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
Daktarin Gold 2% Cream
2. Qualitative And Quantitative Composition
Ketoconazole 2% w/w.
Excipients: Propylene glycol; Cetyl alcohol; Stearyl alcohol
For a full list of excipients, see Section 6.1.
3. Pharmaceutical Form
Cream
White cream
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo.
4.2 Posology And Method Of Administration
For the treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch) and candidal intertrigo (sweat rash).
For tinea pedis, Daktarin Gold 2 % cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (eg involving the sole or sides of the feet), treatment should be continued for 2–3 days after all signs of infection have disappeared to prevent relapse.
For tinea cruris and candidal intertrigo, apply cream to the affected areas once or twice daily until 2-3 days after all signs of infection have disappeared to prevent relapse. Treatment for up to 6 weeks may be necessary. If no improvement in symptoms is experienced after 4 weeks treatment, a doctor should be consulted.
Method of administration: Cutaneous use.
4.3 Contraindications
Daktarin Gold 2 % cream is contra-indicated in patients with a known hypersensitivity to any of the ingredients or to ketoconazole itself.
4.4 Special Warnings And Precautions For Use
Not for ophthalmic use.
If a potent topical corticosteroid has
Dioralyte Natural/Citrus/Blackcurrant
3.56g/470mg/300mg/530mg,
Powder for oral solution
Glucose, sodium chloride, potassium chloride, disodium hydrogen citrate
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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 Dioralyte Sachets 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 after using this medicine for 24-48 hours.
- If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Dioralyte is and what it is used for
- 2. Before you take Dioralyte
- 3. How to take Dioralyte
- 4. Possible side effects
- 5. How to store Dioralyte
- 6. Further information
What Dioralyte is and what it is used for
The name of your medicine is Dioralyte Natural/Citrus/Blackcurrant (called Dioralyte throughout this leaflet). Dioralyte works by replacing the water and salts lost from your body when you have diarrhoea. It helps the watery stools return to normal.
It contains glucose and salts (these are sodium chloride, potassium chloride and disodium hydrogen citrate). The powder is mixed with water before taking.
Before you take Dioralyte
Do not take Dioralyte a
1. Name Of The Medicinal Product
Dalacin C Capsules 75 & 150 mg or Clindamycin Hydrochloride Capsules 75 & 150 mg
2. Qualitative And Quantitative Composition
Each capsule contains clindamycin hydrochloride equivalent to 75 &150 mg Clindamycin.
For excipients, see section 6.1
3. Pharmaceutical Form
Capsule
Hard capsule (Green/White) with markings of 'CLIN 75 & Pfizer'on cap and body.
Hard capsule ( white/white) with markings 'CLIN 150 and Pfizer'. On cap and body
4. Clinical Particulars
4.1 Therapeutic Indications
Antibacterial. Serious infections caused by susceptible GramStreptococcus faecalis) and pneumococci. It is also indicated in serious infections caused by susceptible anaerobic pathogens.
Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities.
4.2 Posology And Method Of Administration
Oral. Dalacin C Capsules should always be taken with a full glass of water. Absorption of Dalacin C is not appreciably modified by the presence of food.
Adults: Moderately severe infection, 150
Elderly patients: The half
Children: 3
Dosage in Renal /Hepatic Impairment: Clindamycin dosage modification is not necessary in patients with renal or hepatic insufficiency.
Note: In cases of beta
4.3 Contraindications
Dalacin C is contra
4.4 Special Warnings And Precautions For Use
Warnings: Dalacin C should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the
1. Name Of The Medicinal Product
DDAVP® Tablets 0.1mg.
2. Qualitative And Quantitative Composition
Each tablet contains 0.1mg Desmopressin acetate
For excipients, see 6.1
3. Pharmaceutical Form
Tablet
Uncoated, white, oval, convex tablets scored on one side and engraved '0.1' on the other side.
4. Clinical Particulars
4.1 Therapeutic Indications
DDAVP Tablets are indicated for the treatment of vasopressin-sensitive cranial diabetes insipidus or in the treatment of post-hypophysectomy polyuria/polydipsia.
4.2 Posology And Method Of Administration
Treatment of Diabetes Insipidus:
Dosage is individual in diabetes insipidus but clinical experience has shown that the total daily dose normally lies in the range of 0.2 to 1.2mg. A suitable starting dose in adults and children is 0.1mg three times daily. This dosage regimen should then be adjusted in accordance with the patient's response. For the majority of patients, the maintenance dose is 0.1mg to 0.2mg three times daily.
Post-hypophysectomy polyuria/polydipsia:
The dose of DDAVP Tablets should be controlled by measurement of urine osmolality.
4.3 Contraindications
DDAVP Tablets are contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents.
Before prescribing DDAVP Tablets the diagnoses of psychogenic polydipsia and alcohol abuse should be excluded.
4.4 Special Warnings And Precautions For Use
Care should be taken with patients who have reduced renal function and/or cardiovascular disease. In chronic renal disease t
1. Name Of The Medicinal Product
POM: Nizoral Cream
P: Daktarin Gold
2. Qualitative And Quantitative Composition
Ketoconazole 2% w/w.
For excipients, see 6.1.
3. Pharmaceutical Form
Cream
4. Clinical Particulars
4.1 Therapeutic Indications
POM
For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus and tinea pedis infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Nizoral cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.
P
For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo.
4.2 Posology And Method Of Administration
POM
Tinea pedis:
Nizoral cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (eg involving the sole or sides of the feet) treatment should be continued until a few days after all signs and symptoms have disappeared in order to prevent relapse.
For other infections:
Nizoral cream should be applied to the affected areas once or twice daily, depending on the severity of the infection.
The treatment should be continued un
1. Name Of The Medicinal Product
Doxadura 4 mg Tablets
Doxazosin 4 mg Tablets
2. Qualitative And Quantitative Composition
Doxazosin 4 mg contains 4.85 mg of doxazosin mesilate to the equivalent of 4 mg of the active constituent doxazosin.
For excipients, see section 6.1.
3. Pharmaceutical Form
Tablets.
Pink biconvex uncoated tablets, scored with a division mark on both sides and embossed with "DZS 4" on one side.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of hypertension.
Doxazosin can be used as a mono-agent in the treatment of hypertension or in patients inadequately controlled on single antihypertensive therapy. Doxazosin tablets may be used in combination with thiazide diuretics, beta-adrenoceptor blocking agents, calcium antagonists or angiotensin
4.2 Posology And Method Of Administration
Doxazosin is used in a once daily regimen. The dose of Doxazosin should be adjusted according to the patient's response. The initial dose of Doxazosin should be 1 mg per day. Dosage may then be increased in intervals of 1 or 2 weeks to 2 mg and thereafter to 4 mg. If necessary, dosage can be further increased to 8 mg or the maximum recommended dose of 16 mg. Dosage may be increased until the desired blood pressure level is achieved, or until undesirable effects occur.
Children up to 16 years of age:
There is insufficient experience to recommend the use of Doxazosin tablets in children.
Elderly:
Normal adult dosage is recommended.
Renal insufficiency:
There is no change in pharmacokinetics of Doxa
1. Name Of The Medicinal Product
Dalacin C Phosphate Sterile Solution
2. Qualitative And Quantitative Composition
Each ml of solution contains clindamycin phosphate equivalent to 150 mg clindamycin.
For excipients, see section 6.1.
3. Pharmaceutical Form
Solution for Injection
Clear, colourless, sterile solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Antibacterial. Serious infections caused by susceptible GramStreptococcus faecalis) and pneumococci. It is also indicated in serious infections caused by susceptible anaerobic pathogens such as Bacteroides spp, Fusobacterium spp, Propionibacterium spp, Peptostreptococcus spp. and microaerophilic streptococci.
Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities.
4.2 Posology And Method Of Administration
Parenteral (IM or IV administration). Dalacin C Phosphate must be diluted prior to IV administration and should be infused over at least 10
Adults: Serious infections: 600 mg
More severe infections: l.2
Single IM injections of greater than 600 mg are not recommended nor is administration of more than 1.2 g in a single one
For more serious infections, these doses may have to be increased. In life
Alternatively, the drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion.
Children (over 1 month of age): Serious infections: 15
More severe infections: 25
Elderly patients: The half
Dosage in Renal/Hepatic Impairment: clindamycin dosage modification is n
1. Name Of The Medicinal Product
Diamorphine Hydrochloride 10mg for Injection
2. Qualitative And Quantitative Composition
Each ampoule contains 10mg of diamorphine hydrochloride
For full list of excipients, see section 6.1.
3. Pharmaceutical Form
A white to off-white, sterile, freeze dried powder of Diamorphine Hydrochloride BP for reconstitution for injection.
4. Clinical Particulars
4.1 Therapeutic Indications
Diamorphine may be used in the treatment of severe pain associated with surgical procedures, myocardial infarction or pain in the terminally ill and for the relief of dyspnoea in acute pulmonary oedema.
4.2 Posology And Method Of Administration
Diamorphine may be given by the intramuscular, intravenous or subcutaneous routes. Glucose intravenous infusion is the preferred diluent, particularly when the drug is administered by a continuous infusion pump over 24 to 48 hours, although it is also compatible with sodium chloride intravenous infusion.
The dose should be suited to the individual patient.
Adults:
Acute pain, 5mg repeated every four hours if necessary (up to 10mg for heavier, well muscled patients) by subcutaneous or intramuscular injection. By slow intravenous injection, one quarter to one half the corresponding intramuscular dose.
Chronic pain, 5-10mg regularly every four hours by subcutaneous or intramuscular injection. The dose may be increased according to individual needs.
Myocardial infarction, 5mg by slow intravenous injection (1mg/minute) followed by a further 2.5mg to 5mg if necessary.
Acute pulmonary oedema, 2.5mg to 5mg by slow intravenous injection (1mg/minute).
1. Name Of The Medicinal Product
DuoTrav 40 micrograms/ml + 5 mg/ml eye drops, solution.
2. Qualitative And Quantitative Composition
Each ml of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate).
Excipient(s): Each ml of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 5 mg, polyoxyethylene hydrogenated castor oil 40 1 mg (see section 4.4).
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Eye drop, solution (eye drop)
Clear, colourless solution
4. Clinical Particulars
4.1 Therapeutic Indications
Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues (see section 5.1).
4.2 Posology And Method Of Administration
Posology
Use in adults, including the elderly population
The dose is one drop of DuoTrav in the conjunctival sac of the affected eye(s) once daily, in the morning or evening. It should be administered at the same time each day.
If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily.
Special Populations
Hepatic and renal impairment
No studies have been conducted with DuoTrav or with timolol 5 mg/ml eye drops in patients with hepatic or renal impairment.
Travoprost h
1. Name Of The Medicinal Product
Denzapine 50 mg/ml Oral Suspension
As a consequence of a recent European regulatory initiative, the Denzapine Summary of Product Characteristics (SmPC) has been harmonised across Europe. The SmPC states that blood monitoring should be carried out in accordance with national-specific official recommendations. These are reproduced below.
The Denzapine Monitoring Service (DMS) was developed in order to manage the risk of agranulocytosis associated with clozapine. It is available 24 hours a day. When a monitoring service is not used, evidence suggests a mortality rate from agranulocytosis of 0.3%[1]. This is compared to a mortality rate when clozapine is used in conjunction with a Monitoring Service, of 0.01%[2].
The Denzapine Monitoring Service provides for the centralised monitoring of leucocyte and neutrophil counts which is a mandatory requirement for all patients in the UK and Ireland who are treated with Denzapine. The use of Denzapine is restricted to patients who are registered with the Denzapine Monitoring Service. In addition to registering their patients, prescribing physicians must register themselves and a nominated pharmacist with the Denzapine Monitoring Service. All Denzapine-treated patients must be under the supervision of an appropriate specialist and supply of Denzapine is restricted to hospital and retail pharmacies registered with the Denzapine Monitoring Service. Denzapine is not sold to, or distributed through wholesalers.
The patient's white cell count with a differential count must be monitored:
• At least weekly for the first 18 weeks of treatment
• At least at 2 week intervals between weeks 18 and 52
• After 1 year of treatment with stable blood counts (green range), patients may be monitored at least at 4 week intervals
•
1. Name Of The Medicinal Product
DIFLUCAN™ POWDER FOR ORAL SUSPENSION 50MG/5ML
DIFLUCAN™ POWDER FOR ORAL SUSPENSION 200MG/5ML
DIFLUCAN™ INTRAVENOUS INFUSION 2MG/ML
2. Qualitative And Quantitative Composition
Diflucan contains as its active ingredient fluconazole as 50mg or 200mg per 5ml as powder for oral suspension on reconstitution with water, and as 2mg/ml in a saline solution for intravenous infusion.
3. Pharmaceutical Form
Diflucan Powder for Oral Suspension is a dry white to off-white powder which yields, on reconstitution with water (24ml), an orange flavoured suspension containing the equivalent of 50mg or 200mg fluconazole per 5ml.
Diflucan Intravenous Infusion 2mg/ml is available in a 0.9% aqueous sodium chloride solution, presented in glass infusion vials (25 or 100ml).
4. Clinical Particulars
4.1 Therapeutic Indications
Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Diflucan is indicated for the treatment of the following conditions:
1. Genital candidiasis. Vaginal candidiasis, acute or recurrent. Candidal balanitis. The treatment of partners who present with symptomatic genital candidiasis should be considered.
2. Mucosal candidiasis. These include oropharyngeal, oesophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic oral atrophic candidiasis (denture sore mouth). Normal hosts and patients with compromised immune function may be treated.
3. Tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal Candida infections. Diflucan is not indicated f
1. Name Of The Medicinal Product
DERMOL™ 200 SHOWER EMOLLIENT
2. Qualitative And Quantitative Composition
Liquid Paraffin 2.5% w/w; Isopropyl Myristate 2.5% w/w; Benzalkonium Chloride 0.1% w/w; Chlorhexidine Dihydrochloride 0.1% w/w.
3. Pharmaceutical Form
White, non-greasy cutaneous emulsion.
4. Clinical Particulars
4.1 Therapeutic Indications
An antimicrobial shower emollient for the management of dry and pruritic skin conditions, especially eczema and dermatitis. Dermol 200 Shower Emollient is for direct application onto the skin and is suitable for use as a soap substitute.
4.2 Posology And Method Of Administration
For adults, children and the elderly: For application to the skin (eg after showering): Apply to the affected areas as required. Massage into the skin, until absorbed. For use as a soap substitute in the shower: As required, use the shower emollient instead of an ordinary shower gel or soap. Pat dry.
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, especially when used on the face. Take care to avoid slipping in the shower or bath. 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 shower
1. Name Of The Medicinal Product
Distilled Witch Hazel BPC
2. Qualitative And Quantitative Composition
Active Ingredient |
% V/V |
Hamamelis Water |
100 |
3. Pharmaceutical Form
Topical Solution.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of the discomfort of bruises and sprains and minor skin irritations, roughness or soreness.
4.2 Posology And Method Of Administration
Apply undiluted to the affected area and bandage. Keep the bandage moist with Witch Hazel.
For topical application to unbroken skin.
4.3 Contraindications
Hypersensitivity to hamamelis water.
4.4 Special Warnings And Precautions For Use
For external use only on unbroken skin.
Keep all medicines out of the reach of children.
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 Distilled Witch Hazel during pregnancy and lactation has not been established but is unlikely to constitute a hazard.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
1. Name Of The Medicinal Product
Diovan®
Valsartan
* Intensive monitoring is requested only when used for the recently licensed indication in heart failure.
2. Qualitative And Quantitative Composition
One capsule contains 160 mg valsartan.
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Capsules.
Appearance: Dark grey cap and flesh opaque body, marked CG GOG in white ink on the cap.
4. Clinical Particulars
4.1 Therapeutic Indications
Hypertension
Treatment of essential hypertension
Recent myocardial infarction
Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours – 10 days) myocardial infarction (see sections 4.4 and 5.1).
Heart Failure
Treatment of symptomatic heart failure when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).
4.2 Posology And Method Of Administration
Posology
Hypertension
The recommended dose of Diovan is 80 mg once daily. The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg.
Diovan may also be administered
1. Name Of The Medicinal Product
Dioctyl 100 mg Capsules.
DulcoEase, 100 mg capsules
2. Qualitative And Quantitative Composition
Docusate sodium 100 mg.
For excipients, see Section 6.1.
3. Pharmaceutical Form
Capsules
A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill.
4. Clinical Particulars
4.1 Therapeutic Indications
a) To prevent and treat chronic constipation.
(i) to soften hard, dry stools in order to ease defaecation and reduce straining at stool; and
(ii) in the presence of haemorrhoids and anal fissure, to prevent hard, dry stools and reduce straining.
b) As an adjunct in abdominal radiological procedures.
4.2 Posology And Method Of Administration
Route of administration: Oral
Adults and elderly:
Up to 500 mg should be taken daily in divided doses. Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.
For use with barium meals:
400 mg to be taken with the meal.
Children under 12 years:
Not recommended.
4.3 Contraindications
These capsules should not be administered when abdominal pain, nausea, vomiting or intestinal obstruction is present.
This product should not be given to patients with a known hypersensitivity to Dioctyl capsules or any of the components.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
4.4 Special Warnings And Precautions For Use
1. Name Of The Medicinal Product
Doribax
2. Qualitative And Quantitative Composition
Each vial contains doripenem monohydrate equivalent to 500mg doripenem.
The medicinal product does not contain any excipients.
3. Pharmaceutical Form
Powder for solution for infusion (powder for infusion)
White to slightly yellowish off-white crystalline powder
4. Clinical Particulars
4.1 Therapeutic Indications
Doribax is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1):
• Nosocomial pneumonia (including ventilator–associated pneumonia)
• Complicated intra-abdominal infections
• Complicated urinary tract infections
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 Posology And Method Of Administration
The recommended dose and administration by infection is shown in the following table:
Posology
Infection |
Dose |
Frequency |
Infusion time |
Nosocomial pneumonia including ventilator–associated pneumonia |
500mg |
every 8 hours |
1. Name Of The Medicinal Product
Docetaxel Actavis 20mg/0.5ml concentrate and solvent for solution for infusion
2. Qualitative And Quantitative Composition
Each single dose vial contains docetaxel 20mg/0.5ml.
Each single dose vial contains 40mg/ml of docetaxel.
Each single dose vial contains 10mg/ml of docetaxel after reconstitution with the accompanying solvent.
Excipients:
Each single dose 20mg/0.5ml vial of concentrate contains 50mg ethanol absolute.
Each single dose vial of solvent contains 9.53% (w/w) ethanol absolute.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Concentrate and solvent for solution for infusion.
The concentrate is a clear, oily, yellow solution.
The solvent is a clear colourless solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Breast cancer
Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node- positive breast cancer.
Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.
Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who previous
1. Name Of The Medicinal Product
Depo-Provera 150 mg/ml
2. Qualitative And Quantitative Composition
Each ml of suspension contains 150 mg medroxyprogesterone acetate Ph. Eur. For excipients, see section 6.1
3. Pharmaceutical Form
Sterile suspension for injection.
4. Clinical Particulars
4.1 Therapeutic Indications
Progestogen: for contraception.
Depo-Provera is a long-term contraceptive agent suitable for use in women who have been appropriately counselled concerning the likelihood of menstrual disturbance and the potential for a delay in return to full fertility.
Depo-Provera may also be used for short-term contraception in the following circumstances:
1) For partners of men undergoing vasectomy, for protection until the vasectomy becomes effective.
2) In women who are being immunised against rubella, to prevent pregnancy during the period of activity of the virus.
3) In women awaiting sterilisation.
Since loss of bone mineral density (BMD) may occur in females of all ages who use Depo-Provera injection long-term (see section 4.4 Special Warnings and Special Precautions for Use), a risk/benefit assessment, which also takes into consideration the decrease in BMD that occurs during pregnancy and/or lactation, should be considered.
Use in adolescents (12-18 years)
In adolescents, Depo-Provera may be used, but only after other methods of contraception have been discussed with the patient and considered unsuitable or unacceptable.
It is of the greatest importance that adequate explanations of the long-term nature of the product, of its possible side-effects and of the impossibility of immediatel
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
Dobutamine 5 mg/ml solution for infusion
2. Qualitative And Quantitative Composition
Each ampoule/vial Dobutamine contains dobutamine hydrochloride corresponding to 250 mg dobutamine.
50 ml ampoule/vial
1 ml contains 5 mg dobutamine.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for infusion
The product is a clear, colourless or almost colourless solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Dobutamine is indicated for patients who require a positive inotropic support in the treatment of cardiac decompensation due to depressed contractility.
In cardiogenic shock characterised by heart failure with severe hypotension and in case of septic shock Dobutamine may be useful if added to dopamine in case of disturbed ventricular function, raised filling pressure of the ventricles and raised systemic resistance.
Dobutamine may also be used for detection of myocardial ischaemia and of viable myocardium within the scope of an echocardiographic examination (dobutamine stress echocardiography), if patients cannot undergo a period of exercise or if the exercise yields no information of value.
4.2 Posology And Method Of Administration
Dobutamine doses must be individually adjusted.
The required rate of infusion depends on the patient's response to therapy and the adverse reactions experienced.
Dosage in adults:
According to experience, the majority of patients respond to doses of 2.5-10 µg dobutamine/kg/min. In individual cases, doses up to 40 µg dobutamine/kg/min have b