MAO inhibitors): Risk of aggravation of pressor action. Alpha-adrenergic blocking agents: Alpha-blockers antagonise the vasoconstriction and hypertension effects of adrenaline, increasing the risk of hypotension and tachycardia. Beta-adrenergic blocking agents: Severe hypertension and reflex bradycardia may occur with non-cardioselective beta-blocking agents. Beta-blockers, especially non-cardioselective agents, also antagonise the cardiac and bronchodilator effects of adrenaline. Insulin or oral hypoglycaemic agents: Adrenaline-induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with insulin or oral hypoglycaemic agents. |
| Pregnancy: Teratogenic effect has been demonstrated in animal experiments. Adrenaline should only be used during pregnancy if the potential benefits outweigh the possible risks to the foetus. If used during pregnancy, adrenaline may cause anoxia to the foetus. Adrenaline usually inhibits spontaneous or oxytocin induced contractions of the uterus and may delay the second stage of labour. In dosage sufficient to reduce uterine contractions, adrenaline may cause a prolonged period of uterine atony with haemorrhage. For this reason parenteral adrenaline should not be used during the second stage of labour. Lactation: Adrenaline is distributed into breast milk. Breast-feeding should be avoided by mothers receiving adrenaline. Fertility No information available concerning impact of adrenaline on fertility. |
Not applicable in normal conditions of use.
| Metabolism and nutrition disorders: Frequency not known: hyperglycaemia, hypokalaemia, metabolic acidosis. Psychiatric disorders: Frequency not known: anxiety, nervousness, fear, hallucinations. Nervous system disorders: Frequency not known: headache, tremors, dizziness, syncope. Eye disorders: Frequency not known: mydriasis. Cardiac disorders: Frequency not known: palpitations, tachycardia. In high dosage or for patients sensitive to adrenaline: cardiac dysrhythmia (sinus tachycardia, ventricular fibrillation/cardiac arrest), acute angina attacks, and risk of acute myocardial infarction. Vascular disorders: Frequency not known: pallor, coldness of the extremities. In high dosage or for patients sensitive to adrenaline: hypertension (with risk of cerebral haemorrhage), vasoconstriction (for example cutaneous, in the extremities or kidneys). Respiratory, thoracic and mediastinal disorders: Frequency not known: dyspnoea. Gastrointestinal disorders: Frequency not known: nausea, vomiting. General disorders and administration site conditions: Frequency not known: sweating, weakness Repeated local injections may produce necrosis at sites of injection as a result of vascular constriction. 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. To report any side effect(s): Saudi Arabia: • The National Pharmacovigilance Centre (NPC): - Fax: +966-11-205-7662 - Call NPC at +966-11-2038222, Ext 2317-2356-2340 - 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. |
Over dosage or inadvertent intravenous administration of adrenaline may produce severe hypertension. Cerebral, cardiac or vascular accidents which could be potentially fatal may occur as a result (cerebral haemorrhage, dysrhythmias such as transient bradycardia followed by tachycardia that may result in arrhythmia, myocardial necrosis, acute pulmonary oedema, renal insufficiency).
The effects of adrenaline may be counteracted, depending on the condition of the patient, by administration of quick-acting vasodilators, of quick-acting alpha-adrenoreceptor blocking agents (e.g. phentolamine), or beta-adrenoreceptor blocking agents (e.g. propanolol). However, due to the short half-life of adrenaline, treatment with these medicines may not be necessary. In case of prolonged hypotensive reaction, administration of another vasopressive agent such as noradrenaline may be required.
| Pharmacotherapeutic group: adrenergic and dopaminergic agents, adrenaline ATC code: C01 CA 24 Adrenaline is a direct acting sympathomimetic agent, which exerts effects on both α and β adrenoceptors. It has more pronounced effects on β than on α adrenoceptors, although α effects prevail at high doses. The effects of adrenaline include increased rate and force of cardiac contraction, cutaneous vasoconstriction and broncho-dilatation. With higher doses, stimulation of peripheral α receptors results in an increase in peripheral resistance and in blood pressure. |
| Pharmacologically active concentrations of adrenaline are not achieved following oral administration as it is rapidly oxidised and conjugated in the gastrointestinal mucosa and the liver. Absorption from subcutaneous tissue is slow due to local vasoconstriction; effects are produced within 5 minutes. Absorption is more rapid after intramuscular injection than after subcutaneous injection. Adrenaline is rapidly distributed into the heart, spleen, several glandular tissues and adrenergic nerves. It readily crosses the placenta and is approximately 50% bound to plasma proteins. Adrenaline is rapidly inactivated in the body, mostly in the liver by the enzymes catechol-O- methyltransferase (COMT) and monoamine oxidase (MAO). Most of a dose of adrenaline is excreted as metabolites in urine. After intravenous administration, the plasma half-life is about 2-3 minutes. |
| There are no pre-clinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC. |
| Sodium chloride Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections |
| In the absence of compatibility studies, this product must not be mixed with other medicinal products. |
| Do not store above 25°C. Do not freeze. Store in the aluminium pouch in order to protect from light and oxygen. |
10 ml solution in a polypropylene pre-filled syringe without a needle, individually packaged in a transparent blister and overwrapped in an aluminium pouch containing an oxygen absorbing sachet. Available in box of 10.
| The aluminium pouch and syringe blister should only be opened immediately prior administration. After opening the pouch the product must be used immediately. The external surface of the syringe and its content are sterile if the blister is unopened and undamaged. The pre-filled syringe is for single patient use only. Discard the syringe after use. Do not reuse. The product should be inspected visually for particles and discolouration prior to administration. Only clear colourless solution free from particles or precipitates should be used. The product should not be used if the pouch or the blister has been opened or if the tamper evident seal on the syringe (plastic film at the basis of the end cap) is broken. 1) Tear open the aluminium pouch by hand only using the indent(s) Do not use sharp instruments to open the pouch. 2) Withdraw the pre-filled syringe from the sterile blister. 3) Push on the plunger to free the bung. The sterilisation process may have caused adhesion of the bung to the body of the syringe. 4) Twist off the end cap to break the seals. Do not touch the exposed luer connection in order to avoid contamination. 5) Check the syringe seal tip has been completely removed. If not, replace the cap and twist again. 6) Expel the air by gently pushing the plunger. 7) Connect syringe to vascular access device or to needle. Push the plunger to inject the required volume. Any unused product or waste material should be disposed of in accordance with local requirements. |
