EPHEDRINE HYDROCHLORIDE 3 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Active substance: EPHEDRINE HYDROCHLORIDE
View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET : INFORMATION FOR THE USER
Ephedrine Hydrochloride 3 mg/ml
Solution for Injection in Pre-filled Syringe
Ephedrine Hydrochloride
(Referred to as Ephedrine Injection in this leaflet) Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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. In this leaflet: 1. What Ephedrine Injection is and what it is used for 2. Before you are given Ephedrine Injection 3. How Ephedrine Injection is given 4. Possible side effects 5. How to store Ephedrine Injection 6. Further information
Take special care with Ephedrine Injection. Tell your doctor if: You are a diabetic, You know or suspect that you suffer from glaucoma, You are about to have an operation which requires that you be given an anaesthetic, You are currently taking or have taken within the last 14 days any monoamine oxidase inhibitor drug used to treat depression. Using other medicines Tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription as they may interact with Ephedrine Injection. This is especially important of the following medicines: cough and cold remedies methylphenidate, used to treat attention deficit hyperactivity disorder anaesthetics that are inhaled such as halothane medicines used to treat depression, sibutramine, a medicine used as an appetite suppressant linezolid, used to treat infections medicines used to treat asthma such as theophylline corticosteroids, a type of medicine used to relieve swelling in a variety of different conditions medicines for epilepsy doxapram, a drug used to treat breathing problems oxytocin, a drug used during labour medicines used to treat high blood pressure such as guanethidine Pregnancy and breast-feeding Please tell your doctor if you are pregnant or think you may be pregnant before you are given this medicine. You should not be given this medicine if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Laboratory Testing This medicinal product contains an active ingredient that can induce positive results in anti-doping controls. Important information about some of the ingredients of Ephedrine Injection This medicinal product contains 3.32 mg (0.144 mmol) of sodium per ml of injection (a total of 33.2 mg or 1.44 mmol sodium in 10 ml syringe). This amount must be taken into consideration by patients on a salt-restricted diet.
1. WHAT EPHEDRINE INJECTION IS AND WHAT IT IS USED FOR
This product is used to treat low blood pressure that can occur during spinal or epidural anaesthesia.
2. BEFORE YOU ARE GIVEN EPHEDRINE INJECTION
Do not use Ephedrine Injection if: You know you are allergic (hypersensitive) to the active substance or to any of the ingredients of Ephedrine Injection (See section 6, Further Information), You suffer from heart disease or any other heart conditions, You have high blood pressure and are currently receiving medication, You have an overactive thyroid gland or an enlarged prostate.
AGUETTANT SYSTEM
The following information is intended for medical or healthcare professionals only: This is an extract from the Summary of Product Characteristics to assist in the administration of Ephedrine Injection. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the Summary of Product Characteristics of the product. Drug name:
Ephedrine Hydrochloride 3 mg/ml
Solution for Injection in Pre-filled Syringe
Safety information:
Ephedrine must be used solely by or under the supervision of the anaesthetist. For intravenous injection.
Incompatibilities:
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Administration:
The pre-filled syringe contains a ready-to-use solution for injection containing 3 mg ephedrine hydrochloride in each ml of solution. Adult and children over 12 years Slow intravenous injection of 3 to 6 mg (maximum 9 mg), repeated as needed every 3-4 min to a maximum of 30 mg. A lack of efficacy after 30 mg should lead to reconsideration of the choice of the therapeutic agent. The dose administered for 24 hours must not exceed 150 mg. Children under 12 years The paediatric dose is 0.5 to 0.75 mg/kg or 17-25 mg/m2 every 3-4 minutes according to response. Elderly As for adults.
Overdose
In the event of overdose, the occurrence of nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias, respiratory depression, convulsions and coma is observed. The lethal dose in humans is approximately 2 g corresponding to blood concentrations of approximately 3.5 to 20 mg/I. Treatment The treatment of ephedrine overdose with this product may require intensive supportive treatment. Slow intravenous injection of labetalol 50-200 mg may be given with electrocardiograph monitoring for the treatment of supraventricular tachycardia. Marked hypokalaemia (< 2.8 mmol.l-1) due to compartmental shift of potassium predisposes to cardiac arrhythmias and may be corrected by infusing potassium chloride in addition to propranolol and correcting respiratory alkalosis, when present.
AGUETTANT SYSTEM
3. HOW EPHEDRINE INJECTION IS GIVEN
Your doctor or nurse will administer Ephedrine Injection to you into a vein (intravenous). Your doctor will decide the correct dosage for you and when and how the injection should be administered. Dosage Adults, elderly and children over 12 years: You will be given a slow injection into a vein of 3 to 6 mg (maximum 9 mg), repeated if necessary every 3-4 minutes to a maximum of 30 mg. The total dose must be lower than 150 mg/24 hours. Children under 12 years Your child will be given a slow injection into a vein of 0.5-0.75 mg/kg or 17-25 mg/m every 3-4 minutes according to response. If you have any further questions on the use of this product, ask your doctor or pharmacist.
5. HOW TO STORE EPHEDRINE INJECTION
Keep out of the reach and sight of children. You should not be given this medicine if it has passed the expiry date shown on the carton and syringe label. Your doctor or nurse will check this. Store the blister in the outer carton in order to protect from light. Any unused product or waste material should be disposed of in accordance with local requirements.
6. FURTHER INFORMATION
What Ephedrine Injection contains: - The active ingredient is Ephedrine Hydrochloride. Each ml of Solution for Injection contains 3 mg ephedrine hydrochloride. Each 10 ml prefilled syringe contains 30 mg ephedrine hydrochloride. - The other ingredients are Sodium Chloride, Citric acid monohydrate, sodium citrate and Water for Injections and may contain hydrochloric acid or sodium hydroxide (for pH adjustments). What Ephedrine Injection looks like and contents of the pack: Ephedrine Injection is a clear and colourless liquid. It is supplied in a 10 ml polypropylene prefilled syringe with a polypropylene tip cap and tamper proof seal, and is individually packaged in a transparent blister pack. The prefilled syringes are available in boxes of 1, 5, 10, 12 and 20 syringes. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: LABORATOIRE AGUETTANT 1, rue Alexander Fleming 69007 LYON - France This leaflet was last approved in 10/2010.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ephedrine Injection can cause side effects, although not everybody gets them. Common (affect less than 1 in 10 patients): Confusion, feeling worried, depression Nervousness, irritability, restlessness, weakness, sleeping problems, headache, sweating Palpitations, high blood pressure, fast heartbeat Shortness of breath Nausea, vomiting Rare (affect less than 1 in 1000 patients): Irregular heartbeat Difficulty in passing urine Other side effects (it is not known how often these occur): Affects blood clotting Allergy Change in your personality or the way you feel/think, fear Tremor, excessive saliva production Increased pressure in the eye (glaucoma) Pain over the heart, slow heartbeat, heart failure (cardiac arrest), low blood pressure Bleeding in the brain Breathing problems Reduced appetite A fall in blood potassium levels, changes in blood glucose levels Build up of a fluid within the lungs (pulmonary oedema) 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.
AGUETTANT SYSTEM Instructions for use:
Please prepare the syringe carefully as follows. The pre-filled syringe is for single patient only. Discard syringe after use. DO NOT REUSE. The content of un-opened and un-damaged blister is sterile, and must not be opened until use. The product should be inspected visually for particles and discoloration prior to administration. Only clear colourless solution free from particles or precipitates should be used. Do not use the product if the tamper evident seal on syringe is broken. The external surface of syringe is sterile until blister is opened 1) Withdraw the pre-filled syringe from the sterile blister.
2) Push on the plunger to free the bung 4) Check that the syringe seal has been completely removed. If not, replace the cap and twist again.
3) Twist off the end cap to break the seals.
5) Expel the air by gently pushing the plunger.
6) Connect the syringe to the IV access. Push the plunger slowly to inject the required volume. Any unused product or waste material should be disposed of in accordance with local requirements.
Storage and Shelf life:
Do not use this product after the expiry date which is stated on the carton and syringe label. The expiry date refers to the last day of that month. After opening: the product must be used immediately. Store the blister in the outer carton in order to protect from light.
AGUETTANT SYSTEM
000000 MM/AA
Ephedrine Hydrochloride 3 mg/ml
Solution for Injection in Pre-filled Syringe
Ephedrine Hydrochloride
(Referred to as Ephedrine Injection in this leaflet) Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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. In this leaflet: 1. What Ephedrine Injection is and what it is used for 2. Before you are given Ephedrine Injection 3. How Ephedrine Injection is given 4. Possible side effects 5. How to store Ephedrine Injection 6. Further information
Take special care with Ephedrine Injection. Tell your doctor if: You are a diabetic, You know or suspect that you suffer from glaucoma, You are about to have an operation which requires that you be given an anaesthetic, You are currently taking or have taken within the last 14 days any monoamine oxidase inhibitor drug used to treat depression. Using other medicines Tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription as they may interact with Ephedrine Injection. This is especially important of the following medicines: cough and cold remedies methylphenidate, used to treat attention deficit hyperactivity disorder anaesthetics that are inhaled such as halothane medicines used to treat depression, sibutramine, a medicine used as an appetite suppressant linezolid, used to treat infections medicines used to treat asthma such as theophylline corticosteroids, a type of medicine used to relieve swelling in a variety of different conditions medicines for epilepsy doxapram, a drug used to treat breathing problems oxytocin, a drug used during labour medicines used to treat high blood pressure such as guanethidine Pregnancy and breast-feeding Please tell your doctor if you are pregnant or think you may be pregnant before you are given this medicine. You should not be given this medicine if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Laboratory Testing This medicinal product contains an active ingredient that can induce positive results in anti-doping controls. Important information about some of the ingredients of Ephedrine Injection This medicinal product contains 3.32 mg (0.144 mmol) of sodium per ml of injection (a total of 33.2 mg or 1.44 mmol sodium in 10 ml syringe). This amount must be taken into consideration by patients on a salt-restricted diet.
1. WHAT EPHEDRINE INJECTION IS AND WHAT IT IS USED FOR
This product is used to treat low blood pressure that can occur during spinal or epidural anaesthesia.
2. BEFORE YOU ARE GIVEN EPHEDRINE INJECTION
Do not use Ephedrine Injection if: You know you are allergic (hypersensitive) to the active substance or to any of the ingredients of Ephedrine Injection (See section 6, Further Information), You suffer from heart disease or any other heart conditions, You have high blood pressure and are currently receiving medication, You have an overactive thyroid gland or an enlarged prostate.
AGUETTANT SYSTEM
The following information is intended for medical or healthcare professionals only: This is an extract from the Summary of Product Characteristics to assist in the administration of Ephedrine Injection. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the Summary of Product Characteristics of the product. Drug name:
Ephedrine Hydrochloride 3 mg/ml
Solution for Injection in Pre-filled Syringe
Safety information:
Ephedrine must be used solely by or under the supervision of the anaesthetist. For intravenous injection.
Incompatibilities:
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Administration:
The pre-filled syringe contains a ready-to-use solution for injection containing 3 mg ephedrine hydrochloride in each ml of solution. Adult and children over 12 years Slow intravenous injection of 3 to 6 mg (maximum 9 mg), repeated as needed every 3-4 min to a maximum of 30 mg. A lack of efficacy after 30 mg should lead to reconsideration of the choice of the therapeutic agent. The dose administered for 24 hours must not exceed 150 mg. Children under 12 years The paediatric dose is 0.5 to 0.75 mg/kg or 17-25 mg/m2 every 3-4 minutes according to response. Elderly As for adults.
Overdose
In the event of overdose, the occurrence of nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias, respiratory depression, convulsions and coma is observed. The lethal dose in humans is approximately 2 g corresponding to blood concentrations of approximately 3.5 to 20 mg/I. Treatment The treatment of ephedrine overdose with this product may require intensive supportive treatment. Slow intravenous injection of labetalol 50-200 mg may be given with electrocardiograph monitoring for the treatment of supraventricular tachycardia. Marked hypokalaemia (< 2.8 mmol.l-1) due to compartmental shift of potassium predisposes to cardiac arrhythmias and may be corrected by infusing potassium chloride in addition to propranolol and correcting respiratory alkalosis, when present.
AGUETTANT SYSTEM
3. HOW EPHEDRINE INJECTION IS GIVEN
Your doctor or nurse will administer Ephedrine Injection to you into a vein (intravenous). Your doctor will decide the correct dosage for you and when and how the injection should be administered. Dosage Adults, elderly and children over 12 years: You will be given a slow injection into a vein of 3 to 6 mg (maximum 9 mg), repeated if necessary every 3-4 minutes to a maximum of 30 mg. The total dose must be lower than 150 mg/24 hours. Children under 12 years Your child will be given a slow injection into a vein of 0.5-0.75 mg/kg or 17-25 mg/m every 3-4 minutes according to response. If you have any further questions on the use of this product, ask your doctor or pharmacist.
5. HOW TO STORE EPHEDRINE INJECTION
Keep out of the reach and sight of children. You should not be given this medicine if it has passed the expiry date shown on the carton and syringe label. Your doctor or nurse will check this. Store the blister in the outer carton in order to protect from light. Any unused product or waste material should be disposed of in accordance with local requirements.
6. FURTHER INFORMATION
What Ephedrine Injection contains: - The active ingredient is Ephedrine Hydrochloride. Each ml of Solution for Injection contains 3 mg ephedrine hydrochloride. Each 10 ml prefilled syringe contains 30 mg ephedrine hydrochloride. - The other ingredients are Sodium Chloride, Citric acid monohydrate, sodium citrate and Water for Injections and may contain hydrochloric acid or sodium hydroxide (for pH adjustments). What Ephedrine Injection looks like and contents of the pack: Ephedrine Injection is a clear and colourless liquid. It is supplied in a 10 ml polypropylene prefilled syringe with a polypropylene tip cap and tamper proof seal, and is individually packaged in a transparent blister pack. The prefilled syringes are available in boxes of 1, 5, 10, 12 and 20 syringes. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: LABORATOIRE AGUETTANT 1, rue Alexander Fleming 69007 LYON - France This leaflet was last approved in 10/2010.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ephedrine Injection can cause side effects, although not everybody gets them. Common (affect less than 1 in 10 patients): Confusion, feeling worried, depression Nervousness, irritability, restlessness, weakness, sleeping problems, headache, sweating Palpitations, high blood pressure, fast heartbeat Shortness of breath Nausea, vomiting Rare (affect less than 1 in 1000 patients): Irregular heartbeat Difficulty in passing urine Other side effects (it is not known how often these occur): Affects blood clotting Allergy Change in your personality or the way you feel/think, fear Tremor, excessive saliva production Increased pressure in the eye (glaucoma) Pain over the heart, slow heartbeat, heart failure (cardiac arrest), low blood pressure Bleeding in the brain Breathing problems Reduced appetite A fall in blood potassium levels, changes in blood glucose levels Build up of a fluid within the lungs (pulmonary oedema) 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.
AGUETTANT SYSTEM Instructions for use:
Please prepare the syringe carefully as follows. The pre-filled syringe is for single patient only. Discard syringe after use. DO NOT REUSE. The content of un-opened and un-damaged blister is sterile, and must not be opened until use. The product should be inspected visually for particles and discoloration prior to administration. Only clear colourless solution free from particles or precipitates should be used. Do not use the product if the tamper evident seal on syringe is broken. The external surface of syringe is sterile until blister is opened 1) Withdraw the pre-filled syringe from the sterile blister.
2) Push on the plunger to free the bung 4) Check that the syringe seal has been completely removed. If not, replace the cap and twist again.
3) Twist off the end cap to break the seals.
5) Expel the air by gently pushing the plunger.
6) Connect the syringe to the IV access. Push the plunger slowly to inject the required volume. Any unused product or waste material should be disposed of in accordance with local requirements.
Storage and Shelf life:
Do not use this product after the expiry date which is stated on the carton and syringe label. The expiry date refers to the last day of that month. After opening: the product must be used immediately. Store the blister in the outer carton in order to protect from light.
AGUETTANT SYSTEM
000000 MM/AA
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
