Pharmaflex may be available in the countries listed below.
Ingredient matches for Pharmaflex
Metronidazole
Metronidazole is reported as an ingredient of Pharmaflex in the following countries:
- Luxembourg
International Drug Name Search
Wednesday, 28 September 2016
Clear Fc
Clear Fc may be available in the countries listed below.
Ingredient matches for Clear Fc
Cresol
Cresol is reported as an ingredient of Clear Fc in the following countries:
- Japan
Formaldehyde
Formaldehyde solution 35% (a derivative of Formaldehyde) is reported as an ingredient of Clear Fc in the following countries:
- Japan
International Drug Name Search
Budenofalk 3mg Capsules
BUDENOFALK 3mg
Gastro-resistant Capsules
BUDESONIDE
Please read this leaflet carefully before you start to take your medicine.
It contains important information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). Keep this leaflet until you have finished all of your medicine. You may want to read it again.
What is in your medicine?
Budenofalk 3mg comes in capsule form. Each gastro-resistant capsule contains 3mg of an active ingredient called budesonide.
The capsules also contain lactose monohydrate, sucrose, maize starch, triethyl citrate, talc, povidone and coating agents known as Eudragit.
The capsules are made of hard gelatin, purified water and sodium laurilsulfate. They are coloured with titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172) and erythrosine (E127).
Each box of Budenofalk 3mg contains either 10, 50, 90, 100 or 120 pink capsules in blister strips.
Marketing Authorisation Holder and Manufacturer:
Dr Falk Pharma GmbH
D-79041 Freiburg
Germany
Distributed by:
Dr Falk Pharma UK Ltd
Unit K
Bourne End Business Park
Cores End Road
Bourne End
Bucks
SL8 5AS
UK
What your medicine is used for
Your medicine contains a type of steroid which reduces inflammation. It may be used to treat Crohn’s disease, an inflammation which predominantly affects the last part of the small bowel and/or the first part of the large bowel but can affect other parts of the gastrointestinal tract.
Sometimes Crohn’s disease may include symptoms in the skin, eyes and joints. These symptoms are unlikely to respond to this medicine.
Budenofalk may also be used for the symptomatic relief of chronic diarrhoea due to collagenous colitis.
Before taking your medicine
You should not take this medicine if:
- You are allergic to budesonide or any of the ingredients listed above.
- You have a serious liver disease.
If you are pregnant, trying to become pregnant or think you may be pregnant, you should avoid taking this drug unless advised by your doctor.
It is not known if budesonide passes into breast milk, therefore you should not breast feed while on treatment.
If you answer yes to any of the following questions, tell your doctor or pharmacist.
- Do you have, or have you ever had, tuberculosis, high blood pressure, diabetes, brittle bones (osteoporosis), stomach ulcers, glaucoma, cataracts or liver problems?
- If you know or think you may have any sort of infection.
- Has anyone in your family ever had diabetes or glaucoma?
- Are you taking colestyramine, digoxin, water tablets, ketoconazole, ritonavir, itraconazole, clarithromycin, carbamazepine, rifampicin, cimetidine, oestrogens and oral contraceptives or antacids?
- Are you taking any other medication (including any medicines you have bought without a prescription) which your doctor does not know about?
Please try to avoid contact with people who have chicken pox, shingles or measles. This is particularly important if you do not think you have had this illness yourself. If you think you may have been exposed to any of these illnesses, tell your doctor as soon as possible. Please tell your doctor if you are about to go abroad and need a vaccination whilst you are taking this medicine.
The capsules contain lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product
How to take your medicine
It is important to take your medicine as directed by your doctor. The label will tell you how much to take and how often. If it does not or you are unsure, ask your doctor or pharmacist.
- The usual dose is one capsule three times a day (morning, midday and evening).
- Take the capsules about 30 minutes before a meal.
- Swallow the capsules whole with a glass of water (avoid taking with grapefruit juice).
- Do not chew the capsules.
This medicine is not recommended for children.
It is important that you do not stop taking your medicine suddenly as it could make you ill. Keep taking your medicine until your doctor tells you to stop, even if you start to feel better. Your doctor will probably want to reduce your dose gradually, first from 3 to 2 capsules daily for one week, (one in the morning and one in the evening) and then only one capsule daily in the last week of treatment (taken in the morning).
Your doctor will not normally want you to take this medicine for more than 8 weeks.
If you go into hospital, or you visit a dentist or another doctor, tell them you are taking Budenofalk 3mg gastro-resistant capsules.
What to do if you forget to take your medicine
If you forget to take your capsules, take a dose as soon as you remember and then continue with the next dose as instructed on the label. Do not take more capsules in a day than you usually do.
What to do if you take too many capsules
If you accidentally take too many capsules, do not worry, but contact your doctor or local hospital casualty department as soon as possible. Take this medicine with you.
After taking your medicine
Like all medicines, Budenofalk 3mg gastro-resistant capsules may occasionally cause unwanted effects in some people. Most of these effects are not serious. This medicine contains a type of steroid, so you might experience unwanted effects typical of steroids. They may include:
- Skin rashes, acne, itchy skin, development of marks and bleeding within the skin, delayed wound healing.
- Tiredness, muscle weakness or pain, brittle bones, wasting of bones and cartilage.
- Roundness of the face, weight gain, fluid retention including leg edema, increased risk of high blood sugar, diabetes mellitus, increased risk of infections, blood clots and high blood pressure.
- Heartburn, stomach complaints such as ulcers, pancreatitis and constipation.
- Cataract, glaucoma.
- Heavy or irregular periods and male hair growth patterns in women, growth retardation in children, impotence.
- Nervous system disorders including headaches, which may or may not be associated with blurred vision or vomiting and mood changes, such as depression, irritability or euphoria.
If you experience these or any other undesirable effects, then tell your doctor or pharmacist as soon as possible.
How to store your medicine
- Do not store above 25°C.
- Do not take this medicine after the expiry date printed on the carton or blister strip.
- If your doctor decides to stop treatment, return any left over capsules to the pharmacist. Only keep them if the doctor tells you to.
PL 08637/0002
PA 573/2/1
Keep this medicine in a safe place. Keep out of reach and sight of children.
REMEMBER: This medicine is for you. Never give it to anyone else. It may harm them, even if their problems seem to be the same as yours.
Leaflet revised: October 2006
Dr Falk Pharma UK Ltd
Unit K
Bourne End Business Park
Cores End Road
Bourne End
Bucks
SL8 5AS
UK
‘Budenofalk’ is a registered trademark, the property of Dr Falk Pharma GmbH
Tuesday, 27 September 2016
Candesar
Candesar may be available in the countries listed below.
Ingredient matches for Candesar
Candesartan
Candesartan is reported as an ingredient of Candesar in the following countries:
- India
Candesartan cilexetil (a derivative of Candesartan) is reported as an ingredient of Candesar in the following countries:
- Myanmar
International Drug Name Search
Xolamol
Xolamol may be available in the countries listed below.
Ingredient matches for Xolamol
Dorzolamide
Dorzolamide hydrochloride (a derivative of Dorzolamide) is reported as an ingredient of Xolamol in the following countries:
- Oman
Timolol
Timolol maleate (a derivative of Timolol) is reported as an ingredient of Xolamol in the following countries:
- Oman
International Drug Name Search
Infanrix IPV
1. Name Of The Medicinal Product
Infanrix-IPV, suspension for injection in pre-filled syringe
Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)
2. Qualitative And Quantitative Composition
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Diphtheria toxoid1 | not less than 30 IU |
Tetanus toxoid1 | not less than 40 IU |
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Pertussis toxoid1 | 25 micrograms |
Filamentous Haemagglutinin1 | 25 micrograms |
Pertactin1 | 8 micrograms |
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3. Pharmaceutical Form
Suspension for injection in pre-filled syringe.
Infanrix-IPV is a turbid white suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
This vaccine is indicated for booster vaccination against diphtheria, tetanus, pertussis, and poliomyelitis diseases in individuals from 16 months to 13 years of age inclusive who have previously received primary immunisation series against these diseases.
The administration of Infanrix-IPV should be based on official recommendations.
4.2 Posology And Method Of Administration
Posology
A single dose of 0.5 ml should be administered.
Infanrix-IPV may be administered to subjects who have previously received whole cell or acellular pertussis-containing vaccines, and oral live attenuated or injected inactivated poliomyelitis vaccines. (See also sections 4.8 and 5.1).
Method of administration
The vaccine is for intramuscular injection, usually into the deltoid muscle. However, the anterolateral thigh may be used in very young subjects if preferred.
Do not administer intravascularly.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients or neomycin, polymyxin or formaldehyde.
Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, or polio vaccines.
Infanrix-IPV is contraindicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances pertussis vaccination should be discontinued and the vaccination should be continued with diphtheria-tetanus and polio vaccines.
As with other vaccines, administration of Infanrix-IPV should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection is not a contra-indication.
4.4 Special Warnings And Precautions For Use
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events). A family history of convulsions or a family history of Sudden Infant Death Syndrome (SIDS) does not constitute a contra-indication.
If any of the following events are known to have occurred in temporal relation to receipt of pertussis-containing vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered:
- temperature of
- collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination,
- persistent, inconsolable crying lasting
- convulsions with or without fever, occurring within 3 days of vaccination.
There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
As for any vaccination, the risk-benefit of immunising with Infanrix-IPV or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
Infanrix-IPV should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
HIV infection is not considered as a contra-indication. The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
For children under immunosuppressive treatment (corticosteroid therapy, antimitotic chemotherapy, etc.), it is recommended to postpone vaccination until the end of treatment.
Infanrix-IPV should under no circumstances be administered intravascularly.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Infanrix-IPV has been administered concomitantly with measles-mumps-rubella vaccine or Hib vaccine in clinical trials. The data available do not suggest any clinically relevant interference in the antibody response to each of the individual antigens.
Interaction studies have not been carried out with other vaccines, biological products or therapeutic medications. However, in accordance with commonly accepted immunisation guidelines, since Infanrix-IPV is an inactivated product, there is no theoretical reason why it should not be administered concomitantly with other vaccines or immunoglobulins at separate sites.
As with other vaccines it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency, a protective immune response to one or more antigens in the vaccine may not be achieved.
4.6 Pregnancy And Lactation
It is anticipated that Infanrix-IPV would only rarely be administered to subjects of child-bearing potential. Adequate human data on the use of Infanrix-IPV during pregnancy and lactation are not available and animal studies on reproductive toxicity have not been conducted. Consequently the use of this combined vaccine is not recommended during pregnancy. It is preferable to avoid the use of this vaccine during lactation.
4.7 Effects On Ability To Drive And Use Machines
It is anticipated that Infanrix-IPV would only rarely be administered to subjects who would be driving or using machines. However, somnolence, commonly reported after vaccination, may temporarily affect the ability to drive and use machines.
4.8 Undesirable Effects
• Clinical trials:
The safety profile presented below is based on data from more than 2200 subjects.
As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix-IPV with respect to the primary course.
Frequencies per dose are defined as follows:
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Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and lymphatic system disorders
Rare: lymphadenopathy
Nervous system disorders
Very common: somnolence, headache (age range 6-13 years old)
Respiratory, thoracic and mediastinal disorders
Rare: bronchitis1, cough1
Gastrointestinal disorders
Common: diarrhoea, vomiting, nausea
Skin and subcutaneous tissue disorders
Uncommon: dermatitis allergic, rash1
Rare: pruritus, urticaria
Metabolism and nutrition disorders
Very common: appetite lost
General disorders and administration site conditions
Very common: fever
Common: fever>39.5°C, malaise, injection site reactions including induration, asthenia
Psychiatric disorders
Very common: crying abnormal, irritability, restlessness
* Information on extensive swelling of the injected limb (defined as swelling with a diameter> 50 mm, noticeable diffuse swelling or noticeable increase of limb circumference) occurring after Infanrix-IPV was actively solicited in two clinical trials. When Infanrix-IPV was administered as either a fourth dose or a fifth dose of DTPa to children 4-6 years of age, extensive injection site swelling was reported with incidences of 13% and 25% respectively. The most frequent reactions were large, localised swelling (diameter> 50 mm) occurring around the injection site. A smaller percentage of children (3% and 6% respectively) experiences diffuse swelling of the injected limb, sometimes involving adjacent joint. In general, these reactions began within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae.
• Post marketing surveillance:
Blood and lymphatic system disorders
Thrombocytopenia2
Nervous system disorders:
Collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions (with or without fever) within 2 to 3 days of vaccination,
Respiratory, thoracic and mediastinal disorders
Apnoea1
Skin and subcutaneous tissue disorders
Angioneurotic oedema1
General disorders and administration site conditions
Injection site vesicles
Immune system disorders
Allergic reactions, including anaphylactic1 and anaphylactoid reactions
1reported with GSK's DTPa containing vaccines
2reported with D and T vaccines
4.9 Overdose
Cases of overdose have been reported during post-marketing surveillance. Adverse events, when reported, are not specific but similar to adverse events reported with normal vaccine administration.
5. Pharmacological Properties
Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code: J07CA02
5.1 Pharmacodynamic Properties
The immune response after booster vaccination with Infanrix-IPV was evaluated in 917 vaccinees. The immune response observed was independent of the number of doses and type of vaccines administered previously (DTPw or DTPa, OPV or IPV) as shown in the tables below.
One month after vaccination of children aged 15 to 26 months, the immune responses were the following:
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* These levels are considered to be protective
One month after vaccination of children aged 4-7 years, the immune responses were the following:
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* These levels are considered to be protective
One month after vaccination of children/adolescents aged 10-13 years, the immune responses were the following:
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* These levels are considered to be protective
After vaccination,
No serological correlate of protection has been defined for the pertussis antigens. The antibody titres to the three pertussis components were in all cases higher than those observed after primary vaccination with the paediatric acellular pertussis combination vaccine (DTPa, Infanrix™), for which efficacy has been demonstrated in a household contact efficacy study. Based on these comparisons, it can therefore be anticipated that Infanrix-IPV would provide protection against pertussis, although the degree and duration of protection afforded by the vaccine are undetermined.
5.2 Pharmacokinetic Properties
Evaluation of pharmacokinetic properties is not required for vaccines.
5.3 Preclinical Safety Data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, specific toxicity and compatibility of ingredients.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium chloride
Medium 199 (containing principally amino acids, mineral salts, vitamins)
Water for injections
For adjuvants, see section 2.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package, in order to protect from light.
6.5 Nature And Contents Of Container
0.5 ml of suspension for injection in a pre-filled syringe (type I glass) with plunger stopper (butyl) - pack sizes of 1, 10 or 20 with or without needles.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Upon storage, a white deposit and clear supernatant may be observed. This does not constitute a sign of deterioration.
The syringe should be well shaken in order to obtain a homogeneous turbid white suspension.
The suspension should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation Holder
SmithKline Beecham plc
Trading as:
GlaxoSmithKline UK
Stockley Park West, Uxbridge
Middlesex UB11 1BT
8. Marketing Authorisation Number(S)
PL 10592/0209
9. Date Of First Authorisation/Renewal Of The Authorisation
7 August 2006
10. Date Of Revision Of The Text
12 April 2010
Monday, 26 September 2016
Promeris Duo
Promeris Duo may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Promeris Duo
Amitraz
Amitraz is reported as an ingredient of Promeris Duo in the following countries:
- Finland
- France
- South Africa
- Sweden
Metaflumizone
Metaflumizone is reported as an ingredient of Promeris Duo in the following countries:
- Finland
- France
- South Africa
- Sweden
International Drug Name Search
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