None.
Cefuroxime is compatible with most commonly used intravenous fluids and electrolyte solutions.
The pH of 2.74% w/v sodium bicarbonate injection BP considerably affects the colour of solutions and therefore this solution is not recommended for the dilution of Cefuroxime. However, if required, for patients receiving sodium bicarbonate injection by infusion the Cefuroxime solution may be introduced into the tube of the giving set.
Cefuroxime should not be mixed in the syringe with aminoglycoside antibiotics.
Cefuroxime is compatible with most commonly used intravenous fluids and electrolyte solutions.
The pH of 2.74% w/v sodium bicarbonate injection BP considerably affects the colour of solutions and therefore this solution is not recommended for the dilution of Zamur. However, if required, for patients receiving sodium bicarbonate injection by infusion the Zamur may be introduced into the tube of the giving set.
Zamur should not be mixed in the syringe with aminoglycoside antibiotics.
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. No carcinogenicity studies have been performed; however, there is no evidence to suggest carcinogenic potential.
Gamma glutamyl transpeptidase activity in rat urine is inhibited by various cephalosporins, however the level of inhibition is less with cefuroxime. This may have significance in the interference in clinical laboratory tests in humans.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. No carcinogenicity studies have been performed; however, there is no evidence to suggest carcinogenic potential.
Gamma glutamyl transpeptidase activity in rat urine is inhibited by various cephalosporins, however the level of inhibition is less with cefuroxime. This may have significance in the interference in clinical laboratory tests in humans.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Intravitreal injection of 1 mg Zamur in albino rabbits resulted in levels of 19-35mg/l and 600-780mg/l after 30min following injection in the aqueous and in the vitreous, respectively. Levels after 6 h decreased to 1.9-7.3 and 190- 260mg/l respectively in these two structures. There was no increase in the intraocular pressure during the first 3 days. Histopathology showed no degenerative changes compared to saline.
ERG: a-, b- and c- waves diminished up until 14 days both in the control and antibiotic-injected eyes.
Recovery occurred and may be slower than in control. ERG showed no definite changes suggestive of retinal toxicity up to 55 days after intravitreal administration.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. No carcinogenicity studies have been performed; however, there is no evidence to suggest carcinogenic potential.
Gamma glutamyl transpeptidase activity in rat urine is inhibited by various cephalosporins; however, the level of inhibition is less with cefuroxime. This may have significance in the interference in clinical laboratory tests in humans.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Constitution/Administration instructions
The bottle should be shaken vigorously before the medication is taken.
The reconstituted suspension when refrigerated between 2 and 8°C can be kept for up to 10 days.
If desired, Zamur suspension from multidose bottles can be further diluted in cold fruit juices, or milk drinks and should be taken immediately.
Directions for reconstituting suspension in multidose bottles
1. Shake the bottle to loosen the content. All the granules should be free-flowing in the bottle. Remove the cap and the heat-seal membrane. If the latter is damaged or not present, the product should be returned to the pharmacist.
2. Add the total amount of cold water as stated on the label or up to the volume line on the cup provided (if supplied). If the water was previously boiled it must be allowed to cool to room temperature before adding. Do not mix Zamur granules for oral suspension with hot or warm liquids. Cold water must be used to prevent the suspension becoming too thick.
3. Replace the cap. Allow the bottle to stand to allow the water to fully soak through the granules; this should take about one minute.
4. Invert the bottle and shake well (for at least 15 seconds) until all the granules have mixed with the water.
5. Turn the bottle into an upright position and shake well for one minute until all the granules have blended with the water.
Store the Zamur suspension immediately at between 2 and 8°C (do not freeze) and let it rest for at least one hour before taking the first dose. The reconstituted suspension when refrigerated between 2 and 8°C can be kept for up to 10 days.
Always shake the bottle well before taking the medication.
Directions for reconstituting suspension from sachets: -
1. Empty granules from sachet into a glass.
2. Add a small volume of cold water.
3. Stir well and drink immediately.
The reconstituted suspension or granules should not be mixed with hot liquids.
Intramuscular injection: Add 6ml of water for injections to 1.5 g. Shake gently to produce a suspension.
Intravenous administration: Dissolve cefuroxime in water for injections using at least 15ml for 1.5g. For short intravenous infusion, 1.5g may be dissolved in 50ml of water for injections. Reconstituted solutions may be diluted with:
5% or 10% dextrose
5% dextrose containing 0.2%, 0.225%, 0.45% or 0.9% sodium chloride injection
5% dextrose containing 20mEq potassium chloride
0.9% sodium chloride injection
M/6 sodium lactate injection
Ringer's injection
Lactated Ringer's injection
Heparin (10 and 50 units/ml) in 0.9% sodium chloride injection
10 and 40 mEqL potassium chloride in 0.9% sodium chloride injection
These solutions may be given directly into a vein or introduced into the tubing of the giving set if the patient is receiving parenteral fluids.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
APROKAM must be administered by intracameral injection, by an ophthalmic surgeon in the recommended aseptic conditions of cataract surgery.
VIAL IS FOR SINGLE USE ONLY.
USE ONE VIAL FOR ONE PATIENT. Stick the flag label of the vial on the patient's file.
To prepare the product for intracameral administration, please adhere to the following instructions:
1. Withdraw flip-off cap
2. Before inserting a sterile needle, the outer part of the rubber stopper of the vial should be disinfected.
3. Push the needle vertically into the centre of the vial stopper, keeping the vial in an upright position. Then, inject into the vial 5ml of sodium chloride 9mg/ml (0.9%) solution for injection using aseptic technique.
4. Shake gently until the solution is free from visible particles.
5. Assemble a sterile needle (18G x 1½â€, 1.2mm x 40mm) with 5-micron filter (acrylic copolymer membrane on a non-woven nylon) onto a 1ml sterile syringe. Push this syringe vertically into the centre of the vial stopper, keeping the vial in an upright position.
6. Aseptically aspire at least 0.1ml of the solution.
7. Disconnect the 5-micron filter needle from the syringe and assemble the syringe with an appropriate anterior chamber cannula.
8. Carefully expel the air from the syringe and adjust the dose to the 0.1ml mark on the syringe. The syringe is ready for injection.
The reconstituted solution should be visually inspected and should only be used if it is a colourless to yellowish solution free from visible particles. It has a pH and osmolality close to the physiological values (pH about 7.3 and osmolality about 335mosmol/kg).
After use, discard the remaining of the reconstituted solution. Do not keep it for subsequent use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Instructions for constitution
Table 4. Additional volumes and concentrations which may be useful when fractional doses are required.
| Additional volumes and concentrations, which may be useful when fractional doses are required | ||||
| Vial size | Routes of administration | Physical State | Amount of water to be added (mL) | Approximate cefuroxime concentration (mg/mL)** |
| 250 mg powder for solution for injection | ||||
| 250 mg | intramuscular intravenous bolus Intravenous infusion | suspension solution solution | 1 mL at least 2 mL at least 2 mL* | 216 116 116 |
| 750 mg powder for solution for injection or infusion | ||||
| 750 mg | intramuscular intravenous bolus intravenous infusion | suspension solution solution | 3 mL at least 6 mL at least 6 mL | 216 116 116 |
| 1.5 g powder for solution for injection or infusion | ||||
| 1.5 g | intramuscular intravenous bolus intravenous infusion | suspension solution solution | 6 mL at least 15 mL 15 mL* | 216 94 94 |
* Reconstituted solution to be added to 50 or 100 mL of compatible infusion fluid (see information on compatibility, below)
** The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/mL.
Zamur 750 mg and 1.5 g powder for solution for infusion (Monovial presentation)
Preparation of solution for intravenous infusion
The contents of the Monovial are added to small volume infusion bags containing 0.9% w/v Sodium Chloride Injection BP, or 5% Dextrose Injection, or another compatible fluid.
1. Peel off the removable top part of the label and remove the cap.
2. Insert the needle of the Monovial into the additive port of the infusion bag.
3. To activate, push the plastic needle holder of the Monovial down onto the vial shoulder until a "click" is heard.
4. Holding it upright, fill the vial to approximately two-thirds capacity by squeezing the bag several times.
5. Shake the vial to reconstitute the cefuroxime sodium.
6. With the vial uppermost, transfer the reconstituted cefuroxime sodium into the infusion bag by squeezing and releasing the bag.
7. Repeat steps 4 to 6 to rinse the inside of the vial. Dispose of the empty Monovial safely. Check that the powder has dissolved, and that the bag has no leaks.
Compatibility
1.5 g cefuroxime sodium constituted with 15 mL Water for Injection may be added to metronidazole injection (500 mg/100 mL) and both retain their activity for up to 24 hours below 25°C.
1.5 g cefuroxime sodium is compatible with azlocillin 1 g (in 15 mL) or 5 g (in 50 mL) for up to 24 hours at 4°C or 6 hours below 25°C.
Cefuroxime sodium (5 mg/mL) in 5% w/v or 10% w/v xylitol injection may be stored for up to 24 hours at 25°C.
Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.
Cefuroxime sodium is compatible with the following infusion fluids. It will retain potency for up to 24 hours at room temperature in:
0.9% w/v Sodium Chloride Injection BP
5% Dextrose Injection BP
0.18% w/v Sodium Chloride plus 4% Dextrose Injection BP
5% Dextrose and 0.9% w/v Sodium Chloride Injection BP
5% Dextrose and 0.45% Sodium Chloride Injection
5% Dextrose and 0.225% Sodium Chloride Injection
10% Dextrose Injection
10% Invert Sugar in Water for Injection
Ringer's Injection USP
Lactated Ringer's Injection USP
M/6 Sodium Lactate Injection
Compound Sodium Lactate Injection BP (Hartmann's Solution).
The stability of cefuroxime sodium in 0.9% w/v Sodium Chloride Injection BP and in 5% Dextrose Injection is not affected by the presence of hydrocortisone sodium phosphate.
Cefuroxime sodium has also been found compatible for 24 hours at room temperature when admixed in IV infusion with:
Heparin (10 and 50 units/mL) in 0.9% w/v Sodium Chloride Injection BP; Potassium Chloride (10 and 40 mEqL) in 0.9% w/v Sodium Chloride Injection BP.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
