bhpardo/ema_en · Datasets at Hugging Face

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Indinavir/ Tenofovir disoproxil fumarate (800 q8h/ 300 q. d.)
Solution for injection.
region of the eyelids and the lips (Quincke's oedema) and shock-like allergic reactions with symptoms of tingling, reddening, itching, hot flush and accelerated pulse.
NAME OF THE MEDICINAL PRODUCT
Medicinal product subject to medical prescription.
Non-specific skin rashes have been described in association with epoetin alfa.
10.
GENERAL CLASSIFICATION FOR SUPPLY
For intravenous use, single use administration only.
General disorders and administration site conditions:
Independent of erythropoietin treatment, thrombotic and vascular events may occur in surgical patients with underlying cardiovascular disease following repeated phlebotomy.
3.
Common side effects (which can occur in less than one in ten but in more than one in a hundred patients treated) are vomiting, abdominal pain, flatulence, tiredness, headache and rash.
Chest pain, Malaise, Sweating
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
A study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment resulted in increased Cmax (42%) and AUC(0-∞) (172%) and a modest (on average 23%) decrease in cortisol levels in patients compared to healthy subjects.
Aprovel 150 mg
In use cartridges Cartridges in use (in the insulin pen) may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light and must not be stored in a refrigerator. Do not use it after this time period.
7.
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dose adjustment is needed.
1 bottle
Resistance
The following related adverse reactions from clinical investigations were listed below by system organ class and in order of decreasing incidence (very common: ≥ 1/ 10; common: ≥ 1/ 100 to < 1/ 10; uncommon: ≥ 1/ 1,000 to < 1/ 100; rare: ≥ 1/ 10,000 to < 1/ 1,000; very rare: < 1/ 10,000), not known (cannot be estimated from the available data).
OTHER SPECIAL WARNING(S), IF NECESSARY
Cough, epistaxis exertional dyspnoea
7.
Aranesp 15 micrograms solution for injection in a pre-filled syringe.
Very common reported side effects (experienced in more than 1 in 10 patients) • Hypoglycaemia Hypoglycaemia (low blood sugars) means that there is not enough sugar in the blood.
Elimination:
1 mg) or as an oral solution (0.05 mg/ ml).
In clinical trials, at the recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to placebo.
Excipient:
6.1 List of excipients
PACKAGE LEAFLET
Österreich Amgen GmbH Tel: +43 (0) 1 50 217
Aerius 5 mg oral lyophilisate desloratadine
Dehydration SIADH Hypo-natremia
Special precautions in sickle cell disease
2.
Store in a refrigerator (2 °C – 8 °C).
Maintenance phase:
4.4 Special warnings and precautions for use
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Tell your doctor or pharmacist if you notice any of the side effects listed above or any other unwanted or unexpected effects.
Luxembourg/ Luxemburg sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00 (Belgique/ Belgien)
PHARMACEUTICAL FORM AND CONTENTS
For excipients, see section 6.1.
hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (e. g. methotrexate) as these combinations are not advisable,
Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Aranesp with a total of 2112 patients (Aranesp 1200, placebo 912).
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium- free”.
The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.
Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years.
Sepsis related to leukopaenia was observed infrequently (< 1%).
Paediatric patients: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).
5.
Then seek medical advice straight away.
6.
CELSENTRI 150 mg film-coated tablets maraviroc
2 modified-release tablets 4 modified-release tablets 7 modified-release tablets 10 modified-release tablets 14 modified-release tablets 20 modified-release tablets
56 tablets 70x1 tablets
In the studies of PI-experienced patients, PRO30017 (amprenavir 600 mg / ritonavir 100 mg twice daily in sub-study A and B with 80 and 37 patients respectively), the following mutations emerged in patients with virological failure:
The most common side effects with Atriance in adults (seen in more than 1 patient in 10) are infection, febrile neutropenia (low white blood cell counts with fever), neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), somnolence (sleepiness), peripheral neuropathy (damage to the nerves in the extremities), hypoesthesia (a reduced sense of touch), paresthesia (abnormal sensations), dizziness, headache, dyspnoea (breathlessness), cough, diarrhoea, vomiting, constipation, nausea (feeling sick), myalgia (muscle pain), oedema (swelling), pyrexia (fever), pain, fatigue (tiredness) and asthenia (weakness).
5.3 Preclinical safety data
Adult peritoneal dialysis patients:
Medicinal product subject to medical prescription.
LOT
10 pre-filled syringes with 0.8 ml
Common
Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ ml (0.5 - 1 µmol) with large interindividual variations.
Injection site pain
The activities of interferon beta-1b are species-restricted and therefore, the most pertinent pharmacological information on interferon beta-1b is derived from studies of human cells in culture or in human in vivo studies.
6 pre-filled syringes
Content
There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
Bridion is used to reverse the effect of the muscle relaxants rocuronium and vecuronium.
Marketing Authorisation Holder 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Common:
Suicidal thoughts and behaviours have been reported during aripiprazole treatment.
These measures will help to protect the environment.
APIDRA
Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.
Paediatric haemodialysis patients:
In case of administration by a non health care professional appropriate training is needed.
16.
4.
1 single use pre-filled syringe
If it occurs, appropriate dose adjustments should be made as provided.
Any unused product or waste material should be disposed of in accordance with local requirements
Therefore, in patients with renal anaemia the medicinal product has to be administered intravenously.
In studies performed in rats and rabbits no clinically relevant evidence of harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development was observed.
5.
4 D-85716 Unterschleißheim Tel: +49 89 31 701
4.5 Interactions with other medicinal products and other forms of interaction
Diarrhoea Hepatomegaly Alopecia, cutaneous vasculitis, injection site pain, rash
You should inject Betaferon into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 to 12 mm under the skin).
PHARMACEUTICAL FORM
Patients with high blood pressure The usual dose is 150 mg once a day.
One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.
Paroxetine/ Emtricitabine Paroxetine/ Tenofovir disoproxil fumarate
Blood and the lymphatic system disorders Immune system disorders Nervous system disorders Cardiac disorders

Indinavir/ Tenofovir disoproxil fumarate (800 q8h/ 300 q. d.)

Solution for injection.

region of the eyelids and the lips (Quincke's oedema) and shock-like allergic reactions with symptoms of tingling, reddening, itching, hot flush and accelerated pulse.

NAME OF THE MEDICINAL PRODUCT

Medicinal product subject to medical prescription.

Non-specific skin rashes have been described in association with epoetin alfa.

10.

GENERAL CLASSIFICATION FOR SUPPLY

For intravenous use, single use administration only.

General disorders and administration site conditions:

Independent of erythropoietin treatment, thrombotic and vascular events may occur in surgical patients with underlying cardiovascular disease following repeated phlebotomy.

3.

Common side effects (which can occur in less than one in ten but in more than one in a hundred patients treated) are vomiting, abdominal pain, flatulence, tiredness, headache and rash.

Chest pain, Malaise, Sweating

Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.

A study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment resulted in increased Cmax (42%) and AUC(0-∞) (172%) and a modest (on average 23%) decrease in cortisol levels in patients compared to healthy subjects.

Aprovel 150 mg

In use cartridges Cartridges in use (in the insulin pen) may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light and must not be stored in a refrigerator. Do not use it after this time period.

7.

In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dose adjustment is needed.

1 bottle

Resistance

The following related adverse reactions from clinical investigations were listed below by system organ class and in order of decreasing incidence (very common: ≥ 1/ 10; common: ≥ 1/ 100 to < 1/ 10; uncommon: ≥ 1/ 1,000 to < 1/ 100; rare: ≥ 1/ 10,000 to < 1/ 1,000; very rare: < 1/ 10,000), not known (cannot be estimated from the available data).

OTHER SPECIAL WARNING(S), IF NECESSARY

Cough, epistaxis exertional dyspnoea

7.

Aranesp 15 micrograms solution for injection in a pre-filled syringe.

Very common reported side effects (experienced in more than 1 in 10 patients) • Hypoglycaemia Hypoglycaemia (low blood sugars) means that there is not enough sugar in the blood.

Elimination:

1 mg) or as an oral solution (0.05 mg/ ml).

In clinical trials, at the recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to placebo.

Excipient:

6.1 List of excipients

PACKAGE LEAFLET

Österreich Amgen GmbH Tel: +43 (0) 1 50 217

Aerius 5 mg oral lyophilisate desloratadine

Dehydration SIADH Hypo-natremia

Special precautions in sickle cell disease

2.

Store in a refrigerator (2 °C – 8 °C).

Maintenance phase:

4.4 Special warnings and precautions for use

A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.

Tell your doctor or pharmacist if you notice any of the side effects listed above or any other unwanted or unexpected effects.

Luxembourg/ Luxemburg sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00 (Belgique/ Belgien)

PHARMACEUTICAL FORM AND CONTENTS

For excipients, see section 6.1.

hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (e. g. methotrexate) as these combinations are not advisable,

Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Aranesp with a total of 2112 patients (Aranesp 1200, placebo 912).

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium- free”.

The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.

Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years.

Sepsis related to leukopaenia was observed infrequently (< 1%).

Paediatric patients: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).

5.

Then seek medical advice straight away.

6.

CELSENTRI 150 mg film-coated tablets maraviroc

2 modified-release tablets 4 modified-release tablets 7 modified-release tablets 10 modified-release tablets 14 modified-release tablets 20 modified-release tablets

56 tablets 70x1 tablets

In the studies of PI-experienced patients, PRO30017 (amprenavir 600 mg / ritonavir 100 mg twice daily in sub-study A and B with 80 and 37 patients respectively), the following mutations emerged in patients with virological failure:

The most common side effects with Atriance in adults (seen in more than 1 patient in 10) are infection, febrile neutropenia (low white blood cell counts with fever), neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), somnolence (sleepiness), peripheral neuropathy (damage to the nerves in the extremities), hypoesthesia (a reduced sense of touch), paresthesia (abnormal sensations), dizziness, headache, dyspnoea (breathlessness), cough, diarrhoea, vomiting, constipation, nausea (feeling sick), myalgia (muscle pain), oedema (swelling), pyrexia (fever), pain, fatigue (tiredness) and asthenia (weakness).

5.3 Preclinical safety data

Adult peritoneal dialysis patients:

Medicinal product subject to medical prescription.

LOT

10 pre-filled syringes with 0.8 ml

Common

Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ ml (0.5 - 1 µmol) with large interindividual variations.

Injection site pain

The activities of interferon beta-1b are species-restricted and therefore, the most pertinent pharmacological information on interferon beta-1b is derived from studies of human cells in culture or in human in vivo studies.

6 pre-filled syringes

Content

There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.

Bridion is used to reverse the effect of the muscle relaxants rocuronium and vecuronium.

Marketing Authorisation Holder 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom

Common:

Suicidal thoughts and behaviours have been reported during aripiprazole treatment.

These measures will help to protect the environment.

APIDRA

Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.

Paediatric haemodialysis patients:

In case of administration by a non health care professional appropriate training is needed.

16.

4.

1 single use pre-filled syringe

If it occurs, appropriate dose adjustments should be made as provided.

Any unused product or waste material should be disposed of in accordance with local requirements

Therefore, in patients with renal anaemia the medicinal product has to be administered intravenously.

In studies performed in rats and rabbits no clinically relevant evidence of harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development was observed.

5.

4 D-85716 Unterschleißheim Tel: +49 89 31 701

4.5 Interactions with other medicinal products and other forms of interaction

Diarrhoea Hepatomegaly Alopecia, cutaneous vasculitis, injection site pain, rash

You should inject Betaferon into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 to 12 mm under the skin).

PHARMACEUTICAL FORM

Patients with high blood pressure The usual dose is 150 mg once a day.

One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.

Paroxetine/ Emtricitabine Paroxetine/ Tenofovir disoproxil fumarate

Blood and the lymphatic system disorders Immune system disorders Nervous system disorders Cardiac disorders