Drugs Index
Medical Conditions:
- Medical Conditions G
- Medical Conditions I
- Medical Conditions P
- Medical Conditions C
- Medical Conditions N
- Medical Conditions T
- Medical Conditions E
- Medical Conditions D
- Medical Conditions F
- Medical Conditions H
- Medical Conditions M
- Medical Conditions B
- Medical Conditions U
- Medical Conditions O
- Medical Conditions S
- Medical Conditions A
- Medical Conditions R
- Medical Conditions L
- Medical Conditions W
- Medical Conditions V
- Medical Conditions K
- Medical Conditions J
- Medical Conditions X
Drug Classes
- Drug Classes A
- Drug Classes M
- Drug Classes H
- Drug Classes C
- Drug Classes B
- Drug Classes U
- Drug Classes T
- Drug Classes O
- Drug Classes I
- Drug Classes N
- Drug Classes V
- Drug Classes E
- Drug Classes G
- Drug Classes P
- Drug Classes L
- Drug Classes Q
- Drug Classes F
- Drug Classes S
- Drug Classes D
- Drug Classes R
- Drug Classes 5
- Drug Classes K
Drugs Information:
Drugs List
1. Name Of The Medicinal Product
Solpadeine Plus Soluble Tablets
2. Qualitative And Quantitative Composition
Each tablet contains Paracetamol Ph. Eur. 500 mg, Codeine Phosphate Hemihydrate Ph. Eur. 8 mg and Caffeine Ph. Eur. 30.0 mg.
3. Pharmaceutical Form
Effervescent tablet.
4. Clinical Particulars
4.1 Therapeutic Indications
For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.
Solpadeine Plus Soluble Tablets are recommended for the relief of migraine, headache, backache, rheumatic pain, period pains, dental pain, strains & sprains and sciatica.
4.2 Posology And Method Of Administration
Adults (including the elderly)
2 tablets dissolved in at least half a tumbler of water. These doses may be given up to 3 or 4 times a day if necessary. The dose should not be repeated more frequently than every 4 hours. Do not take for more than 3 days without consulting a doctor.
Children
Not to be given to children under 12 years of age.
Do not take for more than 3 days continiously without medical review.
4.3 Contraindications
Hypersensitivity to paracetamol, caffeine, codeine, opioid analgesics or any of the other constituents.
Use of codeine containing products is contraindicated in mothers who are breast feeding unless prescribed by a doctor.
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 alcoh
1. Name Of The Medicinal Product
Slow Sodium
2. Qualitative And Quantitative Composition
The active ingredient is Sodium Chloride Ph.Eur. Sodium Chloride contains not less than 99.0 per cent and not more than 100.5 per cent of NaCl. One coated tablet contains 600 mg sodium chloride.
3. Pharmaceutical Form
Coated tablets.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment and prophylaxis of sodium chloride deficiency.
4.2 Posology And Method Of Administration
It is important that the tablets should be swallowed whole with water (approx. 70ml per tablet where kidney function is normal to avoid hypernatraemia), and not chewed.
Adults: For prophylaxis 4-8 tablets per day. For treatment dosage to be adjusted to individual needs up to a maximum of 20 tablets per day in cases of severe salt depletion. For control of muscle cramps during routine maintenance haemodialysis usually 10-16 tablets per dialysis. In some cases of chronic renal salt-wasting up to 20 tablets per day may be required with appropriate fluid intake.
Children: Dosage should be adjusted to individual needs.
Elderly: No special dosage adjustment.
4.3 Contraindications
Slow Sodium is contra-indicated in any situation where salt retention is undesirable, such as oedema, heart disease, cardiac decompensation and primary or secondary aldosteronism; or where therapy is being given to produce salt and water loss.
4.4 Special Warnings And Precautions For Use
Warnings: None
Precautions Use of Slow Sodium without adequate water supplementation can produce hypernatraemia. The matrix (ghost) is often elimina
Stalevo 100 mg/25 mg/200 mg film-coated tablets
Levodopa/carbidopa/entacapone
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 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 Stalevo is and what it is used for
2. Before you take Stalevo
3. How to take Stalevo
4. Possible side effects
5 How to store Stalevo
6. Further information
What Stalevo Is And What It Is Used For
Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Stalevo is used for the treatment of Parkinson’s disease.
Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa and entacapone improve the antiparkinson effects of levodopa.
Before You Take Stalevo
Do not take Stalevo if you
- are allergic (hypersensitive) to levodopa, carbidopa or entacapone, or any of the other ingredients of Stalevo
- have narrow-angle glaucoma (an eye disorder)
- have a tumour
1. Name Of The Medicinal Product
Salvacyl 11.25mg powder and solvent for suspension for injection.
2. Qualitative And Quantitative Composition
One vial of powder contains 11.25mg of triptorelin, as triptorelin embonate.
After reconstitution in the 2mL solvent, the reconstituted solution contains 11.25mg of triptorelin, as triptorelin embonate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Powder and solvent for suspension for injection (Powder for injection).
- Powder: White to off-white powder.
- Solvent: Clear solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Salvacyl is indicated for the reversible reduction of testosterone to castrate levels in order to decrease sexual drive in adult men with severe sexual deviations.
The treatment with Salvacyl is to be initiated and controlled by a psychiatrist. The treatment should be given in combination with psychotherapy, in order to decrease deviating sexual behaviour.
4.2 Posology And Method Of Administration
The recommended dose of Salvacyl is 11.25mg triptorelin (1 vial) administered every twelve weeks as a single intramuscular injection.
The lyophilised microgranules are to be reconstituted using 2mL of water for injections (see section 6.6).
The injection site should be varied periodically.
Since Salvacyl is a suspension of microgranules, inadvertent intravascular injection must be strictly avoided.
No dosage adjustment is necessary for patients with renal or hepatic impairment.
Salvacyl must be administered under the supervision of a medically qualified person (nurse or physician).
SINGULAIR Paediatric 4 mg chewable tablets
montelukast
Read all of this leaflet carefully before your child starts taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- 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 as your child’s.
- 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 SINGULAIR Paediatric is and what it is used for
2. Before SINGULAIR Paediatric is taken
3. How to take SINGULAIR Paediatric
4. Possible side effects
5. How to store SINGULAIR Paediatric
6. Further information
What SINGULAIR Paediatric is and what it is used for
SINGULAIR Paediatric is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in your lungs. By blocking leukotrienes, SINGULAIR Paediatric improves asthma symptoms and helps control asthma.
Your doctor has prescribed SINGULAIR Paediatric to treat your child’s asthma, preventing asthma symptoms during the day and night.
- SINGULAIR Paediatric is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
- SINGULAIR Paediatric may also be used as an alternative treatment to inhaled corticosteroids for 2 to 5 year old patients wh
Starlix 60 mg film-coated tablets
Starlix 120 mg film-coated tablet
Starlix 180 mg film-coated tablets
Nateglinide
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 Starlix is and what it is used for
- 2. Before you take Starlix
- 3. How to take Starlix
- 4. Possible side effects
- 5. How to store Starlix
- 6. Further information
What Starlix Is And What It Is Used For
Starlix is a medicine to lower blood sugar (glucose), which is taken by mouth (these medicines are also known as oral anti-diabetics).
It is used by people with type 2 diabetes. (This kind of diabetes is also called non-insulin-dependent diabetes mellitus.)
Insulin is a substance produced by a body organ called the pancreas. It helps to decrease blood sugar levels, especially after meals. In patients with type 2 diabetes, the body may not start producing insulin quickly enough after meals. Starlix works by stimulating the pancreas to produce insulin more quickly. This helps to keep the blood sugar controlled after meals.
Your doctor will prescribe Starlix together with another oral anti-diabetic containing metformin.
Starlix t
1. Name Of The Medicinal Product
Soliris
2. Qualitative And Quantitative Composition
2.1 General description
Eculizumab is a humanised monoclonal IgG2/4? antibody produced in NS0 cell line by recombinant DNA technology.
2.2 Qualitative and quantitative composition
Each vial of 30 ml contains 300 mg of eculizumab (10 mg/ml).
After dilution, the final concentration of the solution to be infused is 5 mg/ml.
Excipients with known effect: Sodium (5.00 mmol per dose (1 vial))
For the full list of excipients, see section 6.1.
3. Pharmaceutical Form
Concentrate for Solution for Infusion.
Clear, colorless, pH 7.0 solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Soliris (eculizumab) is indicated for the treatment of patients with
- Paroxysmal nocturnal haemoglobinuria (PNH).
Evidence of clinical benefit of Soliris in the treatment of patients with PNH is limited to patients with history of transfusions.
- Atypical haemolytic uremic syndrome (aHUS) (see section 5.1).
4.2 Posology And Method Of Administration
Soliris must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological and/or renal disorders.
Posology
In Paroxysmal Nocturnal Haemoglobinuria (PNH):
The PNH dosing regimen consists of a 4-week initial phase followed by a maintenance phase:
• Initial phase: 600 mg of Soliris administered via
1. Name Of The Medicinal Product
Senokot Syrup Pharmacy.
2. Qualitative And Quantitative Composition
The syrup contains sennosides USP equivalent to a total sennoside content (calculated as sennoside B) of 7.5 mg per 5 ml.
For excipients, see Section 6.1.
3. Pharmaceutical Form
Syrup.
4. Clinical Particulars
4.1 Therapeutic Indications
In the management of constipation.
4.2 Posology And Method Of Administration
Senokot Syrup Pharmacy is for oral administration.
Adults, including the elderly and children over 12: Two to four 5 ml spoonfuls at night.
Children over 6 years: One to two 5 ml spoonfuls in 24 hours.
Children aged 2 to 6 years: Half to one 5 ml spoonful in 24 hours.
New users should start the lowest dose and increase, if necessary, by one half of the initial dose each day. Once regularity has been regained the dosage should be reduced and can usually be stopped.
If no bowel action has occurred after three days of progressively increased dosage, a medical examination should be considered.
4.3 Contraindications
Senokot Syrup Pharmacy should not be given when any undiagnosed acute or persistent abdominal symptoms are present.
4.4 Special Warnings And Precautions For Use
If there is no bowel movement after three days consult a doctor.
If laxatives are needed every day or abdominal pain persists consult a doctor.
Each 5 ml of syrup can provide up to 3.2 kcal and this should be taken into account wh
1. Name Of The Medicinal Product
STILNOCT 5mg
2. Qualitative And Quantitative Composition
Stilnoct 5mg Tablets:
Round white film coated tablets containing 5mg zolpidem tartrate.
3. Pharmaceutical Form
Coated tablets for oral administration.
4. Clinical Particulars
4.1 Therapeutic Indications
The short-term treatment of insomnia in situations where the insomnia is debilitating or is causing severe distress for the patient.
4.2 Posology And Method Of Administration
Route of administration: Oral
Zolpidem tartrate acts rapidly and therefore should be taken immediately before retiring, or in bed.
The recommended daily dose for adults is 10 mg.
The duration of treatment should usually vary from a few days to two weeks with a maximum of four weeks including tapering off where clinically appropriate.
As with all hypnotics, long-term use is not recommended and a course of treatment should not exceed four weeks.
Special Populations
Children
Safety and effectiveness of zolpidem in paediatric patients under the age of 18 years have not been established. Therefore, zolpidem should not be prescribed in this population (see Section 4.4 Special warnings and precautions for use).
Elderly
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate therefore a 5mg dose is recommended. These recommended doses should not be exceeded.
Hepatic impairment
As clearance and metabolism of zolpidem tartrate is reduced in hepatic impairment, dosage should begin at 5mg in these patients with particular caution being exercised in elderly pati
1. Name Of The Medicinal Product
Strepsils Sore Throat and Blocked Nose
Strepsils Sore Throat and Cough
2. Qualitative And Quantitative Composition
Amylmetacresol BP |
0.6mg |
2,4-Dichlorobenzyl alcohol HSE |
1.2mg |
Levomenthol natural or synthetic EP |
8.0mg |
3. Pharmaceutical Form
A blue circular lozenge with a characteristic taste.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of mouth and throat infections, dry, irritating cough associated with the common cold and nasal congestion.
4.2 Posology And Method Of Administration
Adults and children (over 6 years old):
One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours.
Not suitable for children under 6 years.
Elderly: There is no need for dosage reduction in the elderly.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Keep all medicines out of the reach of children.
Seroquel XL 50 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets
quetiapine fumarate
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 Seroquel XL is and what it is used for
- 2. Before you take Seroquel XL
- 3. How to take Seroquel XL
- 4. Possible side effects
- 5. How to store Seroquel XL
- 6. Further information
What Seroquel XL is and what it is used for
Seroquel XL contains a medicine called quetiapine. This belongs to a group of medicines called anti-psychotics. These medicines help with the effects of certain types of mental illness, such as:
- Hallucinations (like hearing unexplained voices), strange and frightening thoughts, changes in how you act and feeling alone and confused. This is also known as schizophrenia.
- Effects on your mood and feeling very ‘high’ or excited. You may find that you need to sleep less than usual. You may be more talkative and have racing thoughts or ideas. You may also feel more irritable than usual. This is also known as bipolar mania.
1. Name Of The Medicinal Product
STARLIX 60 mg film-coated tablets
2. Qualitative And Quantitative Composition
Each film-coated tablet contains 60 mg nateglinide.
Excipient with known effect:
Lactose monohydrate: 141.5 mg per tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical Form
Film-coated tablet
60 mg pink, round, bevelled-edge tablets with “STARLIX” marked on one side and “60” on the other.
4. Clinical Particulars
4.1 Therapeutic Indications
Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
4.2 Posology And Method Of Administration
Posology
Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner).
The dosage of nateglinide should be determined by the physician according to the patient's requirements.
The recommended starting dose is 60 mg three times daily before meals, particularly in patients who are near goal HbA1c. This may be increased to 120 mg three times daily.
Dose adjustments should be based on periodic glycosylated haemoglobin (HbA1c) measurements. Since the primary therapeutic effect of Starlix is to reduce mealtime glucose, (a contributor to HbA1c), the therapeutic response to Starlix may also be monitored with 1–2 hour post-meal glucose.
The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals.
Specific patient groups
1. Name Of The Medicinal Product
Syntocinon® Ampoules 10 IU/ml
2. Qualitative And Quantitative Composition
Oxytocin PhEur 10 units in 1ml.
For excipients, see section 6.1.
3. Pharmaceutical Form
A clear, colourless, sterile solution in 1ml clear glass ampoules.
4. Clinical Particulars
4.1 Therapeutic Indications
Induction of labour for medical reasons; stimulation of labour in hypotonic uterine inertia; during caesarean section, following delivery of the child; prevention and treatment of postpartum uterine atony and haemorrhage.
Early stages of pregnancy as a adjunctive therapy for the management of incomplete, inevitable, or missed abortion.
4.2 Posology And Method Of Administration
Induction or enhancement of labour: Oxytocin should not be started for 6 hours following administration of vaginal prostaglandins. Syntocinon should be administered as an iv drip infusion or, preferably, by means of a variable-speed infusion pump. For drip infusion it is recommended that 5 IU of Syntocinon be added to 500ml of a physiological electrolyte solution. For patients in whom infusion of sodium chloride must be avoided, 5% dextrose solution may be used as the diluent (see Section 4.4 “Special warnings and precautions for use”). To ensure even mixing, the bottle or bag must be turned upside down several times before use.
The initial infusion rate should be set at 1 to 4mU/min (2 to 8 drops/min). It may be gradually increased at intervals not shorter than 20 min, until a contraction pattern similar to that of normal labour is established. In pregnancy near term this can often be achieved with an infusion of less than 10mU/min (20 drops/min), and the recommended maximum rate is 20mU/min
1. Name Of The Medicinal Product
Salofalk Suppositories 500mg
2. Qualitative And Quantitative Composition
Each suppository contains 500mg mesalazine
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Suppository
4. Clinical Particulars
4.1 Therapeutic Indications
Management of mild and moderate attacks of ulcerative colitis, especially in the rectum and sigmoid colon and also in the descending colon.
4.2 Posology And Method Of Administration
Method of administration: Rectal
Adults and the Elderly: 1 to 2 suppositories, 2 to 3 times daily. The action of Salofalk is enhanced if the patient lies on the left side when introducing the suppository. The dosage should be adjusted to suit the progress of the condition. Do not discontinue treatment suddenly.
Children: There is little experience and only limited documentation for an effect in children.
4.3 Contraindications
Severe impairment of renal or hepatic function. Known hypersensitivity to salicylates or the excipients.
4.4 Special Warnings And Precautions For Use
Blood tests (differential blood count; liver function tests such as ALT or AST; serum creatinine) and dip-stick urinalysis should be determined prior to and during treatment, at the discretion of the treating physician. As a guideline, further testing is recommended 14 days after commencement of treatment, then a further two to three times at intervals of 4 weeks.
If the findings are normal, further testing should be carried out every 3 months. If additional symptoms occur, tests should be performed immediately.
Caution is recommended in patients
1. Name Of The Medicinal Product
Sectral 400mg Tablets
2. Qualitative And Quantitative Composition
Each tablet contains 443.40mg of the active substance Acebutolol hydrochloride (equivalent to 400mg of base).
Also contains 21.20mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Tablet
White to off-white, circular, biconvex, film-coated tablets with bevel edges, one face impressed 'SECTRAL 400 or ACB 400. Plain reverse.
4. Clinical Particulars
4.1 Therapeutic Indications
The management of hypertension, angina pectoris and the control of tachyarrhythmias.
4.2 Posology And Method Of Administration
Hypertension: Initial dosage of 400mg orally once daily at breakfast or 200mg orally twice daily. If response is not adequate within two weeks, dosage may be increased up to 400mg orally twice daily; in some patients 1200mg orally daily, given as 800mg at breakfast and 400mg in the evening may be required. A further reduction in blood pressure may be obtained by the concurrent administration of a thiazide diuretic or other anti-hypertensive agent (except Rauwolfia and its alkaloids).
Angina pectoris: Initial dosage of 400mg orally once daily at breakfast or 200mg twice daily. In severe forms up to 300mg three times daily may be required. Up to 1200mg daily has been used.
Cardiac Arrhythmias: When given orally, an initial dose of 200mg is recommended. The daily dose requirement for long term anti arrhythmic activity should lie between 400 and 1200mg daily. The dose can be gauged by response, and better control may be achieved by divided doses rather than single doses. It may take up to three hours for maxima
1. Name Of The Medicinal Product
Sandostatin® LAR® 10 mg, 20 mg or 30 mg powder and solvent for suspension for injection
2. Qualitative And Quantitative Composition
The active substance is octreotide* free peptide, 10 mg, 20 mg or 30 mg nominally 4.15% of fill weight equivalent to 4.65% of octreotide acetate.
Following suspension of the powder (microspheres) with the supplied vehicle solution, Sandostatin LAR suspension contains less than 1mmol (23mg) of sodium per dose, i.e. essentially “sodium-free”.
For a full list of excipients see section 6.1.
* INN rec.
3. Pharmaceutical Form
Powder and solvent for suspension for injection.
Powder: white to off-white powder.
Solvent for suspension for injection: clear, colourless solution.
Sandostatin LAR is a long-acting depot injection form of octreotide. Powder (microspheres for suspension for injection) to be suspended in a vehicle immediately prior to i.m. injection.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of patients with acromegaly:
For symptomatic control and reduction of growth hormone and IGF-1 levels in patients with acromegaly
• who are adequately controlled on s.c. treatment with Sandostatin; in whom surgery or radiotherapy is inappropriate or ineffective, or in the interim period until radiotherapy becomes fully effective.
• in short term treatment (3-12 months) prior to pituitary surgery (see also Section 5.1 Pharmacological properties).
Treatment of patients with advanced neuroendocrine tumours of the midgut; or of unknown primary origin where non-midgut sites of origin have been excluded.
Relief of s
Simulect 20 mg powder and solvent for solution for injection or infusion
Basiliximab
Read all of this leaflet carefully before you are given this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
- 1. What Simulect is and what it is used for
- 2. Before you are given Simulect
- 3. How Simulect is given to you
- 4. Possible side effects
- 5. How to store Simulect
- 6. Further information
What Simulect Is And What It Is Used For
Simulect belongs to a group of medicines called immunosuppressants. It is given in hospital to adults, adolescents and children who are having a kidney transplant. Immunosuppressants reduce the body’s response to anything that it sees as "foreign" – which includes transplanted organs. The body’s immune system thinks a transplanted organ is a foreign body and will try to reject it. Simulect works by stopping the immune cells that attack transplanted organs.
You will only be given two doses of Simulect. These will be given in hospital, around the time of your transplant operation. Simulect is given to stop your body from rejecting the new organ during the first 4 to 6 weeks after the transplant operation, when rejection is most likely. You will be given other medicines to help protect your new kidney during this time, such as ciclosporin and corticosteroids and after you leave hospital.
Before
1. Name Of The Medicinal Product
Salazopyrin Suspension.
2. Qualitative And Quantitative Composition
Sulfasalazine Ph.Eur., 250 mg in 5 mL.
3. Pharmaceutical Form
Oral suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
Induction and maintenance of remission of ulcerative colitis and treatment of active Crohn's disease.
4.2 Posology And Method Of Administration
The dose is adjusted according to the severity of the disease and the patient's tolerance of the drug, as detailed below.
Adults and the Elderly
Severe attacks: 20 to 40 ml four times a day may be given in conjunction with steroids as part of an intensive management regime. Rapid passage of the suspension may reduce the effect of the drug.
The night time interval between doses should not exceed 8 hours.
Moderate attacks: 20 ml four times a day may be taken with or without steroids.
Maintenance therapy: With induction of remission, reduce the dose gradually to 40 ml per day. This dosage should be continued indefinitely, since discontinuance even several years after an acute attack is associated with a four-fold increase in relapse.
Children
The dose is reduced in proportion to body weight.
Acute attack or relapse: 0.8 - 1.2 ml/kg/day.
Maintenance dosage: 0.4 - 0.6 ml/kg/day.
4.3 Contraindications
• Use in infants under the age of two years.
• Use in patients where there is a significant hypersensitivity to sulfasalazine, sulfonamides, salicylates or the sodium benzoate prese
1. Name Of The Medicinal Product
Stesolid® rectal tubes 10 mg.
2. Qualitative And Quantitative Composition
Diazepam 4 mg/ml.
3. Pharmaceutical Form
Enema.
4. Clinical Particulars
4.1 Therapeutic Indications
Diazepam has anticonvulsant, sedative, and muscle relaxant properties. It is used in the treatment of severe anxiety and tension states, as a sedative and premedication, in the control of muscle spasm, and in the management of alcohol withdrawal symptoms.
Stesolid rectal tubes 10 mg may be used in acute severe anxiety and agitation, epileptic and febrile convulsions, tetanus, as a sedative in minor surgical and dental procedures, or in other circumstances in which a rapid effect is required but where intravenous injection is impracticable or undesirable.
Stesolid rectal tubes 10 mg may be of particular value for the immediate treatment of convulsions in infants and children.
4.2 Posology And Method Of Administration
Sensitivity to diazepam varies with age.
Children above 1 year of age: | 0.5 mg/kg body weight |
Adults: | 0.5 mg/kg body weight |
Elderly patients: | 0.25 mg/kg body weight |
A maximum dose of 30 mg diazepam is recommended, unless adequate medica
1. Name Of The Medicinal Product
SUSTIVA 30 mg/ml oral solution
2. Qualitative And Quantitative Composition
Each ml contains 30 mg of efavirenz
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Oral solution
Colourless to slightly yellow clear liquid.
4. Clinical Particulars
4.1 Therapeutic Indications
SUSTIVA oral solution is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older, who are unable to swallow the hard capsules or the film-coated tablets.
SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing SUSTIVA.
For a summary of clinical and pharmacodynamic information, see section 5.1.
4.2 Posology And Method Of Administration
Posology
Therapy should be initiated by a physician experienced in the management of HIV infection.
Concomitant antiretroviral therapy: SUSTIVA must be given in combination with other antiretroviral medicines (see section 4.5).
SUSTIVA oral solution may be taken with or without food (see section 5.2).
In order to improve the tolerability of nervous system undesirable effects, bedtime dosing is recommended during the first two to four weeks of therapy and in patients