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1. Name Of The Medicinal Product

Phenergan Elixir.

2. Qualitative And Quantitative Composition

Promethazine hydrochloride 5 mg / 5 ml.

For excipients see section 6.1

3. Pharmaceutical Form

Elixir

4. Clinical Particulars

4.1 Therapeutic Indications

As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins.

As an adjunct in preoperative sedation in surgery and obstetrics.

As an antiemetic.

For short term use:

Sedation and treatment of insomnia in adults.

As a paediatric sedative.

4.2 Posology And Method Of Administration

Route of administration: Oral.

Not for use in children under the age of 2 years (see section 4.3)

As an antihistamine in allergy:

Children 2-5 years

Either 5–15 mg as a single dose.

Or 5 mg bd.

Maximum daily dose 15 mg.

Children 5-10 years

Either 10–25 mg as a single dose.

Or 5-10 mg bd.

Maximum daily dose 25 mg.

1. Name Of The Medicinal Product

Prandin 0.5 mg, 1 mg and 2 mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains 0.5 mg, 1 mg or 2 mg of repaglinide.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet

Repaglinide tablets are white (0.5 mg), yellow (1 mg), peach-coloured (2 mg), round and convex and engraved with Novo Nordisk logo (Apis bull).

4. Clinical Particulars

4.1 Therapeutic Indications

Repaglinide is indicated in patients with type 2 diabetes (Non Insulin-Dependent Diabetes Mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.

Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

4.2 Posology And Method Of Administration

Repaglinide is given preprandially and is titrated individually to optimise glycaemic control. In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient's blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient. Glycosylated haemoglobin levels are also of value in monitoring the patient's response to therapy. Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i.e. primary failure) and to detect loss of adequate blood glucose-lowering response after an initial period of effectiveness (i.e. secondary failure).

Short-term administration of repaglinide may be sufficient du

1. Name Of The Medicinal Product

Panadol Extra Soluble Tablets

2. Qualitative And Quantitative Composition

Each tablet contains Paracetamol Ph.Eur. 500.0 mg and Caffeine Ph.Eur. 65.0 mg.

3. Pharmaceutical Form

Effervescent tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Panadol Extra is a mild analgesic and antipyretic formulated to give extra pain relief. The soluble tablets are recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, backache, toothache, colds and influenza, sore throat, rheumatic pain and dysmenorrhoea.

4.2 Posology And Method Of Administration

Panadol Extra should be dissolved in at least half a tumblerful of water.

Adults:

Two tablets up to four times daily.

Do not exceed 8 tablets in 24 hours.

Elderly:

As for adults.

Children:

Not recommended for children under 12 years.

Method of Administration

Panadol Extra Soluble Tablets are for oral administration only.

4.3 Contraindications

Hypersensitivity to paracetamol, caffeine or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking thi

1. Name Of The Medicinal Product

Paroxetine 30 mg Film-coated Tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains:

Paroxetine 30 mg (as paroxetine hydrochloride, anhydrous 33.3 mg).

For excipients, see 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Blue, round, coated, biconvex tablets, diameter 12 mm, marked “P” and “30” with score line on one side, the other side is smooth.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of:

Major depressive episode.

Obsessive-compulsive disorder.

Panic disorder with and without agoraphobia.

Social Anxiety Disorders/Social phobia

Generalised Anxiety Disorder

4.2 Posology And Method Of Administration

It is recommended that paroxetine is administered once daily in the morning with food. The 20 mg tablets should be swallowed whole (or halved) with liquid rather than chewed.

Major Depressive Episode: The recommended dose is 20 mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy.

As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. In some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to the patient's response.

Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.

Obsessive Compul

PROPINE

Dipivefrine hydrochloride 0.1% (w/v), eye drops, solution

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

What Propine Is And What It Is Used For

PROPINE is an eye drop solution. It is used to treat a certain type of glaucoma (disease where the pressure in the eyeball is abnormally high) called “open angle” glaucoma (see paragraph below).

Your eyeball contains a watery liquid, which is constantly being drained out of the eye, and new liquid is made to replace this. “Open angle” glaucoma occurs when the liquid cannot drain out quickly enough. This leads to raised pressure within the eyeball which can eventually damage your sight. PROPINE works by reducing the production of liquid and also by increasing the amount of liquid that is drained. This reduces the pressure inside the eye.

Before You Use Propine

Do NOT use PROPINE:

  • if you are alle

PROPECIA 1 mg film-coated Tablets

(finasteride)

This medicine is for use in men only

Read all of this leaflet carefully before you start to take this medicine.

  • Keep this leaflet. You may want 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 Propecia is and what it is used for
  • 2. Before you take Propecia
  • 3. How to take Propecia
  • 4. Possible side effects
  • 5. How to store Propecia
  • 6. Further information.

What Propecia is and what it is used for

Propecia contains a medicine called finasteride. This belongs to a group of medicines called Type II ‘5-alpha reductase inhibitors’.

Your doctor has prescribed Propecia because you have male pattern hair loss (also known as androgenetic alopecia). Propecia increases hair growth on the scalp and prevents further hair loss in men. Men with mild to moderate, but not complete hair loss, can benefit from using Propecia.

How does the hair on your head grow?

On average your hair grows about 1 centimetre (half an inch) each month. Hair grows from hair follicles, which are located under your skin.

A single scalp hair grows continuously for 2-4 years (growth phase) and then stops growing for 2-4 months (rest phase). After this the hair falls out. In it

PEPCID Tablets

(famotidine)

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

What Pepcid is and what it is used for

Pepcid contains a medicine called famotidine (either 20 mg or 40 mg). This belongs to a group of medicines called ‘H2-blockers’. Pepcid works by lowering the amount of acid you produce in your stomach.

Pepcid is used for:

  • preventing ulcers in your stomach (gastric ulcer) or the first part of your intestine (duodenal ulcer)
  • healing ulcers and to give you relief from symptoms. Pepcid may also be used to lower the chance that your duodenal ulcer will come back
  • treating ‘gastro-oesophageal reflux disease’ (GORD) caused by stomach acid and food from your stomach going back up into your food pipe (oesophagus), or for preventing the symptoms from coming back

1. Name Of The Medicinal Product

Procarbazine 50mg Capsules

2. Qualitative And Quantitative Composition

Each capsule contains 58.3mg Procarbazine hydrochloride (equivalent to 50mg of Procarbazine).

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Capsules with white opaque cap and body. Marked 'CL 50' on cap.

4. Clinical Particulars

4.1 Therapeutic Indications

The main indication is Hodgkin's disease (lymphadenoma).

Procarbazine may also be useful in other advanced lymphomata and a variety of solid tumours which have proved resistant to other forms of therapy.

4.2 Posology And Method Of Administration

In combination chemotherapeutic regimens:

Procarbazine is usually administered concomitantly with other appropriate cytostatic drugs in repeated four- to six-weekly cycles. In most such combination chemotherapy regimens currently in use (eg. the so-called MOPP schedule with mustine, Vincristine and Prednisone) Procarbazine is given daily on the first 10 - 14 days of each cycle in a dosage of 100mg per sq. metre of body surface (to nearest 50mg).

As sole therapeutic agent: Adults:

Treatment should begin with small doses which are increased gradually up to a maximum daily dose of 250 or 300mg divided as evenly as possible throughout the day.

Initial dosage scheme

1st day:

50mg

4th day:

200mg

1. Name Of The Medicinal Product

Pramipexole 0.18 mg tablets

2. Qualitative And Quantitative Composition

Pramipexole 0.18 mg tablets contain 0.18 mg of pramipexole base.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

Strength

(mg base)

Appearance

0.18

white, biconvex, oblong, scored on both sides tablets (dimensions: 8mm ? 4mm approximately)

Pramipexole 0.18 mg tablets:

The tablet can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Pramipexole is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).

4.2 Posology And Method Of Administration

Parkinson's disease

The tablets should be taken orally, swallowed with water, and can be taken either with or without food. The daily dosage is administered in equally divided doses 3 times a day.

Initial treatment:

Dosages should be increased gradually from a starting-d

1. Name Of The Medicinal Product

Prialt 100 micrograms/ml solution for infusion

2. Qualitative And Quantitative Composition

One ml solution contains 100 ?g ziconotide (as acetate).

1 ml vial: Each vial contains 100 ?g ziconotide (as acetate).

5 ml vial: Each vial contains 500 ?g ziconotide (as acetate).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for infusion. Clear, colourless solution, free of visible particles.

4. Clinical Particulars

4.1 Therapeutic Indications

Ziconotide is indicated for the treatment of severe, chronic pain in adults who require intrathecal (IT) analgesia.

4.2 Posology And Method Of Administration

Treatment with ziconotide should only be undertaken by physicians experienced in intrathecal (IT) administration of medicinal products.

Adults (including the elderly

Dosing of ziconotide should be initiated at 2.4 ?g/day and titrated on an individual patient basis according to the patient's analgesic response and adverse reactions. Patients should be titrated in dose increments of

Ziconotide must be administered as a continuous infusion via an intrathecal catheter, using an external or internally implanted mechanical infusion pump capable of delivering an accurate infusion volume. As the risk of meningitis secondary to prolonged catheterisation of the intrathecal space is greater with an external catheter infusion system, internal systems are recommended to administer ziconotide for prolonged periods. An external catheter system should only be used when an internal system cannot be implanted.

When low doses of ziconotide are required, for example wh

1. Name Of The Medicinal Product

Pentagastrin Injection BP

2. Qualitative And Quantitative Composition

Pentagastrin 0.025% w/v

3. Pharmaceutical Form

Solution for Injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Pentagastrin Injection BP is used for the diagnostic testing of gastric secretion.

4.2 Posology And Method Of Administration

For administration either subcutaneously or by continuous intravenous infusion.

Adults (including the elderly) and Children

The following procedure is adopted for testing gastric secretion with Pentagastrin Injection BP:

The patient receives no medication (eg. antacids, etc.) that might affect the results of the test for 24 hours and no food for 12 hours before the test. On the morning of the test a radio-opaque tube (Leven no. 7 or Ryles`s 12 – 16Fr.) is passed into the patients stomach by the way of the nose. Radiological observation is used to ensure that the tube is correctly positioned in the lower part of the body of the stomach.

The tube is securely fastened to the patient`s nose and forehead with adhesive tape to ensure that it is not displaced. The patient lies on his left side.

The gastric juices are then collected by applying continuous suction (at 30-50 mm Hg below atmospheric pressure) to this tube, supplemented by manual suction. The patient takes occasional deep breaths to improve collection. The basal secretion is obtained by collecting samples at 15 minute intervals over an hour.

Pentagastrin Injection BP is then given, either at a dose of:

(a) 6 micrograms/kg bodyweight subcutaneously, or

(b) 0.6 micrograms/kg/hour as

1. Name Of The Medicinal Product

ProHance

2. Qualitative And Quantitative Composition

Gadoteridol 279.3mg/ml (0.5M)

3. Pharmaceutical Form

Sterile solution for intravenous injection

4. Clinical Particulars

4.1 Therapeutic Indications

Using Magnetic Resonance Imaging (MRI), ProHance provides contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualization (compared with unenhanced MRI) of lesions with abnormal vascularity or those thought to cause a disruption of the normal blood-brain barrier.

ProHance can also be used for whole body MRI including the head, neck, liver, breast, muscoloskeletal system and soft tissue pathologies.

4.2 Posology And Method Of Administration

Adults

The recommended dose of ProHance for imaging most brain and spinal pathologies is 0.1 mmol/kg. However, doses of 0.3 mmol/kg have been shown to be useful in patients suspected of having cerebral metastases or other poorly enhancing lesions.

The recommended dose for whole body MRI is 0.1 mmol/kg.

Children (2 years and above)

The recommended dose of ProHance for brain imaging and spine pathologies is 0.1 mmol/kg (0.2 ml/kg).

ProHance has been used in only a limited number of children aged between 6 months and 2 years. If an MRI procedure must be performed in this group, particular caution should be exercised.

The safety and efficacy of doses higher than 0.1 mmol/kg and sequential or repeat procedures have not been established.

To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml normal saline flush. The imaging p

1. Name Of The Medicinal Product

Perindopril 4 mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains 4 mg perindopril tert-butylamine salt equivalent to 3.338 mg perindopril.

Excipient: 59.330 mg lactose / tablet

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet

White to off-white coloured, capsule shaped, uncoated tablets with debossing “D” on one side and “5” & “8” on either side of the break line on another side. The tablet can be divided into two equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension

Treatment of hypertension

Heart failure

Treatment of symptomatic heart failure

Stable Coronary Artery Disease

Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation

4.2 Posology And Method Of Administration

It is recommended that perindopril is taken once daily in the morning before a meal.

The dose should be individualized according to the patient profile (see section 4.4) and blood pressure response.

Hypertension

Perindopril may be used in monotherapy or in combination with other classes of antihypertensive therapy.

The recommended starting dose is 4 mg given once daily in the morning.

Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation or seve

1. Name Of The Medicinal Product

Phenytoin Injection B.P. 250mg/5ml.

2. Qualitative And Quantitative Composition

Each 5ml contains Phenytoin Sodium B.P. 250mg.

3. Pharmaceutical Form

Clear, colourless, particle free solution intended for parenteral administration to human beings.

4. Clinical Particulars

4.1 Therapeutic Indications

Phenytoin Injection B.P. is indicated for the control of status epilepticus of the tonic clonic (grand mal) type and prevention and treatment of seizures occurring during or following neurosurgery and/or severe head injury.

4.2 Posology And Method Of Administration

Method of administration: Intravenous. Intramuscular.

Solutions for parenteral administration should be inspected visually for particulate matter and discoloration prior to use.

Only a clear solution should be used and the product should be discarded if a precipitate or haziness develops in the solution. On refrigeration or freezing, a precipitate might form, but this will dissolve when the solution is allowed to stand at room temperature. The product is still suitable for use. Only a clear solution should be used. A faint yellow discoloration may develop, but this does not affect the potency of the solution.

There is a relatively small margin between full therapeutic effect and minimally toxic doses of this drug. Optimum control without clinical signs of toxicity can most often be achieved with serum levels in the range 10 - 20mg/l (40 - 80 micromoles/l).

Phenytoin Injection B.P. should be injected slowly directly into a large vein through a large-gauge needle or intravenous catheter. Because of the alkalinity of the solution, each injection or infusion of phenytoin should be preceded and fol

1. Name Of The Medicinal Product

Prosulf® 10mg/ml Solution for Injection

Protamine Sulphate 10mg/ml Solution for Injection

2. Qualitative And Quantitative Composition

Protamine Sulphate 10mg/ml

3. Pharmaceutical Form

Solution for injection

A clear, colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Protamine sulphate is used to counteract the anticoagulant effect of heparin: before surgery; after renal dialysis; after open-heart surgery; if excessive bleeding occurs and when an overdose has inadvertently been given.

4.2 Posology And Method Of Administration

Adults:

Prosulf should be administered by slow intravenous injection over a period of about 10 minutes. No more than 50mg of protamine sulphate should be given in any one dose.

The dose is dependent on the amount and type of heparin to be neutralised, its route of administration and the time elapsed since it was last given, since heparin is continuously being excreted. Ideally, the dose required to neutralise the action of heparin should be guided by blood coagulation studies or calculated from a protamine neutralisation test.

In gross excess, protamine itself acts as an anticoagulant.

Neutralisation of unfractionated (UF) heparins:

1mg of protamine sulphate will usually neutralise at least 100 international units of mucous heparin or 80 units of lung heparin. The dose of protamine sulphate should be reduced if more than 15 minutes have elapsed since intravenous injection.

For example, if 30-60 minutes have elapsed since heparin was injected intravenously, 0.5-0.75mg protamine sulphate per 100 units of mucous hep

1. Name Of The Medicinal Product

Paroxetine 20 mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains:

Paroxetine 20 mg equivalent to 22.21 mg Paroxetine hydrochloride

For excipients see section 6.1 “List of excipients”.

3. Pharmaceutical Form

Tablet

Diamond-shaped white to off-white tablets, deep score on one side, small score on the other side.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of

- Major Depressive Episode

- Obsessive Compulsive Disorder

- Panic Disorder with and without agoraphobia

- Social Anxiety Disorders/Social phobia

- Generalised Anxiety Disorder

- Post-traumatic Stress Disorder

4.2 Posology And Method Of Administration

It is recommended that paroxetine is administered once daily in the morning with food.

The tablet should be swallowed rather than chewed.

MAJOR DEPRESSIVE EPISODE

The recommended dose is 20 mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy.

As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary

within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. In some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to the patient's response.

Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from s

1. Name Of The Medicinal Product

Perindopril 8 mg Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains perindopril tert-butylamine 8 mg equivalent to 6.676 mg perindopril.

Excipient: Lactose anhydrous. Each tablet contains 170.40 mg lactose anhydrous.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

White, capsule shaped, biconvex tablets, engraved "APO" on one side and "PE" bisect "8" on the other side.

The tablets can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension

Treatment of hypertension

Heart Failure

Treatment of symptomatic heart failure

Stable coronary artery disease

Reduction of risk of cardiac events in patients with a history of myocardial infraction and/or revascularisation.

4.2 Posology And Method Of Administration

It is recommended that Perindopril is taken once daily in the morning before a meal.

The dose should be individualised according to the patient profile (see section 4.4 ) and blood pressure response.

Hypertension

Perindopril may be used in monotherapy or in combination with other classes of antihyper–tensive therapy.

The recommended starting dose is 4 mg given once daily in the morning.

Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation or se

1. Name Of The Medicinal Product

PENTASA Sachet 2g prolonged release granules

2. Qualitative And Quantitative Composition

Each sachet contains mesalazine 2 g

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged release granules

White-grey to pale white-brown granules

4. Clinical Particulars

4.1 Therapeutic Indications

Mild to moderate ulcerative colitis

4.2 Posology And Method Of Administration

Ulcerative colitis

Adults

Active disease

Individual dosage, up to 4 g mesalazine daily divided into 2-4 doses.

Maintenance treatment

Individual dosage. Recommended dosage, 2 g mesalazine once daily.

Paediatric population:

There is only limited documentation for an effect in children (age 6-18 years).

Children 6 years of age and older:

Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).

Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).

It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.

1. Name Of The Medicinal Product

Prostin VR Sterile Solution.

2. Qualitative And Quantitative Composition

Each 1 ml contains 500 micrograms (0.5 mg) alprostadil.

3. Pharmaceutical Form

Sterile solution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Prostin VR is indicated to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in infants who have congenital defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, co-arctation of the aorta, aortic stenosis, aortic atresia, mitral atresia, or transposition of the great vessels with or without other defects.

4.2 Posology And Method Of Administration

For administration by intravenous drip or constant rate infusion pump.

In infants with lesions restricting pulmonary blood flow (blood is flowing through the ductus arteriosus from the aorta to the pulmonary artery), Prostin VR may be administered by continuous infusion through an umbilical artery catheter placed at or just above the junction of the descending aorta and the ductus arteriosus, or intravenously. Adverse effects have occurred with both routes of administration, but the types of reactions are different. A higher incidence of flushing has been associated with intra-arterial than with intravenous administration.

The infusion is generally initiated at a rate of 0.05 to 0.1 micrograms alprostadil per kilogram of body weight per minute. The most experience has been with 0.1 micrograms/kg/min. After a therapeutic response (an increase in pO2 in neonates with restricted pulmo

1. Name Of The Medicinal Product

Pulmicort CFC-free Inhaler 100 micrograms.

2. Qualitative And Quantitative Composition

Each metered dose (ex-valve)/actuation contains budesonide 100 micrograms.

For full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Pressurised inhalation, suspension.

The NebuChamberTM spacer device is the only spacer device to be used with Pulmicort CFC-free Inhaler.

4. Clinical Particulars

4.1 Therapeutic Indications

Asthma.

4.2 Posology And Method Of Administration

For inhalation use.

Adults, including the elderly: 200 micrograms twice daily, in the morning and in the evening. During periods of severe asthma the daily dosage can be increased up to 1600 micrograms.

In patients whose asthma is well controlled, the daily dose may be reduced below 400 micrograms but should not go below 200 micrograms.

The dose should be reduced to the minimum needed to maintain good asthma control.

Children 2-12 years:200 to 800 micrograms daily in divided doses.

A higher strength inhaler (200 microgram) is available for use in children with moderately severe/severe asthma and requiring a dose regimen of Pulmicort CFC-free Inhaler of 800 micrograms as a total daily dose.

The dose should be reduced to the minimum needed to maintain good asthma control.

Pulmicort CFC-free Inhaler is not recommended for use in children less than 2 years of age.

Patients maintained on oral glucocorticosteroids