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1. Name Of The Medicinal Product

Apidra Solostar 100 Units/ml solution for injection in a pre-filled pen

2. Qualitative And Quantitative Composition

Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).

Each pen contains 3 ml of solution for injection, equivalent to 300 Units.

Insulin glulisine is produced by recombinant DNA technology in Escherichia coli.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection in a pre-filled pen.

Clear, colourless, aqueous solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of adults, adolescents and children, 6 years or older with diabetes mellitus, where treatment with insulin is required.

4.2 Posology And Method Of Administration

The potency of this preparation is stated in units. These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues. (see section 5.1).

Apidra should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents.

The dose of Apidra should be individually adjusted.

Special populations

Renal impairment

The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment. However, insulin requirements may be reduced in the presence of renal impairment (see section 5.2).

Hepatic impairment

The pharmacokinetic properties of insulin glulisine have not

1. Name Of The Medicinal Product

Anadin Ibuprofen 200mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 200mg Ibuprofen.

For excipients see 6.1.

3. Pharmaceutical Form

Coated tablet.

White, sugar coated tablets smooth in texture with a polished surface.

'Anadin I' printed on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

GSL

For the relief of mild to moderate pain including rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness and for the relief of the symptoms of cold and influenza.

4.2 Posology And Method Of Administration

For oral administration and short-term use only.

Adults, the elderly and young persons over 12 years of age:

The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if the symptoms worsen, the patient should consult a doctor.

1 or 2 tablets to be taken up to three times a day, as required. The tablets should be taken with water.

Leave at least 4 hours between doses and do not take more than 1200mg (6 tablets) in any 24 hour period.

Not to be given to children under 12 years of age.

4.3 Contraindications

Hypersensitivity to ibuprofen or any of the constituents in the product.

Ibuprofen is contra-indicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angiodema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory dr

1. Name Of The Medicinal Product

AAA Sore Throat Spray

2. Qualitative And Quantitative Composition

Benzocaine 1.5mg

3. Pharmaceutical Form

Aerosol spray with metered dose

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic temporary relief of pain associated with sore throat pain and minor infections

4.2 Posology And Method Of Administration

Adults (including elderly):

Spray two metered doses every two to three hours if required (not more than sixteen doses in every 24 hours) or as directed by the physician.

Children:

Children 6 – 12 years: One metered dose every two to three hours if required (not more than eight doses in every 24 hours) or as directed by the physician.

Not suitable for children under 6 years.

Route of administration

Topical application to the mucosa of the mouth and throat by means of a metered dose aerosol.

Product should not be administered for more than 7 consecutive days.

Can be shaken before use.

4.3 Contraindications

Known hypersensitivity to benzocaine or any of the excipients

Methaemoglobinaemia

4.4 Special Warnings And Precautions For Use

This preparation should not be administered to children under 6 years or used for more than seven consecutive days unless directed by a physician.

If the sore throat is severe, persistent or accompanied by fever or headache, a physician should be consulted before the use of this product. Avoid spraying into the eyes.

Caution should be exercised in the use of this product if there have been prev

1. Name Of The Medicinal Product

Aprinox Tablets 2.5 mg

Aprinox Tablets 5 mg

2. Qualitative And Quantitative Composition

Each Aprinox Tablet 2.5 mg contains bendroflumethiazide 2.5 mg

Each Aprinox Tablet 5 mg contains bendroflumethiazide 5 mg

For excipients, see section 6.1

3. Pharmaceutical Form

White tablets

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of oedema and hypertension. Aprinox may also be used to suppress lactation.

4.2 Posology And Method Of Administration

For oral administration.

Adults:

Oedema

Initially, 5-10 mg in the morning, daily or on alternate days; maintenance dose 5-10 mg one to three times weekly.

Hypertension

The usual dose is 2.5 mg taken in the morning. Higher doses are rarely necessary.

Suppression of lactation

5 mg in the morning and 5 mg at midday for about five days.

Children: Dosage in children may be up to 400 mcg/kg bodyweight initially, reducing to 50-100 mcg/kg bodyweight daily for maintenance.

Elderly: The dosage of thiazide diuretics may need to be reduced in the elderly, particularly when renal function is impaired, because of the possibility of electrolyte imbalance.

4.3 Contraindications

Aprinox is contra-indicated in patients with known hypersensitivity to thiazides; refractory hypokalaemia, hyponatraemia, hyperca

1. Name Of The Medicinal Product

Amoxil® Sachets 3 G Sucrose-Free

2. Qualitative And Quantitative Composition

Amoxil Sachets 3 G Sucrose-Free contain 3 G amoxicillin per sachet

The amoxicillin is present as the trihydrate.

3. Pharmaceutical Form

Amoxil Sachets SF: sucrose-free sachets in a sorbitol base, for reconstitution in water.

Each sachet carries instructions for preparation.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of Infection: Amoxil is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as:

Upper respiratory tract infections

Otitis media

Acute and chronic bronchitis

Chronic bronchial sepsis

Lobar and bronchopneumonia

Cystitis, urethritis, pyelonephritis

Bacteriuria in pregnancy

Gynaecological infections including puerperal sepsis and septic abortion

Gonorrhoea

Peritonitis

Intra-abdominal sepsis

Septicaemia

Bacterial endocarditis

Typhoid and paratyphoid fever

Skin and soft tissue infections

Osteomyelitis

Dental abscess (as an adjunct to surgical management)

In children with urinary tract infection the need for investigation should be considered.

Prophylaxis of endocarditis: Amoxil may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

The wide range of organisms sensitive to the bactericidal action of Amoxil include:

1. Name Of The Medicinal Product

Amaryl 1 mg, tablet

Amaryl 2 mg, tablet

Amaryl 3 mg, tablet

Amaryl 4 mg, tablet

2. Qualitative And Quantitative Composition

Each tablet contains 1mg, 2mg, 3mg or 4mg of glimepiride.

Excipients: 1mg, 2mg, 3mg and 4mg tablets also contain 69.0 mg, 137.2 mg, 137.0 mg and 135.9 mg lactose monohydrate per tablet respectively.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet

1mg tablets are pink, oblong and scored on both sides.

2mg tablets are green, oblong and scored on both sides.

3mg tablets are pale yellow, oblong and scored on both sides.

4mg tablets are light blue, oblong and scored on both sides.

4. Clinical Particulars

4.1 Therapeutic Indications

Amaryl is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate.

4.2 Posology And Method Of Administration

For oral administration

The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood and urine. Tablets or insulin cannot compensate if the patient does not keep to the recommended diet.

Dosage is determined by the results of blood and urinary glucose determinations.

The starting dose is 1 mg glimepiride per day. If good control is achieved this dosage should be used for maintenance therapy.

For the different dosage regimens appropriate strengths are available.

If control is unsatisfactory the dosage should be increased, based on the glycaemic control, in a stepwise

ALFUZOSIN HYDROCHLORIDE

2.5MG TABLETS

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 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.
  • Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.

In this leaflet:

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

What Alfuzosin Is And What It Is Used For?

What alfuzosin is

The name of your medicine is Alfuzosin Hydrochloride 2.5mg Tablets (called alfuzosin throughout this leaflet). This belongs to a group of medicines called alpha-blockers.

How alfuzosin works

Alfuzosin can be used to treat the symptoms of Benign Prostatic Hypertrophy.

This is when the prostate gland enlarges (hyperplasia), but the growth is not cancerous (it is benign). It can cause problems in passing water (u

1. Name Of The Medicinal Product

Anastrozole 1mg Film-coated Tablets

2. Qualitative And Quantitative Composition

One film-coated tablet contains 1 mg anastrozole.

Excipients: 65.78 mg lactose/film-coated tablet

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film-coated tablet.

White, round and biconvex film-coated tablet with embossment “A1” on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of advanced breast cancer in postmenopausal women. Efficacy has not been demonstrated in patients with oestrogen receptor-negative tumours unless they had a previous positive clinical response to tamoxifen.

Adjuvant treatment of postmenopausal women with hormone receptor-positive early invasive breast cancer.

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer who have already received adjuvant treatment with tamoxifen for 2 to 3 years.

4.2 Posology And Method Of Administration

Adults including elderly patients:

One film-coated Anastrozole tablet once daily.

Children and adolescents:

Children should not be treated with Anastrozole 1mg film-coated tablets.

Impaired renal function:

No dose adjustment is required in patients with mild or moderate renal impairment.

Impaired hepatic function:

No dose adjustment is required in patients with mild hepatic impairment.

For adjuvant treatment of early breast cancer, the recommended duration of treatment is 5 ye

1. Name Of The Medicinal Product

Adenoscan® 30 mg/10 ml, solution for infusion

2. Qualitative And Quantitative Composition

Each 10 ml vial of Adenoscan® contains 30 mg of adenosine (3 mg/ml)

Excipient: each vial contains 90 mg of sodium chloride (9 mg/ml).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for infusion.

Adenoscan® is a sterile clear, colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Intravenous (IV) Adenoscan® is a coronary vasodilator for use in conjunction with radionuclide myocardial perfusion imaging in patients who cannot exercise adequately or for whom exercise is inappropriate.

4.2 Posology And Method Of Administration

Adenoscan® is intended for use in hospitals with monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary.

It should be administered following the same procedure as for exercise testing where facilities for cardiac monitoring and cardio-respiratory resuscitation are available. During administration of Adenoscan® continuous ECG control is necessary as life-threatening arrhythmia might occur. Heart rate and blood pressure should be monitored every minute.

Adults :

1. Adenoscan® should be administered undiluted as a continuous peripheral intravenous infusion at a dose of 140 µg/kg/min for six minutes using an infusion pump. Separate venous sites for Adenoscan® and radionuclide administration are recommended to avoid an adenosine bolus effect.

2. After three minutes of Adenoscan®

Adizem-SR 120 mg prolonged-release tablets

Diltiazem hydrochloride

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 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 becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Adizem-SR tablets are and what they are used for
2. Before you take Adizem-SR tablets
3. How to take Adizem-SR tablets
4. Possible side effects
5. How to store Adizem-SR tablets
6. Further information

What Adizem-SR tablets are and what they are used for

These tablets have been prescribed for you to treat angina (chest pain caused by a reduction of oxygen to the heart muscle) or high blood pressure (hypertension). They contain the active ingredient diltiazem. Diltiazem belongs to a group of medicines called calcium antagonists. Calcium antagonists help more blood to reach the heart and reduce blood pressure. The other ingredients of Adizem-SR tablets are listed in section 6 of this leaflet.

Adizem-SR tablets are designed to work properly over 12 hours. If the tablets are crushed or chewed, the entire 12-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose.

Before you tak

1. Name Of The Medicinal Product

Actonel 5 mg film-coated tablets.

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 5 mg risedronate sodium (equivalent to 4.64 mg risedronic acid).

Excipients: Each film-coated tablet contains lactose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Oval yellow film-coated tablet with RSN on one side and 5 mg on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures. Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis (see section 5.1).

To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months), systemic corticosteroid treatment at doses

4.2 Posology And Method Of Administration

The recommended daily dose in adults is one 5 mg tablet orally. The absorption of Actonel is affected by food, thus to ensure adequate absorption patients should take Actonel:

• Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day.

In the particular instance that before breakfast dosing is not practical, Actonel can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Actonel is taken on an empty stomach:

• Between meals: Actonel should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain

1. Name Of The Medicinal Product

APO-go AMPOULES 10 mg/ml Solution for Injection or Infusion (Ireland, UK)

or

APO-go Ampullen 10 mg/ml Injektions-/Infusionsl?sung (Austria, Germany)

or

APO-go Ampul 10 mg/ml injektions-/infusionsv?ske, opl?sning (Denmark)

or

APO-go 10 mg/ml injektionsv?tska, l?sning / infusionsv?tska, l?sning (Sweden)

or

APOGO en solution injectable ou perfusion ? 10 mg/ml en ampoules (France)

2. Qualitative And Quantitative Composition

1ml contains 10mg apomorphine hydrochloride

2ml contains 20mg apomorphine hydrochloride

5ml contains 50mg apomorphine hydrochloride

Excipient: Sodium metabisulphite (E223) 1mg per ml

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Solution for Injection or Infusion

Solution is clear and colourless

pH 3.0-4.0

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of disabling motor fluctuations (“on-off” phenomena) in patients with Parkinson's disease which persist despite individually titrated treatment with levodopa (with a peripheral decarboxylase inhibitor) and/or other dopamine agonists.

4.2 Posology And Method Of Administration

APO-go Ampoules 10 mg/ml Solution for Injection or Infusion is for subcutaneous use by intermittent bolus injection. APO-go Ampoules 10 mg/ml Solution for Injection or Infusion may also be administered as a continuous subcutaneous infusion by minipump and/or syringe-driver (see section 6.6).

Apomorphine must not be used via the intrave

1. Name Of The Medicinal Product

Atimos Modulite

2. Qualitative And Quantitative Composition

Each metered dose contains 12 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose of 10.1 micrograms.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Pressurised inhalation solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the long-term symptomatic treatment of persistent, moderate to severe asthma in patients requiring regular bronchodilator therapy in combination with long-term anti-inflammatory therapy (inhaled and / or oral glucocorticoids).

Glucocorticoid therapy should be continued on a regular basis.

Atimos is indicated for the relief of broncho-obstructive symptoms in patients with chronic obstructive pulmonary disease (COPD).

4.2 Posology And Method Of Administration

The dosage depends on the type and severity of disease.

The following dosages are recommended for adults, including elderly patients, and adolescents aged 12 years and above:

Asthma

Adults, including the elderly, and adolescents aged 12 years and above

Usually one actuation in the morning and evening (24 micrograms of formoterol fumarate dihydrate per day). In severe cases, up to a maximum of two actuations in the morning and evening (48 micrograms of formoterol fumarate dihydrate per day).

The maximum daily dose is 4 actuations (48 micrograms of formoterol fumarate dihydrate).

Chronic Obstructive Pulmonary Disease (COPD)

Adults (aged

1. Name Of The Medicinal Product

Amlodipine 10 mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains Amlodipine besilate equivalent to 10 mg of amlodipine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet

White or almost white, flat, bevelled edges, round tablet debossed with "C" on one side and "59" on the other side.

4. Clinical Particulars

4.1 Therapeutic Indications

Chronic stable and vasospastic angina pectoris.

Essential hypertension.

4.2 Posology And Method Of Administration

For oral use.

The tablets should be taken with a glass of liquid (e.g. a glass of water) with or without food.

In adults

For the treatment of hypertension and angina pectoris, the starting dose is 5 mg once daily. If the desired therapeutic effect cannot be achieved within 2-4 weeks, the dose can be increased to a maximum of 10 mg daily (given as a single dose) depending on the individual response of the patient. Amlodipine can be used as monotherapy or in combination with anti-anginal medication in patients suffering from angina pectoris.

Children with hypertension from 6 years to 17 years of age

The recommended antihypertensive oral dose in pediatric patients ages 6-17 years is 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily have not been studied in pediatric patients (see section 5.1 and section 5.2). The effect of amlodipine on blood pressure in patients less than 6 years of age is not known

Acnecide 5% w/w Gel

benzoyl peroxide

GEL

Acnecide 5% w/w Gel

Benzoyl Peroxide

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Acnecide carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • You must contact a doctor if your symptoms worsen or do not improve
  • If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

What Acnecide is and what it is used for

  • Acnecide contains the active ingredient benzoyl peroxide which attacks the bacteria (germs) known as Propionibacterium acnes, one of the main causes of acne.
  • Your doctor or pharmacist has recommended this medicine to treat your acne. Acne appears as blackheads and whiteheads which people often refer to as pimples or spots.
  • Acne of the face, chest or back may be treated with this medicine.

Before you use Acnecide

ADENURIC 80 mg film-coated tablets

Febuxostat

ADENURIC 120 mg film-coated tablets

Febuxostat

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 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

What Adenuric Is And What It Is Used For

ADENURIC tablets are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body. In some people, the amount of uric acid builds up in the blood and may become too high to remain soluble. When this happens, urate crystals may form in and around the joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack). Left untreated, larger deposits called tophi (TOE-FI) may form in and around joints. These tophi may cause joint and bone damage.

ADENURIC works by reducing uric acid levels. Keeping uric acid levels low by taking ADENURIC once every day stops crystals bui

1. Name Of The Medicinal Product

Amitriptyline Hydrochloride 50mg/5ml Oral Solution

2. Qualitative And Quantitative Composition

Amitriptyline Hydrochloride 50mg/5ml

3. Pharmaceutical Form

Oral Solution

4. Clinical Particulars

4.1 Therapeutic Indications

Amitriptyline is indicated for the treatment of:

-Symptoms of depression (especially where sedation is required).

-Nocturnal enuresis where organic pathology is excluded.

4.2 Posology And Method Of Administration

For oral administration only

Therapy should be started with a low dosage and increased gradually, according to the clinical response and any evidence of intolerance.

Adults - initial dosage: Usually 75mg a day in divided doses (or a single dose at night). If necessary, this may be increased to a total of 150mg a day, the additional doses being given in the late afternoon and/or at bedtime. The sedative effect is usually rapidly apparent. The antidepressant activity may be seen within three or four days or may take up to 30 days to develop adequately.

Adults - maintenance dosage: Usually 50 - 100mg a day. For maintenance therapy, the total dosage may be given in a single dose preferably in the evening or at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. Maintenance therapy should be continued for three months or longer to lessen the chances of relapse.

Children: Due to lack of clinical experience amitriptyline is not recommended for the treatment of depres

1. Name Of The Medicinal Product

AVONEX 30 micrograms powder and solvent for solution for injection

2. Qualitative And Quantitative Composition

Each BIO-SET vial contains 30 micrograms (6 million IU) of interferon beta-1a.

Following reconstitution with the solvent (water for injections) the vial contains 1.0 ml of solution. The concentration is 30 micrograms per ml.

Using the World Health Organisation (WHO) International Standard for Interferon, 30 micrograms of AVONEX contains 6 million IU of antiviral activity. The activity against other standards is not known.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder and solvent for solution for injection.

The vial contains a white to off-white cake.

4. Clinical Particulars

4.1 Therapeutic Indications

AVONEX is indicated for the treatment of

• Patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.

• Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1).

AVONEX should be discontinued in patients who develop progressive MS.

4.2 Posology And Method Of Administration

Treatment should be initiated under supervision of a physician experienced

1. Name Of The Medicinal Product

Augmentin® 625 mg Tablets

2. Qualitative And Quantitative Composition

Augmentin 625 mg Tablets: Each tablet contains co-amoxiclav 500/125.

The amoxicillin is present as amoxicillin trihydrate and the clavulanic acid is present as potassium clavulanate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Augmentin 625 mg Tablets:

Film-coated tablet

White to off-white, oval film-coated tablets debossed with 'AC' and a score line one side and plain on the other side.

4. Clinical Particulars

4.1 Therapeutic Indications

Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):

• Acute bacterial sinusitis (adequately diagnosed)

• Acute otitis media

• Acute exacerbations of chronic bronchitis (adequately diagnosed)

• Community acquired pneumonia

• Cystitis

• Pyelonephritis

• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.

• Bone and joint infections, in particular osteomyelitis.

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

4.2 Posology And Method Of Administration

Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.

The dose of Augmentin that is selected to treat an individual infection should take into account:

• The expected pathogens an

1. Name Of The Medicinal Product

Atriance

2. Qualitative And Quantitative Composition

Each ml contains 5 mg of nelarabine.

Each vial contains 250 mg of nelarabine.

Excipients:

Each ml contains 1.725 mg (75 micromols) of sodium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for infusion.

Clear, colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

4.2 Posology And Method Of Administration

Nelarabine is for intravenous use only and must only be administered under the supervision of a physician experienced in the use of cytotoxic agents.

Posology

Patients receiving nelarabine are recommended to receive intravenous hydration according to standard medical practice for the management of hyperuricaemia in patients at risk for tumour lysis syndrome. For patients at risk of hyperuricaemia, the use of allopurinol should be considered (see section 4.4).

Adults and adolescents (aged 16 years and older)

The recommended dose of nelarabine for adults is 1,500 mg/m2 administered intravenously over two hours on days 1, 3 and 5 and repeated every 21 days.