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1. Name Of The Medicinal Product

Daxas ®

2. Qualitative And Quantitative Composition

Each tablet contains 500 micrograms of roflumilast.

Excipient: This product contains 199 mg lactose monohydrate per film-coated tablet.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet (tablet).

Yellow, D-shaped film-coated tablet, embossed with “D” on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.

4.2 Posology And Method Of Administration

Posology

The recommended dose is one tablet of 500 micrograms roflumilast once daily.

Daxas may need to be taken for several weeks to achieve its effect (see section 5.1). Daxas has been studied in clinical trials for up to one year.

Special populations

Elderly (65 years and older)

No dose adjustment is necessary.

Renal impairment

No dose adjustment is necessary.

Hepatic impairment

The clinical data with Daxas in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daxas should be used with caution in these patients.

Patients with moderate or

1. Name Of The Medicinal Product

Diazepam Rectal Tubes 5mg.

Diazepam Rectal Tubes 10mg.

2. Qualitative And Quantitative Composition

Diazepam Rectal Tubes 5mg:

Each rectal tube contains diazepam BP 5mg in 2.5ml of fluid.

Diazepam Rectal Tubes 10mg:

Each rectal tube contains diazepam BP 10mg in 2.5ml of fluid.

3. Pharmaceutical Form

Rectal tube.

4. Clinical Particulars

4.1 Therapeutic Indications

Diazepam has anticonvulsant, anxiolytic, sedative, muscle relaxant and amnesic properties.

It is indicated:

i. For the short-term relief (2 to 4 weeks only) of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness;

ii. As a sedative and premedicant;

iii. As an anticonvulsant in the management of status epilepticus, febrile convulsions and poisoning;

iv. In the control of muscle spasms as in tetanus;

v. In the management of alcohol withdrawal symptoms;

The use of diazepam to treat short-term anxiety is inappropriate and

unsuitable. Diazepam should be used to treat insomnia only when it is

severe, disabling or subjecting the individual to extreme stress.

4.2 Posology And Method Of Administration

Tubes are for single use only.

The lowest dose that can control the symptoms should be used and treatment should not be continued beyond 4 weeks.

Adults and Children over 3 years: One 10mg tube. If a child is particularly small, the

1. Name Of The Medicinal Product

DERMOL™ 500 LOTION

2. Qualitative And Quantitative Composition

Benzalkonium Chloride 0.1% w/w; Chlorhexidine Dihydrochloride 0.1% w/w; Liquid Paraffin 2.5% w/w; Isopropyl Myristate 2.5% w/w.

Excipient : Cetostearyl Alcohol 5.0% w/w.

3. Pharmaceutical Form

White, non-greasy cutaneous emulsion.

4. Clinical Particulars

4.1 Therapeutic Indications

An antimicrobial emollient for the management of dry and pruritic skin conditions, especially eczema and dermatitis. The lotion is suitable for direct application, and for use as a soap substitute.

4.2 Posology And Method Of Administration

For adults, children and the elderly: For application to the skin: apply the lotion to the affected areas as required. Massage into the skin, until absorbed. For use as a soap substitute: use as a cleanser in the bath or shower, or for other toiletry purposes, instead of ordinary soap or shower gel.

4.3 Contraindications

Do not use in cases of known sensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes. The excipient cetostearyl alcohol may on rare occasions give rise to local skin reactions (e.g. contact dermatitis) in sensitive people.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Although the lotion has been specially formulated for use on dry or problem skin, in the unlikely

1. Name Of The Medicinal Product

DAKTARIN Sugar Free 2% Oral Gel

2. Qualitative And Quantitative Composition

Each gram of Daktarin Sugar Free 2% Oral Gel contains 20 mg of miconazole.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral gel.

White gel with orange taste.

4. Clinical Particulars

4.1 Therapeutic Indications

Oral treatment and prevention of fungal infections of the oropharynx and of superinfections due to Gram-positive bacteria.

4.2 Posology And Method Of Administration

For oral administration

For topical treatment of the oropharynx

Treatment should be continued for up to 2 days after the symptoms have cleared.

Adult, Elderly and Children aged 6 years and over

Apply a small amount of gel directly to the affected area with a clean finger four times a day. The gel should be kept in the mouth for as long as possible.

For oral candidosis, dental prostheses should be removed at night and brushed with the gel.

Children aged 4 months – 6 years:

Apply a small amount of gel directly to the affected area with a clean finger twice daily. The gel should be kept in the mouth for as long as possible.

The lower age limit should be increased by 1-2 months for infants who are pre-term, or infants exhibiting slow neuromuscular development.

4.3 Contraindications

Known hypersensitivity to miconazole or to any of the excipients.

In infants less than 4 months of age or in those whose swallowing reflex is not yet sufficiently developed.

In patien

1. Name Of The Medicinal Product

Deseril® tablets 1mg

2. Qualitative And Quantitative Composition

Methysergide maleate BP 1.33 mg.

3. Pharmaceutical Form

White, biconvex, sugar-coated tablet, branded DSL on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylactic treatment of migraine with or without aura, and cluster headache and other vascular headaches in patients who, despite attempts at control, experience headaches of such severity or regularity that social or economic life is seriously disrupted. (Note: Deseril is not recommended for treatment of the acute attack).

Diarrhoea caused by carcinoid disease.

4.2 Posology And Method Of Administration

Prophylactic treatment of headache: 1 or 2 tablets three times a day with meals. Treatment should start with one tablet at bedtime and dosage should then be increased gradually over about two weeks until effective levels are reached. The minimum effective dose should be used, often that which will prevent 75% of attacks rather than all headaches.

From the outset, patients should understand that regular clinical supervision and periodic withdrawal of treatment are essential so that adverse effects can be recognised and minimised (see Section 4.4 Special warnings and precautions for use).

Carcinoid Syndrome: High doses are usually necessary. In most reported cases, dosage ranged between 12 and 20 tablets daily.

Children: Not recommended.

Elderly: No evidence exists that elderly patients require different dosage from younger patients.

4.3 Contraindications

Hyperse

1. Name Of The Medicinal Product

D-GAM ®, Human Anti-D Immunoglobulin, 1,500 and 2,500 IU, solution for injection.

2. Qualitative And Quantitative Composition

Each vial contains either 1500 IU or 2500 IU human Anti-D immunoglobulin

One mL contains 1250 IU/mL human Anti-D immunoglobulin.

*100 micrograms of human anti-D immunoglobulin correspond to 500 international units (IU).

Human protein content 20 - 180 g/L of which at least 95% is IgG.

For excipients see 6.1.

3. Pharmaceutical Form

A solution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Prevention of RhD immunisation in RhD negative women:

i. Pregnancy/delivery of a RhD positive baby.

ii. Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole.

iii. After ante-partum haemorrhage (APH), amniocentesis, chorionic biopsy or obstetric manipulative procedure e.g. external version, or abdominal trauma, which may cause transplacental haemorrhage (TPH).

Treatment of RhD negative patients after transfusions of RhD positive blood or other products containing RhD positive red blood cells (e.g. platelets).

4.2 Posology And Method Of Administration

Posology

a) Post-Natal Dosage:

The recommended dose is 500 IU.

For postnatal use, the product should be administered as soon as possible within 72 hours of delivery.

If a large fetomaternal haemorrhage is suspected, its extent should be determined by a suitable method and additional doses of anti-D should be administered as indicated.

b) Ante-Natal Prophylaxis:

1. Name Of The Medicinal Product

Dilzem SR 60mg Prolonged-release Hard Capsules

Dilzem SR 90mg Prolonged release Hard Capsules

Dilzem SR 120mg Prolonged-release Hard Capsules

2. Qualitative And Quantitative Composition

Each Dilzem SR 60mg capsule contains diltiazem hydrochloride 60mg.

Each Dilzem SR 90mg capsule contains diltiazem hydrochloride 90mg.

Each Dilzem SR 120mg capsule contains diltiazem hydrochloride 120mg.

Excipients: Sucrose 12.6mg in each SR 60mg capsule.

                  Sucrose 18.9mg in each SR 90mg capsule.

                  Sucrose 25.2mg in each SR 120mg capsule.

For full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Prolonged-release capsule, hard.

Buff coloured, hard gelatin capsules, printed with 60mg and containing roughly spherical white to off-white beads.

Buff coloured, hard gelatin capsules, printed with 90mg and containing roughly spherical white to off-white beads.

Buff coloured, hard gelatin capsules, printed with 120mg and containing roughly spherical white to off-white beads.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of angina pectoris including Prinzmetal's angina.

Treatment of mild to moderate hypertension.

4.2 Posology And Method Of Administration

Oral use only.

Adults:

Hypertension: The usual initial dose is 90 mg twice daily (corresponding to 180 mg of diltiazem hydrochloride). Depending upon clinical response the patient's

1. Name Of The Medicinal Product

Diprivan 10 mg/ml (1%) emulsion for injection or infusion

2. Qualitative And Quantitative Composition

Propofol 10 mg/ml

3. Pharmaceutical Form

Emulsion for injection or infusion.

White aqueous isotonic oil-in-water emulsion.

4. Clinical Particulars

4.1 Therapeutic Indications

Diprivan 1% is a short-acting intravenous general anaesthetic for:

• Induction and maintenance of general anaesthesia in adults and children>1 month.

• Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children>1 month.

• Sedation of ventilated patients >16 years of agein the intensive care unit.

4.2 Posology And Method Of Administration

For specific guidance relating to the administration of Diprivan 1% with a target controlled infusion (TCI) device, which incorporates 'Diprifusor' TCI Software, see Section 4.2.5. Such use is restricted to induction and maintenance of anaesthesia in adults. The 'Diprifusor' TCI system is not recommended for use in ICU sedation or sedation for surgical and diagnostic procedures, or in children.

4.2.1 Induction of General Anaesthesia

Adults

In unpremedicated and premedicated patients, it is recommended that Diprivan 1% should be titrated (approximately 4 ml [40 mg] every 10 seconds in an average healthy adult by bolus injection or infusion) against the response of the patient until the clinical signs show the onset of anaesthesia. Most adult patients aged less than 55 years are likely to require 1.5–2.5 mg/kg of Diprivan 1%. The total dose required can be reduced

1. Name Of The Medicinal Product

Dalacin T Topical Lotion

Clindamycin Phosphate Topical Lotion

2. Qualitative And Quantitative Composition

.

One ml of Dalacin T Topical Lotion contains the equivalent of 10mg clindamycin.

For excipients see Section 6.1 ('List of excipients').

3. Pharmaceutical Form

Topical Emulsion.

White to off-white aqueous emulsion.

4. Clinical Particulars

4.1 Therapeutic Indications

Dalacin T Topical is indicated for the treatment of acne vulgaris.

4.2 Posology And Method Of Administration

Apply a thin film of Dalacin T Topical Lotion twice daily to the affected area.

4.3 Contraindications

Topical clindamycin is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. Clindamycin topical is contraindicated in individuals with a history of inflammatory bowel disease or a history of antibiotic-associated colitis.

4.4 Special Warnings And Precautions For Use

Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe pseudomembranous colitis. However, post-marketing studies have indicated a very low incidence of colitis with Dalacin T Solution. The physician should, nonetheless, be alert to the development of antibiotic-associated diarrhoea or colitis. If diarrhoea occurs, the product should be discontinued immediately.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

Studies indicate a toxin(s) produced by Clostridium difficile is the major cause of antibiotic

1. Name Of The Medicinal Product

DIFLUCAN™ 150 CAPSULE.

2. Qualitative And Quantitative Composition

Diflucan 150 capsule contains as its active ingredient fluconazole 150mg.

3. Pharmaceutical Form

Diflucan 150 capsules are light turquoise blue, coded 'FLU 150' and 'PFIZER'.

4. Clinical Particulars

4.1 Therapeutic Indications

Diflucan 150 is indicated for the treatment of the following conditions:

Genital candidiasis. Vaginal candidiasis, acute or recurrent. Candidal balanitis. The treatment of partners who present with symptomatic genital candidiasis should be considered.

4.2 Posology And Method Of Administration

In adults Vaginal candidiasis or candidal balanitis - 150mg single oral dose.

In children Despite extensive data supporting the use of Diflucan in children there are limited data available on the use of Diflucan for genital candidiasis in children below 16 years. Use at present is not recommended unless antifungal treatment is imperative and no suitable alternative agent exists.

Use in elderly The normal adult dose should be used.

Use in renal impairment Fluconazole is excreted predominantly in the urine as unchanged drug. No adjustments in single dose therapy are required.

4.3 Contraindications

Diflucan 150 should not be used in patients with known hypersensitivity to fluconazole or to related azole compounds or any other ingredient in the formulation.

Fluconazole should not be co-adminstered with cisapride or terfenadine which are known to both prolong the QT –interval and are metabolised

Depixol Low Volume Injection

cis (Z)-flupentixol decanoate

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 further questions, please 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 Depixol Low Volume Injection is and what it is used for
2. Before Depixol Low Volume Injection is given
3. How Depixol Low Volume Injection is given
4. Possible side effects
5. How to store Depixol Low Volume Injection
6. Further information

What Depixol Low Volume Injection Is And What It Is Used For

How does Depixol Low Volume Injection work?

Depixol Low Volume Injection belongs to a group of medicines known as antipsychotics (also called neuroleptics).

These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.

What is Depixol Low Volume Injection used for?

Depixol Low Volume Injection is used for the treatment of schizophrenia and other psychoses.

Your doctor, however, may prescribe Depixol Low Volume Injection for another purpose. Ask your doctor if you have any questions about why Depixol Low Volume Injection has been prescribed for you.

DESTOLIT 150 mg tablets

Ursodeoxycholic acid

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

If you need the information on this leaflet in an alternative format, such as large text, or Braille please ring from the UK: 0800 198 5000.

In this leaflet:

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

What DESTOLIT is and what it is used for

DESTOLIT contains ursodeoxycholic acid, which is one of a group of medicines used to dissolve gallstones. Not all gallstones are suitable for treatment with DESTOLIT but your doctor has decided that your condition may be treated this way. Ursodeoxycholic acid is a chemical present naturally in the body and it helps to control the amount of cholesterol in the blood. DESTOLIT tablets help dissolve gallstones that are made mainly of cholesterol.

Before you take DESTOLIT

Do not take DESTOLIT if:

  • You have a stomach or duodenal ulcer
  • You have had bowel surgery (removal of a part of the

1. Name Of The Medicinal Product

Detrusitol 1 mg filmcoated tablets

Detrusitol 2 mg filmcoated tablets

2. Qualitative And Quantitative Composition

Each filmcoated tablet contains tolterodine tartrate 1 mg or 2 mg corresponding to 0.68 mg and 1.37 mg tolterodine, respectively

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Filmcoated tablets

The filmcoated tablets are white, round and biconvex. The 1 mg tablet is engraved with arcs above and below the letters TO and the 2 mg tablet is engraved with arcs above and below the letters DT.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

4.2 Posology And Method Of Administration

Adults (including elderly):

The recommended dose is 2 mg twice daily except in patients with impaired liver function or severely impaired renal function (GFR<30 ml/min) for whom the recommended dose is 1 mg twice daily (see section 4.4). In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily.

The effect of treatment should be re-evaluated after 2-3 months (see section 5.1).

Paediatric patients:

Efficacy of Detrusitol has not been demonstrated in children (See section 5.1). Therefore, Detrusitol is not recommended for children.

4.3 Contraindications

Tolterodine is contraindicated in patients with

- Urinary retention

- Uncontrolled narro

1. Name Of The Medicinal Product

Distaclor MR* tablets.

2. Qualitative And Quantitative Composition

Each extended release tablet contains cefaclor monohydrate equivalent to 375mg of cefaclor as active ingredient.

3. Pharmaceutical Form

Extended release tablets of cefaclor 'Modified Release' are blue and engraved with GP5.

4. Clinical Particulars

4.1 Therapeutic Indications

Distaclor MR is indicated in the treatment of the following infections when caused by susceptible strains of the designated organisms:

Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), Haemophilus parainfluenzae, Moraxella catarrhalis (including beta-lactamase producing strains), and Staphylococcus aureus.

Pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A streptococci).

Pneumonia caused by S. pneumoniae, H. influenzae (including beta-lactamase producing strains), and M. catarrhalis (including beta-lactamase producing strains).

Uncomplicated lower urinary tract infections, including cystitis and asymptomatic bacteriuria, caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Staphylococcus saprophyticus.

Skin and skin structure infections caused by S. pyogenes (group A streptococci), S. aureus (including beta-lactamase producing strains), and Staphylococcus epidermidis (including beta-lactamase producing strains).

Bacteriological studies, to determine the causative organism and its susceptibility to cefaclor, should

1. Name Of The Medicinal Product

Dalacin Cream 2%.

2. Qualitative And Quantitative Composition

Each gram of cream contains clindamycin phosphate equivalent to 20 mg or 2.0% w/w clindamycin. Each applicator full of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate.

For Excipients, see section 6.1

3. Pharmaceutical Form

Cream

White, semi-solid.

4. Clinical Particulars

4.1 Therapeutic Indications

Antibiotic for the treatment of bacterial vaginosis.

4.2 Posology And Method Of Administration

One applicator full intravaginally at bedtime for 7 consecutive days.

In patients in whom a shorter treatment course is desirable, a 3 day regimen has been shown to be effective.

Paediatric population:

Safety and efficacy in paediatric patients have not been established (see Section 4.4).

Elderly:

No clinical studies have been conducted in populations older than 60.

4.3 Contraindications

Dalacin Cream is contra-indicated in patients previously found to be hypersensitive to preparations containing clindamycin or any of the components of the cream base (see "Presentation"). Although cross-sensitisation to lincomycin has not been demonstrated, it is recommended that Dalacin Cream should not be used in patients who have demonstrated lincomycin sensitivity. Dalacin Cream 2% is also contraindicated individuals with a history of inflammatory bowl disease or a history of antibiotic-associated colitis.

4.4 Special Warnings And Precautions For Use

As there are no data available on the use of Dalacin Cream in patients younger than 12 years of age, it should n

1. Name Of The Medicinal Product

Merbentyl 20mg Tablets

Dicycloverine Hydrocholoride 20mg Tablets

2. Qualitative And Quantitative Composition

Dicycloverine hydrochloride 20mg

3. Pharmaceutical Form

Tablets

Merbentyl 20mg Tablets are white oval biconvex tablets with 'Merbentyl 20' on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Smooth muscle antispasmodic primarily indicated for treatment of functional conditions involving smooth muscle spasm of the gastrointestinal tract.

4.2 Posology And Method Of Administration

Route of administration: Oral

Adults and children over 12 years:

1 tablet three times a day before or after meals.

4.3 Contraindications

Known idiosyncrasy to dicycloverine hydrochloride.

4.4 Special Warnings And Precautions For Use

Products containing dicycloverine hydrochloride should be used with caution in any patient with or suspected of having glaucoma or prostatic hypertrophy. Use with care in patients with hiatus hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate the condition.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Epidemiological studies in pregnant women with products containing dicycloverine hydrochloride (at doses up to 40mg/day) have not shown that dicycloverine hydrochloride increases the risk of foetal abnormalities if administered during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses of up to 100 times

1. Name Of The Medicinal Product

Dequadin

2. Qualitative And Quantitative Composition

Each lozenge contains 0.25 mg dequalinium chloride BP

3. Pharmaceutical Form

Lozenge

4. Clinical Particulars

4.1 Therapeutic Indications

For the local therapy of most of the common infections of the mouth including: Vincents angina, pharyngitis, sore throats, tonsillitis, stomatitis, aphthous ulcers, thrush, glossitis.

4.2 Posology And Method Of Administration

For oral administration.

Adults and children over 10 years: One lozenge to be sucked every 2 to 3 hours, up to a maximum of eight in one day.

Elderly

There is no need for a dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The label states:

Keep all medicines out of the reach of children. If symptoms persist, consult your doctor.

Warning: Do not exceed the stated dose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions known.

4.6 Pregnancy And Lactation

The safety of Dequadin during pregnancy and lactation has not been established, but it is not considered to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Occasional hypersensitivity reactions and soreness of the tongue are possible.

4.9 Overdose

Overdosage should not present a problem other tha

Dermovate Ointment

clobetasol propionate

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

What Dermovate is and what it is used for

Dermovate contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.

Dermovate is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, psoriasis and dermatitis that have not responded to milder steroid creams or ointments.

Before you use Dermovate

Do not use Dermovate:

  • if you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of Dermovate (listed in Section 6)
  • on a child und

1. Name Of The Medicinal Product

Dentinox Infant Colic Drops

2. Qualitative And Quantitative Composition

Activated Dimeticone 42.00 mg/5ml

For excipients, see 6.1

3. Pharmaceutical Form

Oral suspension

Translucent white liquid

4. Clinical Particulars

4.1 Therapeutic Indications

For the gentle relief of wind and griping pains in infants, caused by the accumulation of ingested air. Facilitates eructation. Can be used from birth onwards.

4.2 Posology And Method Of Administration

2? ml (one measured dose of the syringe) with or after each feed. May be added to the infant's bottle or given orally directly from the syringe. Maximum 6 doses per day. For infants can be used from birth onwards.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients

Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach of children.

If symptoms persist obtain medical advice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known..

4.6 Pregnancy And Lactation

Not applicable.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

None known.

4.9 Overdose

From the literature it would appear that all the s

1. Name Of The Medicinal Product

Dyloject® 75 mg/2 ml Solution for Injection

2. Qualitative And Quantitative Composition

The active ingredient is diclofenac sodium [sodium-(o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate)]. Each 2 ml vial contains 75 mg of diclofenac sodium. For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Solution for Injection

4. Clinical Particulars

4.1 Therapeutic Indications

Intramuscular use

Dyloject 75 mg/2 ml Solution for Injection is effective in acute forms of pain, including renal colic, exacerbations of osteo- and rheumatoid arthritis, acute back pain, acute gout, acute trauma and fractures, and post-operative pain.

Intravenous use

For treatment or prevention of post-operative pain in supervised healthcare settings.

4.2 Posology And Method Of Administration

Instructions on using the vial

1. Remove the green flip cap

2. Aseptically withdraw the appropriate amount (not more than 2 ml) for either IV use or deep IM injection. As with all parenteral products, Dyloject should be inspected visually for particulate matter or discoloration prior to administration.

Adults

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.4).

Dyloject 75 mg/2 ml Solution for Injection should not be given for more than two days.

Intramuscular injection: The following directions for intramuscular injection must be adhered to in order to avoid damage to a nerve