Drugs Index
Medical Conditions:
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- 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
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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
ESTRADERM MX 25, 50, 75 and 100
(estradiol)
These patches will usually be referred to as Estraderm MX in this leaflet
What you need to know about Estraderm MX
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to use the patches. It contains important information. Keep the leaflet in a safe place because you may want to read it again.
If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be 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 Estraderm MX patches are, and what they are used for
- 2. Things to consider before you start to use Estraderm MX patches
- 3. How to use Estraderm MX patches
- 4. Possible side effects
- 5. How to store the patches
- 6. Further information
What Estraderm MX patches are and what they are used for
Estraderm MX is a patch which you stick on your skin. The patch contains a supply of estradiol which is released from the patch and absorbed through the skin into your blood stream. This is called a transdermal patch.
The active ingredient in the patches is estradiol. This is one of a group of hormones cal
1. Name Of The Medicinal Product
Electrolade (Lemon & Lime)
2. Qualitative And Quantitative Composition
|
Each sachet contains 5.09 powder |
per/sachet |
| Sodium Chloride Ph.Eur. | 0.236 g |
| Potassium Chloride Ph.Eur. | 0.300 g |
| Sodium Bicarbonate Ph.Eur. | 0.500 g |
| Anhydrous Dextrose Ph.Eur. | 4.000 g |
The reconstituted solution contains Sodium 50 mmol/L, Potassium 20 mmol/L, Chloride 40 mmol/L, Bicarbonate 30 mmol/L, Dextrose 111 mmol/L.
3. Pharmaceutical Form
Powder for oral solution.
.
4. Clinical Particulars
4.1 Therapeutic Indications
Oral replacement therapy of electrolyte and fluid loss in children and adults arising from dehydration associated with acute diarrhoea.
4.2 Posology And Method Of Administration
Reconstitution: Only with water and at the volume stated.
Adults and children: The content of each sachet should be dissolved in approximately 200 ml of cool, fresh, clean drinking water. The resulting solution is both
UK/Malta
Roche
Eucardic 6.25 mg Tablets
Carvedilol
Please 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 troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Eucardic is and what it is used for
- 2. Before you take Eucardic
- 3. How to take Eucardic
- 4. Possible side effects
- 5. How to store Eucardic
- 6. Further information
What Eucardic is and what it is used for
Eucardic contains a medicine called carvedilol. This belongs to a group of medicines called ‘beta-blockers’.
Eucardic is used to treat the following:
- Chronic heart failure.
- High blood pressure (hypertension).
- Angina (chest pain or discomfort that happens when your heart isn’t getting enough oxygen).
Eucardic works by making your blood vessels relax and widen.
- This helps to lower your blood pressure.
- If you have chronic heart failure, this makes it easier for your heart to pump blood around your body.
- If you have angina, this will help stop the chest pain.
Your
1. Name Of The Medicinal Product
Enbrel® 25 mg/ml powder and solvent for solution for injection for paediatric use.
2. Qualitative And Quantitative Composition
Each vial contains 25 mg of etanercept. When reconstituted, the solution contains 25 mg/ml of etanercept.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. This Fc component contains the hinge, CH2 and CH3 regions, but not the CH1 region of IgG1. Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. The specific activity of etanercept is 1.7 x 106 units/mg.
The solution contains benzyl alcohol 9 mg/ml as a preservative (see section 4.4). For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Powder and solvent for solution for injection (powder for injection).
The powder is white. The solvent is a clear, colourless liquid.
4. Clinical Particulars
4.1 Therapeutic Indications
Polyarticular juvenile idiopathic arthritis
Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Enbrel has not been studied in children aged less than 2 years.
Paediatric plaque psoriasis
Tre
1. Name Of The Medicinal Product
Eporatio 10,000 IU/1 ml solution for injection in pre
2. Qualitative And Quantitative Composition
One pre-filled syringe contains 10,000 international units (IU) (83.3 µg) epoetin theta in 1 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.
Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells (CHO
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection (injection) in pre
The solution is clear and colourless.
4. Clinical Particulars
4.1 Therapeutic Indications
- Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.
- Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
4.2 Posology And Method Of Administration
Special requirements
Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned indications.
Routes of administration
The solution can be administered subcutaneously (SC) or intravenously (IV). Subcutaneous use is preferable in patients who are not undergoing haemodialysis, in order to avoid puncturing peripheral veins. If epoetin theta is substituted for another epoetin, the same route of administration should be used. Epoetin theta should be administered by the subcutaneous route to cancer patients with non
Posology
Symptomatic anaemia associate
1. Name Of The Medicinal Product
Eporatio 20,000 IU/1 ml solution for injection in pre
2. Qualitative And Quantitative Composition
One pre-filled syringe contains 20,000 international units (IU) (166.7 µg) epoetin theta in 1 ml solution for injection corresponding to 20,000 IU (166.7 µg) epoetin theta per ml.
Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells (CHO
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection (injection) in pre
The solution is clear and colourless.
4. Clinical Particulars
4.1 Therapeutic Indications
- Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.
- Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
4.2 Posology And Method Of Administration
Special requirements
Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned indications.
Routes of administration
The solution can be administered subcutaneously (SC) or intravenously (IV). Subcutaneous use is preferable in patients who are not undergoing haemodialysis, in order to avoid puncturing peripheral veins. If epoetin theta is substituted for another epoetin, the same route of administration should be used. Epoetin theta should be administered by the subcutaneous route to cancer patients with non
Posology
Symptomatic anaemia associated with chronic
1. Name Of The Medicinal Product
Enbrel® 25 mg solution for injection in pre-filled syringe.
2. Qualitative And Quantitative Composition
Each pre-filled syringe contains 25 mg of etanercept.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. This Fc component contains the hinge, CH2 and CH3 regions, but not the CH1 region of IgG1. Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. The specific activity of etanercept is 1.7 x 106 units/mg.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection.
The solution is clear, and colourless or pale yellow.
4. Clinical Particulars
4.1 Therapeutic Indications
Rheumatoid arthritis
Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Enbre
1. Name Of The Medicinal Product
EFFERVESCENT CALCIUM GLUCONATE TABLETS BP 1g
2. Qualitative And Quantitative Composition
Each tablet contains 1g Calcium Gluconate BP equivalent to 2.23mmol of calcium (Ca2+)
3. Pharmaceutical Form
White uncoated tablets.
White, circular, flat bevelled-edge uncoated tablets impressed “C” and the identifying letters “CN” on one face.
4. Clinical Particulars
4.1 Therapeutic Indications
1) As an adjunct to conventional therapy in the arrest or slowing down of bone demineralisation in osteoporosis where other effective treatment is contraindicated.
2) In the arrest or slowing down of bone demineralisation in osteoporosis where other effective treatment is contraindicated.
3) Therapeutic supplementation in osteomalacia, rickets, post-gastrectomy malabsorption, pregnancy, lactation, malnutrition or dietary deficiency.
4.2 Posology And Method Of Administration
Posology
The tablets must be dissolved in one third to one half a tumblerful of water.
In health the concentration of calcium in serum is maintained close to 2.5mmol/l (normal range 2.25-2.75mmol or 4.5-5.5mEq/l).
Treatment or therapeutic supplementation should aim to restore or maintain this level.
Adults (including elderly):
Osteoporosis: A daily supplement of 800mg (20mmol) calcium or 8-9 tablets may reduce the rate of bone loss, but larger doses have not been shown to be more effective.
|
Indication: |
1. Name Of The Medicinal Product
EpiPen Adrenaline (Epinephrine) Auto-Injector 0.3mg
2. Qualitative And Quantitative Composition
Per 1 ml:
|
Active ingredient |
Quantity / Unit |
Reference Standards |
|
Adrenaline (Epinephrine) |
1.0 mg |
BP/USP |
3. Pharmaceutical Form
Solution for injection in an Auto-lnjector (prefilled, disposable automatic injection device) for intramuscular use.
4. Clinical Particulars
4.1 Therapeutic Indications
EpiPen Auto-Injectors are automatic injection devices containing adrenaline for allergic emergencies. The Auto-Injectors should be used only by a person with a history or an acknowledged risk of an anaphylactic reaction. The Auto-Injectors are indicated in the emergency treatment of allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis. Such reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhoea and abdominal cramps, involuntary voiding, wheezing, dys
EpiPen Auto-Injector 0.3 mg Adrenaline
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 EpiPen is and what it is used for
- 2. Before you use EpiPen
- 3. How to use EpiPen
- 4. Possible side effects
- 5. How to store EpiPen
- 6. Further information
What EpiPen is and what it is used for
EpiPen contains a sterile solution for emergency injection into the muscle (intramuscular injection).
EpiPen is to be used for the emergency treatment of sudden life threatening allergic reactions (anaphylactic shock) to insect stings or bites, foods or drugs or exercise. The reaction is the result of the body trying to protect itself from the allergen (the foreign substance that causes the allergy) by releasing chemicals into the blood stream. Sometimes the cause of the allergic reaction is not known.
Symptoms that signal the onset of an anaphylactic shock occur within minutes of exposure to the allergen and include: itching of the skin; raised rash (li
1. Name Of The Medicinal Product
Erythroped A Tablets
2. Qualitative And Quantitative Composition
Erythromycin as Erythromycin Ethylsuccinate Ph.Eur. 500mg/tablet
3. Pharmaceutical Form
Tablets
4. Clinical Particulars
4.1 Therapeutic Indications
For the prophylaxis and treatment of infections caused by erythromycin-sensitive organisms.
Erythromycin is highly effective in the treatment of a great variety of clinical infections such as:
1. Upper Respiratory Tract infections: tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, sinusitis, secondary infections in influenza and common colds
2. Lower Respiratory Tract infections: tracheitis, acute and chronic bronchitis, pneumonia (lobar pneumonia, bronchopneumonia, primary atypical pneumonia), bronchiectasis, Legionnaire's disease
3. Ear infection: otitis media and otitis externa, mastoiditis
4. Oral infections: gingivitis, Vincent's angina
5. Eye infections: blepharitis
6. Skin and soft tissue infections: boils and carbuncles, paronychia, abscesses, pustular acne, impetigo, cellulitis, erysipelas
7. Gastrointestinal infections: cholecystitis, staphylococcal enterocolitis
8. Prophylaxis: pre- and post- operative trauma, burns, rheumatic fever
9. Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever
4.2 Posology And Method Of Administration
For oral administration
Adults and children over 8 years. For mild to moderate infections 2g daily in divided doses. Up to 4g daily in severe infections.
Elderly: No s
1. Name Of The Medicinal Product
Epanutin 25 mg Hard Capsules
Epanutin 50 mg Hard Capsules
Epanutin 100 mg Hard Capsules
Epanutin 300 mg Hard Capsules
2. Qualitative And Quantitative Composition
Each capsule contains 25 mg phenytoin sodium.
Each capsule also contains 66.857 mg lactose monohydrate
Each capsule contains 50mg phenytoin sodium
Each capsule also contains 90.71 mg lactose monohydrate
Each capsule contains 100mg phenytoin sodium
Each capsule also contains 96.15 mg lactose monohydrate
Each capsule contains 300mg phenytoin sodium
Each capsule also contains 61.88 mg lactose monohydrate
For full list of excipients, see Section 6.1
3. Pharmaceutical Form
Capsules, hard
Epanutin Capsules 25mg: A white powder in a No 4 hard gelatin capsule with a white opaque body and blue-violet cap, radially printed 'EPANUTIN 25'.
Epanutin Capsules 50mg: A white powder in a No 4 hard gelatin capsule with a white opaque body and a flesh-coloured transparent cap, radially printed 'EPANUTIN 50'.
Epanutin Capsules 100mg: A white powder in a No 3 hard gelatin capsule with a white opaque body and orange cap, radially printed 'EPANUTIN 100'.
Epanutin Capsules 300mg: A white powder in a No 1 hard gelatin capsule with a white opaque body and green cap, radially printed 'EPANUTIN 300'.
4. Clinical Particulars
4.1 Therapeutic Indications
Control of tonic-clonic seizures (grand mal epilepsy), partial seizures (focal including temporal lobe) or a combination of these, and the prevention and treatment of seizures occurring during or following neurosurgery an
1. Name Of The Medicinal Product
Magnesium Sulphate Heptahydrate BP.
Epsom Salts BP
2. Qualitative And Quantitative Composition
Magnesium Sulphate Heptahydrate BP 100% W/W.
3. Pharmaceutical Form
Crystals or Crystalline Powder.
Brilliant colourless crystals or a white crystalline powder.
4. Clinical Particulars
4.1 Therapeutic Indications
1. For the relief of occasional constipation.
2. For the relief of pain from sprains, bruises and boils.
4.2 Posology And Method Of Administration
1. Oral. As a dilute solution.
2. Cutaneous. As a concentrated solution or paste.
Recommended doses and dosage schedules
Indication 1
|
Adults and children over 12 years: |
5-15g (13 teaspoons) to be taken as required in 250 ml of water, which may be flavoured with citrus juices. |
|
The elderly: |
To be used with caution, not exceeding the adult dose. |
|
Children under 12 years: |
Not recommended. |
Indication 2
|
As |
ELLIMANS UNIVERSAL MUSCLE RUB Lotion
(turpentine oil, glacial acetic acid)
Important Information about Ellimans
- This medicine relieves symptoms of various rheumatic and muscular pains when applied to the skin.
- It can be used on adults, the elderly and children over 12 years.
Do not use
- On broken or inflamed skin.
- On children under 12 years.
Now read the rest of the leaflet before you use this medicine. It includes other information which might be especially important for you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need any more information or advice.
- 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.
What the medicine is for
Ellimans is a skin lotion which has warming and soothing properties. It is used to relieve the symptoms of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain. It can also be used by athletes to massage the arm or leg muscles.
Before you use this medicine
Do not use the medicine if you have
- An allergy to any of the ingredients listed in section 6.
- Broken or inflamed skin.
- Or on a child under 12 years old.
Epsom salts B.P. (Boots Company plc)
(Magnesium Sulphate)
Relieves occasional constipation
500 g e
Read all of this carton for full instructions.
What this medicine is for
This medicine contains magnesium sulphate, which is a laxative. It can be used to relieve occasional constipation.
Before you take this medicine
Do not take:
- If you have severe stomach pain
- If you are feeling sick or being sick
- For long periods of time (in general more than a week), unless your doctor tells you to
Talk to your pharmacist or doctor:
- If you have kidney problems
- If you are pregnant or breastfeeding
How to take this medicine
Check the carton seal is not broken before first use. If it is, do not take the powder.
This powder should be swallowed with a cup of tea, or stirred into a glass of water and drunk.
Adults and children of 12 years and over
Take one or two 5 ml spoonfuls
Once a day, before breakfast
Children of 5 to 11 years
Take half to one 5 ml spoonful
Once a day, before breakfast
Do not give to children under 5 years.
Do not take more than the amount recommended above.
If symptoms do not go away talk to your doctor.
If you take too much: Talk to a doctor straight away.
Possible side effects
Most people will not have problems, but some may get some of these:
1. Name Of The Medicinal Product
Erythromycin Lactobionate for Intravenous Infusion 1g
2. Qualitative And Quantitative Composition
Each vial, before reconstitution, contains erythromycin 1 g (as lactobionate)
When reconstituted as recommended, each vial provides a concentrate for solution for infusion containing 50 mg/ml erythromycin as erythromycin lactobionate.
For excipients, see 6.1.
3. Pharmaceutical Form
Powder for concentrate for solution for infusion
Clear vials containing a white powder for reconstitution
4. Clinical Particulars
4.1 Therapeutic Indications
1. Upper respiratory tract infections (tonsillitis, pharyngitis, sinusitis, secondary bacterial infections).
2. Lower respiratory tract infections (pneumonia, bronchitis, primary atypical pneumonia, Legionnaire's disease).
3. Skin and soft tissue infections (furunculosis, erysipelas).
4. Other infections - diphtheria carriers and cases as an adjunct to antitoxin, syphilis and gonorrhoea (in cases of penicillin allergy), subacute bacterial endocarditis, otitis media.
4.2 Posology And Method Of Administration
Intravenous injection by:-
1. Continuous intravenous infusion.
2. Intermittent intravenous infusion.
Small volume intravenous infusion, minimum volume 100 ml, is the preferred method so as to minimise venous irritation.
Dosage and Administration
Intravenous administration of erythromycin is suitable to patients who are unable to tolerate oral medication or when it is necessary to produce a high blood concentration to control severe infections. Oral administration should repl
1. Name Of The Medicinal Product
Eporatio 5,000 IU/0.5 ml solution for injection in pre
2. Qualitative And Quantitative Composition
One pre-filled syringe contains 5,000 international units (IU) (41.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.
Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells (CHO
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection (injection) in pre
The solution is clear and colourless.
4. Clinical Particulars
4.1 Therapeutic Indications
- Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.
- Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
4.2 Posology And Method Of Administration
Special requirements
Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned indications.
Routes of administration
The solution can be administered subcutaneously (SC) or intravenously (IV). Subcutaneous use is preferable in patients who are not undergoing haemodialysis, in order to avoid puncturing peripheral veins. If epoetin theta is substituted for another epoetin, the same route of administration should be used. Epoetin theta should be administered by the subcutaneous route to cancer patients with non
Posology
Symptomatic anaemia associated with chronic
Ebixa 10 mg film-coated tablets
Memantine 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 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 Ebixa is and what it is used for
2. Before you take Ebixa
3. How to take Ebixa
4. Possible side effects
5. How to store Ebixa
6. Further information
What Ebixa Is And What It Is Used For
How does Ebixa work
Ebixa belongs to a group of medicines known as anti-dementia medicines.
Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Ebixa belongs to a group of medicines called NMDA-receptor antagonists. Ebixa acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Ebixa used for
Ebixa is used for the treatment of patients with moderate to severe Alzheimer’s disease.
Before You Take Ebixa
Do not take Ebixa
- if you are allergic (hypersensitive) to memantine hydrochloride o
1. Name Of The Medicinal Product
EVRA transdermal patch
2. Qualitative And Quantitative Composition
Each 20 cm2 transdermal patch contains 6 mg norelgestromin (NGMN) and 600 micrograms ethinyl estradiol (EE).
Each transdermal patch releases an average of 203 micrograms of NGMN and 33.9 micrograms of EE per 24 hours. Medicinal product exposure is more appropriately characterized by the pharmacokinetic profile (see section 5.2).
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Transdermal patch.
EVRA is a thin, matrix-type transdermal patch consisting of three layers.
The outside of the backing layer is beige and heat-stamped “EVRA”.
4. Clinical Particulars
4.1 Therapeutic Indications
Female contraception
EVRA is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.
4.2 Posology And Method Of Administration
Posology
To achieve maximum contraceptive effectiveness, patients must be advised to use EVRA exactly as directed. For initiation instructions see 'How to start EVRA' below.
Only one patch is to be worn at a time.
Each used patch is removed and immediately replaced with a new one on the same day of the week (Change Day) on Day 8 and Day 15 of the cycle. Patch changes may occur at any time on the scheduled Change Day. The fourth week is patch-free starting on Day 22.
A new contraceptive cycle begins on the next day following patch-free week; the next EVRA patch should be applied even if there has been no bleeding or if bleeding has not yet stopped.
Under no c
1. Name Of The Medicinal Product
Enbrel® 50 mg solution for injection in pre-filled syringe.
2. Qualitative And Quantitative Composition
Each pre-filled syringe contains 50 mg of etanercept.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. This Fc component contains the hinge, CH2 and CH3 regions, but not the CH1 region of IgG1. Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. The specific activity of etanercept is 1.7 x 106 units/mg.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection.
The solution is clear, and colourless or pale yellow.
4. Clinical Particulars
4.1 Therapeutic Indications
Rheumatoid arthritis
Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Enbre