Drugs Index
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Drug Classes
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Drugs Information:
Drugs List
Uniphyllin Continus 200 mg, 300 mg and 400 mg prolonged-release tablets
Theophylline
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However you still need to take Uniphyllin Continus tablets carefully to get the best results from them.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Uniphyllin Continus tablets are and what they are used for
- 2. Before you take Uniphyllin Continus tablets
- 3. How to take Uniphyllin Continus tablets
- 4. Possible side effects
- 5. How to store Uniphyllin Continus tablets
- 6. Further information
What Uniphyllin Continus tablets are and what they are used for
These tablets are used to treat asthma, long-term breathing difficulties such as chronic obstructive pulmonary disease and chronic bronchitis, and are sometimes used to treat heart failure.
They contain the active ingredient theophylline which belongs to a group of medicines called bronchodilators. Bronchodilat
1. Name Of The Medicinal Product
Uftoral 100 mg/224 mg hard capsules
2. Qualitative And Quantitative Composition
Each capsule contains 100 mg tegafur and 224 mg uracil.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Hard capsule.
The capsules are white, opaque and imprinted with the code TC434.
4. Clinical Particulars
4.1 Therapeutic Indications
Uftoral is indicated for first-line treatment of metastatic colorectal cancer in combination with calcium folinate (see section 5.1).
4.2 Posology And Method Of Administration
Adults: the dose of Uftoral is 300 mg/m2/day tegafur and 672 mg/m2/day uracil combined with 90 mg/day oral calcium folinate, given in three divided doses (preferably every 8 hours). Calcium folinate should be taken at the same time as Uftoral. Doses should be taken at least one hour before or one hour after meals for 28 consecutive days. Subsequent cycles should start after 7 days without Uftoral/calcium folinate (i.e. 35 days per treatment cycle). The daily dose per body surface area (BSA) is presented below:
|
BSA (m2) |
Uftoral (capsules/day) |
Daily schedule (number of capsules) |
||
1. Name Of The Medicinal Product
Univer 120mg Prolonged-release Hard Capsules
Univer 180mg Prolonged-release Hard Capsules
Univer 240mg Prolonged-release Hard Capsules
2. Qualitative And Quantitative Composition
Verapamil hydrochloride 120 mg.
Verapamil hydrochloride 180 mg.
Verapamil hydrochloride 240 mg.
|
Excipients: |
Univer 120mg capsules contain 31.32 mg Sucrose per capsule. Univer 180mg capsules contain 46.98 mg Sucrose per capsule Univer 240mg capsules contain 62.64 mg Sucrose per capsule |
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Prolonged-release capsule, hard.
Capsules are blue and yellow and printed with V120.
Capsules are yellow and printed with V180.
Capsules are blue and yellow and printed with V240.
4. Clinical Particulars
4.1 Therapeutic Indications
Mild to moderate hypertension. Angina pectoris.
4.2 Posology And Method Of Administration
For oral administration only. The capsules should be swallowed whole and not chewed.
The bioequivalence of Univer to other prolonged release verapamil formulations may not have been evaluated. As such, this product should not be directly substituted for other non-identical formulations of verapamil and vice-versa.
Adults:
Mild to moderate hypertension: Initial dose in adult patients
1. Name Of The Medicinal Product
Uniroid-HC™ Ointment
2. Qualitative And Quantitative Composition
Each gram of ointment contains:
Hydrocortisone Ph.Eur. 5.0mg
Cinchocaine Hydrochloride B.P. 5.0mg
3. Pharmaceutical Form
An off-white, odourless, smooth, translucent ointment.
4. Clinical Particulars
4.1 Therapeutic Indications
Uniroid-HC Ointment is indicated primarily for the treatment of external haemorrhoids for the short term relief of pain, irritation and associated pruritus ani. Uniroid-HC Ointment can also be used for internal haemorrhoids.
4.2 Posology And Method Of Administration
Adults
Treatment with Uniroid-HC Ointment should be limited to seven days. Patients should be advised to return to their doctor if the condition persists beyond this time.
Directions for use and dosage schedule:
First wash the anal area gently with water and pat dry with cotton wool. With the finger, spread a small quantity of the ointment on the painful area without rubbing. Do not use toilet paper.
Apply the ointment twice a day (morning and evening) and after each bowel movement, or as prescribed by the doctor.
The ointment can be used internally by means of the nozzle applicator which is supplied. Insert the nozzle applicator to full extent and squeeze the tube gently from the lower end whilst withdrawing.
The nozzle applicator must be cleaned thoroughly in warm, soapy water before and after each use.
The ointment may be used separately or concurrently with the suppositories.
The Elderly
1. Name Of The Medicinal Product
Urokinase medac 500,000 I.U.
Powder for solution for injection or infusion
2. Qualitative And Quantitative Composition
Each vial contains 500,000 I.U. of human urokinase extracted from human urine.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Powder for solution for injection or infusion
4. Clinical Particulars
4.1 Therapeutic Indications
Intravascular lysis of blood clots in the following conditions:
• extensive acute proximal deep vein thrombosis
• acute massive pulmonary embolism
• acute occlusive peripheral arterial disease with limb threatening ischemia
• thrombosed arteriovenous haemodialysis shunts
• thrombosed central venous catheters
4.2 Posology And Method Of Administration
Urokinase medac should only be used by physicians experienced in the management of thrombotic diseases in hospitals where adequate diagnostic and monitoring techniques are available.
Depending on the indication, the route of administration of Urokinase medac is by systemic intravenous infusion, by local intra-arterial catheter-directed infusion during arteriography, or by local instillation.
It must not be given by subcutaneous or intramuscular injection.
For instructions regarding reconstitution and further dilution, see section 6.6.
Adults
The dosage may be adjusted individually depending on the clinical condition. The following dose regimens should be used as a guideline.
Deep vein thrombosis
U
1. Name Of The Medicinal Product
Ultrabase®
2. Qualitative And Quantitative Composition
There are no active constituents.
3. Pharmaceutical Form
Cream
4. Clinical Particulars
4.1 Therapeutic Indications
For general use as:
- an emollient
- a diluent for dermatological preparations and
- a vehicle for various dermatological medicaments.
Additionally, it may be alternated with topical corticosteroids when the latter are being gradually withdrawn, and may be continued alone after complete withdrawal of the topical corticosteroid.
4.2 Posology And Method Of Administration
For topical administration as required.
4.3 Contraindications
Hypersensitivity to any of the components of Ultrabase.
4.4 Special Warnings And Precautions For Use
None stated.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
None stated.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
None known.
4.9 Overdose
Not applicable. Ultrabase contains no active ingredients.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Ultrabase has no specific active ingredient, but the cream formulation has good emollient properties.
5.2 Pharmacokinetic Properties
None stated.
5.3 Preclinical Safety Data
There are no preclinical safety data which cou
UNIVER 120 mg, 180 mg 240 mg Prolonged Release Hard Capsules
(Verapamil hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects 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 UNIVER is and what it is used for.
- 2. Before you use UNIVER.
- 3. How to use UNIVER.
- 4. Possible side effects.
- 5. How to store UNIVER.
- 6. Further information.
What Univer Is And What It Is Used For
The name of this medicine is UNIVER prolonged release hard capsules and it comes in three strengths (120 mg, 180 mg and 240 mg).
The active ingredient in them is verapamil hydrochloride which belongs to a group of medicines called calcium channel blockers.
UNIVER is used to treat high blood pressure (hypertension) and chest pains caused by lack of oxygen getting to the heart (angina pectoris).
Before You Take Univer
Do not take UNIVER if you:
- Are allergic (hypersensitive) to verapamil hydrochloride or any of the other ingredients of UNIVER.
1. Name Of The Medicinal Product
Unguentum M
2. Qualitative And Quantitative Composition
There is no specific active ingredient.
3. Pharmaceutical Form
Cream
4. Clinical Particulars
4.1 Therapeutic Indications
Unguentum M has emollient properties and is recommended for the symptomatic treatment of dermatitis, nappy rash, ichthyosis, eczema, protection of raw and abraded skin areas, pruritus and related skin conditions where dry scaly skin is a problem, and as a pre-bathing emollient for dry/eczematous skin, to alleviate drying effects.
Unguentum M is to be used as a diluent for various topical corticosteriod formulations in those instances where a lower strength preparation is considered desirable by the physician and as a general base for extemporaneous dispensing.
4.2 Posology And Method Of Administration
A thin application of the cream should be gently massaged into the skin three times daily or at appropriate intervals.
When used as a protective cream Unguentum M should be applied sparingly to the affected areas of the skin before, or immediately after, exposure to a potentially harmful factor.
4.3 Contraindications
Unguentum M should not be used:
- if hypersensitivity to any of the ingredients is known.
- near the eyes and on mucous membranes.
4.4 Special Warnings And Precautions For Use
Sorbic acid and Cetostearyl alcohol may cause local skin reactions, (e.g. contact dermatitis)
Propylenglycol may cause skin reactions.
Ingestion of Unguentum M should be avoided.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
1. Name Of The Medicinal Product
Ultiva (remifentanil hydrochloride) for Injection 1 mg
Ultiva (remifentanil hydrochloride) for Injection 2 mg
Ultiva (remifentanil hydrochloride) for Injection 5 mg
2. Qualitative And Quantitative Composition
Ultiva is a sterile, endotoxin-free, preservative-free, white to off white, lyophilized powder, to be reconstituted before use.
When reconstituted as directed, solutions of Ultiva are clear and colourless and contain 1mg/ml of remifentanil base as remifentanil hydrochloride.
Ultiva for injection is available in glass vials containing 1 mg, 2 mg or 5 mg of remifentanil base.
3. Pharmaceutical Form
Lyophilized powder for reconstitution for intravenous administration.
4. Clinical Particulars
4.1 Therapeutic Indications
Ultiva is indicated as an analgesic agent for use during induction and/or maintenance of general anaesthesia under close supervision.
Ultiva is indicated for provision of analgesia and sedation in mechanically ventilated intensive care patients 18 years of age and over.
4.2 Posology And Method Of Administration
Ultiva should be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of anaesthetic drugs and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patent airway and assisted ventilation.
Continuous infusions of Ultiva must be administered by a calibrated infusion device into a fast flowing IV line or via a dedic
1. Name Of The Medicinal Product
Urokinase medac 50,000 I.U.
Powder for solution for injection or infusion
2. Qualitative And Quantitative Composition
Each vial contains 50,000 I.U. of human urokinase extracted from human urine.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Powder for solution for injection or infusion
4. Clinical Particulars
4.1 Therapeutic Indications
Intravascular lysis of blood clots in the following conditions:
• extensive acute proximal deep vein thrombosis
• acute massive pulmonary embolism
• acute occlusive peripheral arterial disease with limb threatening ischemia
• thrombosed arteriovenous haemodialysis shunts
• thrombosed central venous catheters
4.2 Posology And Method Of Administration
Urokinase medac should only be used by physicians experienced in the management of thrombotic diseases in hospitals where adequate diagnostic and monitoring techniques are available.
Depending on the indication, the route of administration of Urokinase medac is by systemic intravenous infusion, by local intra-arterial catheter-directed infusion during arteriography, or by local instillation.
It must not be given by subcutaneous or intramuscular injection.
For instructions regarding reconstitution and further dilution, see section 6.6.
Adults
The dosage may be adjusted individually depending on the clinical condition. The following dose regimens should be used as a guideline.
Deep vein thrombosis
Uro
1. Name Of The Medicinal Product
Ultraproct® Ointment
2. Qualitative And Quantitative Composition
Each 1g of ointment contains:
Fluocortolone pivalate BP 0.92 mg
Fluocortolone hexanoate BP 0.95 mg
Cinchocaine hydrochloride BP 5.00 mg
3. Pharmaceutical Form
Ointment
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of haemorrhoids and of pruritus ani in the short term (5-7 days).
4.2 Posology And Method Of Administration
Apply in a thin layer twice daily. In order to obtain a more rapid improvement, Ultraproct Ointment may be applied three or four times on the first day. The nozzle provided facilitates intrarectal application.
4.3 Contraindications
Viral infections. Primary bacterial or fungal infections. Secondary infections of the skin in the absence of appropriate anti-infective therapy. Known sensitivity to local anaesthetics.
4.4 Special Warnings And Precautions For Use
Warnings: In infants, long-term continuous therapy with topical corticosteroids should be avoided. Occlusion is not appropriate on the perineum. Adrenal suppression can occur even without occlusion. The application of unusually large quantities of topical corticoids may result in the absorption of systemically active amounts of corticoid. Secondarily-infected dermatoses definitely require additional therapy with antibiotics or chemotherapeutics agents. This treatment can often be topical but for heavy infections systemic antibacterial therapy may be necessary. If fungal infections are present, a topically active anti-mycotic should be applied.
4.5 Interaction With Other Medicinal Products And Other Forms
1. Name Of The Medicinal Product
Ursofalk 250mg hard capsules
2. Qualitative And Quantitative Composition
Each capsule of Ursofalk contains the following active ingredient:
ursodeoxycholic acid 250mg
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
White, opaque, hard gelatin capsules (size0) containing a white compressed powder or granules.
4. Clinical Particulars
4.1 Therapeutic Indications
Ursofalk is indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of radiolucent gallstones in patients with a functioning gall bladder
4.2 Posology And Method Of Administration
There are no age restrictions on the use of Ursofalk 250mg hard capsules. For patients weighing less than 47 kg or patients who are unable to swallow Ursofalk 250mg hard capsules, Ursofalk suspension is available.
The following daily dose is recommended for the various indications:
For primary biliary cirrhosis (PBC)
The daily dose depends on body weight, and ranges from 3 to 7 capsules (14 ± 2 mg ursodeoxycholic acid per kg of body weight).
For the first 3 months of treatment, Ursofalk 250mg hard capsules should be taken divided over the day. With improvement of the liver values the daily dose may be taken once daily in the evening.
|
Body weight (kg) |
Daily dose (mg/kg BW) |
Ursofalk 250mg hard capsules |
1. Name Of The Medicinal Product
Urokinase medac 250,000 I.U.
Powder for solution for injection or infusion
2. Qualitative And Quantitative Composition
Each vial contains 250,000 I.U. of human urokinase extracted from human urine.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Powder for solution for injection or infusion
4. Clinical Particulars
4.1 Therapeutic Indications
Intravascular lysis of blood clots in the following conditions:
• extensive acute proximal deep vein thrombosis
• acute massive pulmonary embolism
• acute occlusive peripheral arterial disease with limb threatening ischemia
• thrombosed arteriovenous haemodialysis shunts
• thrombosed central venous catheters
4.2 Posology And Method Of Administration
Urokinase medac should only be used by physicians experienced in the management of thrombotic diseases in hospitals where adequate diagnostic and monitoring techniques are available.
Depending on the indication, the route of administration of Urokinase medac is by systemic intravenous infusion, by local intra-arterial catheter-directed infusion during arteriography, or by local instillation.
It must not be given by subcutaneous or intramuscular injection.
For instructions regarding reconstitution and further dilution, see section 6.6.
Adults
The dosage may be adjusted individually depending on the clinical condition. The following dose regimens should be used as a guideline.
Deep vein thrombosis
1. Name Of The Medicinal Product
UTROGESTAN 100MG CAPSULES
2. Qualitative And Quantitative Composition
Each capsule contains 100 mg micronised progesterone (INN). For excipients, see 6.1.
3. Pharmaceutical Form
Capsules, soft
White
4. Clinical Particulars
4.1 Therapeutic Indications
Adjunctive use with estrogen in post-menopausal women with an intact uterus. (HRT)
4.2 Posology And Method Of Administration
Posology
In women receiving estrogen replacement therapy there is an increased risk of endometrial cancer which can be countered by progesterone administration. The recommended dose is 200 mg daily at bedtime, for twelve days in the last half of each therapeutic cycle (beginning on day 15 of the cycle and ending on day 26). Withdrawal bleeding may occur in the following week. Alternatively 100 mg can be given at bedtime from day 1 to day 25 of each therapeutic cycle, withdrawal bleeding being less with this treatment schedule.
Children: Not applicable.
Elderly: As for adults
Method of Administration: Oral. Utrogestan 100mg Capsules should not be taken with food
4.3 Contraindications
Known allergy or hypersensitivity to progesterone or to any of the excipients. The capsules contain arachis oil (peanut oil) and should never be used by patients allergic to peanuts. Severe hepatic dysfunction. Undiagnosed vaginal bleeding. Mammary or genital tract carcinoma. Thrombophlebitis. Thromboembolic disorders. Cerebral haemorrhage. Porphyria.
4.4 Special Warnings And Precautions For Use
Warnings:
Utrogestan 100mg C
1. Name Of The Medicinal Product
Ucerax Tablets 25 mg.
2. Qualitative And Quantitative Composition
Hydroxyzine hydrochloride 25 mg.
For excipients, see 6.1.
3. Pharmaceutical Form
Film-coated tablets.
4. Clinical Particulars
4.1 Therapeutic Indications
Ucerax is indicated to assist in the management of anxiety.
Ucerax is indicated to assist in the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and in atopic and contact dermatosis in adults and children.
4.2 Posology And Method Of Administration
Adults:
Anxiety.
50 mg/day in 3 separate administrations of 12.5-12.5-25mg. In more severe cases, doses up to 300mg/day can be used.
Pruritus.
Starting dose of 25 mg at night, increasing as necessary to 25 mg three or four times daily.
The maximum single dose in adults should not exceed 200mg whereas the maximum daily doses should not exceed 300mg.
Children:
Children aged from 12 months to 6 years: 1mg/kg/day up to 2.5mg/kg/day in divided doses.
Children aged over 6 years:1mg/kg/day up to 2mg/kg/day in divided doses.
The dosage should be adjusted according to the patient's response to therapy.
In the elderly, it is advised to start with half the recommended dose due to the prolonged action.
In patients with hepatic dysfunction, it is recommended to reduce the daily dose by 33%.
Dosage should be reduced in patients with moderate or severe renal impairment due to decreased excretion of its metabolite cetirizine.
4.3 Contraindications
1. Name Of The Medicinal Product
Urdox 300mg Film-Coated Tablets
2. Qualitative And Quantitative Composition
Ursodeoxycholic acid 300mg.
Excipients: lactose.
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Film coated tablets
Urdox tablets are white. film coated, convex tablets with “URDOX” on one side.
4. Clinical Particulars
4.1 Therapeutic Indications
Urdox tablets are indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of small to medium sized radiolucent, cholesterol-rich gall-stones in patients with a functioning gall bladder.
Cholesterol stones coated with calcium or stones composed of bile pigments are not dissolved by ursodeoxycholic acid. Urdox has a particular place in the treatment of patients in whom surgery is contraindicated or who are anxious to avoid surgery.
4.2 Posology And Method Of Administration
Urdox tablets are for oral administration
To be taken with a drink of water.
Primary Biliary Cirrhosis
Adults and Elderly: 10 - 15mg ursodeoxycholic acid (UDCA) per kg per day in two to four divided doses.
Children: Dosage should be related to bodyweight.
Dissolution of gallstones
Adults and Elderly:
The usual dose is 6 - 12mg/kg/day either as a single night time dose or in divided doses. This may be increased to 15mg/kg/day in obese patients, if necessary.
The duration of treatment may be up to two years, depending on the size of the stone(s), and should be continued fo
INTENDIS
Ultrabase Cream
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Ultrabase carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If you experience any side effect and this becomes serious, tell your doctor or pharmacist.
In this leaflet:
- 1. What Ultrabase is and what it is used for
- 2. Before you use Ultrabase
- 3. How to use Ultrabase
- 4. Possible side effects
- 5. How to store Ultrabase
- 6. Further information
What Ultrabase is and what it is used for
Ultrabase is a moisturiser that can be used to dilute skin preparations and is also used as a base for other medicines. It may be used as an alternative to topical corticosteroids (medicines put on the skin to reduce the redness and itchiness of certain skin problems) when they are being stopped. It may also be used alone after the topical corticosteroid is no longer used.
Before you use Ultrabase
Do not use Ultrabase
1. Name Of The Medicinal Product
Utrogestan 200mg capsules
2. Qualitative And Quantitative Composition
Each capsule contains 200 mg micronised progesterone (INN). For excipients, see 6.1.
3. Pharmaceutical Form
Capsules, soft
White
4. Clinical Particulars
4.1 Therapeutic Indications
Adjunctive use with estrogen in post-menopausal women with an intact uterus. (HRT)
4.2 Posology And Method Of Administration
Posology
In women receiving estrogen replacement therapy there is an increased risk of endometrial cancer which can be countered by progesterone administration. The recommended dose is 200 mg daily at bedtime, for twelve days in the last half of each therapeutic cycle (beginning on day 15 of the cycle and ending on day 26). Withdrawal bleeding may occur in the following week. Alternatively 100 mg can be given at bedtime from day 1 to day 25 of each therapeutic cycle, withdrawal bleeding being less with this treatment schedule.
Children: Not applicable.
Elderly: As for adults
Method of Administration: Oral. Utrogestan 200mg Capsules should not be taken with food
4.3 Contraindications
Known allergy or hypersensitivity to progesterone or to any of the excipients. The capsules contain arachis oil (peanut oil) and should never be used by patients allergic to peanuts. Severe hepatic dysfunction. Undiagnosed vaginal bleeding. Mammary or genital tract carcinoma. Thrombophlebitis. Thromboembolic disorders. Cerebral haemorrhage. Porphyria.
4.4 Special Warnings And Precautions For Use
Warnings:
Utrogestan 200mg C
1. Name Of The Medicinal Product
Ucerax Syrup 10 mg/5ml.
2. Qualitative And Quantitative Composition
Each ml contains hydroxyzine hydrochloride 2 mg/ml.
For excipients, see 6.1.
3. Pharmaceutical Form
Syrup.
Clear colourless solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Ucerax is indicated to assist in the management of anxiety.
Ucerax is indicated to assist in the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and in atopic and contact dermatosis in adults and children.
4.2 Posology And Method Of Administration
Adults:
Anxiety.
50 mg/day in 3 separate administrations of 12.5-12.5-25mg. In more severe cases, doses up to 300mg/day can be used.
Pruritus.
Starting dose of 25 mg at night, increasing as necessary to 25 mg three or four times daily.
The maximum single dose in adults should not exceed 200mg whereas the maximum daily doses should not exceed 300mg.
Children:
Children aged from 12 months to 6 years: 1mg/kg/day up to 2.5mg/kg/day in divided doses.
Children aged over 6 years: 1mg/kg/day up to 2mg/kg/day in divided doses.
The dosage should be adjusted according to the patient's response to therapy.
In the elderly, it is advised to start with half the recommended dose due to the prolonged action.
In patients with hepatic dy
1. Name Of The Medicinal Product
Ultra Chloraseptic Anaesthetic Throat Spray
2. Qualitative And Quantitative Composition
Benzocaine 0.71 % w/v
For full list of excipients, see 6.1
3. Pharmaceutical Form
Oromucosal Spray
Direct application to the throat by spraying
Clear, colourless to straw coloured liquid
4. Clinical Particulars
4.1 Therapeutic Indications
Symptomatic relief of sore throat pain.
4.2 Posology And Method Of Administration
Posology
Adults and children 13 years and over: Administer 3 sprays (3mg) to the back of the throat. Repeat every 2-3 hours up to a maximum of 8 doses per day.
Children 6-12 years: Use only under adult supervision. Administer 1 spray (1mg) to the back of the throat. Repeat every 2-3 hours up to a maximum of 8 doses per day
This product is contraindicated in children under 6 years.
Method of administration: oromucosal
Hold breath and spray to the back of the throat.
Do not use in a child who is unable to hold their breath whilst spraying.
Before first use, or after prolonged storage, activate the pump by spraying 3 times away from the face into the sink.
4.3 Contraindications
Children under 6 years.
Epiglottitis
Known hypersensitivity to benzocaine or any of the other ingredients.
Methaemoglobinaemia
4.4 Special Warnings And Precautions For Use
Do not administer to children under 6 years.
Do not use for more than 3 consecutive days.
Do not spray into eyes.
If sore throa