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Roche

Konakion MM Ampoules 10mg/ml

solution for injection

Phytomenadione (vitamin K1)

Please read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

  • 1. What Konakion MM is and what it is used for
  • 2. Before you are given Konakion MM
  • 3. How Konakion MM is given
  • 4. Possible side effects
  • 5. How Konakion MM is stored
  • 6. Further information

What Konakion MM is and what it is used for

Konakion MM contains a medicine called phytomenadione. This is a man-made vitamin called vitamin K1. Konakion MM is used for the following:

  • To prevent and treat severe bleeding after the use of certain medicines to thin their blood (called anti-coagulants).
  • To treat children (aged 1 year and older) who have liver disease or low levels of vitamin K in their body because of illness. Konakion MM is normally used to treat these children after advice from a specialist haematologist (blood doctor).

Konakion MM works by helping your body make blood clotting factors. These blood clotting factors help stop bleeding.

Before you are given Konakion MM

You must not be given Konakion MM if you are allergic (hypersensitive) to phytomena

UK

Roche

Konakion MM Paediatric 2 mg/0.2 ml

solution for injection or oral administration

Phytomenadione (vitamin K1)

Please read all of this leaflet carefully before your baby or child is given this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask the doctor, nurse or midwife.
  • This medicine has been prescribed for your child. Do not pass it on to others. It may harm them even if their symptoms are the same.
  • If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell the doctor, nurse or midwife.

In this leaflet:

  • 1. What Konakion MM Paediatric is and what it is used for
  • 2. Before your baby or child is given Konakion MM Paediatric
  • 3. How Konakion MM Paediatric is given
  • 4. Possible side effects
  • 5. How Konakion MM Paediatric is stored
  • 6. Further information

What Konakion MM Paediatric is and what it is used for

Konakion MM Paediatric contains a medicine called phytomenadione. This is a man-made vitamin called vitamin K1. Konakion MM Paediatric is used for the following:

  • Babies who do not have enough vitamin K in their bodies. Giving Konakion MM Paediatric prevents and treats bleeding caused by a lack of vitamin K. This is called ‘vitamin K deficiency bleeding’ (VKDB). This is a serious, but rare condition. All newborn babies are given vitamin K1 with their parent’s permission.
  • Babies and young children who may have had

1. Name Of The Medicinal Product

Kineret 100 mg solution for injection in a vial.

2. Qualitative And Quantitative Composition

Each vial contains 100 mg of anakinra* per 0.67 ml (150 mg/ml).

* Human interleukinEscherichia coli cells by recombinant DNA technology.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection (injection) in a vial.

Clear, colourless

4. Clinical Particulars

4.1 Therapeutic Indications

Kineret is indicated for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.

4.2 Posology And Method Of Administration

The recommended dose of Kineret is 100 mg administered once a day by subcutaneous injection. The dose should be administered at approximately the same time each day.

Kineret is supplied ready for use in a vial. The instructions for use and handling are given in section 6.6.

Alternating the injection site is recommended to avoid discomfort at the site of injection.

Kineret treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.

Elderly patients (

No dose adjustment is required. Posology and administration are the same as for adults 18 to 64 years of age.

Children and adolescents (< 18 years)

There are insufficient data to recommend the use of Kineret in children and adolescents under 18 years of age.

1. Name Of The Medicinal Product

Karvol Decongestant Drops

2. Qualitative And Quantitative Composition

Active Ingredients

% W/V

Chlorobutanol Hemihydrate Ph Eur

0.50

Levomenthol Ph Eur

7.90

Pine Oil Sylvestris

2.00

Terpineol BP

14.80

Thymol Ph Eur

0.70

Pumilio Pine Oil

22.90

3. Pharmaceutical Form

Inhalation vapour, liquid

4. Clinical Particulars

4.1 Therapeutic Indications

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

1. Name Of The Medicinal Product

Kytril Infusion 3mg/3ml.

2. Qualitative And Quantitative Composition

Each 3ml contains 3.0mg granisetron (as the hydrochloride).

For excipients, see 6.1.

3. Pharmaceutical Form

An ampoule containing a sterile, clear, colourless or slightly straw-coloured solution equivalent to 1mg of granisetron per 1ml of solution. The content allows withdrawal of 3ml.

Concentrate for solution for infusion, or bolus injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Kytril is indicated for the prevention or treatment of nausea and vomiting induced by cytostatic therapy.

4.2 Posology And Method Of Administration

Adults

Kytril ampoules are for intravenous administration only.

3mg Kytril, which should be administered either in 15ml infusion fluid as an intravenous bolus over not less than 30 seconds or diluted in 20 to 50ml infusion fluid and administered over five minutes.

Prevention:In clinical trials, the majority of patients have required only a single dose of Kytril to control nausea and vomiting over 24 hours. Up to two additional doses of 3mg Kytril may be administered within a 24-hour period. There is clinical experience in patients receiving daily administration for up to five consecutive days in one course of therapy. Prophylactic administration of Kytril should be completed prior to the start of cytostatic therapy.

Treatment:The same dose of Kytril should be used for treatment as prevention. Additional doses should be administered at least 10 minutes apart.

Maximum daily dosag

Kentera 3.9 mg / 24 hours transdermal patch

Oxybutynin

Read all of this leaflet carefully before you start using Kentera

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, please ask your doctor or your 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Kentera is and what it is used for
2. Before you use Kentera
3. How to use Kentera
4. Possible side effects
5. How to store Kentera
6. Further Information

What Kentera Is And What It Is Used For

Kentera is used in adults to control the symptoms of urge incontinence and/or increased urinary frequency and urgency.

Kentera works by allowing the bladder to expand and accommodate more urine.

Before You Use Kentera

Do not use Kentera:

  • If you are hypersensitive (allergic) to oxybutynin or any of the ingredients of Kentera.
  • If you have a rare condition called myasthenia gravis that makes the muscles in the body become weak and tire easily.
  • If you experience incomplete bladder emptying during urination, the use of oxybutynin may increase this problem. You should discuss this problem with your doctor before using Kentera.

1. Name Of The Medicinal Product

Kaolin Mixture BP

2. Qualitative And Quantitative Composition

Kaolin light

1.0gm/5ml

Sodium hydrogen carbonate

250mg/5ml

For full list of excipients see section 6.1

3. Pharmaceutical Form

Oral solution

An off-white suspension which separates on standing to form an off-white sediment and a slightly yellow/brown supernatant liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of occasional diarrhoea and upset stomachs.

4.2 Posology And Method Of Administration

Oral.

Recommended doses and dosage schedules

Adults and children over 12 years:

10 – 20ml

Children 6 – 12 years:

5 – 10ml

The dose may be repeated after 4 hours if required.

Not recommended for children under 6 years.

Shake the bottle before use.

4.3 Contraindications

Hypersensitivity to light ka

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

Kineret 100 mg solution for injection in a pre-filled syringe.

2. Qualitative And Quantitative Composition

Each pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ml).

* Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in Escherichia coli cells by recombinant DNA technology.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection (injection) in a pre-filled syringe.

Clear, colourless-to-white solution for injection that may contain some product-related translucent-to-white amorphous particles.

4. Clinical Particulars

4.1 Therapeutic Indications

Kineret is indicated for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in adults with an inadequate response to methotrexate alone.

4.2 Posology And Method Of Administration

Kineret treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.

Posology

The recommended dose of Kineret is 100 mg administered once a day by subcutaneous injection. The dose should be administered at approximately the same time each day.

Elderly population (

No dose adjustment is required. Posology and administration are the same as for adults 18 to 64 years of age.

Paediatric population (< 18 years)

The safety and efficacy of Kineret in children aged 0 to 18 years have not been established. No data are

1. Name Of The Medicinal Product

Kliovance 1mg/0.5mg film-coated tablet

2. Qualitative And Quantitative Composition

Each film-coated tablet contains:

Estradiol anhydrous 1 mg (as estradiol hemihydrate) and norethisterone acetate 0.5 mg.

Excipients: lactose monohydrate

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

White film-coated, round, biconvex tablets with a diameter of 6 mm. The tablets are engraved with NOVO 288 on one side and the APIS bull on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in women more than one year after menopause.

Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

The experience of treating women older than 65 years is limited.

4.2 Posology And Method Of Administration

Kliovance is a continuous combined hormone replacement product intended for use in women with an intact uterus. One tablet should be taken orally once a day without interruption, preferably at the same time every day.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used.

A switch to a higher dose combination product could be indicated if the response after three months is insufficient for satisfactory symptom relief.

In women with amenorrhea and not taking HRT or women transferring from another continuous combined HRT produc

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

Kaolin Mixture for Children or Children's Diarrhoea Mixture

2. Qualitative And Quantitative Composition

Kaolin light (grade A1) BP 1.0g per 5ml.

3. Pharmaceutical Form

Solution/mixture

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of the symptoms of diarrhoea and upset stomachs in children.

4.2 Posology And Method Of Administration

Oral.

Recommended doses

Children up to 1 year of age: one 5ml spoonful.

Children 1 – 5 years of age: two 5ml spoonfuls.

Directions for use: shake the bottle.

To be repeated every four hours as required.

4.3 Contraindications

Contraindicated in intestinal obstruction; and in patients with known hypersensitivity to kaolin or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Rehydration therapy may be necessary because of fluid and electrolyte depletion.

Keep all medicines out of the reach and sight of children.

If symptoms persist for more than 3 days consult your doctor.

Use with medical advice for infants under 1 year.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

As kaolin is an adsorbent, the absorption of other drugs from the gastrointestinal tract administered concomitantly may be reduced.

4.6 Pregnancy And Lactation

Although not relevant in childrens use, as with all medicines the use of this product should be avoided in pregnancy and lactation unless advised by a doctor.

4.7 Effects On Ability To Drive And Use Machin

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

KERAL 25 mg tablets

Dexketoprofen

This leaflet contains useful information about this medicine. You should keep the leaflet inside the carton, since you may need to read it again. This leaflet does not contain all the information about your medicine. If you are uncertain about anything or want further information, please consult your doctor or pharmacist.

What is Keral and what is it for?

Each tablet contains:

Dexketoprofen trometamol (36.9 mg) corresponding to dexketoprofen 25 mg.

Excipients: maize starch, microcrystalline cellulose, sodium starch glycollate, glycerol distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.

Keral is supplied in packs containing 4, 10, 20, 50 scored, film-coated tablets.

The tablets can be divided into equal halves. Not all pack sizes may be marketed.

Dexketoprofen trometamol, the active ingredient of KERAL 25 mg tablets, is an analgesic from the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). KERAL 25 mg is a medicine for the treatment of pain.

Marketing Authorisation Holder:

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG, S.A.
1, Avenue de la Gare L-1611
LUXEMBOURG

Manufacturer:

LABORATORIOS MENARINI, S.A.
Alfonso XII 587
08918-Badalona (Barcelona)

1. Name Of The Medicinal Product

Klaricid Adult Sachet 250mg or Clarithromycin 250mg Granules for Oral Suspension

2. Qualitative And Quantitative Composition

Active

mg/sachet

Clarithromycin

250.00

3. Pharmaceutical Form

Granules for oral suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

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

Klaricid Adult Sachets 250mg are indicated in adults and children 12 years and older.

Clarithromycin is indicated in the treatment of infections caused by one or more susceptible organisms. Indications include:

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

Upper respiratory tract infections for example, sinusitus and pharyngitis.

Clarithromycin is appropriate for initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atypical respiratory pathogens as listed in the microbiology section.

Clarithromycin is also indicated in skin and soft tissue infections of mild to moderate severity.

Clarithromycin in the presence of acid suppression effected by lansoprazole or omeprazole is also indicated for the eradicatio

Ketek 400 mg film-coated tablets

Telithromycin

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, ask your doctor or your 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What Ketek is and what it is used for
  • 2. Before you take Ketek.
  • 3. How to take Ketek.
  • 4. Possible side effects
  • 5. How to store Ketek
  • 6. Further Information

What Ketek Is And What It Is Used For

Ketek belongs to one of a group of medicines called ketolides, a new class of antibiotics related to macrolides. Antibiotics stop the growth of bacteria which cause infections.

Ketek is used in adults and adolescents of 12 years and older to treat infections due to bacteria against which the medicine is active. In adolescents of 12 years and older, Ketek can be used to treat: infections of the throat. In adults, Ketek can be used to treat infections of the throat, infections of the sinuses, chest infections in patients with long standing breathing difficulties and pneumonia.

Before You Take Ketek

Do not

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 & excipient colouring agent E110 or 1000 mg levetiracetam.

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.

Concentrate for solution for infusion (sterile concentrate).

Clear, colourless, concentrate.

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

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- a-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 L-a-bisabolol.

5.2 Pharmacokinetic Prope

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