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
Rogitine® ampoules 10mg
2. Qualitative And Quantitative Composition
Phentolamine mesilate PhEur 10mg.
3. Pharmaceutical Form
Colourless to pale yellow solution in 1ml Water for Injections PhEur
4. Clinical Particulars
4.1 Therapeutic Indications
Management of hypertensive episodes that may occur in patients with phaeochromocytoma, for example during pre-operative preparation and surgical manipulation.
Diagnosis of phaeochromocytoma by Rogitine blocking test if other more specific tests are not available.
4.2 Posology And Method Of Administration
Adults
Management of hypertensive episodes in patients with phaeochromocytoma
For the management of hypertensive crises that arise during the pre-operative phase or during induction of anaesthesia, intubation, or surgical removal of the tumour, 2 to 5mg of Rogitine is injected intravenously and repeated if necessary. The blood pressure response should be monitored.
Diagnosis of phaeochromocytoma - Rogitine blocking test
The test is most reliable in detecting phaeochromocytoma in patients with sustained hypertension and least reliable in those with paroxysmal hypertension. False-positive tests may occur in patients with hypertension without phaeochromocytoma.
Preparation for the test:
Sedatives, analgesics and all other medications except those that might be deemed essential (such as digitalis and insulin) are withheld for at least 24 hours, and preferably 48 to
1. Name Of The Medicinal Product
Refludan 50 mg powder for solution for injection or infusion
2. Qualitative And Quantitative Composition
Each vial contains 50 mg lepirudin.
(Lepirudin is a recombinant DNA product derived from yeast cells)
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Powder for solution for injection or infusion.
White to almost white lyophilised powder.
4. Clinical Particulars
4.1 Therapeutic Indications
Anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease mandating parenteral antithrombotic therapy.
The diagnosis should be confirmed by the HIPAA (heparin induced platelet activation assay) or an equivalent test.
4.2 Posology And Method Of Administration
Treatment with Refludan should be initiated under the guidance of a physician with experience in coagulation disorders.
Initial dosage
Anticoagulation in adult patients with HIT type II and thromboembolic disease:
– 0.4 mg / kg body weight intravenously as a bolus dose
– followed by 0.15 mg / kg body weight / hour as a continuous intravenous infusion for 2 - 10 days or longer if clinically needed.
Normally, the dosage depends on the patient's body weight. This is valid up to a body weight of 110 kg. In patients with a body weight exceeding 110 kg the dosage should not be incre
1. Name Of The Medicinal Product
REMEDEINE® and REMEDEINE FORTE® tablets
2. Qualitative And Quantitative Composition
REMEDEINE tablets contain Paracetamol 500 mg and Dihydrocodeine Tartrate BP 20 mg.
REMEDEINE FORTE tablets contain Paracetamol 500 mg and Dihydrocodeine Tartrate BP 30 mg.
3. Pharmaceutical Form
White to off-white, circular, flat faced tablets with a bevelled edge.
REMEDEINE tablets are engraved PD/20 on one side.
REMEDEINE FORTE tablets are engraved PD/30 on one side.
4. Clinical Particulars
4.1 Therapeutic Indications
REMEDEINE tablets
For the treatments of severe pain.
REMEDEINE FORTE tablets
For the treatment of severe pain where there is a higher analgesic
4.2 Posology And Method Of Administration
Route of Administration
Oral.
REMEDEINEREMEDEINE FORTE tablets should, if possible, be taken during or after meals.
Adults and children over 12 years
1 or 2 tablets every four to six hours.
Do not exceed eight tablets in any 24-hour period.
Children under 12 years
Not recommended.
Elderly
One tablet every 4 - 6 hours increasing to two tablets every 4 - 6 hours if required and tolerated. Caution should be exercised when increasing the dose in the elderly.
4.3 Contraindications
Respiratory depression, obstructive airways disease, hypersensitivity to paracetamol, dihydrocodeine or other table
1. Name Of The Medicinal Product
RISPERDAL CONSTA
RISPERDAL CONSTA
RISPERDAL CONSTA
2. Qualitative And Quantitative Composition
1 vial contains 25 mg, 37.5 or 50mg risperidone.
1 ml reconstituted suspension contains 12.5 mg, 18.75mg or 25mg of risperidone.
Excipients: 1 ml reconstituted suspension contains 3 mg sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Powder and solvent for prolonged-release suspension for injection.
Vial with powder.
White to off-white free flowing powder.
Pre-filled syringe of solvent for reconstitution.
Clear, colourless aqueous solution.
4. Clinical Particulars
4.1 Therapeutic Indications
RISPERDAL CONSTA is indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics.
4.2 Posology And Method Of Administration
Adults
Starting dose:
For most patients the recommended dose is 25 mg intramuscular every two weeks. For those patients on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered. Patients treated with a dosage of 4 mg or less oral risperidone should receive 25 mg RISPERDAL CONSTA, while patients treated with higher oral doses should be considered for the higher RISPERDAL CONSTA dose of 37.5 mg.
Where patients are not currently taking oral risperidone, the oral pre-treatment dosage should be considered when choosing the i.m. starting dose. The recommended starting dose is 25 mg RISPERDAL CONSTA every two
1. Name Of The Medicinal Product
REGRANEX 0.01% gel
2. Qualitative And Quantitative Composition
Each gram of gel contains100 ?g of becaplermin*.
*Recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB) produced in Saccharomyces cerevisiae by recombinant DNA technology.
Excipients:
Each gram contains E218 (methyl parahydroxybenzoate) 1.56mg and E216 (propyl parahydroxybenzoate) 0.17mg, see section 4.4
For a full list of excipients, see section see 6.1.
3. Pharmaceutical Form
Gel
REGRANEX is a clear colourless to straw-coloured preserved gel.
4. Clinical Particulars
4.1 Therapeutic Indications
REGRANEX is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2.
4.2 Posology And Method Of Administration
Treatment with REGRANEX should be initiated and monitored by physicians (specialists or non-specialists) who are experienced in the management of diabetic wounds.
REGRANEX should always be used in conjunction with good wound care consisting of initial debridement (to remove all the necrotic and/or infected tissue), additional debridement as necessary and a non-weight-bearing regimen to alleviate pressure on the ulcer.
REGRANEX should be applied as a continuous thin layer to the entire ulcerated area(s) once daily using a clean application aid. The site(s) of application should then be covered by a moist saline gauze dressing that maintains a moist wound-healing environment. REGRANEX should not be used in conjunction with occlusive dressings.
1. Name Of The Medicinal Product
Ralgex Cream.
2. Qualitative And Quantitative Composition
Glycol Monosalicylate DAB 10.0% w/w; Methyl Nicotinate BP 1.0% w/w; Capsicum Oleoresin BPC 1973 0.12% w/w.
3. Pharmaceutical Form
Cream.
4. Clinical Particulars
4.1 Therapeutic Indications
Symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis and rheumatic pain.
4.2 Posology And Method Of Administration
Adults and children aged 12 years and over: After trial use, rub into the skin until absorbed. To be applied as required to the affected area. Repeat as necessary up to four times a day. Not to be used on children under 12 years except on medical advice. The elderly: The normal adult directions for use can be followed.
4.3 Contraindications
Known hypersensitivity to salicylates or to any of the ingredients of the cream. Injuries involving broken skin.
4.4 Special Warnings And Precautions For Use
Some people experience stronger effects with Ralgex than others; the product should be tried on a small area first. Do not apply near the eyes, mouth or on sensitive body areas. Day-to-day variation may occur in the sensitivity of the skin, which is more sensitive after a hot bath or in hot weather.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
No evidence of safety of this product has been determined in pregnancy. It is not necessary to contraindicate this product in pregnancy and lactation provided caution is exercised and the directions for use are followed. However, as with all medicines, the advice of a do
1. Name Of The Medicinal Product
Renvela 800 mg film
2. Qualitative And Quantitative Composition
Each tablet contains 800 mg sevelamer carbonate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Film
The white to off
4. Clinical Particulars
4.1 Therapeutic Indications
Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/l.
Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
4.2 Posology And Method Of Administration
Posology
Starting dose
The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level. Renvela must be taken three times per day with meals.
|
Serum phosphorus level in patients |
Total daily dose of sevelamer carbonate to be taken over 3 meals per day |
|
1.78 – 2.42 mmol/l (5.5 – 7.5 mg/dl) |
1. Name Of The Medicinal Product
Reminyl® 4 mg/ml oral solution
2. Qualitative And Quantitative Composition
1 ml oral solution contains 4 mg galantamine (as hydrobromide).
Excipients: methyl parahydroxybenzoate and propyl parahydroxybenzoate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Oral solution.
Clear and colourless oral solution.
4. Clinical Particulars
4.1 Therapeutic Indications
Reminyl is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.
4.2 Posology And Method Of Administration
Adults/Elderly
Administration
Reminyl oral solution should be administered twice a day, preferably with morning and evening meals. Ensure adequate fluid intake during treatment (See section 4.8).
Before start of treatment
The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines (see section 4.4).
Starting dose
The recommended starting dose is 8 mg/day (4 mg twice a day) for four weeks.
Maintenance dose
• The tolerance and dosing of galantamine should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of galantamine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as therapeutic benefit is favourable and the pati
1. Name Of The Medicinal Product
Ranexa 375 mgRanexa 500 mg
Ranexa 750 mg
2. Qualitative And Quantitative Composition
Each tablet contains 375 mg of ranolazine.
Each tablet contains 500 mg of ranolazine.
Each tablet contains 750 mg of ranolazine.
< 750 mg tablet>
Excipients: Each tablet contains 0.04 mg azo colouring agent E102 and 12.0 mg lactose monohydrate.
For a full list of excipients see section 6.1.
3. Pharmaceutical Form
Prolonged-release tablet
Pale blue oval-shaped tablet engraved with CVT375 or 375 on one side.
Light orange oval-shaped tablet engraved with CVT500 or 500 on one side.
Pale green oval-shaped tablet engraved with CVT750 or 750 on one side.
4. Clinical Particulars
4.1 Therapeutic Indications
Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).
4.2 Posology And Method Of Administration
Patients should be given the Ranexa package leaflet and the Patient Alert Card and instructed to present their Patient Alert Card and medication list to their health care professional at each visit.
Ranexa is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets.
Adults: The recommended initial dose of Ranexa is 375 mg twice daily. After 2–4 weeks, the dose should be titrated to 500 mg twice daily and, according to the patient's response, further titrated to a recommended maximum dose of 750 mg twice daily (see section
RENVELA 800 mg film-coated tablets
sevelamer carbonate
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 further questions, ask your doctor or your 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 Renvela is and what it is used for
- 2. Before you take Renvela
- 3. How to take Renvela
- 4. Possible side effects
- 5. How to store Renvela
- 6. Further information
What Renvela Is And What It Is Used For
Renvela contains sevelamer carbonate as the active ingredient. It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood.
Patients who have kidneys that do not work properly are not able to control the level of serum phosphorus in their blood. The amount of phosphate then rises (your doctor will call this hyperphosphataemia). Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body. Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures.
1. Name Of The Medicinal Product
Regaine for Women Regular Strength
2. Qualitative And Quantitative Composition
Minoxidil 20 mg/ml (2% w/v).
Contains propylene glycol.
For full list of excipients see section 6.1.
3. Pharmaceutical Form
Cutaneous Solution (to be applied to the scalp).
4. Clinical Particulars
4.1 Therapeutic Indications
Regaine for Women Regular Strength is indicated for the treatment of alopecia androgenetica in women aged between 18 and 65.
Onset and degree of hair regrowth may be variable among users. Although trends in the data suggest that those users who are younger, whose hair has been thinning for a shorter period of time or who have a smaller area of thinning on the vertex are more likely to respond to Regaine for Women Regular Strength, individual responses cannot be predicted.
4.2 Posology And Method Of Administration
Women aged 18-65:
Hair and scalp should be thoroughly dry prior to topical application of Regaine for Women Regular Strength. A dose of 1 ml Regaine for Women Regular Strength cutaneous solution should be applied to the total affected areas of the scalp twice daily. The total dosage should not exceed 2 ml. If fingertips are used to facilitate drug application, hands should be washed afterwards.
It may take twice daily applications for four months or more before evidence of hair growth can be expected.
If hair re-growth occurs, twice daily applications of Regaine for Women Regular Strength are necessary for continued hair growth. Anecdotal reports indicate that re-grown hair may disappear three to four months after stopping Regaine for Women Regular Strength application and the balding process will continue.
1. Name Of The Medicinal Product
Roaccutane 10 mg soft capsules
2. Qualitative And Quantitative Composition
Each soft capsule contains 10 mg of isotretinoin.
Excipients: Contains soya bean oil (refined, hydrogenated and partially hydrogenated) and sorbitol (E420).
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Capsules, soft
10 mg capsules: Oval, opaque, brown-red capsules imprinted with ROA 10 in black ink.
4. Clinical Particulars
4.1 Therapeutic Indications
Severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic anti-bacterials and topical therapy.
4.2 Posology And Method Of Administration
Isotretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements.
The capsules should be taken with food once or twice daily.
Adults including adolescents and the elderly:
Isotretinoin therapy should be started at a dose of 0.5 mg/kg daily. The therapeutic response to isotretinoin and some of the adverse effects are dose-related and vary between patients. This necessitates individual dosage adjustment during therapy. For most patients, the dose ranges from 0.5-1.0 mg/kg per day.
Long-term remission and relapse rates are more closely related to the total dose administered than to either duration of treatment or daily dose. It has been shown that no substantial additional benefit is to be expected beyond a cum
1. Name Of The Medicinal Product
Radian B Pain Relief Spray / Fiery Jack Pain Relief Spray
2. Qualitative And Quantitative Composition
|
Menthol BP |
1.4%w/v |
|
Camphor BP |
0.6%w/v |
|
Aspirin BP |
1.2%w/v |
|
Equivalent to ammonium salicylate |
1.0%w/v |
|
Methyl Salicylate BP |
0.6%w/v |
|
Equivalent to salicylic acid (as Methyl and Ethyl Esters) |
0.54%w/v |
3. Pharmaceutical Form
Spray for topical application to human beings
4. Clinical Particulars
4.1 Therapeutic Indications
For symptomatic relief of muscular and rheumatic aches and pains, including fibrositis, sciatica, lumbago, sprained ligaments, bruises, muscle stiffness, strains, tennis elbow, golf shoulder
Relifex 500 mg Film-coated Tablets
Nabumetone
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.
- In this leaflet, Relifex 500 mg Film-coated Tablets will be called Relifex.
In this leaflet:
- 1. What Relifex is for
- 2. Before you take Relifex
- 3. How to take Relifex
- 4. Possible side effects
- 5. How to store Relifex
- 6. Further information
What Relifex is for
Relifex belongs to a group of medicines called non-steroidal anti-inflammatory drugs (known as NSAIDs).
It works by reducing the production of some natural chemicals found in the body. These chemicals (prostaglandins) cause the symptoms of inflammation such as pain and swelling.
Relifex is used to treat the pain, stiffness and swelling of joints which are affected by osteoarthritis or rheumatoid arthritis.
Before you take Relifex
Do not take Relifex if:
- You are allergic to nabumetone
- You are allergic to any of the other ingredients of Relifex (see section 6)
- You have ever had an allergic reaction like a rash, itchy, runny or bleeding nose, or become short
1. Name Of The Medicinal Product
Ramipril 10mg Tablets
2. Qualitative And Quantitative Composition
10 mg ramipril.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Tablet
White to almost white, oblong tablets with a score-line.
Upper stamp: HMO/HMO
Lower stamp: anonymous
4. Clinical Particulars
4.1 Therapeutic Indications
- Treatment of hypertension.
- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:
o manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or
o diabetes with at least one cardiovascular risk factor (see section 5.1).
- Treatment of renal disease:
o Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria,
o Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1),
o Manifest glomerular non diabetic nephropathy as defined by macroproteinuria
- Treatment of symptomatic heart failure.
- Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started> 48 hours following acute myocardial infarction.
4.2 Posology And Method Of Administration
Oral use.
It is recommended that RAMIPRIL is taken each day at the same time of the day.
RAMIPRIL can be taken before, with or after meals, because food intake does not
1. Name Of The Medicinal Product
Rivastigmine Sandoz 4.5 mg hard capsules
2. Qualitative And Quantitative Composition
Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 4.5 mg.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Hard capsule
Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “RIV 4.5 mg” on the body.
4. Clinical Particulars
4.1 Therapeutic Indications
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
4.2 Posology And Method Of Administration
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia or dementia associated with Parkinson's disease. Diagnosis should be made according to current guidelines. Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient.
Rivastigmine should be administered twice a day, with morning and evening meals. The capsules should be swallowed whole.
Initial dose
1.5 mg twice a day.
Dose titration
The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two
Ramipril 1.25mg, 2.5mg, 5mg and 10mg Capsules
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.
- Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect
In this leaflet:
- 1. What ramipril is and what it is used for.
- 2. Before you take ramipril.
- 3. How to take ramipril.
- 4. Possible side effects.
- 5. How to store ramipril.
- 6. Further Information.
What Ramipril Is And What It Is Used For
The name of your medicine is Ramipril 1.25mg, 2.5mg, 5mg or 10mg Capsules (called ramipril throughout this leaflet). It belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Ramipril works by:
- Decreasing your body’s production of substances that could raise your blood pressure
- Making your blood vessels relax and widen
- Making it easier for your heart to pump blood around your body.
Ramipril can be used:
1. Name Of The Medicinal Product
Rabies Vaccine BP
2. Qualitative And Quantitative Composition
After reconstitution, 1 dose (1ml) contains:
Rabies virus* (inactivated, strain PM/WI 38 1503-3M)……..
*produced in human diploid MRC-5 cells
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Powder and solvent for suspension for injection
The powder is pinkish beige to orangey yellow.
The solvent is a clear, colourless solution.
4. Clinical Particulars
4.1 Therapeutic Indications
For prophylactic immunisation against rabies. Treatment of patients following suspected rabies contact.
4.2 Posology And Method Of Administration
Administer by intramuscular injection. The vaccine should be administered into the deltoid region. For instructions on the reconstitution of the vaccine before administration, see section 6.6.
Adults, Elderly and Children
Prophylaxis:
Three injections each of 1 millilitre given on days 0, 7 and 28. A single reinforcing dose should be given at two or three year intervals to those at continued risk.
If, for whatever reason, it has not been possible to give a full course of three injections, it is probable that, in the majority of subjects, two doses may be adequate to confer protection, provided these were given four weeks apart. Subjects receiving only two injections who remain at continued risk should receive a reinforcing dose 6-12 months later, with further reinforcing doses given at two to three year intervals.
Treatment
(i) In
1. Name Of The Medicinal Product
Rebif 8.8 micrograms/0.1 ml solution for injection in cartridge
Rebif 22 micrograms/0.25 ml solution for injection in cartridge
Rebif 22 micrograms/0.5 ml solution for injection in cartridge
Rebif 44 micrograms/0.5ml solution for injection in cartridge
2. Qualitative And Quantitative Composition
Rebif 8.8 mcg/0.1ml and Rebif 22 mcg/0.25ml:
Each pre-filled cartridge contains 132 micrograms (36 MIU*) of interferon beta-1a** in 1.5 ml solution, corresponding to 88 micrograms/ml.
Rebif 22mcg/0.5ml:
Each pre-filled cartridge contains 66 micrograms (18 MIU*) of interferon beta-1a** in 1.5 ml solution, corresponding to 44 micrograms/ml.
Rebif 44mcg/0.5ml:
Each pre-filled cartridge contains 132 micrograms (36 MIU*) of interferon beta-1a** in 1.5 ml solution, corresponding to 88 micrograms/ml.
* Million International Units measured by cytopathic effect (CPE) bioassay against the in-house IFN beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531).
** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology.
Excipient: 7.5 mg benzyl alcohol
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection in cartridge.
Clear to opalescent solution, with pH 3.7 to 4.1 and osmolarity 250 to 450 mOsm/l.
4. C
1. Name Of The Medicinal Product
REPEVAX®, suspension for injection, in pre-filled syringe
Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)
2. Qualitative And Quantitative Composition
1 dose (0.5 mL) contains:
Diphtheria Toxoid........................................................... Not less than 2 IU* (2 Lf)
Tetanus Toxoid ........................................................... Not less than 20 IU* (5 Lf)
Pertussis Antigens
Pertussis Toxoid.............................................................................. 2.5 micrograms
Filamentous Haemagglutinin...........................................................5 micrograms
Pertactin.......................................................................................... 3 micrograms
Fimbriae Types 2 and 3................................................................... 5 micrograms
Poliovirus (Inactivated)**
Type 1.......................................................................................... 40 D antigen units
Type 2............................................................................................ 8 D antigen units
Type 3.......................................................................................... 32 D antigen units
Adsorbed on aluminium phosphate....................................................... 1.5 mg (0.33 mg aluminium)
* As lower confidence limit (p = 0.95) of activity measured according to the assay described in the European Pharmacopoeia.
** Produced in Vero cells.
For a full list of excipients, see s