Haflone Ceftriaxone Sodium Injection


(Ceftriaxone for Injection 1g)



Each vial contains Ceftriaxone sodium (Sterile) equivalent to ceftriaxone 1 g



Broad and medium spectrum antibiotics



Ceftriaxone is a broad-spectrum cephalosporin with a long plasma elimination half-life of approximately 8 hours in normal adults.


Antimicrobial Profile

(In Vitro sensitivity does not necessarily imply in vivo efficacy).

The in vitro spectrum of activity of ceftriaxone encompasses:


Gram-positive organisms

Streptococcus pneumoniae, Streptococcus Group A (including Streptococcus pyogenes), Streptococcus Group B (including Streptococcus agalactiae), Streptococcus viridans, Streptococcus bovis (Group D), Staphylococcus aureus (methicillin sensitive). Peptostreptococcus sp., and Clostridium sp.

Note: Methicillin-resistant Staphylococcus spp. are resistant to ceftriaxone. Enterococcus faecalis, Enterococcus faecium and Listeria monocytogenes are resistant.


Gram-negative organism

Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Nisseria meningitidis, Neissera gonorrhoeae (including penicillin-resistant strains), Escherichia coli, Klebsiella sp.**, Enterobacter sp.*, Serratia marcescens, Citrobacter sp., Proteus mirabilis, Indole-positive Proteus (including Morganella morganii), Salmonella sp., Shigella sp., Yersinia pestis and Treponema pallidum (in animal experiments).

*Some isolates of these species are resistant to ceftriaxone, due to the production of the chromosomally encoded beta-lactamases.

**Some isolates of these species are resistant due to production of extended spectrum plasmid mediated beta-lactamase.



Organisms which are only partially sensitive to ceftriaxone in vitro. Staphylococcus epidemidis, Pseudomonas aeruginosa, Acinetobacter sp. and Bacteroides sp. Ceftriaxone is stable in relation to the majority of beta-lactamases.

The following organisms are resistant: Ureaplasma urealyticum, Mycoplasma sp., Mycobaterium sp., Fungi.

It is essential to note that recommended media (free from inhibitory substances especially thymidine and thymine) and methods must be used for satisfactory sensitivity testing.



The maximum plasma concentration after a single IM dose of 1.0 g is about 81 mg/L and is reached in 2-3 hours after the dose. The area under the plasma concentration-time curve after IM administration is equivalent to that after IV administration of an equivalent dose, indicating 100% bioavailability of intramuscularly administered ceftriaxone.

On intravenous administration, ceftriaxone diffuses into the tissue fluid, where-if it is given in the recommended dosage range-bactericidal concentrations lasting 24 hours may be maintained. Ceftriaxone is reversibly bound to albumin, and the binding decreases with the increase in concentration e.g. from 95% binding at plasma concentrations of <100 mg/L to 85% binding at 300 mg/L. Owing to the lower albumin content, the proportion of free ceftriaxone in interstitial fluid is correspondingly higher than in plasma.

The volume of distribution of ceftriaxone is 7-12 L. After a dose of 1-2 g, concentrations above the minimal inhibitory concentrations of most pathogens responsible for infection are detected for more than 24 hours in the following tissues or body  fluids: lung, heart, biliary tract/liver, tonsil, middle ear and nasal mucosa, bone:, and cerebral, pleural, prostatic and synovial fluids.

In healthy, young adult volunteers the total plasma clearance is 10-22 mL/min, The renal clearance is 5-12 mL/min. 50-60% of ceftriaxone is excreted unchanged in the urine, while 40-50% is excreted unchanged in the bile. The elimination half-life in adults is about eight hours. The substance is largely inactivated in the faeces due to metabolism by intestinal flora.

The mean plasma elimination half-life is 8 hours in healthy, young adult volunteers. In neonates, urinary recovery accounts for about 70% of the dose. In infants aged less than eight days and in elderly persons aged over 75 years, the average elimination half-life is usually 2-3 times that in the young adult group.

In patients with renal or hepatic dysfunction, the pharmacokinetics of ceftriaxone is only minimally altered and the elimination half-life is only slightly increased. If kidney function alone is impaired, biliary elimination of ceftriaxone is increased; if liver function alone is impaired, renal elimination is increased.

In meningitis patients, administration of 50 mg per kg body mass leads within 2-24 hours to cerebro spinal fluid concentrations several times as high as the minimum in vitro inhibitory concentrations required for the most common causative organisms of meningitis.



Infections caused by pathogens sensitive to ceftriaxone such as sepsis, meningitis in neonates and infants, perioperative prophylaxis of infections, renal and urinary tract infections, respiratory tract infections, particularly pneumonia, and ear, nose and throat infections, infections of the bones, joints, soft tissue, skin and of wounds, abdominal infections (peritonitis, infections of the biliary tract), and uncomplicated gonorrhea.



Standard Dosage

Adults and children over 12 years 1-2 g ceftriaxone once daily (every 24 hours).
In severe infections and in cases in which the pathogens are only moderately sensitive to ceftriaxone, the daily dosage may be increased to 4 g administered daily.

Infants and young children may receive from 20-80 mg per kg body-mass daily; depending on the severity of the infection, usually 12-24 hourly.

In cases of premature babies, the daily dosage should not exceed 50 mg per kg body mass on account of the immaturity of the infant’s enzyme systems.


Elderly patients

The dosages recommended for adults require no modification in the case of geriatric patients.


Duration of therapy

The duration of therapy varies according to the course of the disease. Administration of ceftriaxone should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.


Special dosage instructions

Meningitis: In bacterial meningitis in neonates and children, treatment begins with doses of 100 mg per kg (not to exceed 4 g) once daily. As soon as the causative organism has been identified and its sensitivity determined, the dosage can be reduced accordingly.

Gonorrhoea: For the treatment of gonorrhoea (penicillinase-producing and non-penicillinase- producing strains), a single IM dose of 250 mg ceftriaxone is recommended.

Perioperative prophylaxis: A single dose of 1-2 g ceftriaxone administered 30-90 minutes prior to surgery. In colorectal surgery, concurrent (but separate) administration of ceftriaxone with a 5-nitroimidazole, e.g. Omidazole has proven effective.


Impaired renal and hepatic function

In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided that the hepatic function is intact.

In case of severe renal failure (creatinine clearance <10 mL/min) the ceftriaxone dosage should not exceed 2 g daily. In patients with liver damage, there is no need for the dosage to be reduced provided renal function is intact.

In cases of concomitant severe renal and hepatic dysfunction, the plasma concentrations of ceftriaxone should be determined at regular intervals.

In patients undergoing dialysis no additional supplementary dosing is required following the dialysis. Serum concentrations should be monitored however, to determine whether dosage adjustments are necessary, since the elimination rate in these patients may be reduced.


Intramuscular Injection

Add 3.5 mL of 1% Lidocaine solution to 1 vial HAFLONE. Lidocaine 1% reduces pain at the site of injection. HAFLONE must be injected well within the body of a relatively large muscle. It is recommended that not more than 1 g be injected on either side.

Reconstitution with 1% Lidocaine (without adrenaline) has no effect on the absorption or the elimination of Ceftriaxone. The Lidocaine solution must never be administered intravenously.


Intravenous Injection

1 g dissolved in 10 mL water for injection. The intravenous administration should be given over two to four minutes.


Intravenous injection

The infusion should be given over a period of at least 30 minutes. For IV infusion, 2 g of HAFLONE is dissolved in approximately 40 ml of sterile water for injection. Ceftriaxone solutions should not be mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, owing to possible incompatibility.



Ceftriaxone should not be added to solutions containing calcium such as Hartmann’s solution and Ringers solution.

Ceftriaxone is incompatible with amsacrine, vancomycin and fluconazole and aminoglycosides.




Gastro-Intestinal complaints: Loose stool/diarrhoea, nausea, vomiting, stomatitis, glossitis.

Haematological changes: Eosinophilia, haematoma or bleeding, thrombocytopenia, neutropenia, leukopenia, granulocytopenia and haemolytic anaemia.

Isolated cases of agranulocytosis (<500/mm3) have been reported, most of them following total doses of 20 g or more.

Exanthema, allergic dermatitis, pruritus, urticaria, oedema, erythema muItiforme may occur.

Other side effects include headaches and dizziness, increase in liver enzymes, oliguria, increase in serum creatinine, mycosis of the genital tract, fever, shivering and anaphylactic or anaphylactic reactions.

Nephrotoxicity has been reported. Acute interstitial nephritis is also a possibility as a manifestation of hypersensitivity.

Anaphylactic shock may occur: Anaphylactic shock requires immediate counter measures.

Acute renal tubular necrosis has followed excessive dosage and has also been associated with the use of HAFLONE in older patients or those with pre-existing renal impairment or with the concomitant administration of nephrotoxic agents such as aminoglycosides.

Hepatitis and cholestatic jaundice have occurred less frequently.

Prolonged use may result in overgrowth of non-susceptible organism.

Pseudomembranous colitis has been reported with HAFLONE. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of HAFLONE. Super infections with non-susceptible micro-organimis may occur.

Local: Inflammatory reactions in the vein wall may occur after IV administration. These may be mimmised by slow (2-4 minutes) injection of HAFLONE.

Intramuscular injection without Lidocaine solution is painful.

Shadows which have been mistaken for gall stones have been detected by sonograms of the gallbladder, usually following higher than the standard recommended dose.

These shadows are, however, precipitates of calcium ceftriaxone which disappear on completion or discontinuation of ceftriaxone therapy. In less frequent cases these findings have been associated with symptoms. In symptomatic cases, conservative non-surgical management is recommended. Discontinuation of HAFLONE treatment in symptomatic cases should be at the discretion of the clinician.

Studies have shown that HAFLONE can displace bilirubin from serum albumin. Caution should be exercised when considering HAFLONE treatment in hyperbilirubinemic neonates. HAFLONE should not be used in neonates (especially the premature) at risk of developing bilirubin encephalopathy.

During prolonged treatment the blood profile should be checked at regular intervals.
Renal and haematological status should be monitored especially during prolonged and high dose therapy.



No impairment of renal function has been observed after concurrent administration of large doses of HAFLONE and potent diuretics (e.g. furosemide). There is no evidence that HAFLONE increases renal toxicity of aminoglycosides. No effect similar to that of disulfiram has been demonstrated after administration of alcohol with HAFLONE.
HAFLONE does not contain an N-methyl-thiotetrazole moiety associated with possible ethanol intolerance and bleeding problems. The elimination of HAFLONE is not altered by probenecid.

In an in vitro study antagonistic effects have been observed with the combination of chloramphenicol and HAFLONE.

There may be antagonism between HAFLONE and bacteriostatic antibacterial agents. HAFLONE may interfere with the Jaffe method of measuring creatinine concentrations and may produce falsely high values; this should be borne in mind when measuring renal function. In patients treated with ceftriaxone the Coombs’ test may become false positive. HAFLONE may result in false positive tests for galactosemia. Likewise, no enzymatic method for the glucose determination in urine may give false positive results. For this reason urine glucose determination during therapy with HAFLONE should be done enzymatically.



Allergy to cephalosporins. In patients hypersensitive to penicillin, the possibility of allergic cross reactions should be borne in mind, (see warnings).



Safety in human pregnancy has not been established. As ceftriaxone is excreted in the breast milk at low concentrations, caution is advised in nursing mothers.



Before therapy with HAFLONE is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other medicines. About 10% of penicillin-sensitive patients may also be allergic to cephalosporins although the true incidence is uncertain. Great care should be taken if HAFLONE is to be given to such patients.



In the case of overdosage, plasma concentration would not be reduced by haemodialysis or peritoneal dialysis. Treatment is supportive and symptomatic.
On constitution a pale yellow to reddish orange clear solution is obtained.



1 clear glass vial Sterile Ceftriaxone powder with 5ml glass ampoule Lidocaine 1% and 10mI glass ampoule water for injection per pack.



Store below 25°C, protected from light and moisture. Do not freeze.



3 Years. Reconstituted solution must be stored in original vials.





No 98, Hainan Road, Economic & Technology Development Zone,

Shijiazhuang, China.


Marketed and Distributed by


Ciprozera Ciprofloxacin Hydrochloride Tablets


Ciprofloxacin tablets U .S. P. 500 mg



Each film coated tablet contains

Ciprofloxacin Hydrochloride U.S.P

Equivalent to Ciprofloxacin 500mg

Cipocil is a fluroquinolone anti-microbial agent with potent activity against a broad spectrum of gram positive and gram negative bacteria including P. aeruginosa, Enterobacteriaceaa and S. areus.



Ciprozera kills bacteria rapidly. At a concentration 1 to 2 folds higher than its MIC, Ciprozera eliminates bacteria in just 19 minutes.

The rapid bactericidal action of Ciprozera is attributed to its unique mode of action Ciprozera like other fluroquinolones, blocks DNA gyrase and disrupts the DNA functions leading to death of bacteria. In addition Ciprozera damages bacterial cell wall membrane leading to extrusion of cell contents. Ciprozera is effective against both replicating strains and bacteria in stationary phase. It is also effective against intracellular bacteria.

It has significant post- antibiotic effect up to 6 hours and thus preventing regrowth of bacteria.

Ciprozera does not disturb the normal intestinal or vaginal flora and has no significant effect against anaerobes.

Bacterial resistance with Ciprozera is extremely rare . There is no plasmid mediated resistance and it does not show any cross resistance with other antibiotics or antibacterial agents except fluoroquinoIones.

Ciprozera is active against a wide range of gram positive and gram negative pathogens including strains resistant to penicillins, cephalosporins and/or aminoglycosides. Ciprozera spectrum includes the following:

Enterobacteriaceae Enteropathogens
E. coli

Klebsiella species

Proteus species

Indole (+) or (-)

Enterobacter species

Morganella morganii

Providencia species

Citrobacter species

Serratia species

Enteropathogenic E. coli

Salmonella species

Shigella species

Y. enterocolitic

A. hydrophilia

Arizona species

V. cholera

V. parahaemolyticus

Campylobacter jejuni


Pseudomonadaceae Miscellaneous
Ps. Aeruginosa

Ps. cepacia

N. gonorrhoeae

N. meningitidis

H. influenzae

Acinetobacter anitratus

Branhamella catarrhatis

Gardnerella vaginalis




Aerobic Gram positive bacteria

Staph aureus including penicillinase producing and methicillin resistant strains.

Staph. epidermidis, Strep. pneumoniae

Strep. pyrogenes Sterp. viridans

Strep. agalactiae, Listeria monocytogenes


Intra-cellular Bacteria Resistant Strains

Chlamydia trachomatis Anaerobes including

Mycoplasma hominis most species of Bacteroides

Legionella species Clostridium and Fusobacterium

Brucella species Actinomyces


The absolute bioavailability of Ciprozera tablets is between 60-85% with no substantial loss by first pass metabolism. Half life is about 3-4 hours. About 40- 50% of an oral dose is recovered unchanged in urine.

Approximately 20-35 % of an oral dose is recovered from faeces within 5 days after dosing. Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Serum concentrations increase proportionately with the dose as shown:




Ciprozera is indicated for the treatment of a wide variety of infections caused by susceptible gram-positive and gram-negative organisms including mixed infections caused by two or more organisms. It may also be used for infections caused by multi-drug resistant bacteria.

The potent broad- spectrum antibacterial activity of Ciprozera (including activity against Pseudomonas) combined with its excellent tissue penetration enables Ciprozera to be used alone effectively pending sensitivity results. However, to provide an effective coverage against anaerobes, it may be combined with metronidazole where presence of anaerobes is suspected.

Ciprozera is indicated for the treatment of the following infections caused by susceptible bacteria.


Respiratory Tract Infections e.g. Pneumonia, bronchopneumonia, infected pleurisy, empyema, lung abscess, infected bronchiectasis, acute excerbation of chronic bronchitis and lung infections in patients with cystic fibrosis.

Urinary Tract Infections e.g. acute and chronic pyelonephritis, prostatitis, cystitis , epididymitis and chronic, complicated or recurrent UTI.

E.N.T. Infections e.g. Otitis media, sinusitis, mastoditis.

Gonorrhoea including urethra, rectal and pharyngeal gonococcal infections, even those caused by resistant gonococci.

Skin and Soft Tissue Infections e.g. infected ulcers, wound infections, abcesses, cellulitis, otitis oedema, infected burns.

Gastro-intestinal Tract Infections e.g. enteric fever, bacterial diarrheas.

Intra-Abdominal Infections e.g. peritonitis, intra abdominal abcess, cholangitis, cholecystitis, ampyema of gall bladder.

Gynaecological Infections e.g. Salpingitis, endometritis, pelvic inflammatory disease.

Bone and Joint Infections e.g. Acute and chronic Osteomyelitis, Septic arthritis.

Severe Systemic Infections e.g. Septicema, bacteremia and infections in immunocompromised patients.



Ciprozera is contraindicated in individuals with a history of hypersensitivity to Ciprofloxacin or any quinolone derivative.

Ciprozera has been shown to cause arthropathy in weight bearing joint of immature animals. Though the relevance of this to man is unknown, its use in children and adolescents is not recommended.



As Ciprozera may cause CNS stimulation, it should be used with caution in patients with CNS disorders such as severe cerebra, arteriosclerosis or epilepsy.

Patients receiving this drug should be well hydrated to prevent crystalluria.

Excessive alkalinisation of urine should be avoided.

The dosage should be reduced in patients with renal impairment. Reproduction studies in animals at doses up to 6 times the usual daily human dose not revealed any evidence of impaired fertility or teratogenicity due to Ciprozera.

However, information from well controlled studies in pregnant women is not available.

Since Ciprozera causes arthropathy in immature animals, it should not be used in pregnant and nursing women.


Side Effects

Ciprozera is generally well tolerated. During clinical trials in a large number of patients adverse effects related to drug occurred infrequently and were commonly reported as diarrhea, vomiting, abdominal pain, headache, restlessness and rash.

Other side effects which have been reported very rarely include local irritation at the site of injection, thrombophlebitis, convulsions, arthralgia and increase in serum transminase levels.



Xanthine Derivatives

When Xanthine derivatives like theophylline were coadministered with Ciprozera, the plasma concentrations of theophylline were raised to toxic range. The total body clearance of theophylline was also decreased. When concurrent administration of theophylline with Ciprozera is considered necessary, the patient must be monitored for signs of theophylline toxicity and suitable dose reduction of theophylline may be considered.


As Probenecid delays the excretion of Ciprozera, it may elevate and prolong the concentrations of the drug in the serum, this should be kept in mind when both drugs are given simultaneously.


Antacids like aluminium hydroxide and magnesium reduce the bioavilability of Ciprozera. Ciprozera should not, therefore, be administered simultaneously with aluminium and magnesium antacids.


Dosage and Administration

Ciprozera is generally administered in oral doses of 250 mg or 500 mg twice daily for 5-7 days in most cases.

Urinary Tract



Respiratory Tract, Bone and Joint, Skin and Skin Structures



Infections Diarrhea











In gonorrhea 250 mg or 500 mg is given as single dose.

The dose may be taken with or without meals, the preferred time is 2 hours after meal.



Ciprozera is usually not recommended for use in children. However if the benefits of Ciprozera therapy are considered to outweigh the potential risk, the dosage should be 5-10 mg/kg/day in 2 divided doses, depending on severity of infection.



Store in cool and dry place. Protect from light.

Keep all medicines away from children.



Blister of 10 tablets.

2 Alu packs of 7 tablets.


Manufactured by

Greenfield Pharmaceutical (Jiang Su) Ltd.

No. 38, Tai Jiu Road, Tai Zhou, Jiang Su Province,

P.R. China.


Marketed by

Kuka Consumer Healthcare Ltd.

7, Sawyer Crescent, Phase 1,

Gbagada Estate, Lagos.

Kriscet Cimetidine USP Caplets



Please read right through this leaflet before you start using this medicine.

Kriscet-400 caplets (Cimetidine USP 400mg caplets) belong to a group of medicines called H2-receptor antagonists which act to decrease the natural production of acid in the stomach.



Ulcers in the stomach or duodenum which may be caused by non-steroidal anti-inflammatory drugs (NSAIDs OFTEN USED TO REDUCE PAIN, FEVER AND INFLAMATION).

Acid from the stomach escaping into the fluid pipe causing pain, inflamation and heartburn (easophageal reflux disease).

Excess acid in the stomach caused by a tumor in the pancreas (Zolinger- Elison syndrome).

Various conditions where reduction of gastric by cimetidine has been shown to be beneficial e.g.

• Indigestion symptoms (e.g. stomach pain or discomfort, heartburn)

• Meal-related upper abdominal pain,

• To prevent stress ulcers from bleeding,

• To be given before general anaesthesia to prevent damage to the lungs caused by breathing in stomach fluids (acids aspiration),

• To improve absorption of food and reduce fluid loss in short bowel syndrome,

• Reduction of breakdown of pancreatic enzyme supplements.



Consult your doctor before taking Kriscet-400:

• If you suffer or have suffered in the past from kidney or liver disease.

• If you have a history of peptic ulcer; particularly if you are taking a non-steroidal anti-Inflammatory drug (NSAID) e.g. Asprin, Ibuprofen, Naproxen, Diclofenac.

• If you are taking drugs or you have an illness that could cause a fall in blood cell count.

• If you are middle aged or over; with new or recently changed indigestion symptoms (e.g. stomach pain or discomfort, heartburn), other causes of your symptoms such as stomach cancer, should be excluded.



Ask your doctor for advice before taking Kriscet-400 if you are pregnant or trying to become pregnant or if you are breastfeeding.


Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines even those not prescribed

• Anticoagulants (to thin your blood) e.g. warfarin.

• Anticonvulsants (to prevent fits) e.g. phenytoxin.

• Bronchodilators (for breathing difficulties) e.g. theophylline.

• Anti-arrhythmics (to slow heart rate) e.g. indocaine.

• Immunodepressants (to prevent transplant rejection) e.g. cyclosporine.



The usual dosage is 400mg to 160mg per day, in divided doses. Do not take more that 2400mg per day. If you suffer from kidney or liver problems, you may require a lower dose. The usual duration of treatment is 4-8 weeks. The tablets should be taken with meals and at bedtime and swallowed whole with a glass of water. Unless specifically directed by your physician. In the event of an accidental overdose, contact your nearest hospital’s casualty department or tell your doctor immediately. Take your tablet pack with you.



Like all medicines, kriscet-400 cause side effects, although not everybody gets them.

Allergic reactions may occur rarely, with symptoms such as rash, itching, swelling of the face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy particularly when standing up. If any of these occur STOP taking the medicine and contact a doctor immediately.

Side effects that have been reported: diarrhea, skin rash, tiredness, breast enlargement in men, hair loss and confusion.

Hallucination, liver disorders (characterized mainly by sore throat, ulcers in the mouth and throat, unusual tiredness or weakness, unusual bleeding, unexplained bruises).

Many of the above mentioned side effects should disappear when treatment is stopped.

Tell your doctor if you have any other unwanted side effect not mentioned above.



Do not store above 25oC. Keep out of reach and sight of children.








Manufactured by


9 Kilometer, Old Lagos Road,

Podo Ibadan, Nigeria.