bhpardo/ema_en · Datasets at Hugging Face

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However, its safety profile is to be closely monitored for the following reasons:
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
Relapsing Remitting
The effect of renal or hepatic dysfunction on the disposition of paclitaxel has not been formally investigated.
Patients who stopped smoking by Week 12 were then randomized to receive either CHAMPIX (1 mg twice daily) or placebo for an additional 12 weeks for a total study duration of 52 weeks.
and part of
Female rats receiving duloxetine before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
2 (0.7)
149
Read the package leaflet before use.
The adverse reactions are listed by system organ class (SOC) and frequency.
What Aerius contains
7.
Manufacturer:
• if you previously had a serious allergic reaction (i. e. life-threatening) to CELVAPAN. • if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine.
AZILECT can only be obtained with a prescription.
Adjusted recovery and terminal half-life (t1/ 2) was approximately 20% lower in young children (less than 6 years of age) than in adults, which may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Common side effects (occurs in less than 1 in 10 people but more than 1 in 100 people who use the medicine) • Loss of appetite • Difficulty in sleeping (insomnia) • Feeling your own heart beat (palpitations) • Nasal congestion • Vomiting, upper abdominal pain and dry mouth • Abnormal redness of the skin (erythema), increased sweating, night sweats and itching (pruritus) • Pain in limbs and back pain • Hives, bruising, rash and swelling at the injection site, weakness and chest pain
OTHER SPECIAL WARNING(S), IF NECESSARY
Dose increases must not be made more frequently than once every four weeks.
It is converted by thrombin/ thrombomodulin-complex on the endothelial surface to activated protein C (APC).
Renal impairment:
Red iron oxide (E172)
In a 26-week repeated dose toxicity study in rhesus monkeys by intramuscular route once per week, administered in combination with another immunomodulating agent, an anti CD40 ligand monoclonal antibody, no immune response toward interferon beta-1a and no signs of toxicity were demonstrated.
Distribution and elimination In man, the disposition of tacrolimus after intravenous infusion may be described as biphasic.
SPECIAL STORAGE CONDITIONS
Most episodes of nausea were mild to moderate and occurred in a dose-dependent fashion.
1.
Experience with Betaferon in patients with MS is limited, consequently those adverse events which occur very rarely may not yet have been observed.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
The analysis of plasma samples was conducted in a central laboratory using a one-stage clotting assay.
Immediately after delivery, insulin requirements decline rapidly.
4.7 Effects on ability to drive and use machines
A forgotten morning dose should be taken as soon as possible on the same day.
Investigations
Common side effects (occurs in less than 1 in 10 people but more than 1 in 100 people who use the medicine) • Sensation of spinning (vertigo) • Your body does not make enough thyroxine, a body chemical called a hormone (hypothyroidism) • Decrease in the number of red blood cells (anaemia) • Dehydration • Depression • Tingling, prickling or numbness of the skin (paraesthesis) • Hot flushes • Wheezing • Constipation, swollen stomach, inflamed mouth • Pain and formation of extra tissue in the skin around the injection site
Irbesartan is excreted in the milk of lactating rats.
Aerius has also been studied in 416 patients with urticaria.
PHARMACOLOGICAL PROPERTIES
Reduction in haemoglobin and platelets were less frequently (< 5%) reported.
4.1 Therapeutic indications
Common Common Common Common Common
General disorders and administration site conditions very common: pain, redness, fatigue common: swelling, fever
In both studies, CHAMPIX was more effective than bupropion or placebo in helping patients to stop smoking.
4.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Caution should be exercised when prescribing to pregnant women.
Problems with your small blood vessels (capillaries) may develop when using medicines like Betaferon (systemic capillary leak syndrome).
Rue de l’ Institut 89 1330 Rixensart Belgium
Driving and using machines
PHARMACEUTICAL FORM AND CONTENTS
Tablet
DATE OF REVISION OF THE TEXT
The treatment is divided into two stages:
Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
Keep out of the reach and sight of children.
Frequency
Data presented from controlled studies included 1357 patients, 766 who received Aranesp and 591 patients who received r-HuEPO.
The amount indicated on the injection button is lower than the dose selected
Depression, suicidal ideation and behaviour Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
Relative risk reduction of clinical
1 bottle with 1 oral syringe
Thrombotic events can be a risk in this population and this possibility should be carefully weighed against the benefit to be derived from the treatment in this patient group.
Try to take the ABILIFY tablet at the same time each day.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.
It is available as a 5 mg tablet, a 5 mg oral lyophilisate (dispersible tablet), 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ ml syrup and a 0.5 mg/ ml oral solution.
APTIVUS should be prescribed by physicians who are experienced in the treatment of HIV-1 infection.
The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia) and injection site reactions, which is mainly due to the pharmacological effects of the medicinal product and injection site reactions.
100% of previous dose
By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase:
Check with your doctor or pharmacist if you are not sure.
10.
4.6 Pregnancy and lactation
Nasal spray suspension
Invented name
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Bristol-Myers Squibb S. r. l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy
NAME OF THE MEDICINAL PRODUCT
Amprenavir is 14% less bioavailable from the Agenerase oral solution than from the capsules; therefore, Agenerase capsules and Agenerase oral solution are not interchangeable on a milligram per milligram basis (see section 5.2).
In all patients receiving epoetin alfa, blood pressure should be closely monitored and controlled as necessary.
Immune system disorders
pre-filled syringe (glass)
S.A.
If you switch from another insulin to insulin glulisine, your dosage may have to be adjusted by your doctor.
15.
Remove and discard the needle
However, in one study triglycerides tended to increased more when Cholestagel was given as a single dose with breakfast.
How to store alli 6.
Nelarabine is a pro-drug of the deoxyguanosine analogue ara-G.
Pull dose knob out until it stops and the
Each ml of solution contains 50 mg of sorbitol.
Therefore, in some cases an adjustment of the dose
EXP After opening:
In small children this can be 4 to 6 times per day.
BATCH NUMBER
BATCH NUMBER
Uncommon * palmar-plantar erythrodysesthesia (Hand- foot syndrome).
2/ 2
5.3 Preclinical safety data
The safety and effectiveness of Adenuric have not been studied in patients with severe kidney or liver problems.

However, its safety profile is to be closely monitored for the following reasons:

- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please

Relapsing Remitting

The effect of renal or hepatic dysfunction on the disposition of paclitaxel has not been formally investigated.

Patients who stopped smoking by Week 12 were then randomized to receive either CHAMPIX (1 mg twice daily) or placebo for an additional 12 weeks for a total study duration of 52 weeks.

and part of

Female rats receiving duloxetine before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).

2 (0.7)

149

Read the package leaflet before use.

The adverse reactions are listed by system organ class (SOC) and frequency.

What Aerius contains

7.

Manufacturer:

• if you previously had a serious allergic reaction (i. e. life-threatening) to CELVAPAN. • if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine.

AZILECT can only be obtained with a prescription.

Adjusted recovery and terminal half-life (t1/ 2) was approximately 20% lower in young children (less than 6 years of age) than in adults, which may be due in part to the known higher plasma volume per kilogram body weight in younger patients.

Common side effects (occurs in less than 1 in 10 people but more than 1 in 100 people who use the medicine) • Loss of appetite • Difficulty in sleeping (insomnia) • Feeling your own heart beat (palpitations) • Nasal congestion • Vomiting, upper abdominal pain and dry mouth • Abnormal redness of the skin (erythema), increased sweating, night sweats and itching (pruritus) • Pain in limbs and back pain • Hives, bruising, rash and swelling at the injection site, weakness and chest pain

OTHER SPECIAL WARNING(S), IF NECESSARY

Dose increases must not be made more frequently than once every four weeks.

It is converted by thrombin/ thrombomodulin-complex on the endothelial surface to activated protein C (APC).

Renal impairment:

Red iron oxide (E172)

In a 26-week repeated dose toxicity study in rhesus monkeys by intramuscular route once per week, administered in combination with another immunomodulating agent, an anti CD40 ligand monoclonal antibody, no immune response toward interferon beta-1a and no signs of toxicity were demonstrated.

Distribution and elimination In man, the disposition of tacrolimus after intravenous infusion may be described as biphasic.

SPECIAL STORAGE CONDITIONS

Most episodes of nausea were mild to moderate and occurred in a dose-dependent fashion.

1.

Experience with Betaferon in patients with MS is limited, consequently those adverse events which occur very rarely may not yet have been observed.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

The analysis of plasma samples was conducted in a central laboratory using a one-stage clotting assay.

Immediately after delivery, insulin requirements decline rapidly.

4.7 Effects on ability to drive and use machines

A forgotten morning dose should be taken as soon as possible on the same day.

Investigations

Common side effects (occurs in less than 1 in 10 people but more than 1 in 100 people who use the medicine) • Sensation of spinning (vertigo) • Your body does not make enough thyroxine, a body chemical called a hormone (hypothyroidism) • Decrease in the number of red blood cells (anaemia) • Dehydration • Depression • Tingling, prickling or numbness of the skin (paraesthesis) • Hot flushes • Wheezing • Constipation, swollen stomach, inflamed mouth • Pain and formation of extra tissue in the skin around the injection site

Irbesartan is excreted in the milk of lactating rats.

Aerius has also been studied in 416 patients with urticaria.

PHARMACOLOGICAL PROPERTIES

Reduction in haemoglobin and platelets were less frequently (< 5%) reported.

4.1 Therapeutic indications

Common Common Common Common Common

General disorders and administration site conditions very common: pain, redness, fatigue common: swelling, fever

In both studies, CHAMPIX was more effective than bupropion or placebo in helping patients to stop smoking.

4.

CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Caution should be exercised when prescribing to pregnant women.

Problems with your small blood vessels (capillaries) may develop when using medicines like Betaferon (systemic capillary leak syndrome).

Rue de l’ Institut 89 1330 Rixensart Belgium

Driving and using machines

PHARMACEUTICAL FORM AND CONTENTS

Tablet

DATE OF REVISION OF THE TEXT

The treatment is divided into two stages:

Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:

Keep out of the reach and sight of children.

Frequency

Data presented from controlled studies included 1357 patients, 766 who received Aranesp and 591 patients who received r-HuEPO.

The amount indicated on the injection button is lower than the dose selected

Depression, suicidal ideation and behaviour Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.

Relative risk reduction of clinical

1 bottle with 1 oral syringe

Thrombotic events can be a risk in this population and this possibility should be carefully weighed against the benefit to be derived from the treatment in this patient group.

Try to take the ABILIFY tablet at the same time each day.

If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.

It is available as a 5 mg tablet, a 5 mg oral lyophilisate (dispersible tablet), 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ ml syrup and a 0.5 mg/ ml oral solution.

APTIVUS should be prescribed by physicians who are experienced in the treatment of HIV-1 infection.

The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia) and injection site reactions, which is mainly due to the pharmacological effects of the medicinal product and injection site reactions.

100% of previous dose

By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase:

Check with your doctor or pharmacist if you are not sure.

10.

4.6 Pregnancy and lactation

Nasal spray suspension

Invented name

Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.

Bristol-Myers Squibb S. r. l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy

NAME OF THE MEDICINAL PRODUCT

Amprenavir is 14% less bioavailable from the Agenerase oral solution than from the capsules; therefore, Agenerase capsules and Agenerase oral solution are not interchangeable on a milligram per milligram basis (see section 5.2).

In all patients receiving epoetin alfa, blood pressure should be closely monitored and controlled as necessary.

Immune system disorders

pre-filled syringe (glass)

S.A.

If you switch from another insulin to insulin glulisine, your dosage may have to be adjusted by your doctor.

15.

Remove and discard the needle

However, in one study triglycerides tended to increased more when Cholestagel was given as a single dose with breakfast.

How to store alli 6.

Nelarabine is a pro-drug of the deoxyguanosine analogue ara-G.

Pull dose knob out until it stops and the

Each ml of solution contains 50 mg of sorbitol.

Therefore, in some cases an adjustment of the dose

EXP After opening:

In small children this can be 4 to 6 times per day.

BATCH NUMBER

Uncommon * palmar-plantar erythrodysesthesia (Hand- foot syndrome).

2/ 2

5.3 Preclinical safety data

The safety and effectiveness of Adenuric have not been studied in patients with severe kidney or liver problems.