1. Name Of The Medicinal Product

Kenalog Intra-articular / Intramuscular Injection

2. Qualitative And Quantitative Composition

Kenalog Intra-articular / Intramuscular Injection contains triamcinolone acetonide 40mg per ml of sterile suspension.

3. Pharmaceutical Form

Sterile aqueous suspension for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Intra-articular use: for alleviating the joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis, with an inflammatory component; also for bursitis, epicondylitis, and tenosynovitis.

Intramuscular use: Where sustained systemic corticosteroid treatment is required: Allergic states, e.g. bronchial asthma, seasonal or perennial allergic rhinitis. In seasonal allergies, patients who do not respond to conventional therapy may achieve a remission of symptoms over the entire period with a single intramuscular injection (see Dosage); Endocrine disorders, e.g. primary or secondary adrenocortical insufficiency. Collagen disorders, e.g. during an exacerbation of maintenance therapy of selected cases of SLE or acute rheumatic carditis; Dermatological diseases, e.g. pemphigus, severe dermatitis and Stevens Johnson Syndrome; Rheumatic, Gastrointestinal or Respiratory disorders - as an adjunctive, short-term therapy; Haematological disorders, e.g. acquired (autoimmune) haemolytic anaemia; Neoplastic diseases, e.g. palliative management of leukaemia and lymphomas; Renal disease, such as acute interstitial nephritis, minimal change nephrotic syndrome or lupus nephritis.

4.2 Posology And Method Of Administration

Kenalog is for Intra-articular/Intramuscular injection. The safety and efficacy of administra

1. Name Of The Medicinal Product

KOGENATE Bayer 1000 IU powder and solvent for solution for injection.

2. Qualitative And Quantitative Composition

2.1 General description

Each vial contains nominally 1000 IU human coagulation factor VIII (octocog alfa).

Human coagulation factor VIII is produced by recombinant DNA technology (rDNA) in baby hamster kidney cells containing the human factor VIII gene.

2.2 Qualitative and quantitative composition

One ml of KOGENATE Bayer 1000 IU contains approximately 400 IU (1000 IU / 2.5 ml) of human coagulation factor VIII (octocog alfa) after reconstitution.

The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in International Units (IU).

The specific activity of KOGENATE Bayer is approximately 4000 IU/mg protein.

Solvent: water for injections.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder and solvent for solution for injection.

Powder: dry white to slightly yellow powder or cake.

Solvent: water for injection, a clear, colourless solution.

The reconstituted medicinal product is a clear and colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.

4.2 Posology And Method Of Administration

Treatment should be initiated

1. Name Of The Medicinal Product

Klaricid XL or Clarithromycin 500 mg Modified Release Tablets

2. Qualitative And Quantitative Composition

	mg/tablet
Active: Clarithromycin	500.00

3. Pharmaceutical Form

A yellow, ovaloid tablet containing 500mg clarithromycin in a modified-release preparation.

4. Clinical Particulars

4.1 Therapeutic Indications

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Klaricid XL or Clarithromycin 500 mg Modified Release Tablets are indicated in adults and children 12 years and older.

Klaricid XL or Clarithromycin 500 mg Modified Release Tablets is indicated for treatment of infections caused by susceptible organisms. Indications include:

Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia.

Upper respiratory tract infections for example, sinusitis and pharyngitis.

Klaricid XL or Clarithromycin 500 mg Modified Release Tablets is also indicated in skin and soft tissue infections of mild to moderate severity, for example folliculitis, cellulitis and erysipelas.

4.2 Posology And Method Of Administration

Adults: The usual recommended dosage of Kl

1. Name Of The Medicinal Product

Keppra 250 mg film-coated tablets.

Keppra 500 mg film-coated tablets.

Keppra 750 mg film-coated tablets.

Keppra 1000 mg film-coated tablets.

Keppra 100 mg/ml, oral solution.

Keppra 100 mg/ml concentrate for solution for infusion

2. Qualitative And Quantitative Composition

Tablets:

Each film-coated tablet contains 250 mg levetiracetam, 500 mg levetiracetam, 750 mg levetiracetam or 1000 mg levetiracetam.

Excipient:

Keppra 750 mg film-coated Tablets:

Each film-coated tablet contains 0.19 mg of sunset yellow FCF (E110).

Oral solution:

Each ml contains 100 mg levetiracetam.

Excipients: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and 300 mg maltitol liquid.

Solution for infusion:

Each ml contains 100 mg of levetiracetam.

Each 5 ml vial contains 500 mg of levetiracetam.

Excipients:

Each dose contains 57 mg of sodium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet:

Blue, oblong, scored and debossed with the code “ucb” and “250” on one side.

Yellow, oblong, scored and debossed with the code “ucb 500” on one side.

Orange, oblong, scored and debossed with the code “ucb 750” on one side.

White, oblong, scored and debossed with the code “ucb 1000” on one side.

Oral solution:

Clear liquid.

1. Name Of The Medicinal Product

Kytril Tablets 1mg and 2mg.

2. Qualitative And Quantitative Composition

Each tablet contains 1mg or 2mg granisetron (as hydrochloride).

Excipients include lactose (see section 4.3 Contraindications).

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated Tablet.

White triangular film-coated tablets marked 'K1' or 'K2' on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Kytril tablets are indicated for the prevention of nausea and vomiting induced by cytostatic therapy.

4.2 Posology And Method Of Administration

Adults

The dose of Kytril is 1mg twice a day or 2mg once a day during cytostatic therapy.

The first dose of Kytril should be administered within one hour before the start of cytostatic therapy.

Concomitant use of dexamethasone: The efficacy of Kytril may be enhanced by the addition of dexamethasone.

Maximum Dose and Duration of Treatment

Kytril is also available as ampoules for intravenous administration. The maximum dose of Kytril administered orally and/or intravenously over 24 hours should not exceed 9mg.

Children

There is insufficient evidence on which to base appropriate dosage regimens for children under 12 years old. Kytril Tablets are therefore not recommended in this age group.

Elderly

As for adults.

1. Name Of The Medicinal Product

Kolanticon Gel

2. Qualitative And Quantitative Composition

Kolanticon Gel is a white viscous suspension containing 2.5mg dicycloverine hydrochloride, 200mg aluminium hydroxide, 100mg light magnesium oxide, 20mg simethicone per 5ml.

3. Pharmaceutical Form

Suspension for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment and prophylaxis of symptoms of peptic ulcer and functional dyspepsia especially in patients in whom gastric distress results from hyperacidity, smooth muscle spasm, including irritable bowel syndrome (IBS), and flatulence. Also indicated for symptomatic relief in oesophagitis, hiatus hernia, gastritis and iatrogenic gastritis.

4.2 Posology And Method Of Administration

Two to four 5ml spoonfuls every four hours as required.

4.3 Contraindications

Known idiosyncrasy to any of the ingredients. Should not be used in patients with prostatic enlargement, glaucoma, obstructive uropathy, obstructive disease of the gastro-intestinal tract, paralytic ileus and intestinal atony, severe ulcerative colitis, and myasthenia gravis.

4.4 Special Warnings And Precautions For Use

In the presence of renal insufficiency magnesium salts may cause central nervous system depression. Aluminium hydroxide in the presence of low phosphorous diets may cause phosphorous deficiency. Aluminium hydroxide may reduce absorption of tetrayclines when given concomitantly. Use with care in patients with hiatus hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate this condition.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Antacids may in

1. Name Of The Medicinal Product

KERAL 25 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each tablet contains: Dexketoprofen trometamol 36.9 mg corresponding to dexketoprofen 25 mg.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film coated tablets.

Keral 25 mg: white, round, scored film-coated tablets. The tablets can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic treatment of pain of mild to moderate intensity, such as musculo-skeletal pain, dysmenorrhoea, dental pain.

4.2 Posology And Method Of Administration

General population:

According to the nature and severity of pain, the recommended dosage is generally 12.5 mg every 4-6 hours or 25 mg every 8 hours. The total daily dose should not exceed 75 mg.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

KERAL tablets are not intended for long term use and the treatment must be limited to the symptomatic period.

Concomitant administration with food delays the absorption rate of the drug (see Pharmacokinetic Properties), thus in case of acute pain it is recommended that administration is at least 30 minutes before meals.

Elderly:

In elderly patients it is recommended to start the therapy at the lower end of the dosage range (50 mg total daily dose). The dosage may be increased to that recommended for the general population only after good general tolerance has been ascertained.

Hepatic

1. Name Of The Medicinal Product

KLEAN-PREP 69g, sachet powders for oral solution.

2. Qualitative And Quantitative Composition

Each sachet of KLEAN-PREP contains the following active ingredients:

Macrogol 3350	59.000 g
Anhydrous Sodium Sulphate	5.685 g
Sodium Bicarbonate	1.685 g
Sodium Chloride	1.465 g
Potassium Chloride	0.7425 g

The content of electrolyte ions per sachet when made up to one litre of water is as follows:

Sodium	125 mM
Sulphate	40 mM

1. Name Of The Medicinal Product

Karvol Decongestant Capsules

2. Qualitative And Quantitative Composition

Active ingredient	mg/capsule
Chlorobutanol	2.25
Levomenthol	35.55
Pine Oil Sylvestris	9.0
Terpineol	66.6
Thymol	3.15
Pumilio Pine Oil	103.05

3. Pharmaceutical Form

Capsule

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of colds in the head and the symptomatic rapid relief of nasal congestion.

1. Name Of The Medicinal Product

Kytril Paediatric Liquid.

2. Qualitative And Quantitative Composition

Granisetron hydrochloride equivalent to 200?g granisetron (free base equivalent) per 1ml.

3. Pharmaceutical Form

An orange coloured and flavoured clear solution equivalent to 200?g of granisetron free base per 1ml.

4. Clinical Particulars

4.1 Therapeutic Indications

Kytril Paediatric Liquid is indicated for the prevention of nausea and vomiting induced by cytostatic therapy.

4.2 Posology And Method Of Administration

Children

A single dose of 20?g/kg bodyweight (up to 1mg)twice a day up to 5 days during cytostatic therapy. The first dose of Kytril should be administered within one hour before the start of cytostatic therapy.

Patients with renal or hepatic impairment

No special requirements apply.

4.3 Contraindications

Hypersensitivity to granisetron, or related substances, or any of the other constituents.

4.4 Special Warnings And Precautions For Use

As Kytril may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following administration of Kytril.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In studies in healthy subjects, no evidence of any interaction has been indicated between Kytril and cimetidine or lorazepam. No evidence of drug interactions has been observed in clinical studies.

4.6 Pregnancy And Lactation

Whilst animal studies have shown no teratogenic effects, there is n

1. Name Of The Medicinal Product

'Kefadim'.

2. Qualitative And Quantitative Composition

			Vial Size
		500mg	1g	2g
Active constituent
	Ceftazidime pentahydrate	580mg	1.16g

1. Name Of The Medicinal Product

Ketorolac Trometamol 30mg/ml Injection Solution

2. Qualitative And Quantitative Composition

Each 1ml ampoule contains 30 mg Ketorolac trometamol

For excipients please see section 6.1

3. Pharmaceutical Form

Solution for Injection

Colourless or slightly yellowish solution in amber glass ampoules.

4. Clinical Particulars

4.1 Therapeutic Indications

Ketorolac Injection is indicated for the short-term management of moderate to severe acute post-operative pain.

4.2 Posology And Method Of Administration

Ketorolac Injection is for administration by intramuscular or bolus intravenous injection. Bolus intravenous doses should be given over at least 15 seconds. Ketorolac Injection should not be used for epidural or spinal administration.

The time to onset of analgesic effect following both IV and IM administration is similar and is approximately 30 minutes, maximum analgesia occurs within one to two hours. Analgesia normally lasts for four to six hours.

Dosage should be adjusted according to the severity of the pain and the patient response. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

The administration of continuous multiple daily doses of ketorolac intramuscularly or intravenously should not exceed two days because adverse events may increase with prolonged usage. There has been limited experience with dosing for longer periods since the vast majority of patients have transferred to oral medication or no longer require analgesic therapy after this time.

Adults

The recommended initial dose of Ketorolac Inje

1. Name Of The Medicinal Product

Konakion MM.

2. Qualitative And Quantitative Composition

Each Konakion MM Ampoule contains 10.0mg vitamin K₁ (phytomenadione) Ph. Eur in 1ml.

3. Pharmaceutical Form

Amber glass ampoules containing 10mg phytomenadione in 1ml. The ampoule solution is clear to slightly opalescent, pale yellow in colour and contains the active constituent in a mixed micelles vehicle of glycocholic acid and lecithin.

4. Clinical Particulars

4.1 Therapeutic Indications

Konakion MM is indicated as an antidote to anticoagulant drugs of the coumarin type in the treatment of haemorrhage or threatened haemorrhage, associated with a low blood level of prothrombin or factor VII.

4.2 Posology And Method Of Administration

Adults: As an antidote to anticoagulant drugs

For potentially fatal and severe haemorrhages: Konakion MM therapy should be accompanied by a more immediate effective treatment such as transfusions of whole blood or blood clotting factors. The anticoagulant should be withdrawn and an intravenous injection of Konakion MM given slowly in a dose of 10 – 20mg. The prothrombin level should be estimated three hours later and, if the response has been inadequate, the dose should be repeated. Not more than 40mg of Konakion MM should be given intravenously in 24 hours. Coagulation profiles must be monitored on a daily basis until these have returned to acceptable levels; in severe cases more frequent monitoring is necessary and where there is no immediate efficacy, transfusion of whole blood or blood clotting factors should be used.

Less severe haemorrhage: Oral treatment with Konakion tablets may be used.

1. Name Of The Medicinal Product

Kaolin and Morphine Mixture BP

2. Qualitative And Quantitative Composition

Active Ingredient	%w/v
Irradiated light kaolin BP	20
Morphine Hydrochloride Ph Eur	0.0092

3. Pharmaceutical Form

A slowly separating buff suspension with the odour and taste of chlorodyne.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of occasional diarrhoea.

For oral administration.

4.2 Posology And Method Of Administration

Adults and children over 12 years: 10ml (two teaspoonfuls) in water.

May be repeated three times a day until the condition is relieved.

Children under 12 years: Not recommended for children under 12 years.

Elderly: There is no need for dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Respiratory depression, acute alcoholism, head injuries and conditions in which there is raised intracranial pressure. Impaired liver function.

4.4 Special Warnings And Precautions For Use

1. Name Of The Medicinal Product

Kamillosan Chamomile Ointment

2. Qualitative And Quantitative Composition

Each tube or sachet of Kamillosan Ointment contains 10.5% extracts of chamomile standardised to give 0.01% L- ?-bisabolol active ingredient.

3. Pharmaceutical Form

Light brown ointment with Characteristic odour.

4. Clinical Particulars

4.1 Therapeutic Indications

For prophylaxis and treatment of uncomplicated inflammation of the skin including sore nipples, nappy chafe, nappy rash and chapped hands.

4.2 Posology And Method Of Administration

Kamillosan ointment is for topical application as follows:

Sore nipples in nursing mothers: after breast feeding.

Nappy chafe and nappy rash: at change of nappy.

Other conditions: twice daily as necessary.

4.3 Contraindications

None known

4.4 Special Warnings And Precautions For Use

None known

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

Kamillosan may be used during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None known.

4.9 Overdose

There are no known symptoms of overdosage.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The chamomile extract possesses topical anti-inflammatory properties due to the presence of the natural anti-inflammatory substance ?-?-bisabolol.

5.2 Pharmacokinetic Properti

1. Name Of The Medicinal Product

KOGENATE Bayer 500 IU powder and solvent for solution for injection.

2. Qualitative And Quantitative Composition

2.1 General description

Each vial contains nominally 500 IU human coagulation factor VIII (octocog alfa).

Human coagulation factor VIII is produced by recombinant DNA technology (rDNA) in baby hamster kidney cells containing the human factor VIII gene.

2.2 Qualitative and quantitative composition

One ml of KOGENATE Bayer 500 IU contains approximately 200 IU (500 IU / 2.5 ml) of human coagulation factor VIII (octocog alfa) after reconstitution.

The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in International Units (IU).

The specific activity of KOGENATE Bayer is approximately 4000 IU/mg protein.

Solvent: water for injections.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder and solvent for solution for injection.

Powder: dry white to slightly yellow powder or cake.

Solvent: water for injection, a clear, colourless solution.

The reconstituted medicinal product is a clear and colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.

4.2 Posology And Method Of Administration

Treatment should be initiated und

1. Name Of The Medicinal Product

Keflex* tablets.

Keflex capsules.

Keflex Granules for Oral Suspension BP.

2. Qualitative And Quantitative Composition

Each tablet contains, as the active ingredient, cefalexin monohydrate equivalent to 250mg or 500mg of cefalexin base.

Each capsule contains, as the active ingredient, cefalexin monohydrate equivalent to 250mg or 500mg of cefalexin base.

Each bottle, when prepared as directed, contains, as the active ingredient, cefalexin monohydrate equivalent to 125mg/5ml or 250mg/5ml of cefalexin base.

3. Pharmaceutical Form

Tablets 250mg: 9.5mm diameter, peach, marked 'GP3'.

Tablets 500mg: Pillow-shaped, 16mm long, scored, peach, marked 'GP4'.

Capsules 250mg: Green and white, coded 'GP1'.

Capsules 500mg: Pale green and dark green, coded 'GP2'.

Granules for oral suspension 125mg: White granules.

Granules for oral suspension 250mg: White granules.

4. Clinical Particulars

4.1 Therapeutic Indications

Cefalexin is a semi-synthetic cephalosporin antibiotic for oral administration.

Cefalexin is indicated in the treatment of the following infections due to susceptible micro-organisms:

Respiratory tract infections

Otitis media

Skin and soft tissue infections

Bone and joint infections

Genito-urinary tract infections, including acute prostatitis

Dental infections

4.2 Posology And Method Of Administration

Cefalexin is administered orally.

The bottle is first inverted and tapped to loosen the powder t