AMPICILLIN 500MG VIALS FOR INJECTION
Active substance: AMPICILLIN SODIUM
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Package Enclosure Leaflet
Ampicillin 500 mg
Ampicillin Sodium EP for Injection
Vials for Injection
70/L/t/4
Content Ampicillin is available as vials containing the equivalent of 500 mg ampicillin presented as Ampicillin Sodium EP as a powder for reconstitution. Therapeutic Indications Ampicillin is a broad-spectrum penicillin indicated for the treatment of a wide range of bacterial infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, gastrointestinal infections, enteric fever, peritonitis, septicaemia, endocarditis, meningitis. Extraperitoneal application of ampicillin to wounds can be used to prevent infection following abdominal surgery. Parenteral usage is indicated where oral dosage is inappropriate. Routes of administration: intramuscular, intravenous, intraperitoneal, intrapleural, intra-articular, extraperitoneal. Posology and Method of Administration Usual adult dosage (including elderly patients): Septicaemia, endocarditis, osteomyelitis: Peritonitis, intra-abdominal sepsis: Meningitis: 500 mg four to six times a day IM or IV for one to six weeks. 500 mg four times a day IM or IV. Adult dosage: 2 g six-hourly IV. Childrens dosage: 150 mg/kg daily IV in divided doses.
Pregnancy and lactation Pregnancy: Animal studies with ampicillin have shown no teratogenic effects. The product has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, ampicillin may be considered appropriate. Lactation: During lactation, trace quantities of penicillins can be detected in breast milk. Adequate human and animal data on use of Ampicillin during lactation are not available. Effects on ability to drive and use machines Adverse effects on the ability to drive or operate machinery have not been observed. Undesirable effects Hypersensitivity reactions: If any hypersensitivity reaction occurs, the treatment should be discontinued. Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. As with other antibiotics, anaphylaxis (see Special warnings section) has been reported rarely. Renal effects: Interstitial nephritis can occur rarely. Gastrointestinal reactions: Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and haemorrhagic colitis has been reported rarely. Hepatic effects: As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported. Haematological effects: As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin time have also been reported rarely. Overdosage Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically. Ampicillin may be removed from the circulation by haemodialysis. Pharmacological Properties Pharmacodynamic properties: Ampicillin is a broad spectrum penicillin, indicated for the treatment of a wide range of bacterial infection caused by ampicillin sensitive organisms. Pharmacokinetic properties: Ampicillin is excreted mainly in the bile and urine with a plasma half life of one to two hours. Preclinical safety data: No further information of relevance. Directions for use Ampicillin vials are not suitable for multidose use. Any residual Ampicillin solution should be discarded. Stability and Compatibility Ampicillin solutions for injection should be used immediately. The stability of Ampicillin is improved in dilute solutions such as those commonly prepared for intravenous infusion and the drug can be added to most intravenous fluids. Preparation of Ampicillin infusion solutions must be carried out under appropriate aseptic conditions if these extended storage periods are required. Reconstituted solutions of Ampicillin should be stored in a refrigerator at 2-8C. Refrigerated solutions should be restored to ambient temperature before use. Intravenous fluids Sodium chloride 0.9% with glucose 5% (dextrose saline), 5% glucose, 10% dextran 40 in 5% glucose M/6 sodium lactate, 1.4% sodium bicarbonate,10% dextran 40 in normal saline Water for Injections BP, sodium chloride 0.9% (normal saline), Ringers solution Ampicillin has been shown to be compatible with heparin sodium in intravenous infusions and these agents may be administered concurrently in normal saline. If Ampicillin is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions. Ampicillin should not be mixed with blood products or other proteinaceous fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions. Storage Availability Ampicillin vials should not be stored above 25C. Strength 500 mg POM Chemidex Pharma Ltd., trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB Packs 10 Product Licence PL 17736/0070
Ampicillin may also be administered by other routes in conjunction with systemic therapy. Intraperitoneal: 500 mg daily in up to 10 ml Water for Injections BP. Intrapleural: 500 mg daily in 5-10 ml Water for Injections BP. Intra-articular: 500 mg daily, in up to 5 ml Water for Injections BP or sterile 0.5% procaine hydrochloride solution. Local use in abdominal surgery: 1 g sterile powder sprinkled into the wound extraperitoneally or into muscle layers to prevent wound infection post-operatively. Usual children's dosage (under 10 years): Half adult routine dosage. All recommended dosages are a guide only. In severe infections the above dosages may be increased. Renal Impairment In the presence of severe renal impairment (creatinine clearance < 10 ml/min) a reduction in dose or extension of dose interval should be considered. In case of dialysis, an additional dose should be administered after the procedure. Administration: Intramuscular: Add 1.5 ml Water for Injections BP to 500 mg vial contents. Intravenous: Dissolve 500 mg in 10 ml Water for Injections BP. Administer by slow injection (three to four minutes). Ampicillin may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of three to four minutes. Contra-indications Ampicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins). Special warnings and precautions for use Before initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity. Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin. Prolonged use may occasionally result in overgrowth of non-susceptible organisms. Dosage should be adjusted in patients with renal impairment (see dosage section). Sodium Content: one vial contains 33.7 mg sodium. This sodium content should be included in the daily allowance of patients on sodium restricted diet. Interaction with other medicaments and other forms of interaction If ampicillin is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions. Bacteriostatic drugs may interfere with the bactericidal action of ampicillin. In common with other oral broad-spectrum antibiotics, ampicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Probenecid decreases the renal tubular secretion of ampicillin. Concurrent use with ampicillin may result in increased and prolonged blood levels of ampicillin. Concurrent administration of allopurinol during treatment with ampicillin can increase the likelihood of allergic skin reactions. It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of ampicillin, false positive readings are common with chemical methods.
Legal category Product Licence Holder Leaflet prepared July 2012
70/L/t/4
Patient Information Leaflet
Ampicillin 500 mg Vials for Injection
Ampicillin
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What this medicine is and what it is used for 2. Before you use 3. How to use 4. Possible side effects 5. How to store 6. Further information Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations. Some medicines may be affected by Ampicillin or they may affect how well Ampicillin will work. Tell your doctor or pharmacist if you are taking: any other antibiotics allopurinol or probenecid for conditions such as gout oral contraceptives (the pill). You will need an additional method of contraception, such as condoms. Speak to your doctor or pharmacist about how long you need to take extra precautions for. Urine tests: Tell the doctor if you are having urine tests for glucose, as your medicine may affect the results. Pregnancy and breast-feeding Ampicillin will not harm your unborn baby. Small quantities of the medicine may be present in breast milk. Ask your doctor for advice before taking any medicine. Driving and using machines Ampicillin vials for injection is unlikely to affect your ability to operate machinery or to drive. Important information about some of the ingredients of Ampicillin vials for injection sodium Each vial of Ampicillin injection contains 33.7 mg of sodium. This should be taken into consideration by patients on a controlled sodium diet.
70/L/t/4
3. How to use
You will most likely receive Ampicillin injection from a doctor or nurse. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure. Your doctor or nurse will usually inject Ampicillin into your muscles or veins. Ampicillin injection can also be used in other ways depending on your condition. Doses Adults and children over 10 years: the usual dose is 500 mg four to six times a day. Children under 10 years: half the adult dose. In severe infections the above doses may be increased by your doctor. Patients with kidney problems: if your kidneys are not working very well, your doctor may change the dose. Your doctor will give you special instructions if you are on kidney dialysis. If you use more than you should Having too much Ampicillin is unlikely as the injection will be given to you by a doctor or nurse. However, if you are given too much Ampicillin, you may experience nausea, vomiting and diarrhoea. Ask your doctor or nurse if you have any concerns. If you forget to use If you think you have missed an injection, speak to your doctor or nurse. If you stop using Do not stop just because you feel better. If you stop too soon, the infection may come back. Keep having the injection until the prescribed course is finished. If you have any further questions on the use of this product, ask your doctor or pharmacist.
yellowing of your skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness unusual bleeding or bruising fever, sore throat, mouth ulcers, repeated infections or infections that will not go away feeling tired, breathless, and looking pale fever, rash, nausea, aches and pains, passing more or less urine than usual or passing urine at night. Some of these reactions may happen several weeks after finishing the treatment. The following side effects usually settle without changing the dose: upset stomach, nausea or diarrhoea. Blood tests: tell your doctor if you are having blood tests as your medicine can cause short-term changes in blood cell counts. If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What this medicine is and what it is used for
Ampicillin vials contain ampicillin which belongs to the penicillin group of antibiotics. Ampicillin works by killing bacteria that cause infections, such as: ear, nose and throat infections bronchitis, pneumonia, chest infections urinary tract infections sexually transmitted infections skin and soft tissue infections gastrointestinal infections blood poisoning.
5. How to store
Keep out of the reach and sight of children. Do not use after the expiry date which is stated on the vial label and on the carton. The expiry date refers to the last day of that month. Do not store above 25C. Store prepared solutions for injection in a refrigerator (2C - 8C) for up to 24 hours. Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
2. Before you use
Do NOT use Ampicillin vials for injection if you: are allergic to ampicillin, other antibiotics called beta-lactams (e.g. penicillin or cephalosporin) or any of the other ingredients (see Section 6). If this applies to you, speak to your doctor or pharmacist. Take special care with Ampicillin vials for injection Before treatment with the injection, tell your doctor if you: have ever had a skin rash or swelling of the face or neck when taking any antibiotic are already being treated with another antibiotic have glandular fever or low immune system leukaemia have kidney problems.
6. Further information
What Ampicillin vial for injection contains The active ingredient is ampicillin (500 mg) as ampicillin sodium. (See end of Section 2 for further information on sodium). There are no other ingredients. What Ampicillin vial for injection looks like and contents of the pack Ampicillin is a white powder which is made up into a solution before it is given to you. It is supplied to doctors in packs of 10 vials. Marketing Authorisation Holder Chemidex Pharma Ltd, trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB. Manufacturer Laboratorio Reig Jofre, S.A. C/ Jarama 111, Polgono Industrial Toledo, 45007 Toledo (Spain) This leaflet was last revised in July 2012
4. Possible side effects
Like all medicines, Ampicillin can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them. Tell you doctor or nurse immediately if you have any of the following allergic reactions: difficulty breathing or swallowing, swelling of the face, lips, tongue or throat severe itching of the skin, with a red rash or raised lumps blistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin. Seek immediate medical attention if you have any of the following symptoms: severe stomach cramps, watery and severe diarrhoea which may be bloody, fever
Continued over page
70/L/t/4
Ampicillin 500 mg
Ampicillin Sodium EP for Injection
Vials for Injection
70/L/t/4
Content Ampicillin is available as vials containing the equivalent of 500 mg ampicillin presented as Ampicillin Sodium EP as a powder for reconstitution. Therapeutic Indications Ampicillin is a broad-spectrum penicillin indicated for the treatment of a wide range of bacterial infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, gastrointestinal infections, enteric fever, peritonitis, septicaemia, endocarditis, meningitis. Extraperitoneal application of ampicillin to wounds can be used to prevent infection following abdominal surgery. Parenteral usage is indicated where oral dosage is inappropriate. Routes of administration: intramuscular, intravenous, intraperitoneal, intrapleural, intra-articular, extraperitoneal. Posology and Method of Administration Usual adult dosage (including elderly patients): Septicaemia, endocarditis, osteomyelitis: Peritonitis, intra-abdominal sepsis: Meningitis: 500 mg four to six times a day IM or IV for one to six weeks. 500 mg four times a day IM or IV. Adult dosage: 2 g six-hourly IV. Childrens dosage: 150 mg/kg daily IV in divided doses.
Pregnancy and lactation Pregnancy: Animal studies with ampicillin have shown no teratogenic effects. The product has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, ampicillin may be considered appropriate. Lactation: During lactation, trace quantities of penicillins can be detected in breast milk. Adequate human and animal data on use of Ampicillin during lactation are not available. Effects on ability to drive and use machines Adverse effects on the ability to drive or operate machinery have not been observed. Undesirable effects Hypersensitivity reactions: If any hypersensitivity reaction occurs, the treatment should be discontinued. Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. As with other antibiotics, anaphylaxis (see Special warnings section) has been reported rarely. Renal effects: Interstitial nephritis can occur rarely. Gastrointestinal reactions: Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and haemorrhagic colitis has been reported rarely. Hepatic effects: As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported. Haematological effects: As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin time have also been reported rarely. Overdosage Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically. Ampicillin may be removed from the circulation by haemodialysis. Pharmacological Properties Pharmacodynamic properties: Ampicillin is a broad spectrum penicillin, indicated for the treatment of a wide range of bacterial infection caused by ampicillin sensitive organisms. Pharmacokinetic properties: Ampicillin is excreted mainly in the bile and urine with a plasma half life of one to two hours. Preclinical safety data: No further information of relevance. Directions for use Ampicillin vials are not suitable for multidose use. Any residual Ampicillin solution should be discarded. Stability and Compatibility Ampicillin solutions for injection should be used immediately. The stability of Ampicillin is improved in dilute solutions such as those commonly prepared for intravenous infusion and the drug can be added to most intravenous fluids. Preparation of Ampicillin infusion solutions must be carried out under appropriate aseptic conditions if these extended storage periods are required. Reconstituted solutions of Ampicillin should be stored in a refrigerator at 2-8C. Refrigerated solutions should be restored to ambient temperature before use. Intravenous fluids Sodium chloride 0.9% with glucose 5% (dextrose saline), 5% glucose, 10% dextran 40 in 5% glucose M/6 sodium lactate, 1.4% sodium bicarbonate,10% dextran 40 in normal saline Water for Injections BP, sodium chloride 0.9% (normal saline), Ringers solution Ampicillin has been shown to be compatible with heparin sodium in intravenous infusions and these agents may be administered concurrently in normal saline. If Ampicillin is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions. Ampicillin should not be mixed with blood products or other proteinaceous fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions. Storage Availability Ampicillin vials should not be stored above 25C. Strength 500 mg POM Chemidex Pharma Ltd., trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB Packs 10 Product Licence PL 17736/0070
Ampicillin may also be administered by other routes in conjunction with systemic therapy. Intraperitoneal: 500 mg daily in up to 10 ml Water for Injections BP. Intrapleural: 500 mg daily in 5-10 ml Water for Injections BP. Intra-articular: 500 mg daily, in up to 5 ml Water for Injections BP or sterile 0.5% procaine hydrochloride solution. Local use in abdominal surgery: 1 g sterile powder sprinkled into the wound extraperitoneally or into muscle layers to prevent wound infection post-operatively. Usual children's dosage (under 10 years): Half adult routine dosage. All recommended dosages are a guide only. In severe infections the above dosages may be increased. Renal Impairment In the presence of severe renal impairment (creatinine clearance < 10 ml/min) a reduction in dose or extension of dose interval should be considered. In case of dialysis, an additional dose should be administered after the procedure. Administration: Intramuscular: Add 1.5 ml Water for Injections BP to 500 mg vial contents. Intravenous: Dissolve 500 mg in 10 ml Water for Injections BP. Administer by slow injection (three to four minutes). Ampicillin may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of three to four minutes. Contra-indications Ampicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins). Special warnings and precautions for use Before initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity. Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin. Prolonged use may occasionally result in overgrowth of non-susceptible organisms. Dosage should be adjusted in patients with renal impairment (see dosage section). Sodium Content: one vial contains 33.7 mg sodium. This sodium content should be included in the daily allowance of patients on sodium restricted diet. Interaction with other medicaments and other forms of interaction If ampicillin is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions. Bacteriostatic drugs may interfere with the bactericidal action of ampicillin. In common with other oral broad-spectrum antibiotics, ampicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Probenecid decreases the renal tubular secretion of ampicillin. Concurrent use with ampicillin may result in increased and prolonged blood levels of ampicillin. Concurrent administration of allopurinol during treatment with ampicillin can increase the likelihood of allergic skin reactions. It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of ampicillin, false positive readings are common with chemical methods.
Legal category Product Licence Holder Leaflet prepared July 2012
70/L/t/4
Patient Information Leaflet
Ampicillin 500 mg Vials for Injection
Ampicillin
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What this medicine is and what it is used for 2. Before you use 3. How to use 4. Possible side effects 5. How to store 6. Further information Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations. Some medicines may be affected by Ampicillin or they may affect how well Ampicillin will work. Tell your doctor or pharmacist if you are taking: any other antibiotics allopurinol or probenecid for conditions such as gout oral contraceptives (the pill). You will need an additional method of contraception, such as condoms. Speak to your doctor or pharmacist about how long you need to take extra precautions for. Urine tests: Tell the doctor if you are having urine tests for glucose, as your medicine may affect the results. Pregnancy and breast-feeding Ampicillin will not harm your unborn baby. Small quantities of the medicine may be present in breast milk. Ask your doctor for advice before taking any medicine. Driving and using machines Ampicillin vials for injection is unlikely to affect your ability to operate machinery or to drive. Important information about some of the ingredients of Ampicillin vials for injection sodium Each vial of Ampicillin injection contains 33.7 mg of sodium. This should be taken into consideration by patients on a controlled sodium diet.
70/L/t/4
3. How to use
You will most likely receive Ampicillin injection from a doctor or nurse. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure. Your doctor or nurse will usually inject Ampicillin into your muscles or veins. Ampicillin injection can also be used in other ways depending on your condition. Doses Adults and children over 10 years: the usual dose is 500 mg four to six times a day. Children under 10 years: half the adult dose. In severe infections the above doses may be increased by your doctor. Patients with kidney problems: if your kidneys are not working very well, your doctor may change the dose. Your doctor will give you special instructions if you are on kidney dialysis. If you use more than you should Having too much Ampicillin is unlikely as the injection will be given to you by a doctor or nurse. However, if you are given too much Ampicillin, you may experience nausea, vomiting and diarrhoea. Ask your doctor or nurse if you have any concerns. If you forget to use If you think you have missed an injection, speak to your doctor or nurse. If you stop using Do not stop just because you feel better. If you stop too soon, the infection may come back. Keep having the injection until the prescribed course is finished. If you have any further questions on the use of this product, ask your doctor or pharmacist.
yellowing of your skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness unusual bleeding or bruising fever, sore throat, mouth ulcers, repeated infections or infections that will not go away feeling tired, breathless, and looking pale fever, rash, nausea, aches and pains, passing more or less urine than usual or passing urine at night. Some of these reactions may happen several weeks after finishing the treatment. The following side effects usually settle without changing the dose: upset stomach, nausea or diarrhoea. Blood tests: tell your doctor if you are having blood tests as your medicine can cause short-term changes in blood cell counts. If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What this medicine is and what it is used for
Ampicillin vials contain ampicillin which belongs to the penicillin group of antibiotics. Ampicillin works by killing bacteria that cause infections, such as: ear, nose and throat infections bronchitis, pneumonia, chest infections urinary tract infections sexually transmitted infections skin and soft tissue infections gastrointestinal infections blood poisoning.
5. How to store
Keep out of the reach and sight of children. Do not use after the expiry date which is stated on the vial label and on the carton. The expiry date refers to the last day of that month. Do not store above 25C. Store prepared solutions for injection in a refrigerator (2C - 8C) for up to 24 hours. Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
2. Before you use
Do NOT use Ampicillin vials for injection if you: are allergic to ampicillin, other antibiotics called beta-lactams (e.g. penicillin or cephalosporin) or any of the other ingredients (see Section 6). If this applies to you, speak to your doctor or pharmacist. Take special care with Ampicillin vials for injection Before treatment with the injection, tell your doctor if you: have ever had a skin rash or swelling of the face or neck when taking any antibiotic are already being treated with another antibiotic have glandular fever or low immune system leukaemia have kidney problems.
6. Further information
What Ampicillin vial for injection contains The active ingredient is ampicillin (500 mg) as ampicillin sodium. (See end of Section 2 for further information on sodium). There are no other ingredients. What Ampicillin vial for injection looks like and contents of the pack Ampicillin is a white powder which is made up into a solution before it is given to you. It is supplied to doctors in packs of 10 vials. Marketing Authorisation Holder Chemidex Pharma Ltd, trading as Essential Generics, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB. Manufacturer Laboratorio Reig Jofre, S.A. C/ Jarama 111, Polgono Industrial Toledo, 45007 Toledo (Spain) This leaflet was last revised in July 2012
4. Possible side effects
Like all medicines, Ampicillin can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them. Tell you doctor or nurse immediately if you have any of the following allergic reactions: difficulty breathing or swallowing, swelling of the face, lips, tongue or throat severe itching of the skin, with a red rash or raised lumps blistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin. Seek immediate medical attention if you have any of the following symptoms: severe stomach cramps, watery and severe diarrhoea which may be bloody, fever
Continued over page
70/L/t/4
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.
