VENOFER 20 MG/ML SOLN FOR INJ OR CONC. FOR SOLN FOR INFUSION
Active substance: IRON SUCROSE
View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Venofer 20 mg iron/ml Solution for injection or concentrate for solution for infusion Iron Sucrose Read all of this leaflet carefully before you are given this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor. If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1.What Venofer is and what it is used for 2.Before Venofer is given to you 3.How Venofer is given 4.Possible side effects 5.How to store Venofer 6.Further information
vial 2.5ml and vial 5ml pI Manufacturer GP Grenzach
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Venofer can affect the way some other medicines work. Also some other medicines can affect the way Venofer works. In particular tell your doctor or pharmacist if you are taking: Medicines that contain iron which you take by mouth. These may not work if they are taken at the same time that V enofer is given to you. When you have finished treatment with Venofer, wait 5 days before taking iron by mouth. Pregnancy and breast-feeding Venofer should not be given during the first three months of pregnancy. Your doctor will decide if Venofer can be used during the fourth to ninth months of preg ancy. n It is unlikely that Venofer can pass into the mothers milk. Therefore breast-feeding when you are being given this medicine should not harm your baby. Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding. Driving and using machines You may feel dizzy, confused or lightheaded after being given Venofer. If this happens, do not drive or use any tool or machines. Ask your doctor if you are not sure.
1. HAT Venofer IS AND WHAT IT W IS USED FOR
Venofer is a medicine that contains iron. Medicines that contain iron are used when you do not have enough iron in your body. This is called iron deficiency. Venofer is given when: You cannot take iron by mouth such as when iron tablets make you feel ill. You have taken iron by mouth and it has not worked.
2. BEFORE Venofer IS GIVEN TO YOU
You must not be given Venofer if: You are allergic (hypersensitive) to any of the ingredients of Venofer (listed in Section 6). You have anaemia which is not caused by a shortage of iron. You have too much iron in your body or a problem in the way your body uses iron. You have ever had asthma, eczema or other allergies. This is because you are more likely to have an allergic reaction. You are in the first three months of pregnancy. You must not be given Venofer if any of the above apply to you. If you are not sure, talk to your doctor before having Venofer. Take special care with Venofer Check with your doctor before you are given Venofer if: You have any infections. You have liver problems. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before you are given Venofer.
3. HOW Venofer IS GIVEN
Venofer will be given to you by a doctor. Your doctor will decide how much Venofer to give you. He or she will also decide how often you need it and for how long. Your doctor will do a blood test to help work out the dose. If you have never had Venofer before, you will have a small amount of the medicine first (a test dose). This is to check that you are not allergic to it. How Venofer is given Venofer can be given in 3 different ways: Slow injection into your vein 1 to 3 times per week.
Perforation
Perforation
The following information is intended for medical or healthcare professionals only:
Administration Mode of Administration: Venofer must only be administered as a slow intravenous injection or as an intravenous drip infusion. Venofer must not be used for intramuscular injection. Before administering the first dose to a new p atient, a test dose of Venofer should be given. Treatment for serious allergic reactions and facilities with the established cardiopulmonary resuscitation procedures should be available because allergic or anaphylactoid reactions and hypotensive episodes may occur. Paravenous leakage must be avoided be cause leakage of Venofer at the injection site may lead to pain, inflammation, tissue necrosis and brown discoloration of the skin.
Intravenous drip infusion: Venofer must be diluted only in sterile 0.9% m/V sodium chloride solution: 2.5 ml Venofer (50 mg iron) in max. 50 ml sterile 0.9% m/V sodium chloride s olution 5 ml Venofer (100 mg iron) in max. 100 ml sterile 0.9% m/V sodium chloride s olution 10 ml Venofer (200 mg iron) in max. 200ml sterile 0.9% m/V sodium chloride s olution For stability reasons, dilutions to lower V enofer concentrations are not permis sible. Dilution must take place immediately prior to infusion and the solution should be adminis ered as follows: t 100 mg iron (5 ml Venofer) over at least 15 minutes 200 mg iron (10 ml Venofer) over at least 30 minutes
81426910
Pf 530-00
As an infusion (drip) into your vein 1 to 3 times per week. During dialysis it will be put into the venous limb of the dialyser. Venofer is a brown liquid and so the injection or infusion will look brown. Children Venofer is not recommended for use in chil ren. d
Other side effects include: feeling less alert, light-headed or confused; swelling of your joints, face and tongue; increased sweating; back pain; low pulse rate; changes to the colour of your urine. If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE Venofer
Keep out of the reach and sight of chil dren. Do not use Venofer after the expiry date which is stated on the label. Do not store above 25C. Do not freeze. Keep the ampoules or vials in the outer carton. Once the Venofer ampoules or Venofer vials have been opened, they should be used immediately. After dilution with sodium chloride solution, the diluted solution should be used immediately. Venofer will normally be stored for you by your doctor or the hospital.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Venofer can cause side effects, although not everybody gets them. Allergic reactions (affects less than 1 in 1,000 people) If you have an allergic reaction, tell your doctor or nurse straight away. The signs may include: Low blood pressure (feeling dizzy, lightheaded or faint). Swelling of your face. Difficulty breathing. Tell your doctor or nurse straight away if you think you are having an allergic r a e ction. Other side effects include: Common (affects less than 1 in 10 people) Changes in your taste such as a metallic taste. This does not usually last very long. Uncommon (affects less than 1 in 100 people) Fast pulse rate. Headache or feeling dizzy. Low blood pressure and collapse. Pounding heart beat (palpitations). Stomach pain or diarrhoea. Feeling sick (nausea) or being sick (vomitng). i Wheezing, difficulty in breathing. Itching, hives, rash or skin redness. Muscle cramps or muscle pain. Flushing. Fever or shivering. Chest pain and chest tightness. Reactions around the site of injection such as inflammation, a feeling of burn ing and swelling.
6. FURTHER INFORMATION
What Venofer contains The active substance is iron (as iron s crose). Each millilitre contains 20 mg u iron. The other ingredients are water for injections and sodium hydroxide. What Venofer looks like and contents of the pack Venofer is a dark brown, non transparent, aqueous solution. Venofer comes in following pack-sizes: 5 Glass ampoules of 5 ml. Each ampoule of 5 ml corresponds to 100 mg of iron. 5 Glass vials of 2.5 ml. Each vial of 2.5 ml corresponds to 50 mg of iron. 5 Glass vials of 5 ml. Each vial of 5 ml corresponds to 100 mg of iron. Not all pack-sizes may be marketed. Marketing Authorisation Holder and Manufacturer Vifor France SA 713, Bd Paul Emile Victor 92200 Neuilly-sur-Seine, France Tl.+33 (0)1 41 06 58 90 Fax+33 (0)1 41 06 58 99 This leaflet was approved in: 02/2011 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Vifor Pharma UK Limited The Old Stables, Bagshot Park Bagshot Surrey GU19 5PJ United Kingdom Tel: +44 1276 853600 Fax :+44 1276 452341 Perforation
Rare (affects less than 1 in 1,000 people) Fainting. Loss of consciousness. Tingling or pins and needles. A feeling of burning. High blood pressure. Feeling hot. Swelling (dropsy). Pain in your joints. Swelling of hands and feet. Tiredness, weakness or general feeling of illness.
Perforation
The first 25 mg of iron (i.e. 25 ml of solution) should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur during this time then the re aining portion of the infusion should be m given at an infusion rate of not more than 50 ml in 15 minutes. Intravenous injection: Venofer may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute and not exceeding 10 ml Venofer (200 mg iron) per injection. Before administering a slow intravenous injection, a test dose of 1 ml (20 mg iron) should be injected slowly over a period of 1 to 2 minutes. If no adverse reactions occur within 15 minutes of completing the test dose, then the remaining portion of the injection may be given. Injection into the dialyser: Venofer may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as those outlined for intravenous injection.
Incompatibilities Venofer must only be mixed with sterile 0.9% m/V sodium chloride solution. No other solutions and therapeutic agents should be used, as there is the potential for precipita ion and/or interaction. The comt patibility with containers other than glass, polyethylene and PVC is not known. Stability The product must not be used after the expiry date which is stated on the label and on the outer carton. From a microbiological point of view, the product should be used immediately after first opening or immedi ately after dilution with sterile 0.9% m/V sodium chloride. Instruction for use and handling Ampoules/Vials should be visually inspected for sediment and damage before use. Only those with sediment free and homogenous solution must be used. The dilution solution must appear as brown and clear. Any unused product or waste material should be disposed of in accordance with local requirements. Pf 530-00
81426910
Venofer 20 mg iron/ml Solution for injection or concentrate for solution for infusion Iron Sucrose Read all of this leaflet carefully before you are given this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor. If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1.What Venofer is and what it is used for 2.Before Venofer is given to you 3.How Venofer is given 4.Possible side effects 5.How to store Venofer 6.Further information
vial 2.5ml and vial 5ml pI Manufacturer GP Grenzach
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Venofer can affect the way some other medicines work. Also some other medicines can affect the way Venofer works. In particular tell your doctor or pharmacist if you are taking: Medicines that contain iron which you take by mouth. These may not work if they are taken at the same time that V enofer is given to you. When you have finished treatment with Venofer, wait 5 days before taking iron by mouth. Pregnancy and breast-feeding Venofer should not be given during the first three months of pregnancy. Your doctor will decide if Venofer can be used during the fourth to ninth months of preg ancy. n It is unlikely that Venofer can pass into the mothers milk. Therefore breast-feeding when you are being given this medicine should not harm your baby. Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding. Driving and using machines You may feel dizzy, confused or lightheaded after being given Venofer. If this happens, do not drive or use any tool or machines. Ask your doctor if you are not sure.
1. HAT Venofer IS AND WHAT IT W IS USED FOR
Venofer is a medicine that contains iron. Medicines that contain iron are used when you do not have enough iron in your body. This is called iron deficiency. Venofer is given when: You cannot take iron by mouth such as when iron tablets make you feel ill. You have taken iron by mouth and it has not worked.
2. BEFORE Venofer IS GIVEN TO YOU
You must not be given Venofer if: You are allergic (hypersensitive) to any of the ingredients of Venofer (listed in Section 6). You have anaemia which is not caused by a shortage of iron. You have too much iron in your body or a problem in the way your body uses iron. You have ever had asthma, eczema or other allergies. This is because you are more likely to have an allergic reaction. You are in the first three months of pregnancy. You must not be given Venofer if any of the above apply to you. If you are not sure, talk to your doctor before having Venofer. Take special care with Venofer Check with your doctor before you are given Venofer if: You have any infections. You have liver problems. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before you are given Venofer.
3. HOW Venofer IS GIVEN
Venofer will be given to you by a doctor. Your doctor will decide how much Venofer to give you. He or she will also decide how often you need it and for how long. Your doctor will do a blood test to help work out the dose. If you have never had Venofer before, you will have a small amount of the medicine first (a test dose). This is to check that you are not allergic to it. How Venofer is given Venofer can be given in 3 different ways: Slow injection into your vein 1 to 3 times per week.
Perforation
Perforation
The following information is intended for medical or healthcare professionals only:
Administration Mode of Administration: Venofer must only be administered as a slow intravenous injection or as an intravenous drip infusion. Venofer must not be used for intramuscular injection. Before administering the first dose to a new p atient, a test dose of Venofer should be given. Treatment for serious allergic reactions and facilities with the established cardiopulmonary resuscitation procedures should be available because allergic or anaphylactoid reactions and hypotensive episodes may occur. Paravenous leakage must be avoided be cause leakage of Venofer at the injection site may lead to pain, inflammation, tissue necrosis and brown discoloration of the skin.
Intravenous drip infusion: Venofer must be diluted only in sterile 0.9% m/V sodium chloride solution: 2.5 ml Venofer (50 mg iron) in max. 50 ml sterile 0.9% m/V sodium chloride s olution 5 ml Venofer (100 mg iron) in max. 100 ml sterile 0.9% m/V sodium chloride s olution 10 ml Venofer (200 mg iron) in max. 200ml sterile 0.9% m/V sodium chloride s olution For stability reasons, dilutions to lower V enofer concentrations are not permis sible. Dilution must take place immediately prior to infusion and the solution should be adminis ered as follows: t 100 mg iron (5 ml Venofer) over at least 15 minutes 200 mg iron (10 ml Venofer) over at least 30 minutes
81426910
Pf 530-00
As an infusion (drip) into your vein 1 to 3 times per week. During dialysis it will be put into the venous limb of the dialyser. Venofer is a brown liquid and so the injection or infusion will look brown. Children Venofer is not recommended for use in chil ren. d
Other side effects include: feeling less alert, light-headed or confused; swelling of your joints, face and tongue; increased sweating; back pain; low pulse rate; changes to the colour of your urine. If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE Venofer
Keep out of the reach and sight of chil dren. Do not use Venofer after the expiry date which is stated on the label. Do not store above 25C. Do not freeze. Keep the ampoules or vials in the outer carton. Once the Venofer ampoules or Venofer vials have been opened, they should be used immediately. After dilution with sodium chloride solution, the diluted solution should be used immediately. Venofer will normally be stored for you by your doctor or the hospital.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Venofer can cause side effects, although not everybody gets them. Allergic reactions (affects less than 1 in 1,000 people) If you have an allergic reaction, tell your doctor or nurse straight away. The signs may include: Low blood pressure (feeling dizzy, lightheaded or faint). Swelling of your face. Difficulty breathing. Tell your doctor or nurse straight away if you think you are having an allergic r a e ction. Other side effects include: Common (affects less than 1 in 10 people) Changes in your taste such as a metallic taste. This does not usually last very long. Uncommon (affects less than 1 in 100 people) Fast pulse rate. Headache or feeling dizzy. Low blood pressure and collapse. Pounding heart beat (palpitations). Stomach pain or diarrhoea. Feeling sick (nausea) or being sick (vomitng). i Wheezing, difficulty in breathing. Itching, hives, rash or skin redness. Muscle cramps or muscle pain. Flushing. Fever or shivering. Chest pain and chest tightness. Reactions around the site of injection such as inflammation, a feeling of burn ing and swelling.
6. FURTHER INFORMATION
What Venofer contains The active substance is iron (as iron s crose). Each millilitre contains 20 mg u iron. The other ingredients are water for injections and sodium hydroxide. What Venofer looks like and contents of the pack Venofer is a dark brown, non transparent, aqueous solution. Venofer comes in following pack-sizes: 5 Glass ampoules of 5 ml. Each ampoule of 5 ml corresponds to 100 mg of iron. 5 Glass vials of 2.5 ml. Each vial of 2.5 ml corresponds to 50 mg of iron. 5 Glass vials of 5 ml. Each vial of 5 ml corresponds to 100 mg of iron. Not all pack-sizes may be marketed. Marketing Authorisation Holder and Manufacturer Vifor France SA 713, Bd Paul Emile Victor 92200 Neuilly-sur-Seine, France Tl.+33 (0)1 41 06 58 90 Fax+33 (0)1 41 06 58 99 This leaflet was approved in: 02/2011 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Vifor Pharma UK Limited The Old Stables, Bagshot Park Bagshot Surrey GU19 5PJ United Kingdom Tel: +44 1276 853600 Fax :+44 1276 452341 Perforation
Rare (affects less than 1 in 1,000 people) Fainting. Loss of consciousness. Tingling or pins and needles. A feeling of burning. High blood pressure. Feeling hot. Swelling (dropsy). Pain in your joints. Swelling of hands and feet. Tiredness, weakness or general feeling of illness.
Perforation
The first 25 mg of iron (i.e. 25 ml of solution) should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur during this time then the re aining portion of the infusion should be m given at an infusion rate of not more than 50 ml in 15 minutes. Intravenous injection: Venofer may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute and not exceeding 10 ml Venofer (200 mg iron) per injection. Before administering a slow intravenous injection, a test dose of 1 ml (20 mg iron) should be injected slowly over a period of 1 to 2 minutes. If no adverse reactions occur within 15 minutes of completing the test dose, then the remaining portion of the injection may be given. Injection into the dialyser: Venofer may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as those outlined for intravenous injection.
Incompatibilities Venofer must only be mixed with sterile 0.9% m/V sodium chloride solution. No other solutions and therapeutic agents should be used, as there is the potential for precipita ion and/or interaction. The comt patibility with containers other than glass, polyethylene and PVC is not known. Stability The product must not be used after the expiry date which is stated on the label and on the outer carton. From a microbiological point of view, the product should be used immediately after first opening or immedi ately after dilution with sterile 0.9% m/V sodium chloride. Instruction for use and handling Ampoules/Vials should be visually inspected for sediment and damage before use. Only those with sediment free and homogenous solution must be used. The dilution solution must appear as brown and clear. Any unused product or waste material should be disposed of in accordance with local requirements. Pf 530-00
81426910
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.
