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1. Name Of The Medicinal Product

Xylocaine 1% with Adrenaline (Epinephrine) 1:200,000.

Xylocaine 2% with Adrenaline (Epinephrine) 1:200,000.

2. Qualitative And Quantitative Composition

Xylocaine 1% with Adrenaline (Epinephrine) 1:200,000:

Each ml of solution for injection contains lidocaine hydrochloride monohydrate Ph. Eur., equivalent to 10 mg of lidocaine hydrochloride anhydrous (200 mg per 20 ml vial), 5 micrograms of adrenaline (epinephrine) as the acid tartrate (100 micrograms per 20 ml vial).

Xylocaine 2% with Adrenaline (Epinephrine) 1:200,000:

Each ml of solution for injection contains lidocaine hydrochloride monohydrate Ph. Eur., equivalent to 20 mg of lidocaine hydrochloride anhydrous (400 mg per 20 ml vial), 5 micrograms of adrenaline (epinephrine) as the acid tartrate (100 micrograms per 20 ml vial).

For excipients see 6.1

3. Pharmaceutical Form

Solution for injection

4. Clinical Particulars

4.1 Therapeutic Indications

Xylocaine with Adrenaline is indicated for the production of local anaesthesia by the following techniques:

- Local infiltration

- Minor and major nerve blocks

4.2 Posology And Method Of Administration

Adults and children above 12 years of age

The dosage is adjusted according to the response of the patient and the site of administration. The lowest concentration and smallest dose producing the required effect should be given (see section 4.4). The maximum single dose of Xylocaine when given with adrenaline is 500 mg.

The following table is a guide for the more commonly used techniques in the average adult. The figures reflect the expected avera

1. Name Of The Medicinal Product

Xanax® Tablets 250 and 500 micrograms

2. Qualitative And Quantitative Composition

Alprazolam 250 and 500 micrograms

3. Pharmaceutical Form

White, oval, biconvex tablets containing 250 microgram (0.25 mg) alprazolam, scored on one side and marked "Upjohn 29" on the other.

Pink, oval, biconvex tablets containing 500 microgram (0.5 mg) alprazolam, scored on one side and marked "Upjohn 55" on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Xanax is indicated for the short-term treatment of moderate or severe anxiety states and anxiety associated with depression. It is only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

Xanax should not be used to treat short-term mild anxiety, such as anxiety or tension associated with the stress of everyday life. As the efficacy of Xanax in depression and in phobic or obsessional states has yet to be established, specific treatment may have to be considered.

4.2 Posology And Method Of Administration

Treatment should be as short as possible. It is recommended that the patient be reassessed at the end of no longer than 4 weeks' treatment and the need for continued treatment established, especially in case the patient is symptom free. The overall duration of treatment should not be more than 8-12 weeks, including a tapering off process.

In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status with special expertise. As with all benzodiazepines, physicians should be aware that long-term use might lead to dependence in certain patients.

The optimum dosage o

Xolair 150 mg powder and solvent for solution for injection

Omalizumab

Read all of this leaflet carefully before you start using Xolair.

  • 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.

In this leaflet:

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

What Xolair Is And What It Is Used For

Xolair is used to prevent asthma from getting worse by controlling symptoms of severe allergic asthma in patients (6 years of age and older) who are already receiving asthma medication, but whose asthma symptoms are not well controlled by medicines such as high-dose steroid inhalers or beta-agonist inhalers.

Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the body. IgE plays a key role in causing allergic asthma.

Before You Are Given Xolair

You should not be given Xolair

  • if you are allergic (hypersensitive) to omalizumab or any of the other

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

One film-coated tablet contains:

Rifaximin 200 mg

Excipients:

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet

Pink circular biconvex film-coated tablets, with “AW” printed on both sides.

4. Clinical Particulars

4.1 Therapeutic Indications

Xifaxanta 200mg film-coated tablets are indicated for the treatment of travellers' diarrhoea that is not associated with any of:

Fever

Bloody diarrhoea

Eight or more unformed stools in the previous 24 h

Occult blood or leucocytes in the stool.

Xifaxanta 200mg film-coated tablets may shorten the duration of diarrhoea when this is associated with non-invasive strains of E.coli (see sections 4.4 and 5.1).

4.2 Posology And Method Of Administration

Posology

200 mg every 8 hours for three days (total 9 doses).

Rifaximin must not be used for more than 3 days even if symptoms continue and a second course of treatment must not be taken (see section 4.4).

Rifaximin can be administered with or without food.

Paediatric population

The safety and efficacy of Xifaxanta 200 mg film-coated tablets in children (aged less than 18 years) have not been established.

A dosage adjustment for patients with hepatic or renal insufficiency is not necessary.

Method of administration

Orally with a glass of water.

4.3 Contrai

1. Name Of The Medicinal Product

Xalatan 0.005% w/v eye drops solution.

2. Qualitative And Quantitative Composition

100 ml eye drops solution contains 0.005 g latanoprost.

One drop contains approximately 1.5 micrograms latanoprost.

Excipient: Benzalkonium chloride 0.02% w/v is included as a preservative.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Eye drops, solution.

The solution is a clear colourless liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension.

Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.

4.2 Posology And Method Of Administration

Recommended dosage for adults (including the elderly):

Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Xalatan is administered in the evening.

The dosage of Xalatan should not exceed once daily since it has been shown that more frequent administration decreases the intraocular pressure lowering effect.

If one dose is missed, treatment should continue with the next dose as normal.

As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop.

Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.

Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.

If you have any doubts or queries about your medication, please contact your doctor or pharmacist.

Xarelto 10 mg film-coated tablets

Rivaroxaban

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.

In this leaflet:

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

What Xarelto Is And What It Is Used For

Xarelto is used to prevent blood clots in your veins after a hip or knee replacement operation. Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots.

Xarelto belongs to a group of medicines called antithrombotic agents. It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots.

Xylocaine 10 mg Spray

lidocaine

Read all of this leaflet carefully before Xylocaine spray is given to you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, dentist 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 dentist.

In this leaflet:

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

What Xylocaine Spray is and what it is used for

The name of your medicine is ‘Xylocaine 10 mg Spray’. It is referred to as ‘Xylocaine Spray’ in the rest of this leaflet.

Xylocaine Spray contains a medicine called lidocaine. This belongs to a group of medicines called local anaesthetics.

Xylocaine Spray is used to numb (anaesthetise) parts of the body. It stops pain happening during:

  • Medical examinations and operations of the nose and throat.
  • Childbirth, and after the birth if stitches are needed.
  • Treatment at the dentist.

Before Xylocaine Spray is given to you

1. Name Of The Medicinal Product

Omalizumab

Omalizumab

2. Qualitative And Quantitative Composition

Xolair 75 mg solution for injection:

Each pre-filled syringe of 0.5 ml solution contains 75 mg of omalizumab*.

Xoliar 150 mg solution for injection:

Each pre-filled syringe of 1 ml solution contains 150 mg of omalizumab*.

*Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection.

Clear to opalescent, slightly yellow to brown solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Xolair is indicated in adults, adolescents and children (6 to <12 years of age).

Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).

Adults and adolescents (12 years of age and older)

Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Children (6 to <12 years of age)

Xolair is indicated as add-on therapy to improve asthma co

Xyloproct 5%/0.275% Ointment

lidocaine, hydrocortisone acetate

Read all of this leaflet carefully before you start using 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 Xyloproct Ointment is and what it is used for
  • 2. Before you use Xyloproct Ointment
  • 3. How to use Xyloproct Ointment
  • 4. Possible side effects
  • 5. How to store Xyloproct Ointment
  • 6. Further information

What Xyloproct Ointment is and what it is used for

What Xyloproct Ointment is

The name of your medicine is ‘Xyloproct 5%/0.275% Ointment’. It is referred to as ‘Xyloproct Ointment’ in the rest of this leaflet.

Xyloproct Ointment contains two medicines: lidocaine and hydrocortisone.

  • Lidocaine (sometimes known as lignocaine) belongs to a group of medicines called local anaesthetics.
  • Hydrocortisone belongs to a group of medicines called corticosteroids.

What Xyloproct Ointment is used for

  • Xyloproct Oi

1. Name Of The Medicinal Product

Xamiol 50 micrograms/g + 0.5 mg/g gel

2. Qualitative And Quantitative Composition

One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).

Excipient: 160 micrograms butylated hydroxytoluene/g gel.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Gel.

An almost clear, colourless to slightly off-white gel.

4. Clinical Particulars

4.1 Therapeutic Indications

Topical treatment of scalp psoriasis in adults.

4.2 Posology And Method Of Administration

Posology

Xamiol gel should be applied to affected areas once daily. The recommended treatment period is 4 weeks. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular medical supervision.

When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30% (see section 4.4).

All the affected scalp areas may be treated with Xamiol gel. Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4g corresponds to one teaspoon).

Special populations

Renal and hepatic impairment

The safety and efficacy of Xamiol gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.

Paediatric population

The safety

1. Name Of The Medicinal Product

Xyzal 0.5 mg/ml oral solution

2. Qualitative And Quantitative Composition

1 ml of oral solution contains 0.5 mg levocetirizine dihydrochloride.

Excipients:

0.675 mg methyl parahydroxybenzoate/ml

 

0.075 mg propyl parahydroxybenzoate/ml

 

0.4 g maltitol/ml

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral solution

Clear and colorless liquid

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria.

4.2 Posology And Method Of Administration

Instruction for use

A dosing oral syringe is included in the package. The appropriate volume of oral solution should be measured with the oral syringe, and poured in a spoon or in a glass of water. The oral solution must be taken orally immediately after dilution, and may be taken with or without food.

Adults and adolescents 12 years and above:

The daily recommended dose is 5 mg (10 ml of solution).

Elderly:

Adjustment of the dose is recommended in elderly pat

1. Name Of The Medicinal Product

ISIB 60 XL Prolonged Release Tablets

and

CIBRAL 60 XL Prolonged Release Tablets

and

XISMOX 60 XL Prolonged Release Tablets

2. Qualitative And Quantitative Composition

Isosorbide mononitrate 60.0 mg

For excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged Release Tablets

Light yellow, biconvex, oval-shaped, prolonged release tablets, scored on both sides and marked "DX 31" on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis of angina pectoris

4.2 Posology And Method Of Administration

Adults: The recommended dose is one 60 mg tablet once daily to be taken in the morning. The dose may be increased to 120 mg (two tablets) daily, both to be taken once daily in the morning. The dose can be titrated, by initiating treatment with 30 mg (half tablet) for the first 2-4 days to minimize the possibility of headache.

Children: The safety and efficacy in children has not been established.

Elderly: No evidence of a need for routine dosage adjustment in the elderly has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.

There is a risk of tolerance developing when nitrate therapy is given. For this reason it is important that the tablets are taken once a day to achieve an interval with low nitrate concentration, thereby reducing the risk of tolerance development.

When necessary the product may be used in combination with beta-adrenoreceptor blocker

1. Name Of The Medicinal Product

Xigris* 5mg powder for solution for infusion.

Xigris 20mg powder for solution for infusion.

2. Qualitative And Quantitative Composition

Xigris 5mg: Each vial contains 5mg of Drotrecogin alfa (activated).

After reconstitution with 2.5ml of Water for Injection each ml contains 2mg of Drotrecogin alfa (activated).

Excipient: Each vial contains approximately 17mg sodium.

Xigris 20mg: Each vial contains 20mg of drotrecogin alfa (activated).

After reconstitution with 10ml of Water for Injection, each ml contains 2mg of Drotrecogin alfa (activated).

Excipient: Each vial contains approximately 68mg sodium.

Drotrecogin alfa (activated) is a recombinant version of the endogenous activated Protein C and is produced by genetic engineering from an established human cell line.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for solution for infusion. Xigris is supplied as a lyophilised, white to off-white powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The use of Xigris should be considered mainly in situations when therapy can be started within 24 hours after the onset of organ failure (for further information see section 5.1).

4.2 Posology And Method Of Administration

Xigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis.

Treatment should be started within 48 hours, and preferably within 24 hours, of onset of the fir

1. Name Of The Medicinal Product

Xenical 120 mg hard capsules

2. Qualitative And Quantitative Composition

Each hard capsule contains 120 mg orlistat.

For a full list of excipients, see 6.1.

3. Pharmaceutical Form

Hard capsule.

The capsule has a turquoise cap and turquoise body bearing the imprint of “ROCHE XENICAL 120”.

4. Clinical Particulars

4.1 Therapeutic Indications

Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m?, or overweight patients (BMI > 28 kg/m?) with associated risk factors.

Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of therapy.

4.2 Posology And Method Of Administration

Adults

The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted.

The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30 % of calories from fat. It is recommended that the diet should be rich in fruit and vegetables. The daily intake of fat, carbohydrate and protein should be distributed over three main meals.

Doses of orlistat above 120 mg three times daily have not been shown to provide additional benefit.

The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing. Upon discontinuation of therapy,

1. Name Of The Medicinal Product

Xagrid

2. Qualitative And Quantitative Composition

Each hard capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride)

Excipients

Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous lactose (65.8 mg).

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Hard capsule.

An opaque white hard capsule imprinted with S 063.

4. Clinical Particulars

4.1 Therapeutic Indications

Xagrid is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.

An at risk patient

An at risk essential thrombocythaemia patient is defined by one or more of the following features:

• > 60 years of age or

• a platelet count> 1000 x 109/l or

• a history of thrombo-haemorrhagic events.

4.2 Posology And Method Of Administration

Treatment with Xagrid should be initiated by a clinician with experience in the management of essential thrombocythaemia.

The recommended starting dose of anagrelide is 1 mg/day, which should be administered orally in two divided doses (0.5 mg/dose).

The starting dose should be maintained for at least one week. After one week the dose may be titrated, on an individual basis, to achieve the lowest effective dose required to reduce and/or maintain a platelet count below 600 x 109/l and id

1. Name Of The Medicinal Product

Xiapex 0.9 mg powder and solvent for solution for injection.

2. Qualitative And Quantitative Composition

Each vial of powder contains 0.9 mg of collagenase clostridium histolyticum*.

*A formulation of two collagenase enzymes co-expressed and harvested from anaerobic fermentation of a phenotypically selected strain of Clostridium histolyticum bacterium.

Excipients:

Sodium injected per joint:

Metacarpophalangeal (MP) joints: 0.9 mg.

Proximal interphalangeal (PIP) joints: 0.7 mg.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder and solvent for solution for injection.

(Powder for injection).

The powder is a white lyophilised powder.

The solvent is a clear colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Xiapex is indicated for the treatment of Dupuytren's contracture in adult patients with a palpable cord.

4.2 Posology And Method Of Administration

Xiapex must be administered by a physician appropriately trained in the correct administration of the product and experienced in the diagnosis and management of Dupuytren's disease.

Posology

The recommended dose of Xiapex is 0.58 mg per injection into a palpable Dupuytren's cord. The volume of reconstituted Xiapex to be administered into the Dupuytren's cord differs depending on the type of joint being treated (see Table 1).

Approximately 24 hours after injection, a finger extension procedure may be performed, as necessary, to fac

1. Name Of The Medicinal Product

Xatral XL 10 mg prolonged release tablets

2. Qualitative And Quantitative Composition

Each tablet contains 10mg alfuzosin hydrochloride.

Excipient: Hydrogenated castor oil

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Prolonged release tablet.

Round biconvex, three layer tablet: one white layer between two yellow layers.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of the functional symptoms of benign prostatic hypertrophy (BPH).

For information on use in acute urinary retention (AUR) related to BPH see sections 4.2 and 5.1.

4.2 Posology And Method Of Administration

Xatral XL should be swallowed whole (see section 4.4).

BPH: The recommended dose is one 10mg tablet to be taken once daily after a meal.

AUR: In patients 65 years and older, one 10 mg tablet daily after a meal to be taken from the first day of catheterisation. The treatment should be administered for 3-4 days, 2-3 days during catheterisation and 1 day after its removal. In this indication no benefit has been established in patients under 65 years of age or if treatment is extended beyond 4 days.

Paediatric Population

Efficacy of Xatral XL has not been demonstrated in children aged 2 to 16 years (see section 5.1). Therefore Xatral XL is not indicated for use in the paediatric population.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients (see Section 6.1 List of excipients);

• history of orthostatic hypotension;

• combination with other

1. Name Of The Medicinal Product

Xatral 2.5 mg film coated tablet

2. Qualitative And Quantitative Composition

Each tablet contains 2.5mg alfuzosin hydrochloride.

Excipient: Lactose

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film coated tablet.

White round tablet marked Xatral 2.5 on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of the functional symptoms of benign prostatic hypertrophy.

4.2 Posology And Method Of Administration

Xatral tablets should be swallowed whole. The first dose should be given just before bedtime.

Adults

The usual dose is one tablet three times daily. The dose may be increased to a maximum of 4 tablets (10mg) per day depending on the clinical response.

Elderly and treated hypertensive patients

As a routine precaution when prescribing alfuzosin to elderly patients (aged over 65 years) and the treated hypertensive patient, the initial dose should be 1 tablet in the morning and 1 tablet in the evening.

Renal insufficiency

In patients with renal insufficiency, as a precaution, it is recommended that the dosing be started at Xatral 2.5mg twice daily adjusted according to clinical response.

Hepatic insufficiency

In patients with mild to moderate hepatic insufficiency, it is recommended that therapy should commence with a single dose of Xatral 2.5mg/day to be increased to Xatral 2.5mg twice daily according to clinical response.

1. Name Of The Medicinal Product

XGEVA®

2. Qualitative And Quantitative Composition

Each vial contains 120 mg of denosumab in 1.7 ml of solution (70 mg/ml).

Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.

Excipients with known effects:

Each 1.7 ml of solution contains 78 mg sorbitol (E420).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection (injection).

Clear, colourless to slightly yellow solution and may contain trace amounts of translucent to white proteinaceous particles.

4. Clinical Particulars

4.1 Therapeutic Indications

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours.

4.2 Posology And Method Of Administration

Posology

The recommended dose of XGEVA is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm.

Supplementation of at least 500 mg calcium and 400 IU vitamin D is required in all patients, unless hypercalcaemia is present (see section 4.4).

Patients with renal impairment

No dose adjustment is required in patients with renal impairment (see section 5.2). Experience in patients on dialysis or with severe renal impairment (creatinine clearance < 30 ml/min) is limited.

Patients with hepatic impairment

The safety and efficacy of denosumab have not been studied in pati

Xenical 120mg hard capsules

Orlistat

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

What Xenical Is And What It Is Used For

Xenical is a medicine used to treat obesity. It works in your digestive system to block about one-third of the fat in the food you eat from being digested.

Xenical attaches to the enzymes in your digestive system (lipases) and blocks them from breaking down some of the fat you have eaten during your meal. The undigested fat cannot be absorbed and is eliminated by your body.

Xenical is indicated in the treatment of obesity in conjunction with a low calorie intake diet.

Before You Take Xenical

Do not take XENICAL

  • if you are allergic (hypersensitive) to orlistat or to any of the other in