Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Negaban 1 g, powder for solution for injection/infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Temocillin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Negaban is an antibiotic that contains the active substance temocillin. It belongs to a group of antibiotics called penicillins (beta-lactam family).. It works by killing some types of bacteria that may cause infections. Negaban is used to treat the following infections:
- bacterial infections of the chest and lungs,
- bacterial infections of the kidneys and bladder,
- other types of infections when there are bacteria in the bloodstream.
2.
What you need to know before you take it
e Negaban
Do not use Negaban
- if you are allergic to temocillin.
- if you ever had an allergic reaction to other antibiotics of the beta-lactam family such as penicillins, cephalosporins, carbapenems or monobactams. If you are not sure, you should talk to your doctor, pharmacist or nurse before you receive Negaban. This is especially important if you have ever had an allergic reaction to any antibiotic but you are not sure what type of antibiotic it was. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Negaban.
- if you have been told that your kidneys do not work normally.
- if you have been told that your potassium levels are low. If any of the above applies to you, your doctor may still decide to give you Negaban but may choose a lower dose than is usually given. This medicine contains approximately 5 mmol (115 mg) of sodium per each vial which should be taken into consideration by patients on a controlled sodium diet. Other medicines and Negaban You should continue to take all other medicines that you may be taking on a regular basis on the advice of your doctor while you are receiving Negaban.
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Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Negaban with food and drink Food and drink does not affect your treatment with Negaban. 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 or pharmacist for advice before taking any medicine.
- You should tell your doctor or nurse if you are pregnant or think you may be pregnant before you receive Negaban because it should not usually be given to pregnant women.
- You should tell your doctor or nurse if you are breastfeeding before you receive Negaban. Small quantities of this medicine appear in breast milk and can be passed on to your baby. Your doctor may decide that you should not have Negaban or may advise you to have Negaban but stop breast-feeding while you are being treated. Driving and using machines Negaban should not interfere with your ability to drive or operate machinery. Negaban does not contain any excipient.
3.
How to take it
Negaban
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Recommended dose Your doctor will decide how much of this medicine you need each day and how often the injections should be given. The usual doses used are: Adults of all ages The usual dose for adults is 4 g per day. You will receive this dose in two administrations per day or as continuous infusion. In case of severe infections, a higher dose is recommended (6 g per day). You will receive this higher dose in three administrations per day or as continuous infusion. Before start of the continuous infusion you will receive an additional dose of 2 g. Adults with kidneys that do not work normally People whose kidneys do not work normally may need a lower daily dose of Negaban. The dose may be reduced to no more than 1 gram per day or even 1 gram every other day. Because some temocillin is removed from the body during haemodialysis treatments for very poor kidneys, a dose of Negaban is usually given after completing a haemodialysis session. Your doctor will tell you how much you should have if your kidneys do not work normally. Use in children Insufficient data are available to recommend an appropriate dosage regime. Your doctor will decide how long your treatment with Negaban will last. Method of administration Negaban will first be dissolved by your doctor, nurse or pharmacist. This solution will then be given to you either by injection into a vein or by injection into a muscle. When Negaban is injected into a vein:
- It may be given in 3-4 minutes, be put into an infusion (drip) and given over about 30 minutes or more, or by continuous infusion using an electrical syringe.
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Your doctor or nurse will make sure that Negaban is not given into a drip that also contains blood or blood products, other fluids that contain proteins or fats, or antibiotics called aminoglycosides.
When Negaban is injected into a muscle:
- It may be dissolved in a weak solution of lidocaine so as to lessen the local pain that is sometimes felt when it is given in this way.
- If your doctor decides to give Negaban with lidocaine,
- he/she will check with you that you are not allergic to lidocaine or to any similar local anaesthetics,
- and your doctor or nurse will ensure that the injection is not accidentally given into a blood vessel. If you use more Negaban than you should Since Negaban is given by a doctor or nurse, it is very unlikely that you will receive too much temocillin. If you think that you may have been given too much, or an extra dose, tell your doctor or nurse. If you forget to use Negaban If you think that an injection has been missed, speak to your nurse, doctor or pharmacist. If you stop using Negaban Not applicable. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions such as a rash, itching, breathing problems, swelling of the tongue, lips, face and neck can occur occasionally. Some of these reactions can be very severe, can occur very soon after having a dose of Negaban or up to 48 hours later, and can happen after the first dose. In these cases, discontinuance of treatment and urgent medical treatment is needed: contact your doctor or nurse immediately. Other side effects that have been reported with Negaban treatment include diarrhoea (several loose bowel movements a day) and pain in the muscles or in the joints at the injection site, inflammation of a vein with or without formation of a clot. In case of persistent diarrhoea, treatment must be discontinued immediately. Bleeding manifestations and disorders of the nerves with muscular contractions have been reported in patients suffering from severe malfunction of the kidneys. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme on the website www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
Negaban
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Since Negaban is usually given in hospitals, your doctor, nurse or pharmacist will take care that unopened vials are stored in a refrigerator (2°C – 8°C) in the original package and will check that they are not used after the expiry date.
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They will also ensure that the powder is made into a solution immediately before it is given to you. Solutions prepared with certain diluents are stable for 24 hours at 25°C. 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.
6.
Contents of the pack and other information
What Negaban contains The active substance is temocillin. There are no other ingredients. What Negaban looks like and contents of the pack Each vial of Negaban 1 g powder for solution for injection/infusion contains 1 gram of the active ingredient temocillin. Negaban 1 g powder for solution for injection/infusion is supplied in packs that contain 1 vial. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Eumedica S.A. Winston Churchill Avenue 67 BE-1180 Brussels Belgium Manufacturer Eumedica S.A. Chemin de Nauwelette 1 BE-7170 Manage Belgium
This leaflet was last approved in 06/2018.
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The following information is intended for healthcare professionals only: For single-use only. Negaban is not intended for multi-dose use, any part-used antibiotic solution should be discarded. Solutions are normally a pale yellow colour. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Special precautions for disposal and other handling The solutions should preferably be used immediately after their preparation. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C for the following solvents: water for injection, physiological saline (0.9% sodium chloride), dextrose 5%, sodium chloride compound (Ringer's solution), Hartmann solution (sodium lactate compound + Ringer's lactate solution). From a microbiological point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and should normally not be longer than 24 hours at 2-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions. Intravenous administration Intravenous injection Dose Suitable solvents 1g
Water for injection Physiological saline
Recommended volume of solvent to be added for dissolution Dissolve in 10 mL of one suitable solvent.
Final volume 10.7 ml
Inject I.V. solutions in 3-4 minutes, within one hour following their preparation. Intermittent intravenous infusion Solutions should be prepared as described for intravenous injection and then added to an intravenous infusion solution in a mini-bag or in-line burette and administered over a period of 30-40 minutes. Alternatively, using a suitable reconstitution device, the appropriate volume of intravenous fluid may be transferred from the infusion bag into the vial and then drawn back into the bag after dissolution. Dose
Suitable solvents
1g
Water for injection Physiological saline (0.9% sodium chloride) Dextrose 5% Sodium chloride compound (Ringer's solution) Hartmann (Sodium lactate compound – Ringer's lactate solution) Dextrose 10% Sodium lactate M/6 Sorbitol Dextran solutions
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Recommended volume of solvent to be added for dissolution Dissolve in 10 mL of one suitable solvent and shake it well until the contents of the vial have dissolved completely. The solution should be visually inspected prior to use. Only clear solutions practically free from particles should be used. Then dilute into a 50-, 100- or 150mL solution for infusion.
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Continuous intravenous infusion Solutions should be prepared as described and administered over 24 h at a rate of 2 mL/hour. A loading dose of 2 g temocillin is required before starting the continuous infusion. Daily Suitable solvents dose 4g
6g
Water for injection Physiological saline (0.9% sodium chloride) Dextrose 5% Sodium chloride compound (Ringer's solution) Hartmann (Sodium lactate compound – Ringer's lactate solution)
Recommended volume of solvent to be added for dissolution Dissolve the contents of 4 or 6 vials of Negaban 1 g in 48 mL of one suitable solvent and shake it well until the contents have dissolved completely. The solution should be visually inspected prior to use. Only clear solutions practically free from particles should be used.
Intramuscular administration Intramuscular injection Dose
Suitable solvents
1g
Water for injection Physiological saline 0.5 or 1% lidocaine solution. Lidocaine solution should not be administered intravenously.
Recommended volume of solvent to be added for dissolution
Final volume
2 ml
2.7 ml
After addition of water to the vial, shake vigorously. Inject I.M. solutions immediately after preparation.
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Frequently asked questions about Negaban 1 g, powder for solution for injection/infusion
How do I take Negaban 1 g, powder for solution for injection/infusion?
Negaban 1 g, powder for solution for injection/infusion comes as injection containing 1g. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Negaban 1 g, powder for solution for injection/infusion?
The active substance in Negaban 1 g, powder for solution for injection/infusion is temocillin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Negaban 1 g, powder for solution for injection/infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Negaban 1 g, powder for solution for injection/infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: temocillin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Negaban is indicated for the treatment of septicaemia, urinary tract infection and lower respiratory tract infection where susceptible gram-negative bacilli are suspected or confirmed.
In mixed infections where gram-positive or anaerobic bacteria are also liable to be implicated, co-administration with other appropriate antibacterial agents should be considered.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2. Posology and method of administration
Posology
Patients with normal renal function
Adults (including the elderly):
Usual dose: 4 g per day to be divided into 2 administrations or as continuous infusion.
High dose notably in critically ill patients: 6 g per day to be divided into 3 administrations or as continuous infusion.
A loading dose of 2 g should be administered before starting the continuous infusion (see Method of administration).
Children: Insufficient data are available to recommend an appropriate dosage regimen.
Patients with renal insufficiency
Adults (including the elderly):
Temocillin is mainly excreted renally and unchanged. Excretion is reduced in renal impairment and half-life is increased according to the severity of renal failure. In moderate and severe renal failure, dose adjustments are necessary in accordance with the following regimen:
Creatinine clearance (ml/min)
Posology : Usual dose
Dosage per administration
Interval between administrations
More than 60
2 g
12 h
60 to 30
1 g
12 h
30 to 10
1 g
24 h
Less than 10
1 g or 500 mg
48 h or 24 h
In case of intermittent high-flux hemodialysis:
As a rule, the I.M. route should be avoided, considering the patient's treatment with heparin. I.V. injection of Negaban is recommended, using water for injection or physiological saline as solvent: 1 g (I.V. injection) per 24 h of inter-dialytic session, preferably at the end of the hemodialysis (1 g q24 h, 2 g q48 h, 3 g q72 h).
In case of continuous peritoneal dialysis in ambulatory patients:
1 g Negaban I.M. every 24 hours.
These data are based on studies where creatinine clearance was used to estimate the degree of renal impairment.
Patients with impaired liver function
Limited experience in patients with impaired hepatic function has not indicated a need for a reduction in dosage.
Method of administration
Negaban may be administered by intravenous injection, intermittent or continuous intravenous infusion, or intramuscular injection.
Intravenous solutions: Negaban solutions should be administered by slow injection into the vein (3-4 minutes) or as an intravenous infusion over a period of 30-40 minutes. Continuous intravenous infusion of temocillin might be considered when therapeutic objectives are difficult to reach with intermittent administrations. A loading dose of 2 g should be administered before starting the continuous infusion.
Intramuscular injection: Negaban may be given intramuscularly after reconstitution. If pain is experienced at the site of I.M. injection, a sterile solution of lidocaine hydrochloride 0.5-1% may be used in place of water for injection.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
The use of Negaban is contraindicated in patients with a history of allergic reactions to any of the penicillins or any other type of beta-lactam drug.
4.4. Special warnings and precautions for use
Serious and occasionally fatal anaphylactic reactions have been reported in patients receiving therapy with penicillins. If an allergic reaction occurs during therapy with Negaban, the drug must be discontinued.
Cross-allergy with cephalosporins is frequent (10 to 15%).
In patients with kidney failure, the posology must be adapted to the degree of insufficiency, as recommended in Section 4.2. Posology and Method of Administration.
Bleeding manifestations have occurred in some patients receiving beta-lactam antibiotics. These reactions have sometimes been assessed with abnormalities of coagulation tests and are more likely to occur in patients with renal failure.
If bleeding manifestations occur, the antibiotic should be discontinued and appropriate therapy instituted.
As with any antibiotic, temocillin may be associated with induced pseudomembranous colitis, although animal studies have never shown any induction of Clostridium difficile infection. In case of severe, persistent diarrhoea, caution is recommended, Negaban must be discontinued and suitable therapy be initiated (eg oral metronidazole or oral vancomycin). Preparations which inhibit peristalsis are contra-indicated.
As with other antibiotics, the possibility of emergence of resistant organisms which might cause superinfections should be kept in mind, particularly during prolonged treatment. Microbiological follow-up may be required to detect any important superinfection. If this occurs, appropriate measures should be taken.
As with other penicillins, patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously.
Periodic electrolyte determinations should be made in patients with low potassium reserves and the possibility of hypokalaemia should be kept in mind with patients who have potentially low potassium reserves and who are receiving cytotoxic therapy or diuretics. Modest elevations of indices of liver function may be observed.
Sodium content: approximately 5 mmol per vial.
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Fertility, pregnancy and lactation
Pregnancy
Animal studies with temocillin have shown no teratogenic effects. There is no experience of temocillin in human pregnancy. Therefore, its use in pregnancy cannot be recommended.
Breastfeeding
Trace quantities of penicillins can be detected in the milk of lactating mothers. Therefore, mothers should not breastfeed their infants while receiving temocillin.
Fertility
In animal studies, no effects on fertility have been observed with temocillin (see Section 5.3).
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Undesirable effects are typical of the injectable penicillins: they may include diarrhoea, pain at the site of I.M. injection, occasionally rash, either urticarial or erythematous.
Certain reactions such as fever, arthralgia or myalgia, sometimes develop more than 48 hours after the start of the treatment. In any case, discontinuance of treatment and recourse to another appropriate antibiotic therapy are essential.
In common with other ß-lactam antibiotics angioedema and anaphylaxis have been reported.
There is also a risk of phlebitis and thrombophlebitis with intravenous administration of ß-lactam antibiotics, although to a lesser extent in the case of Negaban.
In patients suffering from renal failure, neurological disorders with convulsions have been reported following the I.V. injection of high doses of penicillin.
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 via the Yellow Card Scheme on the website www.mhra.gov.uk/yellowcard.
4.9. Overdose
There have been no reported cases of overdosage. Dosages of up to 8 g daily have been administered to volunteers without untoward effects.
Negaban may be removed from the circulation by haemodialysis.
💬 Ask about this leaflet
Ask anything about Negaban 1 g, powder for solution for injection/infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.